Optimizing NSCLC Staging:...

Optimizing NSCLC Staging: Mediastinoscopy

Stephen G. Swisher, MD

University of Texas M.D. Anderson Cancer Center

13th Annual International Lung Cancer Congress

Huntington Beach, CA

July 19, 2012

Why is accurate mediastinal staging important?

• Non-invasive ablative methods are utilized

increasingly and target only the primary

– SBRT, RFA

• Presence of multi-level N2 or N3 favors

non-surgical approach (CRT) and helps

define RT field

Staging of NSCLC

• Non-invasive:

– CT

– PET (PET/CT)

• Invasive:

– Mediastinoscopy (Standard, Extended)

– EBUS/FNA

– EUS/FNA

– Transthoracic FNA (CT guided)

– Thoracoscopy

– Chamberlain

Non-Invasive Mediast Staging CT and PET Imaging

False

Negative

False

Positive Prevalence

CT (n=3438) 43% 18% 28%

PET (n=1045) 16% 11% 32%

Toloza, CHEST 2003;123:137S Birim, Ann Thorac Surg 2005;79:375

Toloza et al., Chest, 2003

False Positive PET

0

10

20

30

40

0-2.0 2.1-3.0 >3.0

Peripheral

Central

N2 m

eta

sta

se

s %

Tumor size (cm) Lee et al., Ann Thor Surg, 2007

False Negative PET

Personal Indications for Mediastinal Nodal Sampling

• Positive CT or PET

• Negative CT and PET

– Centrally located tumors

– ‘High Risk’ Surgery

– Ablative Therapy (SBRT/RFA) ?

Mediastinoscopy vs EBUS

Leyn et al., MMCTS, 2004

Standard Cerv Med Extended Cerv Med

Leschber et al., EJTCVS, 2003; 24:192-95

Invasive Mediastinal Staging Video-assisted Mediastinoscopic Lymphadenctomy

(VAMLA)

Kuzdzal et al., EJTCVS, 2005; 27: 384-90

Zielinski et al., MMCTS, 2007

Invasive Mediastinal Staging Transcervical Extended Mediastinal Lymphadenctomy

(TEMLA)

Mean Op Time - 191 minutes

Op Mort – 2.2%

Invasive Mediastinal Staging EBUS vs Mediastinoscopy – ACCP

False

Negative

False

Positive Prevalence

EBUS (n=918) 20% 0% 78%

Med.(n=6505) 11% 0% 39%

Detterbeck et al., Chest, 2007

Mediastinal Staging EBUS vs Mediastinoscopy – ACCP

False

Negative

False

Positive Prevalence

CT (n=3438) 43% 18% 28%

PET (n=1045) 16% 11% 32%

EBUS (n=918) 20% 0% 78%

Med.(n=6505) 11% 0% 39%


Toloza et al., Chest, 2003

E

n

r

o

l

l

e

d

cT1-4 N0-3 M0

NSCLC

CT+/- PET

Mediastinoscopy

N=153

Yasufuku et al., JTCVS, 2011

EBUS

N=153

Surgery

EBUS Mediastinoscopy NSCLC Staging - Toronto


EBUS Mediastinoscopy LN Stations Inadequately Sampled

LN Station EBUS

Adequate

EBUS

Inadeq.

Med.

Adequate

Med.

Inadeq.

2R 24 6 (20%) 113 2 (2%)

4R 99 38 (28%) 150 1 (2%)

2L 1 1 (50%) 24 2 (8%)

4L 54 54 (50%) 130 2 (2%)

7 126 23 (15%) 146 3 (2%)

Total 304 122 (29%) 563 10 (2%)


EBUS Mediastinoscopy False Negative Patients (n=153)

EBUS

False Neg

Med

False Neg

EBUS + Med

False Neg

2R/L 3 0 0

4R 1 1 1

4L 1 4 0

7 1 2 0

5 or 6 ---- ---- 3

False Neg 6% 6% 3%


EBUS Mediastinoscopy Conclusions - NSCLC Staging - Toronto

• EBUS and Mediastinoscopy complementary

• EBUS needs LMA for 2R nodes

• EBUS more difficult for small nodes

• EBUS and Standard Cerv Med miss Level 5, 6

EBUS: Cost/Expertise

BF-UC160F-OL8 EU-C60

$45,900 $20,000

$65,900 $114,300

EBUS Accessible

EBUS Inaccessible


Level: 5 and 6

EBUS Inaccessible


Level: 5 and 6

Accessible by Extended

Cervical Mediastinoscopy

Invasive Mediastinal Staging Extended Med. Vs Chamberlain– LUL Tumors

False

Negative

False

Positive Prevalence

Ext. Med. Alone 25% 0% 39%

Chamb. Alone 27% 0% 39%

Ext. Med +

Chamberlain 15% 0% 39%


EBUS Inaccessible

Extend Cerv Med

Accessible

EUS Access EUS Access


R

a

n

d

o

m

i

z

e

d

Non-Metastatic

NSCLC

CT Node Pos

or

PET Node Pos

or

Central Tumor

Thoracotomy

N=65

Mediastinoscopy

N=65

Annema et al., JAMA, 2010

EBUS/EUS

N=123

Mediastinoscopy

N=111

Thoracotomy

N=57

Med vs EBUS/EUSSelect Med NSCLC Staging - ASTER

Annema et al., JAMA, 2010; Sharples et al., HTA, 2012

Med vs EBUS/EUSSelect Med NSCLC Staging - ASTER

Med Alone

(n=118)

EBUS/EUS

Select Med

(n=123)

P

Value

False Pos 0 0 NS

False Neg 21% 6% 0.02

Futile Thorac 21 9 0.02

Complication 7 6 NS

EQ-5D 0.117 (0.042 to 0.192) 0.003

Cost £10,459 £9713 NS

Annema et al., JAMA, 2010

Med vs EBUS/EUSSelect Med Conclusions-NSCLC Staging - ASTER

EBUS/EUSSelect Med optimal strategy vs Med Alone

• Reduced false negatives

• Reduced futile thoracotomies

• Similar complications

• Improved quality of life

• Slightly reduced cost

Mediastinoscopy High Risk Procedure / PET Negative

Sarwate et al., JTCVS, 2012; 144: 81-6

Invasive Mediastinal Staging STRT or RFA; PET NEGATIVE, Peripheral EBUS Alone

10/50 patients occult LNs

Conclusions

• Optimal staging for PET/CT + Med LNs is combination of EBUS and Cerv Med

– EBUS Select Med for EBUS Neg

• EBUS inaccessible Level 5, 6 require Extended Cerv Med (Chamb, VATS or CT fna)

• EBUS inaccessible Level 8 require EUS

Conclusions • PET/CT Negative Med LNs but central

tumors, high risk procedure

– EBUS Select Med for EBUS Neg

• PET/CT Negative Med LNs but ablative treatment

– EBUS Alone

• PET/CT Negative Med LNs, Peripheral, Small, Lobect + MLND

– EBUS optional

Thank You!

Tournoy et al., Lancet Onc, 2012

Invasive Mediastinal Staging Abnormal vs normal Imaging

Normal Mediastinal Imaging Abnormal Mediastinal Imaging

Morbidity of Mediastinoscopy

• RLN paresis 12 (0.55%)

• Hemorrhage 7 (0.32%)

• Tracheal injury 2 (0.09%)

• Pneumothorax 2 (0.09%)

• Death 1 (0.05%)

• Total Cerv Med n=2145

Lemaire et al., Ann Thor Surg, 2006

Tournoy et al., Lancet Onc, 2012

Invasive Mediastinal Staging Abnormal vs normal Imaging

Abnormal Mediastinal Imaging

Annema et al., Tech Gastro Endosc, 2007

Invasive Mediastinal Staging EUS vs EBUS

EBUS Expertise Number of Aspirations or ROSE for Accuracy

False

Negative

False

Positive Accuracy

Aspiration No 1 30% 0% 90%




Lee et al., Chest, 2008; 134;368-374

Consensus Statements

• European Society of Thoracic Surgeons:

‘PET positive mediastinal findings should be histologically or

cytologically confirmed.’

2007

• American College of Chest Physicians:

‘In patients with abnormal FDG-PET scan findings, further evaluation of the mediastinum with sampling of the abnormal lymph node should be performed prior to surgical resection of the primary tumor.’

2003

Optimizing NSCLC Staging:...

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