SAKK Lung Cancer Group. Current activities and future projects

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1 SAKK Lung Cancer Group Current activities and future projects

2 SAKK Lung Cancer Group Open group of physicians interested in lung cancer Mostly Medical Oncologists, but also Thoracic Surgeons Radiation oncologists Pathologists Pneumologist Meet 4x/year

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4 NSCLC Stages Ib-II Participation in IALT and Notch trial Bad recruitement Participation in EORTC trial Adjuvant Chemotherapy +/- Bevacizumab

5 Overview Stage IIIA -> SAKK 16/00 Stage IIIB -> SAKK 16/01 Stage IV -> SAKK 19/05 Mesothelioma -> SAKK 17/04 Translational research -> all

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7 Stage III, how it started SAKK 16/96

8 Results of SAKK 16/96 Study: 3 x Cisplatin/Taxotere neoadjuvant (Betticher, JCO 2003) Overall Survival (ITT population, n=90) Overall survival 1.8 complete resection.6.4 all.2 0 p< incomplete resection Months

9 SAKK 16/00 Hypothesis: Neoadjuvant RT increases complete resection rate -> EFS Chemotherapy: SAKK 16/00 TRIAL DESIGN Cisplatin 100 mg/m 2 d1 Docetaxel 85 mg/m 2 d1 Radiotherapy: Randomization Arm A Arm B Chemotherapy Chemotherapy Radiotherapy Surgery Surgery 3 weeks after last chemotherapy 44 Gy in 22 fractions concomitant boost in 3 weeks, Surgery 3-4 weeks after termination of radiotherapy

10 SAKK 16/00 Preliminary pooled data on 47 patients RR (CT) % operable % CR PR no 14.9 NC PD yes 72.3 NA unknown Information missing 12.8 No perioperative deaths!

11 RTOG study, activated 05/05 accrual 5, planned 574

12 N3

13 SAKK 16/01 - Hypothesis: IIIB trimodality therapy with neoadjuvant RT Staging / Mediastinocopy Chemotherapy Cycle 1 Cycle2 Cycle 3 RT 44 Gy 21 d d d Surgery Chemotherapy: Docetaxel 85 mg/m2 Cisplatin 100 mg/m2 Accelerated concomitant boost 22 x 2 Gy in 3 weeks (7 fx/week) R. Stupp

14 Preliminary results: EFS (n = 20/46) Figure 1: SAKK 16/01 event-free survival (primary endpoint) / // / / / / Event-free survival (months)

15 Study Design: Pilot 16/07 NSCLC IIIB T4, N0-N2 N3, Organ infitration* Pl. or per. effusion S o r a f e n i b RT 44 Gy yes Chemotx x 4 cy Response no RT- Chemo 60 Gy Chemotx x 4 cy Like stage IV disease Surgery S. Peters * Aorta, Esophagus, myocardium

16 Stage IV, a new paradigm: Experimental first line therapy? Multicenter phase II trial of gefitinib first-line therapy followed by chemotherapy in advanced non-small cell lung cancer (NSCLC) preliminary results of SAKK 19/03 Giannicola D'Addario Registration Gefitinib 250 mg/day until progression Gemcitabine 1250 mg/m 2 d1 and d8 Cisplatin 80 mg/m 2 d1 every 3 weeks for up to 6 cycles Follow-up

17 Response to gefitinib ( n = 63 ) Week CR PR SD PD NA* DSR % ORR% Response to chemotherapy ( n = 23 ) CR PR SD PD NA DSR % ORR % Median overall survival was 42.7 weeks (10.0 months)

18 Stage IV: SAKK 19/05 - Hypothesis: First line combined targeted therapy in NSCLC? Registration Erlotinib 150 mg/day + Bevacizumab 15 mg/kg q3w until progression Gemcitabine 1250 mg/m 2 d1 and d8 plus Cisplatin 80 mg/m 2 d1 or Carboplatin AUC 5 every 3 weeks for up to 6 cycles Follow-up For stage IIIB/IV non-squamous NSCLC No cavitation, CNS metatastases, anticoagulation Not requiring immediate chemotherapy F. Zappa

19 SAKK 17/00 R. Stahel et SAKK 61 pts 58 operated 1 postoperative death 1 year OS 67%

20 Multicenter randomized phase II trial (SAKK 17/04) Q Part 1 Part 2 Registration after staging Chemotherapy * Restaging Surgery Follow-up if not operable Reassessment R0 or R1 R2 Follow-up Randomisation Arm A: No Radiotherapy Arm B: Hemithoracic Radiotherapy *3 cyles of cisplatin/pemetrexed R. Stahel

21 A randomised, multi centre Phase II trial of ZD6474 vs Vinorelbine in patients with relapsed mesothelioma (T. Rordorf) Primary endpoint: clinical benefit (CB=CR+PR+SD) CB<30% not worth further investigation; CB>45% promissing Total number of patients needed: 65 stage I analysis after 46 patients Inoperable or relapsed MPM after First line treatment (N=65) Zactima 300 mg po Stage I Analysis (46 pts) Zactima 300 mg po Navelbine 30 mg/m2 iv weekly Navelbine 30 mg/m2 iv weekly

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23 Gene expression in blood discriminates patients with lung cancer from healthy volunteers M. Brutsche et al., Barcelona 2005 BLOOD Normal (n=20) SCLC (n=10) NSCLC (n=8)

24 planned trials Stage IV SAKK 19/08??? SCLC In planning: phase II trial with targeted agent

25 Please come!