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Int. J. Radiation Oncology Biol. Phys., Vol. 64, No. 5, pp. 1432–1441, 2006Copyright © 2006 Elsevier Inc.

Printed in the USA. All rights reserved0360-3016/06/$–see front matter

doi:10.1016/j.ijrobp.2005.10.007

LINICAL INVESTIGATION Normal Tissues

A MODIFIED INFLAMMATORY BOWEL DISEASE QUESTIONNAIRE ANDTHE VAIZEY INCONTINENCE QUESTIONNAIRE ARE MORE SENSITIVE

MEASURES OF ACUTE GASTROINTESTINAL TOXICITY DURING PELVICRADIOTHERAPY THAN RTOG GRADING

USMAN KHALID, B.SC.,* CAMILLA MCGOUGH, B.SC., R.S.D.,* CLAIRE HACKETT, R.G.N., B.SC.,*PETER BLAKE, M.D., M.B.B.S., B.SC., F.R.C.R.,†

KEVIN J. HARRINGTON, B.SC., M.B.B.S., M.R.C.P., F.R.C.R.,†

VINCENT S. KHOO, F.R.A.C.R., F.R.C.R., M.D.,† DIANA TAIT, M.D., F.R.C.P., F.R.C.R.,†

ANDREW R. NORMAN, B.SC., PH.D.,‡ H. JERVOISE N. ANDREYEV, M.A., PH.D., F.R.C.P.*

Departments of *Medicine, †Radiotherapy, ‡Computing, The Royal Marsden Hospital, London and Surrey, UK

Purpose: Simple scales with greater sensitivity than Radiation Therapy Oncology Group (RTOG) grading todetect acute gastrointestinal toxicity during pelvic radiotherapy, could be clinically useful.Methods and Materials: Do questionnaires used in benign gastrointestinal diseases detect toxicity in patientsundergoing radiotherapy? The patient-completed Inflammatory Bowel Disease (IBDQ) and Vaizey Incontinencequestionnaires were compared prospectively at baseline and at Week 5 to physician-completed RTOG grading.Results: A total of 107 patients, median age 63 years, were recruited. After 5 weeks of treatment, patients withgynecologic and gastrointestinal cancer were more symptomatic than urologic patients (p � 0.012; p � 0.014).Overall, 94% had altered bowel habits, 80% loose stool, 74% frequency, 65% difficult gas, 60% pain, >48%distress, 44% tenesmus, >40% restrictions in daily activity, 39% urgency, 37% fecal incontinence, and 40%required antidiarrheal medication. The median RTOG score was 1 (range, 0–2), median IBDQ score 204.5(range, 74–224), and median Vaizey score 5 (range, 0–20). Chemotherapy preceding radiotherapy increased fecalincontinence (p � 0.002). RTOG scores stabilized after 3 weeks, IBDQ scores peaked at Week 4, and Vaizeyscores worsened throughout treatment. IBDQ and Vaizey scores distinguished between groups with differentRTOG scores.Conclusion: The IBDQ and Vaizey questionnaires are reliable and sensitive, offering greater insight into theseverity and range of symptoms compared with RTOG grading. © 2006 Elsevier Inc.

Pelvic radiotherapy, Acute gastrointestinal toxicity, Inflammatory Bowel Disease Questionnaire, Vaizey Incon-
tinence questionnaire, RTOG grading.
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INTRODUCTION

adiotherapy is used in the treatment of 40% of patientsith cancer. In the United Kingdom, this includes about2,000 patients who receive radiotherapy with curative in-ent for pelvic cancer annually (1). Of all the problems thatan arise after pelvic radiotherapy, new bowel symptomseem to have the greatest impact on quality of life (2–4).

During pelvic radiotherapy, the majority of patients de-elop acute gastrointestinal symptoms (5). After treatment,0–90% of all patients report a permanent change in theay their bowels behave and, in approximately 50%, new

hronic gastrointestinal symptoms affect quality of life (6,). Severe acute gastrointestinal toxicity may increase the

Reprint requests to: H.J.N. Andreyev, M.A., Ph.D., F.R.C.P.,epartment of Medicine, Royal Marsden Hospital, Fulham Road,ondon, SW3 6JJ, UK. Tel: (�44) 207-808-2105; Fax: (�44)
07-351-2477; E-mail: [email protected]. A
1432

isk of severe chronic problems (8, 9). It may be helpful todentify those patients at an early stage who are most likelyo develop long-term problems, so that treatment can beltered or appropriate measures can be introduced to try toelp them. However, toxicity scales should probably recordeveral different aspects. They should measure changesffecting the patients’ overall health, their quality of life,nd finally, symptoms or features that may or may not bemportant to the patient but that may have a prognostic role.

The long-term effects of pelvic radiation on the gastro-ntestinal tract have been inadequately studied (10). Forxample, within the literature, there is a wide variation inhe reported incidence of significant chronic toxicity rang-ng from 6% to 78% (11, 12). Although this may partly

This study was approved by the Research and Ethics committeesf the Royal Marsden Hospital.Received July 25, 2005, and in revised form Oct 6, 2005.

ccepted for publication Oct 10, 2005.

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1433Modified inflammatory bowel disease questionnaire ● U. KHALID et al.

eflect difference in individual responses in different tumorypes to different therapeutic regimens, the main issueeems to be one of inadequate measures of toxicity (13–17).

This may also be a problem in the acute setting. Theidely used assessment of acute toxicity to radiotherapy,

he Radiation Therapy Oncology Group (RTOG) toxicitycale (Table 1) is simple and is designed to give a rapid yetbjective assessment (18). However, it is certainly not com-rehensive. For example, it does not assess the developmentf anorectal symptoms such as fecal incontinence or tenes-us, and, because it produces scores that range from 0 � no

ymptoms to 5 � dead—and because most patients score 1r 2—it does not reflect the subtlety of the problems expe-ienced by patients. If a consequential late effect truly existsfter radiotherapy, the RTOG tool is certainly too blunt todentify most of the patients at risk.

There is a need, therefore, to investigate whether alter-ative simple yet reliable methods can provide better infor-ation about the effects of radiotherapy on the degree of

owel dysfunction and whether this can predict those pa-ients who will develop significant chronic gastrointestinalroblems.Acute exacerbations of inflammatory diseases such as

lcerative colitis and Crohn’s disease cause many of theame symptoms as radiotherapy toxicity. The long estab-ished patient completed Inflammatory Bowel Diseaseuestionnaire (IBDQ) is a good measure of disease activity

cross cultural divides in primary care and the hospitaletting (19–22) and provides a helpful assessment of phys-cal, functional, social and emotional well-being. Theaizey Incontinence questionnaire has been shown to out-erform other questionnaires as an effective measure ofetermining degree/severity of fecal incontinence (23).

We have recently shown that a modified IBDQ and theaizey questionnaire are simple ways to document chronicastrointestinal symptoms after pelvic radiotherapy (7), andhat these questionnaires are accurate and correlate wellith results obtained using the The Late Effects on Normalissues (LENT)–Subjective, Objective, Management andnalytic (SOMA) questionnaire. However, unlike LENTOMA, the modified IBDQ and Vaizey questionnaire doot require an interview, but are completed by a patient infew minutes with ease.We postulate that these simple questionnaires can be

pplied to oncology patients receiving pelvic radiotherapyn the acute setting and their precision will provide a muchore sensitive measure of acute gastrointestinal toxicity

uring pelvic radiotherapy than the current RTOG scoringystem. In turn, this may help identify those patients whoill progress to long-term problems.The study aimed to assess whether the modified IBDQ

nd Vaizey questionnaire could accurately measure the de-ree of acute gastrointestinal toxicity that occurs duringadiotherapy for different pelvic cancers and, second, toompare the results obtained using these questionnaires to
hose measured using the RTOG scoring system. B
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1434 I. J. Radiation Oncology ● Biology ● Physics Volume 64, Number 5, 2006

Table 2. Modified Inflammatory Bowel Disease Questionnaire

In the last 2 weeks please tell ushow often you have:

More thanever

beforeExtremelyfrequently

Veryfrequently

Moderateincrease infrequency

Someincrease infrequency

Slightincrease infrequency

Not atall/normal

1 had your bowel open?2 felt tired and worn out?3 felt frustrated, impatient, or

restless?4 been unable to do what you

want because of your bowels?5 had loose bowel movements?6 worried about your energy

levels?7 worried about having to have

something done about yourbowels?

8 you had to cancel anengagement because of yourbowels?

9 been troubled by pain in yourbottom?

10 felt generally unwell?11 worried about not being able to

find a lavatory?12 been prevented doing leisure or

sports by your bowels?13 been troubled by pain in your

tummy or bottom?14 been waking at night or having

difficulty sleeping?15 been depressed or discouraged?16 not gone somewhere because

there is no lavatory nearby?17 passed large amounts of gas?18 worried about getting to the

weight you would like?19 worried about your illness?20 been troubled by bloating?21 been relaxed and free of

tension?22 had a problem with bleeding

from your bottom?23 been embarrassed about your

bowels?24 felt like you need to have your

bowels open but nothinghappens?

25 felt tearful and upset?26 been troubled by accidental

soiling?27 felt angry as a result of your

bowel problems?28 felt limited in sexual activity

because of your bowels?29 felt disgusted about your bowel

problems?30 felt irritable?31 experienced lack of

understanding from others?32 felt satisfied, happy, or pleased

with your life?

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METHODS AND MATERIALS

ubjectsAll adult patients attending the Royal Marsden Hospital to start

adiotherapy for a histologically proven gynecologic, urologic, orelvic gastrointestinal cancer were eligible for this study. Subjectsith a previous history of radiotherapy were excluded. All dataere collected prospectively. Written, informed consent was ob-

ained from all patients. This study was approved by the Researchnd Ethics committees of the Royal Marsden Hospital.

ethodsA record of age, primary tumor site, and dose, fractionation, and

ype of radiotherapy, administration of any chemotherapy, previ-us bowel surgery, and the presence of chronic gastrointestinalisease were documented.Each patient was asked to fill in the modified IBDQ and Vaizey

uestionnaire before the start of radiotherapy, and then at 5 weeks.ome patients were at the end of radiotherapy at this 5-weekssessment, some (mainly prostate and bladder) had several moreemaining days of treatment. An assessment of bowel toxicity wasade by one investigator using the RTOG scale. In a subset, these

uestionnaires were also filled in on a weekly basis (Weeks 1, 2,, and 4).The modified IBDQ (Table 2) contains 32 questions. It takes

–7 min to complete. Each question is scored 1 to 7 according toymptom severity, with a score of 7 reflecting absence or nohange in the last 2 weeks and a score of 1 reflecting that theymptom is worse than ever before. Thus the highest score attain-ble is 224 suggesting that the patient is asymptomatic, and theowest score 32, a severely symptomatic patient. The modifiedBDQ consists of 10 questions specifically for the bowel, the scoref which can provide a bowel specific component (IBDQ-B) to theool. A maximum IBDQ-B of 70 (no bowel symptoms) and ainimum of 10 (severe bowel morbidity) is attainable.The Vaizey Incontinence questionnaire is usually completed

ithin 2–3 min. It contains 7 questions and is scored as shown inable 3. A score of 0 suggests perfect bowel continence, and acore of 24 suggests very severe bowel incontinence.

adiotherapy technique and dose prescriptionThe various radiotherapy techniques were chosen according to

Table 3. Vaizey In

Never Ra

ncontinence for solid stool 0ncontinence for liquid stool 0ncontinence for gas 0lteration to lifestyle 0

eed to wear a pad or plugaking constipating medicinesack of ability to defer defecation for 15 minutes

Never � no episodes in past 4 weeksRarely � 1 episode in past 4 weeksSometimes � �1 episode in past 4 weeks but �1 per weekWeekly � 1 or more episodes a week but �1 per dayDaily � 1 or more episodes per day

ifferent tumor types. Treatments and doses were individualized to 0

uit the needs of each patient. Typical pelvic radiotherapy proto-ols according to tumor site delivered to these patients are sum-arized elsewhere (7). However, most patients with gynecologic

r gastrointestinal tumors received approximately 45–60 Gy,hereas those receiving radiotherapy for genitourinary cancer hadarying doses of approximately 20–30 Gy or 64–74 Gy.

tatistical rationale and analysisTo determine whether these questionnaires measured acute tox-

city accurately during pelvic radiotherapy, we calculated that 100atients would allow a correlation of r � 0.3 to be detected with0% power using Spearman’s correlation. The Mann-Whitney Und chi-squared tests were used to compare questionnaire scoresnd symptoms between the different pelvic cancers.

RESULTS

atient demographicsBetween February and May 2005, 107 consecutive pa-

ients were recruited onto the study; 38 were to start radio-herapy for gynecological cancer, 39 for urologic cancer,nd 30 for a gastrointestinal cancer in the pelvis. Theirharacteristics are shown in Table 4. All patients success-ully completed the questionnaires before radiotherapy and4 completed them after 5 weeks of treatment. Sixty-fiveatients (13 with gynecologic cancer, 32 with urologicancer, and 20 with gastrointestinal cancer) completed theuestionnaires at Weeks 1, 2, 3, and 4 during the course ofadiotherapy.

aseline dataBaseline data are described in Table 5. Patients with

ynecologic cancer were significantly more symptomatichan those with urologic cancer (RTOG p � 0.039; IBDQ p

0.004; IBDQ-B p � 0.043, Vaizey p � 0.9). Gastroin-estinal cancer patients were significantly more symptom-tic than patients with gynecologic cancer (RTOG andBDQ-B p � 0.001; Vaizey p � 0.026; IBDQ p � 0.005)nd urologic cancer (RTOG, IBDQ, and IBDQ-B p �

nce Questionnaire

Sometimes Weekly Daily

2 3 42 3 42 3 42 3 4

No Yes0 20 20 4

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.001; Vaizey p � 0.005). The high levels of symptoms in

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he gastrointestinal cancer patients seemed to be related tohe tumor itself, which frequently caused gastrointestinalymptoms, and because all of this group had received che-otherapy before the start of radiotherapy. Baseline symp-

oms in the gynecologic cancer patients appeared in many toe a consequence of recent pelvic surgery.

ive-week dataThe Modified Inflammatory Bowel Disease Question-

aire: The data suggest that 88 patients (94%) had noticedchange in their bowel habit of varying severity (Table 6).he median score on the IBDQ was 204.5 (range, 74–224).mong the symptomatic patients, the median score was04 (range, 74–222). A significant proportion of patients�48%) were emotionally distressed as a result of theirowel problems, and �40% of the patients had symptomsausing considerable social implications.

The IBDQ scores were significantly higher (i.e., better) in

Table 4. Pat

Gynecology

umber of patients (%) 38 (36)edian age 57.5ange 29–82rior IBD or abdominal/pelvic surgery 25 (66%)rior/concomitant chemotherapy 17 (45%)umor site:Cervix 14Uterus 19Ovary 3Vagina 1Vulva 1Prostate —Bladder —Anus —Rectum —Rectosigmoid junction —Colon —

Abbreviations: GI � gastrointestinal; IBD � irritable bowel di

Table 5. Scores for entire cohor

Gynecology Urology Gastrointestinal

Before radiotherapy

TOGedian score 0 0 1ange 0–1 0–0 0–2aizeyedian score 0 1 2ange 0–11 0–6 0–16

BDQedian score 215.5 222 199.5ange 152–224 171–224 134–224

BDQ-Bedian score 69 70 64ange 53–70 47–70 44–70

Abbreviations: RTOG � Radiation Therapy Oncology Group; IBDQ

atients with urologic cancer than those with gynecologicancer (p � 0.012).

Change in scores from baseline: To examine the effect onymptoms from radiotherapy as opposed to preexisting ef-ects from previous surgery or tumor within the bowel,hanges from baseline for individual groups and for thehole cohort were assessed. In the gynecologic patients, theifferences of the mean scores from baseline was 1.24 (95%I, 0.92–1.56; p � 0.001) for the RTOG scale, 5.27 in theaizey scores (95% CI, 3.48–7.06; p � 0.001), �21.48 in

he IBDQ scale (95% CI, �12.22 to �30.75; p � 0.001),nd �10.52 for the IBDQ-B (95% CI, �7.43 to �13.61; p

0.001). In the urology group, the same values were 1.1695% CI, 0.92–1.39; p � 0.001), 2.76 (95% CI, 1.38–4.15;� 0.002), �13.17 (95% CI, �7.46 to �18.87; p � 0.001),

nd �6.56 (95% CI, �4.43 to �8.68; p � 0.001), respec-ively. In the gastrointestinal patients, they were 0.59 (95%

aracteristics

Urology GI Total

39 (36) 30 (28) 10768 61.5 63

48–81 47–79 29–8212 (31%) 11 (37%) 50 (47%)

3 (8%) 30 (100%) 50 (47%)

— —— —— —— —— —34 —5 —

— 3— 23— 2— 2

re radiotherapy and at 5 weeks

al Gynecology Urology Gastrointestinal Total

At week 5 of radiotherapy

2 1 1 10–2 0–2 0–2 0–2

6 2 8 50–20 0–18 1–16 0–20

197 209 199 204.5224 121–224 134–222 74–221 74–224

59 63 60 610 35–70 43–70 33–68 33–70

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I, 0.17–1.02; p � 0.102), 4.72 (1.85–7.6; p � 0.007),6.57 (95% CI, �22.85–9.71; p � 0.903), and �4.00

�9.74–1.74; p � 0.251), respectively. In summary, in theynecologic and urologic patients consistent changes fromaseline are seen, which are likely to reflect toxicity fromreatment, whereas the changes in the gastrointestinal pa-ients are much more varied, suggesting a reduction inymptoms from the tumor over time, which might maskome of the negative effects on symptoms from the radio-herapy treatment.

Results from the bowel-specific questions (IBDQ-B) fromhe modified IBDQ: Median score was 61 (range, 33–70).

Table 6. Results

Gynecology

ncrease in bowel frequency 26 (79%oose motions 28 (85%ain in abdomen or bottom 24 (73%assing large amount of gas 22 (67%eeling of bloating 15 (45%ectal bleeding 7 (21%enesmus 15 (45%ccidental soiling 7 (21%eeling disgusted about bowel problems 4 (12%

elt tired and worn out 26 (79%orried about energy levels 23 (70%

elt generally unwell 18 (55%aking at night or having difficulty sleeping 19 (58%orried about getting to the weight youwould like

8 (24%

elt frustrated, impatient, or restless 17 (52%orried about having something done aboutyour bowels

8 (24%

orried about not being able to find alavatory

19 (58%

een depressed or discouraged 13 (39%orried about your illness 16 (48%ot relaxed or free of tension 13 (39%een embarrassed about your bowels 9 (27%elt tearful or upset 10 (30%elt angry as a result of bowel problems 5 (15%elt irritable 14 (42%xperienced lack of understanding fromothers

5 (15%

ot felt satisfied, happy, or pleased withyour life

9 (27%

nable to do what you want because of yourbowels

18 (55%

ancelled an engagement because of yourbowels

7 (21%

ot done leisure or sport because of yourbowels

10 (30%

ot gone somewhere because there is nolavatory nearby

12 (36%

imited in sexual activity because of yourbowels

6 (18%

BDQ-B scores were significantly higher (i.e., better) in i

atients with urologic cancer than those with gynecologicancer (p � 0.015) (Table 6).

The Vaizey Incontinence Questionnaire: Forty (37%)atients were incontinent for solid or liquid stools; 26%63% of these) felt that their incontinence altered theirifestyle (Table 7). The median score on the Vaizeyncontinence questionnaire was 5 (range, 0 –20). If thoseatients who had no fecal incontinence problems werexcluded, the median score for the remaining symptom-tic patients was 6 (range, 1–20). The Vaizey score wasignificantly lower (i.e., better) in patients with urologicancer than gynecologic cancer (p � 0.014) and gastro-

IBDQ at week 5

Urology (%) Gastrointestinal (%) Total (%)

Proportion of patients with bowel symptoms27 (71%) 17 (74%) 70 (74%)29 (76%) 18 (78%) 75 (80%)15 (39%) 17 (74%) 56 (60%)24 (63%) 15 (65%) 61 (65%)10 (26%) 2 (9%) 27 (29%)2 (5%) 5 (22%) 14 (15%)

13 (34%) 13 (57%) 41 (44%)6 (16%) 9 (39%) 22 (23%)5 (13%) 5 (22%) 14 (15%)

roportion of patients with systemic symptoms27 (71%) 15 (65%) 68 (72%)14 (37%) 12 (52%) 49 (52%)11 (29%) 10 (43%) 39 (41%)21 (55%) 13 (57%) 53 (57%)7 (18%) 5 (22%) 20 (21%)

roportion of patients with emotional symptoms14 (37%) 11 (48%) 42 (45%)9 (24%) 9 (39%) 26 (28%)

13 (34%) 13 (57%) 45 (48%)

9 (24%) 11 (48%) 33 (35%)14 (37%) 13 (57%) 43 (46%)12 (32%) 9 (39%) 34 (36%)

7 (18%) 7 (30%) 23 (24%)2 (5%) 8 (35%) 20 (21%)3 (8%) 6 (26%) 14 (15%)

14 (37%) 13 (57%) 41 (44%)0 (0%) 1 (4%) 6 (6%)

5 (13%) 7 (30%) 21 (22%)

Proportion of patients with social symptoms9 (24%) 11 (48%) 38 (40%)

5 (13%) 7 (30%) 19 (20%)

5 (13%) 10 (43%) 25 (27%)

7 (18%) 9 (39%) 28 (30%)

1 (3%) 6 (26%) 13 (14%)

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RTOG scores: The median RTOG score was 1 (range,–2) (Table 8). For the symptomatic patients, the mediancore was 2 (range, 1–2). No statistically significant differ-nces in scores occurred between the different tumorubgroups.

Correlations between IBDQ and Vaizey with RTOG: Allcores correlated significantly at baseline and Week 5 ofreatment (Figs. 1 and 2).

Risk factors and bowel dysfunction: This study was notowered to identify which risk factors correlate with sub-equent bowel toxicity. However, the presence of chronicowel disease or surgery before radiotherapy did not sig-ificantly affect scores at Week 5. Chemotherapy adminis-ration did appear to be associated with a significant in-rease in RTOG score, a significant decrease in IBDQ andBDQ-B scores at baseline (p � 0.001), and a significantncrease in the Vaizey score at Week 5 (p � 0.002). Thereas no significant difference for Vaizey scores at baseliner RTOG, IBDQ, and IBDQ-B scores at Week 5.Trends in symptom severity during the course of

adiotherapy: RTOG scores rose reaching a plateau aftereek 3. Vaizey scores continue to rise steadily throughout.

BDQ and IBDQ-B scores were highest (i.e., best) at Weekand lowest (i.e., worst) at Week 4, after which they began

o rise again.

DISCUSSION

This study shows that two simple patient-completeduestionnaires validated for benign inflammatory diseasesan accurately measure the degree of acute gastrointestinaloxicity during radiotherapy for pelvic cancer. Results ob-ained with these questionnaires correlate significantly withcores recorded using the RTOG tool, but within eachTOG scoring band, a wide variation in symptoms can be

dentified using the IBDQ and Vaizey scales. Therefore,

Table 7. Vaizey Incontinence Questionna

Gynecology(% of gynecology patients)

Uro(% of urolo

ncontinent for solidstools

10 (26%) 6 (

ncontinent forliquid stools

11 (29%) 12 (

ncontinence for gas 19 (50%) 18 (ncontinence

affecting lifestyle11 (29%) 7 (

eed to wear a pador plug

3 (8%) 3 (

eed forconstipatingmedicines

23 (61%) 13 (

annot deferdefecation for 15min

18 (47%) 10 (

hese more sensitive symptom measurement scales can con- V

ribute important knowledge undetected by the isolated usef the RTOG scale.There are several reasons why it is important to measure

cute toxicity accurately. First, it may indicate why somereatments should be preferred to others. Perhaps equallymportant, if the concept of the “consequential late effect” isorrect (8, 9), identifying those early on who are at high riskf significant late toxicity may allow intervention at an earlytage with antifibrotic agents to ameliorate that late toxicity.hird, if side effects are not measured accurately, cliniciansay remain unaware of problems that are important to

atients, but that the patients do not voluntarily divulge.The correlation of IBDQ and Vaizey scores with RTOG

or acute toxicity agrees with our earlier study in whichBDQ and Vaizey scores correlated with LENT SOMA forhronic toxicity (7). This establishes that these simple pa-ient-administered questionnaires are not only accurate inssessing gastrointestinal dysfunction in benign gastrointes-inal disease, but can assess toxicity to pelvic radiotherapyn oncology patients both in acute and chronic settings.

oreover, the IBDQ and Vaizey questionnaires offer aignificantly more sensitive indicator of gastrointestinalysfunction and its impact on quality of life than the RTOGcale. Importantly, the RTOG failed to detect the degree ofymptomatology before the start of radiotherapy. This maye because many patients have bowel symptoms such asonstipation, bloating, tenesmus, and fecal incontinence,hich are not picked up by the RTOG, but are reflected in

he IBDQ and Vaizey scores.The IBDQ detected that nearly all patients (94%) in this

ohort developed a change in their bowel habit during treat-ent in agreement with one previous study (24). However,hen RTOG scale was used 17% were classed as having no

oxicity at Week 5, a similar proportion to that reported in theiterature (5). It remains to be determined whether the in-reased incidence of abnormalities detected by the IBDQ and

portion of patients with positive results)

ients)Gastrointestinal

(% of all gastrointestinal patients)Total

(% of all patients)

9 (30%) 25 (23%)

10 (33%) 33 (31%)

15 (50%) 52 (49%)10 (33%) 28 (26%)

4 (13%) 10 (9%)

7 (23%) 43 (40%)

14 (47%) 42 (39%)

ire (pro

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31%)

46%)18%)

8%)

33%)

26%)

aizey questionnaires are clinically relevant.

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The gradual deterioration of IBDQ scores during radio-herapy in Weeks 1–4 is another indicator that these ques-ionnaires are sensitive measures of radiotherapy-inducedoxicity. The maximal histologic changes after radiotherapyeem to occur within the first 2 weeks of treatment (25–29),ut as with all inflammatory bowel diseases, the timing andeverity of symptoms may not always reflect the degree ofistologic change and stool consistency or the degree ofystemic and psychologic upset together with other factorsay contribute.The median IBDQ score at Week 5 was 204.5 (range,

4–224) and the median IBDQ-B (bowel-specific) scoreas 61 (range, 33–70). More than a third (37%) of theatients were incontinent for stool. The median Vaizeycore was 5 (range, 0–20). These scores may seem tondicate minor changes only. However, these data can in-

RTOG vs VAIZEY

0

5

10

15

20

0 0.5 1 1.5 2 2.

RTOG

yeziaV

RTOG vs IBDQ-B

0

1020

30

40

5060

70

80

0 0.5 1 1.5 2 2.

RTOG

B-Q

DBI

VAIZEY vs IBDQ-B

010

203040

5060

7080

0 5 10 15 20

Vaizey

B-Q

DBI

Spearman’s correlation = - 0.39

Spearmans’s correlation = 0.33


Fig. 1. Correlation graphs (baseline). IBDQ � InflammatOncology Group.

icate significant social implications for the patients as just c

ne point difference in the Vaizey score, for example, canean the difference between being able to carry out normal

ctivities of daily living and having to rely on help fromthers. Some patients may not leave their house except to goo their hospital appointments because of their urgency ando may report that they are rarely incontinent, in which caseVaizey score will not accurately reflect the degree of fecal

ncontinence. Indeed, 30% of our cohort and 36% of theynecologic cancer population did not go somewhere be-ause there was no lavatory nearby. A total of 58% of theynecologic cancer patients were worried about not beingble to find a lavatory.

The wide range in scores may be due to several factors.t may reflect that a large difference in normal sensitivity toadiotherapy exists between patients. We found that patientsith gynecologic or gastrointestinal cancers were signifi-

RTOG vs IBDQ

0

50

100

150

200

250

0 0.5 1 1.5 2 2.5

RTOG

QD

BI

VAIZEY vs IBDQ

0

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200

250

0 5 10 15 20

Vaizey

QD

BI

All correlation values are significant at the 0.01 level (2-tailed)



wel Disease Questionnaire; RTOG � Radiation Therapy

5

5

ory Bo

antly more symptomatic than urologic cancer patients.

ImUskwtwoeumvsm2

ti

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ncreased symptoms in patients with gastrointestinal tumorsay be due to a combination of treatment and tumor site.rologic patients may be less symptomatic because of the

maller volume of the bowel irradiated. However, it is alsonown that men tend to report symptoms less often andhen they do, they tend to minimize the severity/impact of

hat symptom on their quality of life (30). Different patientsill tend to score subjective symptoms differently. On thether hand, the data may be skewed by the inclusion withinach of the three groups—gastrointestinal, gynecology, andrology—of patients who received quite different treat-ents in terms of fractions delivered, field arrangements,

olume of bowel irradiated, and total dose delivered topecific structures. Finally, the addition of antidiarrhealedication, which by definition scores the patient as Grade

RTOG vs VAIZEY

0

5

10

15

20

25

0 0.5 1 1.5 2 2.5

RTOG

Vai

zey

RTOG vs IBDQ-B

010203040

50607080

0 0.5 1 1.5 2 2.5

RTOG

IBD

Q-B

VAIZEY vs IBDQ-B

0

10

20

3040

50

60

70

80

0 5 10 15 20 2

Vaizey

IBD

Q-B

Spearman’s correlation = 0.54



Fig. 2. Correlation graphs (Week 5). IBDQ � InflammatoOncology Group.

, may depend on the whim of a variety of doctors who see r

he patient and who may have a very variable threshold forntroducing antidiarrheal medication.

We have shown in the current study that chemotherapyay worsen fecal incontinence during the course of radio-

herapy. This is not a surprising finding because chemother-py and radiotherapy together are thought to cause in-reased toxicity. However, in patients with gastrointestinalancer, it is more difficult to be certain about the relativeontribution to symptoms from the tumor itself, which mayhrink and become less symptomatic as treatment proceedst the same time as potential toxicity from the chemotherapynd radiotherapy starts to manifest itself. In addition, be-ause we failed to recruit our target number of gastrointes-inal cancer patients, it is possible that the full spectrum ofastrointestinal toxicity was not represented and further

RTOG vs IBDQ

0

50

100

150

200

250

0 0.5 1 1.5 2 2.5

RTOG

IBD

Q

VAIZEY vs IBDQ

0

50

100

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250

0 5 10 15 20 25

Vaizey

IBD

Q



All correlation values are significant at the 0.01 level (2-tailed)

el Disease Questionnaire; RTOG � Radiation Therapy

5

ry Bow

esearch needs to be carried out in this group of patients

ps

qP(hmdit

tidrigsat

1

1

1

1

1

1


articularly to determine how different factors contribute toymptoms.

Although these questionnaires are validated tools, someuestions may have been inappropriate for oncology patients.atients often found it distressing to answer questions 21“been relaxed and free of tension”) and 32 (“felt satisfied,appy, or pleased with your life”) of the IBDQ. Also, patientsay not completely understand the term incontinence, or may

efine it differently. Patients often refuse to admit to fecalncontinence because it is highly stigmatized; they prefer to use
erms such as leakage or soiling instead (31). w
REFEREN

The comparison of LENT/SOMA and RTOG/EORTC late-

1

1

1

1

2

2

2

2

2

2

2

2

2

2

3

3

In conclusion, long-established simple gastroenterologyools used in benign gastrointestinal diseases and validatedn primary care and hospital settings and across culturalivides are applicable to oncology patients receiving pelvicadiotherapy. Their simplicity and precision makes themdeal in providing a sensitive measure of acute and chronicastrointestinal toxicity, such that those patients requiringpecialist help can be identified. Further prospective studiesre required to determine whether use of more sensitiveoxicity scales such as these in the acute phase can predict
hich patients will develop late toxicity.
CES

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