Management of Breast Cancer in Women (a National Clinical Guideline)

7/30/2019 Management of Breast Cancer in Women (a National Clinical Guideline)

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ManagementofbreastcancerinwomenA national clinical guideline

1 Introction 1

2 diagnosis,referraaninvestigation 2

3 Srger 7

4 Raioterap 13

5 Sstemicterap 16

6 Pscoogicacare 24

7 Foowp 29

8 Informationforiscssionwitpatientsancarers 31

9 deveopmentoftegieine 35

10 Impementationanait 38

Abbreviations 40

Annexes 41

References 44

december2005

84

COPIESOFAllSIGNGuIdElINESAREAVAIlABlEONlINEATWWW.SIGN.AC.uk

Scottish Intercollegiate Guidelines Network

SIGN


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kEyTOEVIdENCESTATEMENTSANdGRAdESOFRECOMMENdATIONS

lEVElSOFEVIdENCE

1++ High quality meta-analyses, systematic reviews of randomised controlled trials(RCTs), or RCTs with a very low risk of bias

1+ Well conducted meta-analyses, systematic reviews of RCTs, or RCTs with a lowrisk of bias

1-

Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias2++ High quality systematic reviews of case control or cohort studies

High quality case control or cohort studies with a very low risk of confounding orbias and a high robability that the relationshi is causal

2+ Well conducted case control or cohort studies with a low risk of confounding orbias and a moderate robability that the relationshi is causal

2 - Case control or cohort studies with a high risk of confounding or bias andasignifcantriskthattherelationshipisnotcausal

3 Non-analytic studies, eg case reorts, case series

4 Exert oinion

GRADES OF RECOMMENDATION

Note: The grade of recommendation relates to the strength of the evidence on which therecommendation is based. It does not reect the clinical importance of the recommendation.

A At least one meta-analysis, systematic review of RCTs, or RCT rated as 1++

and directly alicable to the target oulation; or

A body of evidence consisting rincially of studies rated as 1+, directly alicableto the target oulation, and demonstrating overall consistency of results

B A body of evidence including studies rated as 2++, directly alicable to the target

oulation, and demonstrating overall consistency of results; orExtraolated evidence from studies rated as 1++ or 1+

C A body of evidence including studies rated as 2+, directly alicable to the targetoulation and demonstrating overall consistency of results; or

Extraolated evidence from studies rated as 2++

d Evidence level 3 or 4; or

Extraolated evidence from studies rated as 2+

Verbatim extract from SIGN 29 ublished in 1998. This material covers areas that were not

udated in the current version of the guideline.

GOOD pRACTICE pOINTS

Recommended best ractice based on the clinical exerience of the guidelinedeveloment grou

Thisdocumentisproducedfromelementalchlorine-freematerialandissourcedfromsustainableforests

Scottish Intercollegiate Guidelines NetworkISBN1899893342First ublished 2005

SIGN consents to the hotocoying of this guideline for the urose of imlementation in NHSScotland

ScottisIntercoegiateGieinesNetwor,28TisteStreet,EinbrgEh21ENwww.sign.ac.


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1 INTRODUCTION

1 Introduction

1.1 The NeeD fOR a gUIDelINe

Breast cancer in wen represents a signicant heath prbe because f the nubers findiiduas affected b this disease. Thirt percent f a cancers in wen ccur in the breastaing it the st cn diagnsed feae cancer. Fie ear incidence in Sctand is116 per 100,000 in wen, with er 3,600 wen new diagnsed with breast cancer in2002. 80% f breast cancers ccur in pstenpausa wen. Despite the fact that breastcancer is ne f the best-researched areas in edicine, there reain signicant gaps in thepubished eidence t ied answers t the questins that are iprtant t patients and heathprfessinas.

1.2 RemIT Of The gUIDelINe

Since the pubicatin f Breast Cancer in Wen, SIGN guideine 29, in 19982 there hae beennew data pubished t update recendatins in seera areas such as pschgica issues,surger, raditherap techniques, and ssteic treatents. This new guideine, which repacesSIGN 29, fcuses attentin n the eidence t supprt practices in the re cntrersia areas(see section 1.5), as it is ften in these that there is the greatest ariatin in practice.

1.3 key qUesTIONs

The infratin in this guideine was btained fr iterature searches cnducted t answer equestins in ine with current SIGN ethdg.3 The e questins used in this guideineare isted in annex 1. The ethd f eidence searching eant that nt a the tpics fr theast breast cancer guideine, SIGN 29, cud be reiewed. Saient recendatins fr SIGN29 hae been incuded, t pride a dcuent that is usefu t thse wh want guidance na wide range f aspects f breast cancer treatent.

1.4 sTaTemeNT Of INTeNT

This guideine is nt intended t be cnstrued r t sere as a standard f care. Standardsf care are deterined n the basis f a cinica data aaiabe fr an indiidua case andare subect t change as scientic nwedge and techng adance and patterns f careee. Adherence t guideine recendatins wi nt ensure a successfu utce ineer case, nr shud the be cnstrued as incuding a prper ethds f care r excudingther acceptabe ethds f care aied at the sae resuts. The utiate udgeent ust beade b the apprpriate heathcare prfessina(s) respnsibe fr cinica decisins regardinga particuar cinica prcedure r treatent pan. This udgeent shud n be arried atfwing discussin f the ptins with the patient, cering the diagnstic and treatent

chices aaiabe. Hweer, it is adised that signicant departures fr the natina guideiner an ca guideines deried fr it shud be fu dcuented in the patients case ntesat the tie the reeant decisin is taen.

1.5 RevIew aND UpDaTINg

This guideine was issued in 2005 and wi be cnsidered fr reiew in three ears. An updatest the guideine in the interi perid wi be nted n the SIGN website: .in.c.u

Odr rcondtion tn dirct ro sIgN 29 r cr rd it sIgN29 bo nd rn ont. It oud b rbrd tt t odr rcondtion not bn dod it t riour o currnt sIgN todoo nd t idnc

on ic t r bd bn urdd.


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maNagemeNT Of BReasT CaNCeR IN wOmeN

+

2 Dinoi, rrr nd intition

2.1 INTRODUCTION

This sectin addresses the specic triggers which shud prpt referra t a breast cinic(section 2.2.1); deas fr diagnsis t treatent which a affect patient utce (section2.2.2) and eidence fr the st effectie ethd f diagnsing sptatic breast cancer(section 2.3).

Wen aged 5070 ears are inited eer three ears fr screening thrugh the NHS BreastScreening Prgrae (NHSBSP).4 Wen er the age f 70 ears are encuraged t cntinuet attend eer three ears athugh the are nt rutine inited. Wen shud be encuragedb the priar care tea t participate in the prgrae. 5

The anageent f indiiduas at an increased genetic ris f suffering fr breast cancerhas been addressed b the NICE guideine n faiia breast cancer.6 Eidence reating t theincreased ris f breast cancer in wen treated with raditherap fr Hdgins Disease isaaiabe in the SIGN guideine n ng ter fw up f surirs f chidhd cancer. 7

There is eidence that breast sef exainatin des nt reduce rbidit r rtait fr breastcancer.8,9 Hweer, since the arit f breast cancers are fund b wen thesees, sefexainatin ptiises the chances f a wan nding a change fr nra. 0

C won oud b ncourd to bco r o t nd o tir brt, ott t r iir it t i nor or t.

C won oud b ncourd to rort n cn ro nor to tir nrrctitionr.

2.1.1 STAFFING

RadiographersRadigraphers perfring agraph shud hae undertaen the pstgraduate ee cursen agraph, and shud attend reguar curses fr updates n the technique.

Radiologists

Radigists with apprpriate training, a specia interest in breast disease and an apprpriatewrad shud be part f the utidiscipinar tea.

Radigists shud be perfring at east ne sessin f breast wr per wee and reprtingat east 500 agras per ear and, idea, shud be ined in bth screening andsptatic serices. The shud as be abe t perfr breast utrasund and breastinterentin prcedures.

Screening radigists shud read apprxiate 5,000 agras per ear, participate inassessent cinics and hae their wr reguar audited.

2.1.2 RADIATIoN RISk FRom mAmmoGRAPHy

It is thught that inising radiatin increases the ris f breast cancer deepent after aatent perid f 10 ears, that the ris is cuuatie, and that the ris is greatest fr adescentexpsure and decreases with increasing age at expsure.2 In thse aged er 50, the risf cancer inductin is, er apprxiate, 1:100,000 per singe iew exainatin.13-17 Theaerage dse per exainatin (singe iew per breast) is apprxiate 2 G, the dse beingdependent n breast thicness and expsure factrs used.6


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2 DIagNOsIs, RefeRRal aND INvesTIgaTION

2.2 DIagNOsINg BReasT CaNCeR

2.2.1 TRIGGERS FoR PRomPT REFERRAl To A BREAST ClINIC

There is iited pubished eidence n the signs and spts st ie t be assciated

with the diagnsis f breast cancer.

18,19

The Scttish Cancer Grup has prduced guidance20 n criteria fr referra based n theGuideines fr Referra f Patients with Breast Prbes8 and incrprating wr dne b theNHS Breast Screening Prgrae and the Cancer Research Capaign (see Table 1).

Se wen with breast spts can be anaged initia b their genera practitiner(GP), as isted in Tabe 1.

Referra fr priar t speciaist care shud be ade in accrdance with theScttish Cancer Grup referra guideine.

Table 1: Scottish Cancer Group Referral Guideline

sourc orob

wo to rr wo to n in rir cr

lUmp wen with an new discrete up

wen with an new up in pre-existing nduarit

wen with an new asetrica nduarit that persistsat reiew after enstruatin

wen with a nn actatina abscess r astitis whichdes nt sette after ne curse f antibitics

abscess in patient >40 ears een after setted (fragra)

wen with an cst persistent reing r recurrent cst

wen with uniatera axiar ph nde up

ung wen 40 with abscess r inaatin een aftersetted t excude undering cause (agra)

wen with bius sipe sinesins, eg sebaceus csts shud beanaged as when present esewhereand nt referred t a breast cinic


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2++

3

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2.2.2 EFFECT oF DElAyS FRom DIAGNoSIS To TREATmENT

N eidence was identied that deas f ess than three nths hae an effect n suria.

There is se eidence fr an aderse effect f deas in referra f between three t six nths.This eidence incudes deas fr rst spts t treatent as we as deas fr seeing

a prfessina t treatent.2

2.3 INvesTIgaTION Of sympTOmaTIC BReasT CaNCeR

methds f assessent f a breast abnrait incude cinica exainatin, iaging andsaping the esin with a neede fr ctgica/histgica assessent (ne neede aspiratectg; FNAC, r cre bips). These three inestigatins cectie cprise tripeassessent.

There is eidence that tripe assessent prides re accurate diagnses than a saernuber f tests. 22

B a tint oud u cinic intion.

B wr ocid bnorit i rnt, tint oud iin uu ood byneneedleaspiratecytologyor cor bio.

B a ion conidrd innt ooin cinic intion, iin or ctoo on should,wherepossible,havehistopathologicalconrmationofmalignancybeforeany denitivesurgicalproceduretakesplace (eg mastectomy or axillary clearance).

There is eidence that a ne-stp sptatic breast cinic prides an accurate and effectieeans f estabishing a crrect diagnsis in wen referred with breast spts. A ne-stp,utidiscipinar cinic wi usua ine breast cinicians, radigists and ctgists. 23

D ptint oud b n t on-to, utidiciinr cinic inoin brt cinicin,

rdiooit nd ctoo.

Patients attending fr diagnstic purpses shud be seen b a cinician with specia trainingin breast diseases (cnsutant surgen, breast phsician r staff grade surgen with speciatraining in breast diseases) r a senir trainee in breast surger. Higher surgica trainees shudn gie unsuperised pinins in breast diagnstic cinics when udged cpetent t d sb the superising cnsutant.

Breast care nurses with apprpriate training are part f the cinica tea. Gd cunicatinbetween the hspita and priar care teas is essentia. The GP shud be infred f theanageent pan after the initia isit, and at the tie f discharge shud be sent data basedn the iediate discharge dcuent issued b SIGN.24

C Cr in o couniction oud b intind btn t rir cr t ndt in t brt unit.

C T gp oud b d r o t inortion in to t tint nd rti.

There is se eidence that wen diagnsed with breast cancer at a ne-stp cinic are atgreater ris f aderse pschgica sequeae than wen attending re than nce. onestud denstrated this effect n in wen with cnred aignant disease eight weesafter diagnsis,25 and a secnd stud shwed a siiar deaed effect but did nt present datab aignant r benign diagnsis.26

a pcooic uort oud b ib to on dinod it brt cncr t tcinic.


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It is cnsidered gd practice fr patients, under the anageent f breast phsicians and theirceagues, t hae their case discussed at a utidiscipinar cinic-pathgica eeting

Patients in wh the tripe assessent has nt excuded cancer shud hae their casediscussed at a utidiscipinar eeting ining speciaists fr surger, nursing,

pathg, ncg and iaging.

Units nra seeing at east 100 new cases f cancer per annu shud be abe t aintaintheir expertise. In areas where the densit f ppuatin is w and hence the nuber f newcancers seen is w, fra cabratie ins with adacent arger units/centres shud giepatients access t a necessar faciities as we as heping t aintain expertise in the saerunit.

C Cntr nd unit oud do n intrtd ntor o cncr cr uin cooncinic uidin, nnt rotoco nd trti o cr.

2.3.1 ImAGING oF SymPTomATIC DISEASE

magnetic resnance iaging (mRI) has been shwn t be hepfu in patients with breast ipantswh hae deeped spts where utrasund has nt been diagnstic. Patients withsuspected recurrent disease in the cnsered breast a benet fr mRI if agraph,utrasund and ctg hae been unhepfu.27-29 mRI a as be hepfu in wen withetastatic depsits in axiar ndes where n priar cancer has been identied. 30-33

Table 2: Summary of investigations

Intition

magraph must be perfred as a part f tripe assessent - cannt beused ane t excude breast cancer. magraph is ntrecended under the age f 35 uness there is a strngcinica suspicin f carcina.34-39

Utrasund ma pride additina infratin t agraph. Canbe usefu fr fca breast disease in wen under 35 ears. 40

magnetic Resnance Hepfu in sptatic patients with ipants, whereIaging (mRI) utrasund resuts hae nt been diagnstic. ma be hepfu

in wen with etastatic depsits in axiar ndes wheren priar cancer has been identied.27-29

B In tint it totic di to-i or oud b rord rt o tri nt (clinical assessment, imaging and tissue sampling) in dintdbrt cinic.

B mor i not rcondd in on undr t o 35 r un tr i tron uicion o crcino.

C Magneticresonanceimagingshouldbeconsideredinspecicclinicalsituationswhereotr iin oditi r not rib, or bn inconcui, nd r trr indiction tt mRI i uu.

2 DIagNOsIs, RefeRRal aND INvesTIgaTION


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2.3.2 STAGING oF BREAST CANCER

In ear perabe breast cancer (T1-2, N0-1; see annex 2), there is n current eidence t supprtrutine screening fr etastatic disease in asptatic wen. Patients with sptssuggestie f etastases at a particuar site d require apprpriate inestigatin. The incidencef asptatic etastases increases as the T and N stage f the cregina cancer increases.If it wi affect treatent, patients with re adanced but perabe disease (T3, N1-2), arequire staging t excude distant etastases.

2.3.3 PATHoloGICAl EXAmINATIoN oF THE BIoPSy

The use f specien radigraphs is necessar in the pathg departent t aw histgicaexainatin f the apprpriate prtin f the bips specien and t cnr excisin f theagraphic esin.4


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3 surr

3.1 CONseRvaTION sURgeRy veRsUs masTeCTOmy

There are tw we estabished surgica prcedures fr ca treatent f inasie breastcancer:

cnseratin surger which ines rea f the tuur with a ri f surrundingnra breast tissue with retentin f the breast

astect

A cases f inasie breast cancer shud hae an axiar prcedure (see section 3.3).

one rbust eidence based guideine recends:42

wen with priar perabe inasie breast cancer, wh are candidates fr cnseratinsurger shud be ffered the chice f breast cnseratin surger r died radicaastect;

the chice is an indiidua ne fr the patient. Patients shud be fu infred f theptins incuding the riss and benets f each prcedure, that breast irradiatin is part f theprcedure fr breast cnsering surger, and shud be aware f the ptentia need frfurther surger if the argins are psitie.

The updated mian cnseratin tria cpared the efcac f radica astect with that fbreast cnseratin surger pus raditherap in 701 wen (349 astect, 352 cnseratin)er 20 ears.43 The resuts shwed an increase in ca recurrence in the cnseratin grup(crude cuuatie incidence f 8.8% ersus 2.3% after 20 ears). There was n difference inthe ng ter suria between the tw grups. At a edian fw up f 20 ears death fr acauses was 41.7% in the cnsered grup ersus 41.2% in the astect grup. Death frbreast cancer was 26.1% and 24.3% respectie. The stud cncudes that breast-cnseringsurger is the treatent f chice in wen with reatie sa breast cancers.

A tria cnducted b the Natina Surgica Aduant Breast and Bwe Prect (NSABP) Grup44cpared the efcac f astect against cnseratin with r withut raditherap. Thetria, ining 1851 wen, nted an increase in ca recurrence if raditherap was ittedfwing cnseratin. There was n signicant difference between disease-free suria, distantdisease-free suria and era suria between the three grups. Radiatin therap wasassciated with a sight decrease in deaths due t breast cancer. This was ffset b an increasein deaths fr ther causes. This increase a hae been the resut f use f der raditheraptechniques. The stud cncuded that upect and irradiatin is an apprpriate therap frwen with breast cancer, prided that the argins f the resected specien are free frtuur and an acceptabe csetic resut can be btained.

The Eurpean organisatin fr Research and Treatent f Cancer (EoRTC) tria45 compareddied radica astect with breast cnsering surger and cpared quait f ifebetween the tw grups, with 278 patients cpeting quait f ife questinnaires at twears. The cnseratin grup shwed a signicant benet in bd iage and satisfactin.There was n signicant difference with respect t fear f recurrence.

Seera randised cntred trias (RCTs) hae cpared the additin/issin f raditherapfwing cnseratin surger. The mian grup cncuded that raditherap is necessar ina wen up t the age f 55, ptina in wen aged 55-65 with negatie ndes and abe aided in wen er 65 ears.46 The ndings reate t quadrantect where the rissf ca recurrence are wer, reecting the uch arger argin f nra tissue resected. mstUk surgens perfr uch re cnseratie surger with narrwer argins. Anther studadised that raditherap is necessar in a cases, een when there are faurabe prgnsticfeatures.47 An update f the NSABP B-06 tria cncuded that n cinica r pathgica features

aw fr the issin f raditherap fwing cnseratin surger.

48

Breast cnsering surger requires the cpete excisin f the tuur with cear argins andan acceptabe csetic resut fwing excisin and raditherap.

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a a on it r t ini brt cncr o r cndidt or brtconrin urr oud b ord t coic o brt conrin urr (excisionof tumour with clear margins)ormodiedradicalmastectomy.

a T coic o urr ut b tiord to t indiidu tint, o oud b u

inord o t otion nd o oud b r tt brt irrdition i ruirdooin conrtion nd tt urtr urr b ruird i t rin roiti.

C Brt conrin urr i contrindictd i:

t rtio o t iz o t tuour to t iz o t brt oud not rut incctb coi

tr i utioc di or tni innt icrocciiction onor

tr i contrindiction to oc rdiotr (eg previous radiotherapy at this site,connective tissue disease, severe heart and lung disease, pregnancy).

C Cntr itution o t tuour i not contrindiction to conrtion, tou it ruir ciion o t ni nd ro, ic coroi coi.

3.2 BReasT ReCONsTRUCTION afTeR masTeCTOmy

Breast recnstructin des nt appear t be assciated with an increase in the rate f cacancer recurrence, nr t ipede the abiit t detect recurrence if it deeps49 and can iedpschgica benet.50

Breast recnstructin a be perfred either at the tie f astect r as a deaedprcedure. Iediate recnstructin has been reprted t prduce better csetic resuts.51The pschscia effects f breast recnstructin, and the reatie erits f iediate anddeaed surger, hae nt been adequate studied.

The chice f peratin fr an indiidua patient depends n seera factrs incuding breastsie, the adequac f sin aps and whether raditherap is panned r has been preiusused. Surger t the ppsite breast a be required t achiee setr. Techniques frrecnstructin f the nippe/area cpex hae been described.49,52,53 Aternatie acceptabenippe prstheses a be ade b taing a ud fr the existing nippe.53

Siicne ipants are current icensed in the United kingd fr breast recnstructin.Despite se aderse pubicit there is n eidence that siicne prstheses are assciatedwith signicant ssteic prbes.54

The surgen perfring the recnstructin shud be fu trained in a the apprpriatetechniques and in st units, wi be a pastic surgen. Patients wh are being prepared fra astect shud be infred f the ptin f recnstructin and, if apprpriate, shud

discuss the ptins with a surgen trained in recnstructie techniques, prir t their surger.

C T oibiit o brt rcontruction oud b dicud it tint rior totcto.

3.3 sURgICal maNagemeNT Of The axIlla

Spread f etastatic disease t axiar ndes is the st signicant prgnstic indicatr andis used as ne f the ar deterinants f apprpriate ssteic aduant therap.55,56 Axiarsurger is necessar fr adequate staging and treatent f inasie breast carcina. Axiarcearance as seres t treat etastatic disease b surgica reing it fr the inedaxia.


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3 sURgeRy

There is se rbidit assciated with surger which is we dcuented b trias andguideines. one Scttish stud shwed n difference in the axiar recurrence rate betweena ee 3 cearance and a fur nde wer axiar nde sape with a seectie pic faxiar irradiatin in nde psitie patients. There was se increased rbidit assciatedwith cearance.57

a air urr oud b rord in tint it ini brt cncr.

There is n cnsensus regarding the best wa t anage the axia in patients with inasiebreast cancer. Tabe 3 describes the prcedures in current practice.

An RCT cparing 232 patients underging axiar nde cearance with 234 patients whreceied axiar sape pus raditherap fr nde psitie, at a edian fw up f 4.1ears, fund that there was n signicant difference in ca r distant recurrence (14 ersus15 patients and 8 ersus 7 patients). There was n reprted difference in e ear suria rates(82.1% s 88.6%; p=0.20) r in disease-free suria (79.1% ersus 76%; p=0.68). Axiarcearance was assciated with signicant phedea f the upper ib when cparedt axiar sape. Saping with raditherap was assciated with a signicant reductin in

range f shuder eent at three ears.

57

Axiar surger a reduce the ris f axiarrecurrence.58

N pubished RCTs were identied cparing sentine nde bips with fra axiardissectin. The frer prcedure has been assciated with technica difcuties and a signicantearning cure. It is assciated with a fase negatie rate f 5-7% in experienced hands.42 Atpresent it is nt pssibe t recend sentine nde bips, uness undertaen as part f arandised cntred tria r fwing an eauated training prgrae. An such trias ustcnsider the cinica signicance f icretastatic disease.

Sentine nde bips is n recended as part f a randised cntred tria rfwing an eauated training prgrae.

Table 3: Surgical management of the axilla

procdur

Axiar nde sape pics ut a iniu f fur indiidua ph ndes fr theaxiar fat. Suitabe fr staging n.

Axiar nde cearance bc dissectin f the axiar cntents

ee 1 - up t the atera brder f pectrais inr

ee 2 - up t the edia brder f pectrais inr

ee 3 - up t the apex f the axia

Sentine nde bips seectie rea f the rst draining ndes

3.3.1 SUmmARy oF EXISTING SURGICAl GUIDElINES

Seera guideines and RCTs hae cnsidered the reatie erits f the different surgicaappraches t the axia.

The Cancer Care ontari guideine recends axiar dissectin (ee 1 and 2 withpathgica exainatin) as the standard f care in wen with stage 1 and 2 breast cancer.42The guideine reprts that there is insufcient eidence t supprt sentine nde bips ane,but encurages the participatin f patients in reeant cinica trias, as the prcedure appearst be prising. The guideine bases its cncusins n the resuts f six RCTs suarised ina singe eta-anases.

The Natina Heath and medica Research Cunci cinica practice guideine n the

anageent f ear breast cancer

recends that anageent f the axia shud bedecided fwing utidiscipinar tea discussin ining the patient, but that a iniuf ee 1/2 axiar nde dissectin shud be ffered as the standard prcedure. 59


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Further guidance is as ffered:59

Treatent f the axia b either dissectin r irradiatin wi reduce rates f axiar recurrence.In practice, st wen wi be ffered axiar dissectin as the rst chice since this wias pride infratin t assist in staging and in cntributing t decisins abut ssteicand cregina aduant treatent. Axiar irradiatin wi be the preferred treatent ethdin some patients

Fr se wen, irradiatin rather than dissectin wi be the preferred ethd f axiarcntr. This incudes seected wen in wh the resut f axiar dissectin wud beunie t inuence the decisins abut ssteic aduant therap. other wen a ntwish t hae further surger, and an decisin shud ine cnsutatin with apprpriateebers f the utidiscipinar tea

Se wen at high ris f axiar recurrence wi require bth axiar dissectin andaxiar irradiatin. In particuar, this wi incude thse wen wh hae reaining axiardisease fwing dissectin

There shud be natina crdinatin f trias f sentine nde bips.

3.4 maNagemeNT Of DUCTal CaRCINOma IN sITU

Ducta carcina in situ (DCIS) cers a hetergenus grup f esins and is cassied bhistgica tpe, grade, and the presence f necrsis.60

3.4.1 CHoICE oF mASTECTomy oR BREAST CoNSERvING SURGERy

Patients with ducta carcina in situ a be surgica anaged b either astect r breastcnsering upect. N randised studies which were designed t direct cpare theutces f these frs f surger were identied. Patients with DCIS in the NSABP B-06 tria fbreast cnsering surger in patients with ear stage inasie breast cancer were acated t thethree treatent ars: tta astect, upect n, and upect with pstperatieradiatin. A subgrup anasis f the tria shwed the rate f ipsiatera breast cancer recurrence

was 43% (9/21) in the upect n grup, and 7% (2/27) in the upect and radiatingrup (p=0.01); there were n ca faiures in the astect grup (0/28).6

one eta-anasis f chrt studies f patients with DCIS wh were treated b astectr breast cnsering surger as incuded the abe NSABP B-06 tria. 62 The reprted ratesf ca recurrence at e ears were higher fr patients treated b breast cnsering surger,with r withut radiatin, (21.5%; 95% cndence intera [CI], 14.0% t 30.7%) ersus thsetreated b astect (4.6%; 95% CI, 2.3% t 7.6%). In studies reprting n patients treatedb breast cnsering surger pus radiatin, the ris f ca recurrence did nt appear t beincreased cpared with astect (10.6%; 95% CI, 5.6% t 16.9% fr breast cnseringsurger pus radiatin ersus 7.3%; 95% CI, 2.7% t 14.1% fr astect). mrtait rates ate ears were siiar fr patients treated b breast cnsering surger r astect (4.2%;95% CI, 1.4% t 8.5% and 3.9%; 95% CI, 1.7% t 6.8%, respectie). The interpretatin f

this data is iited t a arge extent b crss stud cparisns, ac f randisatin, ac fcparisn grups in se studies and ptentia chrt effect.

B won it duct crcino in itu o r cndidt or brt urr oud bord t coic o ucto or tcto.


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3.4.2 IRRADIATIoN FolloWING BREAST CoNSERvING SURGERy

Three arge randised trias, detected a signicant benet fr ipsiatera breast irradiatinfwing breast cnsering surger (BCS) in reducing the ris f inasie and nn-inasiebreast recurrence in the ipsiatera breast. The trias reprted an increased ris f deepingcntraatera breast cancer in thse wh receied raditherap. If this was due t raditherap,then the new priar cancers wud be expected t be predinant cated edia, whichis nt the case.

In the NSABP B-17 tria, 818 wen with DCIS treated b upect with cear resectinargins were randised t ne f tw ars: breast irradiatin (5,000 cG in 25 fractins ere wees) r bseratin n.63 At a fw up f 12 ears, there was a signicant reductinin ipsiatera breast tuur recurrence with radiatin (16.4% ersus 7%, p10, there was n benet t radiatin therap in ters f ratesf recurrence at eight ears (reatie ris; 1.14; CI 0.10 t 12.64, p=0.92). Fr patients withargins ranging fr 1 t


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3.4.3 THE RolE oF TAmoXIFEN IN DCIS

one randised tria has reprted that the use f taxifen in wen with DCIS is assciatedwith a wer disease recurrence, particuar in wen ess than 50 ears r with receptrpsitie disease.68 on this basis, it has been recended that wen shud be infredf the ptin f e ears f taxifen therap and f the hars and benets assciated withtaxifen use, but that the absute benet is sa.69 Taxifen is nt icensed fr the treatentf DCIS utwith a tria setting.

The Uk DCIS tria des nt shw adantage in preenting recurrence f DCIS r deepentf inasie cancer. The use f taxifen shud n be cnsidered in the cntext f a cinicatria, een in estrgen receptr psitie patients.65

The benets and hars f hrna therap shud be discussed with wen withducta carcina in situ and treatent decisins ade based n indiiduacircustances.


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4 Rdiotr

4.1 INTRODUCTION

Aduant raditherap cntinues t hae an iprtant re in the anageent f breast cancer.mre patients are treated nw with pstastect raditherap (PmRT) than was the case10 ears ag.70 The scheduing f raditherap is an iprtant issue and is addressed in thissectin.

4.2 aDjUvaNT RaDIOTheRapy

The additin f raditherap t surger and aduant ssteic treatent reduces the ris f anrecurrence f breast cancer b 30%, ain as a resut f an increase in cregina cntr.71

A arge eta-anasis estiates that the ris f cregina recurrence is reduced b tw thirdsfwing aduant raditherap.72 The effect was seen t be arge independent f the tpef patient r tpe f raditherap (8.8% s 27.2% ca recurrence b ear 10). As a resut fipred ca cntr breast cancer rtait was reduced (p=0.0001) but ther, particuarascuar, rtait was increased (p=0.0003), and era 20-ear suria was 37.1% in patientsreceiing raditherap ersus 35.9% in patients in the cntr ar (p=0.06).

4.2.1 RADIoTHERAPy FolloWING mASTECTomy

The effect f PmRT n rtait is ariabe. A ssteatic reiew (ining 34 RCTs)cparing astect with astect fwed b raditherap t the chest wa fundthat raditherap did nt reduce a-cause rtait r breast cancer rtait after astectane r astect pus axiar cearance. Raditherap did reduce a cause rtait andbreast cancer rtait after astect pus axiar saping.73 In the reiew, raditherapa hae been assciated with ate aderse effects, which are rare, incuding pneunitis,pericarditis, ar edea, brachia pexpath, and radinecrtic rib fracture, ain due t

utdated raditherap techniques which are n nger in use.This stud exained apprxiate 20,000 wen entered int randised trias f aduantraditherap befre 1990. The raditherap techniques and dses used in the studies are essadanced than thse f the present da. In additin, the patient ppuatin is different fr thsepresenting current, with an under-representatin f patients with screen-detected tuursand f thse wh receied taxifen fr e ears. Fr exape, st f the studies incudedin this reiew were f trias f irradiatin f chest, axia, supracaicuar fssa, and internaaar nde chain a inrit (7%) f patients receied raditherap t the breast n.This a expain the derate, but signicant, increase in nn-cancer reated deaths, suchas ascuar deaths. Excess ascuar deaths are as eident fr tw ears after raditherap,but are particuar signicant if re than 10 ears hae eapsed after aduant raditherap.Current, and perhaps cnseratie, estiates are that if ng ter treatent-reated side effects are

aided, then aduant raditherap a ffer a 1% ipreent in rtait rate fr w riswen (eg thse with sa screen-detected cancers r with n eidence f nda ineentafter astect with axiar cearance) and 2-4% ipreent in thse at high ris. 73

4.2.2 RADIoTHERAPy FolloWING BREAST CoNSERvING SURGERy

one ssteatic reiew73 and a subsequent RCT74 fund that adding raditherap t breastcnsering surger reduced the ris f ca recurrence cpared with breast cnsering surgerane. The reiew fund that pstperatie raditherap signicant reduced the annua risf breast cancer rtait cpared with n raditherap, but fund n signicant differencebetween treatents in the annua ris f a cause rtait (dds rati (oR) fr breast cancerrtait 0.86; p = 0.04; oR fr a cause rtait 0.94; p > 0.1). The reiew fund thatpstperatie raditherap signicant decreased the annua ris f isated ca recurrence

cpared with n pstperatie raditherap (oR 0.32; p < 0.00001). It as indicatedthat raditherap increased the annua rate f nn-breast cancer deaths cpared with nraditherap, this increase was f brderine signicance (oR 1.34; p = 0.05).

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A subsequent RCT ining 1187 wen with stage III inasie nde negatie breast cancerfund n signicant difference in era suria between aduant raditherap and naduant raditherap, but fund that aduant raditherap signicant reduced ipsiaterabreast recurrence cpared with n aduant raditherap at e ears (era suria at eears: (RR) 1.16, 95% (CI) 0.81 t 1.65; ipsiatera breast recurrence at e ears: absute ris

14% withut raditherap v4% with raditherap; RR 3.33, 95% CI 2.13 t 5.19).74

one ssteatic reiew75 and ne additina RCT76 were identied which cpared raditherapafter breast cnsering surger ersus sipe r died radica astect in wen withinasie breast cancer. The reiew fund n signicant difference in annua ris f death er10 ears (oR 1.02; p = 0.7), r annua ris f an recurrence r ca recurrence (era oRfr an recurrence: astect s breast cnseratin pus raditherap 0.96, 95% CI 0.88t 1.04; absute ris ; AR fr ca recurrence: 6.2% with raditherap after breast cnseringsurger vs 5.9% with radica astect; nt signicant).

a Rdiotr oud b in ooin tcto or brt conrin urr to rduc localrecurrencewherethebenettotheindividualislikelytooutweighrisksofradiation

rtd orbidit.

4.3 seleCTINg The appROpRIaTe sITe

4.3.1 CHEST WAll AND SUPRAClAvICUlAR FoSSA RADIoTHERAPy

The questin f whether aduant raditherap shud be gien t the chest wa andsupracaicuar fssa has been addressed in anther guideine.77 Fewer data are aaiabe whichdiscuss the benet f PmRT in subgrups f patients with specic nubers f psitie axiarndes. Supracaicuar nda faiures are re cn in unirradiated patients with fur rre psitie axiar ndes.

In ne series, supracaicuar nda faiure appeared in 17% f unirradiated r inadequateirradiated patients (17 f 102), cpared with 2% f 56 irradiated patients.78 In anther series,

the ris f supracaicuar faiure was 13% (six f 46) ang unirradiated patients with fur rre psitie ndes, cpared with 4% (tw f 52) fr thse irradiated. 79

An RCT shwed ipreents in ris f c-regina faiure (lRF) in irradiated patients in thesubgrups with either ne t three r fur r re psitie ndes. 80 The difference in crudelRF rates fr patients with ne t three psitie ndes was f brderine signicance betweenthe ars (20% in the cntr ar and 8% in the irradiated ar, p=0.066), whie the differencebetween the ars fr patients with fur r re psitie ndes reained high signicant (lRFrates f 51% and 17% in the tw ars, respectie, p=0.004).

In anther tria, patients with ne t three psitie ndes and thse with fur r re psitiendes had statistica signicant ipreents in disease-free suria when gien PmRTin additin t chetherap, but n patients with fur r re ined ndes deried a

signicant adantage in cancer-specic suria fr the additin f PmRT.8

D Thesupraclaviculareldshouldbeirradiatedinallpatientswithfourormorepositiveir nod.


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4.3.2 AXIllARy RADIoTHERAPy

The Aerican Sciet f Cinica oncg recends that after adequate surger b acpete r ee I/II axiar dissectin, rutine aduant axiar raditherap is nt necessarand a add t rbidit.77

4.3.3 INTERNAl mAmmARy NoDE CHAIN RADIoTHERAPy

There are studies that address whether raditherap t the interna aar nde chain (ImC)is f benet. The eidence fr ImC is cnicting.

Tw trias shwed n ipreent in suria in patients wh underwent interna aarnde dissectin in additin t standard radica astect.82 ,83

A tria f 150 patients with interna aar nde ineent randised indiiduast either radica resectin f the interna aar supracaicuar chain, irradiatin f thesupracaicuar and interna aar ndes, r n further surger r deiberate irradiatin fthese areas. The e-ear disease-free suria rates were siiar in the three ars (57%, 53%,and 51%, respectie), athugh the ris f supracaicuar and/r interna aar recurrencewas west in the irradiated grup (12%, 0%, and 16%, respectie). 84

one eriew f case series and randised cntred trias shwed n benet f ImCraditherap.85Studies reiewed incuded patient data fr 1938 nwards, raising the pssibiitthat the side effects f antiquated treatents a hae inuenced the resuts against ImCirradiatin. There is n eidence that ImC irradiatin shud be perfred rutine in anpatient grup.77,85 The nuber f screen-detected cancers is increasing and, tgether with thefact that fewer patients present with ca adanced cancers, shud resut in a reductin inImC ineent.

4.4 sCheDUlINg Of RaDIOTheRapy

The ptia tiing f aduant raditherap fwing surger has nt been estabished

in a randised tria. In ne arge RCT, 244 patients were randised t receie eitherchetherap rst r raditherap rst fwing cnseratie breast surger. There weren signicant differences between the chetherap rst and raditherap rst ars in tiet an eent, distant etastasis, r death. The stud cncudes that there is n adantage tgiing raditherap befre aduant chetherap. Hweer, this stud des nt hae enughstatistica pwer t rue ut a cinica iprtant suria benet fr either sequence.86 It is usuafr tria eigibiit criteria that raditherap is cenced within at east 12 wees f surgeruness receiing aduant chetherap.87 Eidence fr this is described in a guideine whichincuded patients wh had breast-cnsering surger, but it is nt unreasnabe t extrapatethis as t patients wh hae undergne astect. Access t raditherap within furwees is a current pitica target,88 and a iniu f 95% f patients receiing raditherapt the breast after cnseratin fr inasie cancer is a desirabe criterin within fur wees fna peratin/chetherap dse.89 There is insufcient eidence t recend the idea

sequencing f PmRT and ssteic therap.

4.5 DOse fRaCTIONaTION

A ssteatic reiew suggests that ca recurrence a be higher bew certain bigicaeffectie dses.90 Current eidence is nt abe t identif an ptia dse/fractinatin frpstperatie raditherap.87,91 It is therefre reasnabe t treat patients with current acceptedregiens such as 50G in 25 dai fractins er 5 wees, 45G in 20 fractins, r 40 G in15 r 16 fractins. Resuts f nging trias inestigating fractinatin are awaited.

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5 stic tr

5.1 aDjUvaNT ChemOTheRapy

The abiit f pstperatie aduant chetherap t reduce the ris f recurrence and deathfr breast cancer has been estabished b a series f eta-anases f an cinica trias. 92

The cncept f aduant chetherap is a difcut ne fr an patients. It is ften hard tcne the reasns fr giing a txic treatent that n cures a inrit f thse wh receieit, whereas the prprtin haing se benet wi depend n the era ris f recurrence.Heping patients ae crrect chices abut treatent is iprtant, as chetherap usuaipairs the patients shrt ter quait f ife.

There is n cear cnsensus n hw indiidua chetherap drugs shud be sequenced.Drugs are ften cbined, and there is iited eidence that bc sequentia adinistratina be better,93 and if gien with granucte-cn stiuating factr (G-CSF) supprt, redse-dense regiens can be gien which a ipre disease-free suria.94 ,95 G-CSF isaaiabe in a pegated (sw-reease dept) preparatin, gien n nce per chetherap

cce, which a be as effectie as the standard preparatin, and a be better at preentingneutrpenic feer.96 The resuts f further trias are awaited. Bigica arers t predict risf reapse hae been shwn t be effectie97 athugh the difcut in recruiting patients tsuch trias suggests that siper re reiabe tests are sti needed. 98

In wen er the age f 70 ears there is a paucit f data n the benet f aduantchetherap, with n cear eidence fr r against its use.

There are data t suggest that the degree f benet a be reduced with increasing age. 92There is eidence that the use f a structured isua aid can ipre patient satisfactin andunderstanding f the ratinae f aduant chetherap.99

The decisin regarding which patients shud be ffered aduant chetherap is based na ris-benet anasis ade n the basis f their tuur detais, incuding whether r nt the

cancer was screen-detected; age; and tpe f therap ffered. In deterining prgnsis, thereare a nuber f ts aaiabe, fr guideines t bigica anases and sipe and cpexatheatica/cputer des, but nne hae been aidated in a prspectie randisedtria. Chetherap has a negatie effect n patients sexuait that des nt rese fwingcessatin f treatent. The additin f hrna therap t chetherap des nt ipairsexuait further (athugh the use f hrna therapies ane ipairs sexua functin). 00

a a on undr t o 70 r, it r brt cncr oud b conidrd ordunt cotr.

Se f the benecia effects f aduant chetherap a be ediated b arian suppressin.Thse wh bece aenrrheic during chetherap hae fewer reapses.0 Endcrinetherap ane (arian suppressin with r withut taxifen), in preenpausa wen er

35 ears with derate r high ris estrgen receptr (ER) psitie tuurs, is as effectie asccphsphaide, ethtrexate and 5-ururaci (CmF) chetherap ane102,103 and abe superir.04 other studies hae fund the additin f CmF chetherap t taxifen t bebenecia t preenpausa wen with ess than fur axiar ph gands ined.105

There is a paucit f data n the additin f taxifen t chetherap in preenpausawen, athugh there is n eidence that it is nt f additina benet. Siiar, there are ncear data n the benet f additina arian suppressin t wen with hrne receptrpsitie tuurs aread receiing chetherap and taxifen.


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Breast cancer patients aged ess than 35 ears hae a wer suria and higher reapse ratethan der patients. In a stud where st patients did nt get additina endcrine therap,unger patients with estrgen receptr psitie disease had wer suria rates than thsewith estrgen receptr negatie disease.06 oissin f hrna therap in unger patientsa be especia detrienta t their utce.

C won it otron rctor-oiti tuour o rci cotr oud bconidrd or ddition ndocrin tr, ci i t r undr 35 r.

5.2 NeOaDjUvaNT ChemOTheRapy

There is gd quait eidence that there is n difference in ng ter suria if the saechetherap is gien befre rather than after surger fr patients with perabe breast cancers,with the added benet that neaduant chetherap appears t be assciated with a reductinin requireent fr astect.107-109 It is ften ffered t faciitate surger in wen with eitherarge T3 tuurs in wh astect a be difcut, r with arge T2T3 tuurs wherebreast cnseratin is nt pssibe at presentatin, but wud be apprpriate if the tuur were

saer. There is se eidence t shw that the tpe f chetherap gien a affect thenubers f cpete pathgica respnses seen0 athugh the difference between regiensis nt awas apparent.

a Nodunt cotr oud b conidrd or on it r cncr itiro t rt o brt conrtion nd i not dtrint to on troutco.

5.3 aNThRaCyClINe aND TaxaNe TheRapy

In the aduant setting there is eidence that anthraccines ffer superir suria benetscpared with nn-anthraccines regiens (such as CmF).92,112 The are re txic, withhigher rates f edspasia (bne arrw abnraities) and neutrpenic sepsis in se

studies.2 The are as assciated with a dest ris f cardiac daage. 4

Taxanes are actie in the aduant setting, but athugh the hae been shwn t ipreupn se adriacin-based regiens,113 there are nt et an pubished data that the fferadditina suria benets er ptia anthraccines regiens.

5.3.1 ADvANCED DISEASE

eirubicin

Randised cntred trias in adanced breast cancer hae shwn that epirubicin anddxrubicin hae equiaent efcac when easured b respnse rates r suria. In a pedanasis f six trias cparing equa dses f these drugs, ane r as part f cbinatintherap, respnse rates were equiaent (RR, 1.04; 95% CI, 0.92 t 1.18; p=0.51). In dses

equa t dxrubicin, epirubicin had ess carditxicit (eectrcardigra changes, decrease inentricuar eectin fractin, increase in pre-eectin perid/eft entricuar pre-eectin peridrati), (RR, 0.43; 95% CI, 0.24 t 0.77; p=0.0044) and fewer episdes f cngestie heartfaiure. Respnse rates are higher with escaating dses f epirubicin but suria the sae,athugh txicities are re cn with increasing dse.4 The British Natina Fruarrecends a axiu cuuatie dse f 0.91 g/2 t hep aid carditxicit.115 TheScttish medicines Cnsrtiu has adised (Deceber 2003) that the pegated ipsapreparatin f dxrubicin is nt recended fr etastatic breast cancer. 6 It has beenshwn that the use f anthraccine based chetherap in adanced disease is assciatedwith a dest suria adantage.117

a antrccin oud b rcribd in rrnc to non-ntrccin rin in t adjuvantsetting,astheyofferadditionalbenets.Epirubicinmaybepreferredasitcauses

crdic dr ct.

5 sysTemIC TheRapy


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A eta-anasis f fur trias f pacitaxe, singe-agent fr rst ine treatent, has shwn a 25-34% era respnse rate with tie t prgressin (TTP) e nths.8 mst patients reapsewithin 12 nths and edian suria is 17-22 nths. When using pacitaxe in cbinatinwith ther agents fr rst ine treatent, neutrpenia is seen in 40-68% f cases athugh it isuncear if cbining with anthraccines aes this wrse. Thrbctpenia (a decrease inthe nuber f bd pateets) is re cn when pacitaxe is used in cbinatin, a 10%periphera neurpath rate is seen, and apecia ccurs in three-quarters f patients, but withn signicant difference in quait f ife when pacitaxe added (fur studies, n=1545). Theipred respnse rate and suria adantage hae been repicated in ther trias. 119,120

a Tn oud b conidrd in tint it dncd di.

5.4 BIOlOgICal TheRapIes

5.4.1 TRASTUzUmAB moNoTHERAPy

A ssteatic reiew2 f trastuuab as ntherap fund se anti-tuur effects inters f era respnse (partia and cpete) ranging fr 12% t 24%.122-124 The reiewincuded ne randised tria which cpared tw regiens f trastuuab as a singe agentin wen with etastatic breast cancer wh had nt preius receied chetherap.24The bectie respnse rate was 24% (95% CI, 18.0 t 34.3%) ang 111 eauabe patients.median duratin f suria was 24.4 nths. A retrspectie anasis eauating the respnset trastuuab accrding t er-expressin f the huan epidera grwth factr receptr 2(HER2) denstrated b urescence in situ hbridiatin (FISH), fund that patients with FISH-psitie tuurs (n=79) had a respnse rate f 34% (95% CI, 23.9% t 45.7%) cpared t7% (95% CI, 0.8% t 22.8%) in 29 wen with tuurs that were FISH-negatie. The respnserate in such patients is cparabe t se ther ssteic therapies when used as rst-inetherap fr etastatic breast cancer, such as taxifen (20-45% respnse rate), etre (30%),

dxrubicin (32%) and dxrubicin pus inrebine (39%).125,126

C Trtuzub oud b rrd or to tint o tuour heR2 or-rion.

5.4.2 ADjUvANT TRASTUzUmAB THERAPy

Seera arge internatina trias are being cnducted t test the benet f this agent in earbreast cancer, and preiinar reprts fr se indicate that ne ears treatent pridesa signicant benet.

The HERA tria randised wen wh had cpeted cregina therap and aduantchetherap t either ne ear f three wee trastuuab therap, tw ears f trastuuabtherap r bseratin.127 Interi resuts are aaiabe fr the cparisn between bseratin

and ne ear f therap. A tta f 127 rst eents were reprted in the ne-ear trastuuabgrup and 220 in the bseratin grup. The unadusted haard rati in the ne-ear trastuuabgrup as cpared with the bseratin grup was 0.54 (95% cndence intera, 0.43 t0.67; p< 0.0001) which crrespnded t an absute disease-free suria benet f 8.4% attw ears. Apprxiate tw thirds f reprted rst eents were distant etastases. The haardrati fr tie t a distant recurrence in the ne-ear trastuuab grup cpared with thebseratin grup was 0.49 (95% cndence intera, 0.38 t 0.63; p < 0.0001).


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Tw trias which cpared aduant chetherap with r withut cncurrent trastuuab inwen with surgica reed HER2-psitie breast cancer hae pubished cbined resuts.28The Natina Surgica Aduant Breast and Bwe Prect tria B-31 cpared dxrubicin andccphsphaide fwed b pacitaxe eer three wees (grup 1) with the sae regienpus 52 wees f trastuuab gien cncurrent with pacitaxe (grup 2). The Nrth Centra

Cancer Treatent Grup tria N9831 cpared dxrubicin and ccphsphaide fwedb wee pacitaxe (grup A), with the sae regien pus 52 wees f trastuuab initiatedcncitant with pacitaxe (grup C). The studies were aended t incude a int anasiscparing grups 1 and A (the cntr grup, n=1679) with grups 2 and C (the trastuuabgrup, n=1672). At interi anasis the trastuuab grup was assciated with arund haf fthe nuber f eents (cancer recurrence, secnd priar cancer, r death befre recurrence) fthe cntr grup; (261 s 133 eents; haard rati, 0.48; 95 % CI, 0.39 t 0.59, p


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5.5 vINORelBINe aND CapeCITaBINe TheRapy

N eidence was identied t supprt the use f these agents in the aduant setting, athughthere are nging studies which wi address their re. Tw ssteatic reiews reprt thefwing eidence in patients with etastatic disease. 135,136

5.5.1 vINoRElBINE

A singe RCT was identied which cpared singe agent inrebine t ephaan in patientswh faied t respnd t anthraccine-cntaining chetherap (n=179).137 The stud shweda suria benet fr inrebine (p=0.034). The edian suria tie was 35 ersus 31 wees,with ipred quait f ife. A phase 2 stud f inrebine/ inrebine pus 5-ururaci(5FU) pus eucrin and itxantrne pus 5FU pus eucrin (n=99) shwed equiaentbectie respnse rates and suria ties in a three grups (RR 21-30%).138 An RCT exaininginrebine ersus inrebine pus dxrubicin (n=289 assessabe), shwed n difference inrespnse, duratin f respnse, r suria. Txicit was ain haeatgica and apeciawas seen in 12%.139

vinrebine is an actie drug in the treatent f adanced disease, but its ptiu psitin

within a treatent agrith is uncear due t a paucit f randised trias.

5.5.2 CAPECITABINE

A phase 2 stud f capecitabine ersus pacitaxe fr patients wh had nt respnded tanthraccine treatent was discntinued ear because f strng patient preferences frcapecitabine with resuts shwing siiar efcac. Capecitabine shwed 8/22 respnses f whichthree were cpete, (36%, CI 17-59%) and pacitaxe 4/20, with n cpete respnses, (21%;6-46%). median TTP was the sae at ust er 90 das. Aderse eents, tpica neutrpeniaand neurpath, were re cn with pacitaxe.40

A phase 2 stud f capecitabine in patients with pacitaxe-resistant etastatic cancer shweda 20% respnse rate, three cpete respnses, edian duratin f respnse f eight nths,

edian suria f 13 nths, edian TTP f three nths, and a ne ear suria f 52%.There was a 30% respnse rate in patients cnsidered t be bth anthraccine and pacitaxe-resistant. Aderse eents nted were diarrhea, fatigue, statitis, nausea, and neutrpeniain 3%.4

As rst ine treatent in etastatic disease, a phase 2 stud cparing capecitabine with CmFshwed 25% RR fr capecitabine and 16% RR fr CmF (n=95). The edian tie t prgressinwas 132 das fr capecitabine and 92 fr CmF.42

A randised phase 3 tria f dcetaxe with r withut capecitabine in patients wh hadpreius undergne anthraccine treatent shwed that the respnse rate was higher withthe cbinatin (42% ersus 30%).143 median suria was 14 nths with the cbinatinand 11 nths with dcetaxe ane. The edian TTP was six nths fr the cbinatinand fur nths fr capecitabine, hweer, patients were nt assigned t receie capecitabine

upn prgressin in the singe agent dcetax ar.

Capecitabine appears t be effectie as a rst ine and secnd ine treatent f adanced disease,een after anthraccines and taxanes. It is nt pssibe t ae a r recendatin abutits precise pace in the treatent f adanced breast cancer gien the paucit f randisedtrias.

a eitr ccitbin or inorbin oud b conidrd or tint it dncd brtcncr.


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5.6 ROle Of BIsphOsphONaTes

5.6.1 BISPHoSPHoNATES IN ADjUvANT THERAPy

The eidence fr the effectieness f bisphsphnates in reducing bne etastases in patients

with high ris ear breast cancer is cnicting.

91,144

The argest tria (n=1,069) shwed thatathugh the bsered incidence f bne etastases was wer in the cdrnate grup (12% s15% with paceb), the difference between cdrnate and paceb er the e-ear fw-upperid was nt statistica signicant (haard rati, 0.77; 95% CI, 0.56 t 1.08; p=0.127). 145

When the anasis was restricted t the tw-ear treatent perid, the haard rati was 0.44(95% CI, 0.22 t 0.86; p=0.016). These data were reprted as the na anasis fr a tria thatwas designed t hae the pwer t detect a 50% reductin in the incidence f bne etastasesat three ears and a 25% reductin at e ears.

5.6.2 BISPHoSPHoNATES AND mETASTATIC DISEASE

The re f bisphsphnates in adanced disease has been extensie inestigated. Threessteatic reiews and an eidence based guideine hae addressed the effectieness f these

drugs in patients with etastatic disease.

91,144,146,147

Bisphsphnates hae a benecia effectn bne pain, and reduce the rate f seeta eents in patients with etastatic bne disease.The ptia duratin f therap is uncear athugh the benets are arge based n triasusing tw ears therap. There was n cear benet fr bisphsphnate therap in adanceddisease withut bne etastases, as dened b deepent f bne etastases, in the grupstreated with bisphsphnate cpared with paceb r n additina treatent. Using indirectcparisns, the third generatin bisphsphnate ibandrnate is siiar t paidrnate anda be used as an aternatie.91 The third generatin bisphsphnate edrnate has shwn20% superirit er paidrnate in a randised cntred tria.48

There is eidence fr a w ee f rena txicit, particuar with se intraenusbisphsphnates, which ust be brne in ind during their use in patients with adancedbreast cancer.48

a Bioont oud b routin ud in cobintion it otr tic tr intint it tttic brt cncr it totic bon tt. T coic ont or n indiidu tint dnd on indiidu circutnc.

5.7 eNDOCRINe TheRapy

5.7.1 PREmENoPAUSAl WomEN

oarian suppressin and taxifen as aduant treatent hae been shwn t ipre e earsuria, een when gien t a ppuatin fr wh estrgen-receptr status is nt nwn.149There are data t cnr that it is f n benet in patients whse tuurs d nt expresshrna receptrs, it is standard practice t easure the hrna status f a patient with

breast cancer.150 oarian suppressin has been shwn t be as effectie as CmF chetherapane and, when gien in cbinatin with taxifen, t be re effectie.151-153 Endcrinetherap ane has neer been cpared with anthraccine r taxane-based regiens that arenw seen as standard.

As there are n cear data t suggest that the benet f taxifen added t chetherap seenin pstenpausa wen is nt as seen in preenpausa wen athugh this has ntbeen fra eauated.

In adanced breast cancer, the additin f taxifen t arian suppressin with uteiniinghrne-reeasing hrne (lHRH) agnists ipres respnse rate and era suria.154

a prnou on o tuour r not on to bnt otron orrotron rctor oud b conidrd or dunt ndocrin tr.

a In rnou on it dncd di, t cobintion o toin uorin btion oud b ord bor toin tr on.

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5.7.2 PoSTmENoPAUSAl WomEN

Taxifen gien t patients with adanced disease, er a e ear perid in the aduantsetting signicant reduces breast cancer recurrence, deepent f secnd breast cancersand ipres era suria.150 Neertheess patients a sti reapse despite its use, and itis assciated with txicities incuding thrb-ebic disease and endetria thicening,atpia, and rare cancer.155 These changes can be preented b the use f intra-uterineprgestagen-reeasing deices, athugh these a nt be acceptabe t a wen. The usef an aratase inhibitr, which is nt assciated with such uterine effects, is an aternatiein susceptibe wen.156

adunt tr

The n grup f wen wh d nt benet fr taxifen are thse with estrgen receptrnegatie tuurs.150 Fr pstenpausa wen wh are candidates fr aduant endcrinetherap e ears f taxifen therap is nt the ptia regien in ters f shrt/ediuter disease-free suria, with superirit being shwn fr either e ears f anastre, eears f taxifen fwed b a edian f tw and a haf ears f etre, r tw t threeears f taxifen fwed b tw t three ears f exeestane r anastrae. Se f these

aternaties hae et t shw cnincing era suria benet, athugh it has recent beenreprted in a subgrup f patients. The mA17 tria, inestigated whether extended aduanttherap with the aratase inhibitr etre after taxifen reduced the ris f ate recurrencesand shwed that etre ipred disease-free suria (HR) fr recurrence r cntraaterabreast cancer = 0.58, 95% (CI) = 0.45 t 0.76; p< 0.001).157 oera suria was the saein bth ars (HR fr death fr an cause = 0.82, 95% CI = 0.57 t 1.19; p = 0.3). Angph ndepsitie patients, era suria was statistica signicant ipred withetre (HR = 0.61, 95% CI = 0.38 t 0.98; p = 0.04). In additin, there is a different pref side effects, with fewer gnaecgica and thrbtic eents, but re uscuseetadisrders, incuding fractures.155

No-dunt tr

There is n eidence that the use f a few wees r nths f endcrine therap befre c-regina surger has an ng-ter benecia r detrienta effects. It a, as with ne-aduantchetherap, faciitate surgica ptins but there are n data t cnr this. Fur nthsetre ffers a higher respnse rate than taxifen fr the sae duratin. 158

adncd di

There is n cear eidence that an particuar sequence f endcrine agents ffers an erasuria adantage er anther. The third generatin aratase inhibitrs shw eidence fsuperirit in cinica eaningfu endpints, incuding respnse rate and TTP as cparedto taxifen, irrespectie f the prir use f aduant taxifen.150 There is gd eidencethat in patients wh d nt respnd t taxifen the third generatin aratase inhibitrs aresuperir t egestr acetate.150

a In otnou on it brt cncr toin rin t trtnt o coic initi tr in t dunt ttin. I tr r rti contrindiction to it u(high risk of thromboembolism or endometrial abnormalities) or intornc, n rotinibitor cn b ud in it c.

a potnou tint oud b conidrd or itc to n rot inibitor aftereithertwotothreeyearsorafterveyearsoftamoxifentherapy.

a In otnou on it dncd di, tird nrtion rot inibitoroud b conidrd bor itr toin or tro ctt.

5.8 TImINg Of sURgeRy aND ChemOTheRapy

N eidence was identied t supprt a recendatin t dea surger pending ssteictherap. Deaing raditherap fr aduant chetherap a increase the rate f carecurrence, whereas deaing chetherap fr the raditherap a hae se detrientaipact in ters f ssteic recurrence.159


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There is cnicting eidence regarding the effect f deaing chetherap fwing surgerin wen with ER negatie tuurs. one eta-anasis shwed that the 10-ear disease freesuria rate in wen wh cenced chetherap within 21 das was signicant higherthan in thse wh cenced chetherap at 21-86 das fwing surger (60% s 34%; (HR),0. 49; 95% (CI), 0.33 t 0.72; p=0.0003).60

A retrspectie anasis f a siiar chrt f 1161 patients fund n signicant difference indisease free suria between thse wen wh had receied chetherap within 21 dasf surger and thse wh had started chetherap at a ater tie. 6

C a trtnt or tint it r brt cncr oud b trtd oon i rctic. Youngwomenwithoestrogenreceptornegativetumoursmaybenetparticularlyfrom

r initition o cotr ooin urr.

5.9 maNagemeNT Of meNOpaUsal sympTOms

There is gd eidence that bth w dse egestr acetate and dept intrauscuaredrxprgesterne acetate can reduce the frequenc f ht ushes in pstenpausa

wen with breast cancer.62 There are fewer data n whether these agents affect the utcef the breast cancer treatent. There are n cear data as t whether the use f cnentinaHRT aeiates these spts r aters utce in wen with breast cancer treated withendcrine agents.163 Current use f HRT is assciated with an increased ris f incident and fatabreast cancer; the effect is substantia greater fr estrgen-prgestagen cbinatins thanfr ther tpes f HRT.64 Cnidine appears t hae se effect n the cntr f ht ushes,but there is se eidence that it des nt ipre quait f ife. 165

B mtro ctt or dot intrucur drorotron ctt b conidrd tocontroltheseverityofhotushesinwomenwithbreastcancer.

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6 pcooic cr

6.1 INTRODUCTION

This sectin discusses the re f the speciaist breast care nurse (section 6.2) and pschgicadistress in breast cancer patients (section 6.3). It as expres the st effectie techniques fpschscia supprt fr breast cancer patients and/r their carers and faiies (section 6.4) andexaines the cunicatin ethds that hae been shwn t be st effectie in ipringpatient satisfactin r pschscia rbidit (section 6.5).

6.2 The ROle Of The BReasT CaRe NURse

The re f the breast care nurse speciaist is we estabished within the utidiscipinar teaand has deeped and expanded t reect ca circustances and the diersit f Sctandand its ppuatin. Wen hae cpex needs at diagnsis and thrughut their experiencef the disease, requiring the input fr an ebers f the tea. Athugh there is iitedresearch in this ed, supprting wen fr diagnsis is acnwedged as an iprtantinterentin aued b wen.166 ,167

Using a structured apprach t the anageent f pschgica care aws breast care nursespeciaists t ipre the cntinuit f care, infratin and supprt wen receied frdiagnsis thrugh t fw up.167

C a on it otnti or non dinoi o brt cncr oud cc to brt cr nur ciit or inortion nd uort t r t o dinoi ndtrtnt.

Cntact detais and infratin abut the re f the breast care nurse shud be aaiabet the patients, their faiies and a the ebers f the utidiscipinar tea incudingthe priar care tea.

6.2.1 EDUCATIoN

Breast care nurse speciaists are wring within a speciaised nursing re and shud beapprpriate experienced and educated. opprtunities fr cntinua prfessina deepentshud be aaiabe fr nurses wring at this ee. The Ra Cege f Nursing fraewrfr adut cancer nursing prides recendatins n educatina expectatins.68

D Brt cr nur ciit oud rorit duction nd rinc.

6.3 IDeNTIfyINg DIsTRess

A nuber f studies hae exained the incidence f pschgica and pschiatric rbidit inwen with breast cancer. The hae shwn a high ris f cinica signicant ees f anxietand/r depressin, seere sexua difcuties and ther prbes reated t bd iage.169,170 Thisis in additin t the nra reactins f wen t the diagnsis f a ptentia ife threateninginess and the side effects f treatent.

Cinica staff frequent fai t identif pschgica prbes, fr arius reasns. Whencinicians identif cinica signicant distress, the a nt ffer treatent because the seethe distress as being a nra reactin t the diagnsis, treatent side effects, r prgnsis.

Signicant ees f pschgica distress are cn assciated with experiences assciatedwith the diagnsis f and treatent fr breast cancer. In a stud f 303 wen entering arandised cntred tria, up t 45% f the participants were fund t hae cinica signicantees f pschgica distress using standardised criteria.171


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Identifing distress is a signicant tas fr the uti-prfessina tea caring fr patients withbreast cancer. Distress can be the resut f a range f factrs and is nt awas a anifestatinf an etina r pschgica prbe. man patients with high ees f distress are ntrecgnised.

Rutine screening fr distress ang pepe with cancer has been recended b the USNatina Cprehensie Cancer Netwr.172 The Natina Heath and medica Research Cuncif Austraia173 recends an apprach t screening fr signicant pschgica prbesthat incudes adice t dcuent ris factrs fr the presence f distress ( see Table 4).

Athugh there hae been an studies that hae used a range f reiabe and aid assessenteasures t exaine pschscia aspects f breast cancer, there are few studies that specicacpare the utiit f assessent ethds.

A nuber f easures hae been used in an attept t screen fr pschgica spts inwen with breast cancer. The Hspita Anxiet and Depressin (HAD) scae is a reiabe andaid questinnaire t screen fr the presence f pschgica spts and distress in thecinica setting.174 The Eurpean organisatin fr Research and Treatent f Cancer Quait flife Questinnaire (EoRTC QlQ-C30) as has gd reiabiit and aidit as an assessent

f iprtant quait f ife diensins in research and the cinica settings. 175

A arge ssteatic reiew f the eidence reating t screening fr distress in a genera hspitasetting indicated that the rutine adinistratin f questinnaires in screening fr distress is acst exercise with itte bearing n pschgica utces.176 This is supprted b researchexaining the utiit f the HAD in detecting diagnsabe enta disrders ang wenwith breast cancer.177

Decisins t use these questinnaires shud be taen when assessent reeas the presence fris factrs fr seere pschgica prbes (see Table 4). Distress is ften a anifestatin fa phsica, scia, nancia r spiritua cncern and it shud nt be assued that the presencef distress is awas the resut f an etina r pschgica prbe.

B T urnt o t rnc o cooic to in on it brt

cncr oud b tiord to t indiidu circutnc o t tint (eg presence ofhigh level of distress or risk factors for problems).

B Routin dinitrd utionnir r not rcondd or t dtction o clinicallysignicantpsychologicalsymptomsinwomenwithbreastcancerwhodonot havespecicriskfactorsforsevereanxietyordistress.

Breast cancer serices shud rutine screen fr the presence f distress and risfactrs fr er high ees f distress fr the pint f diagnsis nwards (incudingduring fw up reiew phases)

mutidiscipinar teas shud hae agreed prtcs fr distress assessent andanageent. These shud incude recendatins fr referra and care

pathwas.

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Table 4: Factors associated with increased risk of psychosocial problems

Crctritic o t indiidu

yunger

Singe, separated, dirced r widwed

liing ane

Chidren unger than 21 ears

Ecnic adersit

lac f scia supprt, perceied pr scia supprt

Pr arita r fai functining

Histr f pschiatric prbes

Cuuatie stressfu ife eents

Histr f ach r ther substance abuse

Crctritic/t o di nd trtnt

At the tie f diagnsis and recurrence

During adanced stage f the disease

Prer prgnsis

mre treatent side effects

Greater functina ipairent and disease burden

Experiencing phdea

Experiencing chrnic pain

Fatigue

Source: Clinical Practice Guidelines for Psychosocial Care of Adults with Cancer173

6.4 psyChOlOgICal sUppORT fOR wOmeN wITh BReasT CaNCeR aND TheIR

famIlIes

6.4.1 GRoUP BASED PSyCHoloGICAl INTERvENTIoNS

mst f the studies eauating a pschgica interentin that has been deiered in a grupfrat hae eauated supprtie expressie therap, cgnitie behaiura grup therap r

psch-educatin in a grup frat.

Supprtie expressie pschtherap has been shwn t hae psitie effects in reducingtrauatic stress spts,178 d disturbance and pain perceptin ang wen withadanced breast cancer.179 This has nt been shwn in eer stud.80 Supprtie expressietherap appears t hae n effect n suria fr wen with adanced breast cancer.179Cgnitie behaiura fcused grup therap in patients with caised breast cancer hasbeen shwn t be assciated with a reductin in depressin, d disturbance, and withenhanced quait f ife.8 These benets hae as been fund in wen with adancedbreast cancer, where enhanced sef estee was as reprted.82 The sustainabiit f thesebenets is nt et pren, with studies reprting aring resuts with regard t aintenancef gains.181-183 Athugh patients expressed high ees f satisfactin with their experiencesf cgnitie existentia grup pschtherap (a therap that cbines eeents f supprtie

expressie and cgnitie behaiura therapies) an RCT has nt shwn benecia pschsciautces.84 Discussin frus where wen share their experiences ffer shrt ter benetin aintaining patient hpe.185


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A grou cooic intrntion oud b ib to on it brt cncro it oud uit tir nd.

suorti ri tr i rcondd or tint it dncd cncrnd coniti biour tr or tint it ocid, ocorion ordncd di.

Chice f pschgica treatent dait in adanced breast cancer shud be basedn patient preference.

6.4.2 INDIvIDUAl INTERvENTIoNS

Indiidua pschgica interentins that hae a psch-educatina r cgnitie behaiuraephasis prduce signicant ipreents in d, cping and distress.186-189 The as haeptentia t aeirate the specic side effects f cttxic chetherap.190,191 Prbe sing,ne-t-ne appraches t pschscia supprt can reduce distress in unger wen withbreast cancer and hae a re in diinishing unreprted need. These effects are nt sustainednce the interentin has nished.192 The prisin f cputers and iited training can aidinfratin and patient cndence, but appears t hae n effect n quait f ife in genera.

Effects n cndence and nwedge are shrt ter.193 The benet f cputer-based supprter re usua eans f supprt is n argina.194 Where teephne therap has beentried it has been wide acceptabe but ffers itte benet.195 There is eidence fr ne RCTthat a pschgica interentin ipeented b cinica pschgists resuted in ipredutces fr participating patients, when cpared with the sae interentin deiered bther prfessinas.84

The iited eidence aaiabe fr the different frs f therap and supprt aaiabe is in partdue t the different standards and was in which the interentins were used in the researchsetting.196

a Coniti biour tr (in group or individual format according to preference andavailability) oud b ord to ctd tint it nit nd dri

diordr.

a Coutr nd ton-bd intrntion oud not routin b ord totint.

Pschgica interentins shud be ipeented accrding t the aidated prtcsand prcedures used in the trias that hae reprted benets within the iterature and incnsutatin with ca speciaist pschgica serices.

6.5 COmmUNICaTION meThODs

Effectie cunicatin with breast cancer patients is a crnerstne f gd practice. The

preference fr, and abiit t cpe with, infratin aries between patients and discrepanciesbetween the need fr and actua cunicatin f infratin can resut in pschsciaprbes.197

Faciitating patient chice abut treatent decisins benets pschgica rbidit.198

Cunicatin is enhanced b the prisin f either tapes f cnsutatins that cntaininfratin n diagnsis, anageent r prgnsis, r f fw up etters.199 Nt a wenwant t ae r share decisin aing.200 Fwing a written agenda at cnsutatinssignicant ipres the experience fr breast cancer patients.20 Prpt sheets aid satisfactinwith utpatient encunters.202 Decisin aids fr chetherap ipre patient nwedge andsatisfactin.203

Cunicatin sis training deiered b expert faciitatrs has been shwn t resutin denstrabe ipreents in cunicatin behaiurs f participating senircinicians.204

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a won it brt cncr oud b ord udiot or oo u ur ttr oiortnt conuttion.

a Cinic ncountr it on it brt cncr oud ciitt tint coic bouttrtnt dciion (assuming patients wish to participate in the decision making

process).

a writtn nd, rot t nd dciion id oud b ud to irocouniction it on it brt cncr.

a Cinicin oud b ncourd to ttnd idtd trinin in counictioni.

Cunicatin sis training prgraes shud be ipeented in accrdance withepirica aidated prtcs, ensuring that attentin is paid t the transfer andaintenance f new cunicatin behaiurs within cinica settings.


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7.1 ImpROvINg OUTCOmes

Fw up fr breast cancer patients fwing their priar treatent is an iprtant aspect fcare. Traditina it has been carried ut in hspitas b breast cancer teas.

Fw up sureiance is utifaceted in nature and fus a nuber f purpses, it:

prides patients with supprt and cunseing

detects ptentia curabe ca recurrence in the treated and ppsite breast

prides care fr patients wh deep etastases

prides accurate data n rbidit and utces.

There is er itte eidence ined t utces t suggest the effectieness f ng ter fwup r t indicate the ptia fw up regien.88 one ssteatic reiew f RCTs suggestedthat reguar hspita based reiew has n suria benet er GP fw up.205 This reiewed at fw up strategies fr wen treated with ear breast cancer and reprted ne RCTining 296 wen which cpared fw up b hspita-based speciaists t fw upperfred b genera practitiners and fund n signicant differences in the tie t detectinf the recurrence and patient quait f ife.206 Anther RCT ining 196 wen cparedreguar schedued fw up, restricting it t the tie f agraph and fund n signicantdifferences t interi use f teephne and frequenc f GP cnsutatins.207

7.1.1 PATIENTS WITHoUT RECURRENCE

Ipreents in suria hae eant there are thusands f wen wh hae cpetedpriar treatent and are disease free and eigibe fr ng-ter fw up. It has bece achaenge t ffer effectie fw up strategies. There are a nuber f different was t pridefw up incuding patient initiated,208 GP and nurse-ed fw up.88 The eidence t deterinethe frequenc f fw up is er iited and fw up practices are nt awas cnsistent.

Dtction o oc rcurrnc

Cinica exainatin is the best ethd fr detecting recurrence in the chest wa r axia. 209

Dtction o rcurrnc in t trtd brt nd n rir in t contrtr brt

Reapses in the treated breast are detected cinica r agraphica. magraph isthe gd standard ethd f iaging fr cancer detectin20 but n eidence was identied tsuggest the ptia frequenc f this prcedure with this grup f wen. Current practiceffers this ne t twice ear within the rst e ears.

C mor oud b ud to dtct rcurrnc in tint o undronriou trtnt or brt cncr.

7.1.2 PATIENTS WITH RECURRENCE

N eidence n the frequenc f fw up f patients wh hae recurrence was aaiabe.This shud be rganised reating t patient need. The ineent f the paiatie care teaat this stage is iprtant t ensure patients receie ptiu anageent.

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7.2 IDeNTIfyINg paTIeNTs wITh meTasTaTIC DIsease

7.2.1 DETECTIoN oF DISTANT mETASTASES

The presentatin f distant etastasis a ccur at an tie and nt necessari at rutine

fw up cinics. Patients wi cntact the breast care nurse, ca GP r a eber f thepriar care tea if the are cncerned abut spts. There is eidence that perfringdiagnstic tests such as X-ras, bd tests and scans n this grup f wen des nt ipresuria.205,209,210

B Routin dinotic tt to crn or ditnt tt in totic on oudnot b rord.

Patients and priar care teas shud hae prcedures in pace fr prpt re-referrat a persn with respnsibiit fr fw up and access t supprt serices. The shudbe encuraged t reprt new, persistent spts prpt withut waiting fr the nextschedued appintent.

7.3 speCIalIsT pallIaTIve CaRe

Speciaist paiatie care has an integra pace in the care f wen with breast cancer whsedisease is nt aenabe t cure. This requires a carefu utidiscipinar apprach with inputwhere necessar fr speciaist paiatie care teas. A thse ined in the care f wenwith adanced disease require basic paiatie care sis apprpriate t their prfessin. Thereare agreed natina standards in pace fr the prisin f paiatie care. 2

Wen with adanced breast cancer a hae cpex needs reated t the pschsciaipact f disease, phedea and spts, especia pain, fatigue and breathessness.The cntr f pain in cancer patients is cered in detai in SIGN guideine 44. 22

The ineent f speciaist paiatie care teas has resuted in dest psitie utces

incuding spt cntr, patient and carer satisfactin and chsen pace f death.

213

There is n eidence fr the best pint at which speciaist paiatie care shud beceined in care, but a signicant prprtin f referras arrie t ate t gie ptia benett patients.24

B ptint it brt cncr oud cc to inut ro ciit iti crt.


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8 Inortion or dicuion it tint nd

crr

8.1 gaTheRINg vIews fROm paTIeNTs wITh BReasT CaNCeR

Patients and carers want infratin t hep the understand and cpe with the diagnsis fbreast cancer, the treatent ptins aaiabe and the care the can expect fr the heathprfessinas the eet.

A iterature search f patient iews and experiences was carried ut t infr the deepentf this guideine. one f the ar thees that eerged was cncern that the infratin needsf cancer patients are nt et during their urne f care.

A ne da wrshp, n the brad issues f infratin needs and resurces reating t anaspect f the disease, was hed t gather iews and suggestins fr a grup f wen wha hae direct experience f treatent fr breast cancer. This was attended b 29 wen freight different heath bard areas in Sctand. Their age at diagnsis aried as fws: 30-39ears (n=1); 40-49 (n=10); 50-59 ears (n=12); 60-69 ears (n=5); nt specied (n=1).

Patients were ased t cnsider the infratin the hae receied thrughut their urnef care, and the infratin the wud hae ied t hae receied. Fie cn theeseerged:

deier f infratin

resuts f inestigatins

side effects f treatent

infratin fr carers

he care/fw up

8.1.1 DElIvERy oF INFoRmATIoNThe anner in which iprtant infratin was prided appeared t ipact n bth thereatinship between the cinica staff and the patient and the patients abiit t understandand absrb it. The st effectie care partnerships were thse where the patients indiiduawishes regarding infratin and ineent were acnwedged b their cinicians anddeterined the nature f their cunicatins.

A need fr cear, accurate infratin gien face t face was identied. Decisins gien erthe teephne, cnicting r isaid infratin fr cinicians and pr cunicatinacrss the different heath settings (priar, secndar and tertiar) created increased anxietfr patients. Infratin was required abut bth NHS rganisatins and cancer charities thatcan ffer further infratin in a erba, written and isua frat.

Frequently asked questions: Where can fai and I nd further infratin?

What are treatent ptins?

Cud u write dwn treatent pan?

Is there sene I cud see befre next appintent?

Wi GP nw resuts?

8.1.2 RESUlTS oF INvESTIGATIoNS

A rapid referra fr priar t secndar care was cnsidered iprtant t pschgicawe -being but this was seties deaed, as wen were nt awas aware that a ieihdf breast cancer was being cnsidered b the GP. There was n cnsistent apprach t priding

infratin abut the tripe assessent and an wen were unaware f what t expectas the ed fr priar t secndar and tertiar care. GPs, cnsutants and breast carenurses were cnsidered gateeepers t infratin abut resuts and their apprach t patientswas er iprtant.

8 INfORmaTION fOR DIsCUssION wITh paTIeNTs aND CaReRs


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Frequently asked questions:

T the GP what are u ing fr?

Hw ng wi I wait fr an appintent?

Wi I be seen at ca hspita?

What is the nae f the dctr wh wi see e? What wi happen at the hspita?

Cud u write this dwn fr e?

Is there an infratin that I cud read?

When wi I get the resuts?

Wh wi gie e the resuts?

8.1.3 SIDE EFFECTS oF TREATmENT

There were a nuber f treatents that were beieed t cause signicant side effects incudingsurger, chetherap and raditherap. The cn thee was that the quantit and quaitf infratin abut side effects was insufcient and, at ties, gien in an ad hc anner. The

arit f participants had nt receied written infratin r taped cnsutatins, and thereappeared t be n cnsistent apprach t updating and adding t the infratin gien r theuse f pubished aterias. There was se er psitie feedbac abut using a recrd bwhie underging chetherap t recrd the different side effects experienced.


What des the surger ine?

Are there an side effects f surger?

Hw ng wi I need t sta ff wr?

What des the scar ie?

What are the side effects f chetherap?

Can I hae infratin n the specic chetherap drugs I a n?

Can I hae infratin abut raditherap; adex; taxifen; ariidex r the nae fthe drug u are n?

Wh wi be in charge f care?

Wh d I cntact if I hae a particuar cncern?

8.1.4 INFoRmATIoN FoR CARERS

Infratin fr the patients persna supprt netwrs i.e. fai, carers and friends, was eriprtant. The as need t be ined in cnsutatins when cnsidered apprpriate b thepatient. Specic issues were identied that addressed different age grups f wen.

yunger wen raised cncerns abut the ipact f the diagnsis n ung chidren,reatinships and epent.

Ethnic inrities had iited access t written infratin that is bth cutura apprpriateand in the crrect anguage.

Wen r their carers wh had pr reading sis, were isua ipaired r deaf needed tbe abe t access a range f infratin ther than written ateria. This a incude tapes,ide ateria incuding British sign anguage signing and died pictria infratin.


Can partner, carer, friend ce int the r with e?

Are their paces fr carer t access supprt?

Is there sene we can get adice abut benets?


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8.1.5 HomE CARE / FolloW UP

There were signicant ariatins between wens experiences f aftercare. Se fund theirGP and breast care nurse a great surce f supprt whie thers fet abandned and isatedwithut nwing wh t cntact. Wen had a nuber f cncerns abut recurrence,practica supprt incuding wigs and prsthesis, pschgica supprt and nging fw upcare.


Wh ts prsthesis?

Hw ften can it be repaced?

D I hae t pa fr it?

Wh d I cntact when treatent is nished in the hspita?

Des GP nw what treatent I hae had?

Hw ften wi I be fwed up?

Wh wi d the fw up?

Wi the d additina tests?

Hw wi I nw if the cancer is bac? Are there an supprt grups I can attend?

8.2 sOURCes Of fURTheR INfORmaTION fOR paTIeNTs aND CaReRs

Brt Cncr Cr4th r, 40 St Ench SquareGasgw G1 4DHTe: 0845 077 1892 Fax: 0141 221 9499 Eai: [email protected] www.breastcancercare.rg.u

Breast Cancer Care prides infratin, practica assistance and etina supprt fr anneaffected b breast cancer.

CncrBaCUp scotndSuite 2, 3rd Fr, Cranstn Huse, 104-114 Arge StreetGasgw G2 8BHTe: 0141 223 7676 Fax: 0141 248 8422 Freephne hep ine: 0808 800 1234, mnda t Frida 9a t 7pwww.cancerbacup.rg.u

offers a free cancer infratin serice staffed b quaied and experienced cancer nurses.There are a grwing nuber f CancerBACUP centres in hspitas and a freephne infratinserice n a tpes f cancer, staffed b speciaist cancer nurses. Prduces er 50 betsand CancerBACUP News three ties a ear.

Cncr Rrc UkPo Bx 123, 61 lincns Inn Fiedslndn WC2A 3PXTe: 020 7242 0200 Fax: 020 7269 3100 www.cancerresearchu.rg

mcin Cncr Ri scotndosburne Huse, 1-5 osburne TerraceEdinburgh EH12 5HGTe: 0131 346 5346 Fax: 0131 346 5347 Hepine: 0808 808 2020, mnda t Frida 9a t 6p www.acian.rg.u

A Uk charit supprting pepe with cancer and their faiies with speciaist infratin,treatent and care.

8 INfORmaTION fOR DIsCUssION wITh paTIeNTs aND CaReRs


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mi Cntr scotndThe Stabes, Western Genera HspitaEdinburgh EH4 2XUTe: 0131 537 3131 Fax: 0131 537 3130

The Gatehuse, Western Inrar, 10 Dubartn RadGasgw G11 6PATe: 0141 330 3311 Fax: 0141 330 3363 Eai: [email protected] www.aggiescentres.rg

The ga f maggies is t eep pepe wh hae cancer as heath in ind and bd as ispssibe, b enabing the t participate actie in the treatent f their disease.

T Tnt Cncr suort scotndFat 5, 30 Shee Curt, Gartnae CpexGasgw G12 0yNTe: 0141 211 0122 Fax: 0141 211 3988Eai: [email protected] www.tatent.rg.u

Prtes the care f cancer patients, their faiies, friends and the staff ined prfessinain cancer care b priding practica and etina supprt, infratin, cunseing andtherapies as required. Netwr f ca supprt grups thrughut Sctand.


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9 DevelOpmeNT Of The gUIDelINe

9 Dont o t uidin

9.1 INTRODUCTION

SIGN is a cabratie netwr f cinicians and ther heathcare prfessinas, funded b NHSQuait Ipreent Sctand. SIGN guideines are deeped b utidiscipinar grups fpractising cinicians using a standard ethdg based n a ssteatic reiew f the eidence.Further detais abut SIGN and the guideine deepent ethdg are cntained

Management of Breast Cancer in Women (a National Clinical Guideline)

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Transcript of Management of Breast Cancer in Women (a National Clinical Guideline)