- Email: [email protected]
04
Annals of Oncology 25 (Supplement 5): v1–v41, 2014 doi:10.1093/annonc/mdu438.65
17
Klinik für Chirurgie, Kantonsspital St. Gallen, St. Gallen, SWITZERLAND Radio-onkologie, Inselspital Bern, Bern, SWITZERLAND Klinik für Onkologie, Luzerner Kantonsspital, Lucerne, SWITZERLAND 20 Division of Thoracic Surgery, Universitätsspital Zürich, Zurich, SWITZERLAND 18
thoracic malignancies, other LBA37 PR
abstracts
R.A. Stahel1, O. Riesterer2, X. Alexandros3, I. Opitz4, M. Beyeler5, A. Ochsenbein6, M. Früh7, R. Cathomas8, K. Nackaerts9, S. Peters10, C. Mamot11, A. Zippelius12, C. Mordasini13, K. Clemens14, K. Eckhardt15, R. Schmid16, W. Nagel17, D. Aebersold18, O. Gautschi19, W. Weder20 1 Clinic of Oncology, Universitätsspital Zürich, Zurich, SWITZERLAND 2 Radio-onkologie, Universitätsspital Zürich, Zurich, SWITZERLAND 3 Biostatistics, SAKK Cordination Center, Bern, SWITZERLAND 4 Thoracic Surgery, University Hospital Zurich, Zurich, SWITZERLAND 5 SAKK Coordination Center, Bern, SWITZERLAND 6 Medical Oncology, Inselspital Bern, Bern, SWITZERLAND 7 Medical Oncology, Kantonsspital St. Gallen, St. Gallen, SWITZERLAND 8 Medizinische Onkologie, Kantonsspital Graubünden, Chur, SWITZERLAND 9 Respiratory Oncology Unit, Univ Hospital Leuven, Leuven, BELGIUM 10 Oncology, Centre Hospitalier Universitaire Vaudois - CHUV, Lausanne, SWITZERLAND 11 Medical Oncology, Kantonsspital Aarau, Aarau, SWITZERLAND 12 Medical Oncology, University Hospital Basel, Basel, SWITZERLAND 13 Onkologie, Tifenau Spital, Bern, SWITZERLAND 14 Onkologie, Kantonsspital Baden, Baden, SWITZERLAND 15 SAKK Coordination Center, Bern, SWITZERLAND 16 Thoracic Surgery, Inselspital Bern, Bern, SWITZERLAND
Aim: We have previously documented the feasibility of neoadjuvant chemotherapy and EPP in a multicenter trial of MPM (Weder, Ann Oncol 18: 1196, 2007). The objectives of the trimodality trial SAKK17/04 (NCT00334594) were to evaluate the time to loco-regional relapse with or without high dose hemithoracic radiotherapy in a prospective multicenter randomized phase II trial in patients with R0 and R1 resection after neoadjuvant chemotherapy and EPP. Methods: Eligible patients had pathologically confirmed MPM, surgically resectable TNM stage (T1-3 N0-2 M0), PS0-1, ages 18-70 years. Part 1 had a phase II design, and included neoadjuvant chemotherapy with 3 cycles of cisplatin and pemetrexed, followed by restaging and EPP. The primary endpoint of part 1 was complete macroscopic resection (R0-1). Part 2 randomized consenting patients with R0-1 resection into two parallel phase II arms (control arm A and radiotherapy arm B). The primary endpoint for part 2 was loco-regional relapse-free survival (RFS). To detect a 1 year increase with 80% power and 10% alpha, 37 patients were needed for arm B. Secondary endpoints included operability, tolerability of chemotherapy and radiotherapy, survival, and translational research Results: Because accrual of part 2 was slower than planned, the trial was stopped in 2013. Overall, 153 patients entered the trial, of whom 125 underwent surgery and 99 had a complete macroscopic resection ( primary endpoint part 1). Of the later patients, 54 could be randomized 1:1 into each arm. Reasons for non-randomization included patient refusal in 24 and ineligibility or protocol deviations in 21. Of the 27 patients randomized to hemithoracic radiotherapy, 25 completed the treatment as planned. For part 1 the median RFS was 8.8 (95%CI: 7.3–10.7) and median OS was 15.0 (95% CI: 12.1–19.3) months. For part 2 the median local RFS for group A was 7.6 (95%CI: 5.5–10.7) and for group B 9.4 (95%CI: 6.5-11.9) months ( primary endpoint part 2), while the overall RFS and OS for group A were 5.7 (95%CI: 3.5-8.8) and 16.9 (95%CI:
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/mdu438.65/1746545 by guest on 26 October 2019
NEOADJUVANT CHEMOTHERAPY AND EXTRAPLEURAL PNEUMONECTOMY (EPP) OF MALIGNANT PLEURAL MESOTHELIOMA (MPM) WITH OR WITHOUT HEMITHORACIC RADIOTHERAPY: FINAL RESULTS OF THE RANDOMIZED MULTICENTER PHASE II TRIAL SAKK17/04
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© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
17
Klinik für Chirurgie, Kantonsspital St. Gallen, St. Gallen, SWITZERLAND Radio-onkologie, Inselspital Bern, Bern, SWITZERLAND Klinik für Onkologie, Luzerner Kantonsspital, Lucerne, SWITZERLAND 20 Division of Thoracic Surgery, Universitätsspital Zürich, Zurich, SWITZERLAND 18
thoracic malignancies, other LBA37 PR
abstracts
R.A. Stahel1, O. Riesterer2, X. Alexandros3, I. Opitz4, M. Beyeler5, A. Ochsenbein6, M. Früh7, R. Cathomas8, K. Nackaerts9, S. Peters10, C. Mamot11, A. Zippelius12, C. Mordasini13, K. Clemens14, K. Eckhardt15, R. Schmid16, W. Nagel17, D. Aebersold18, O. Gautschi19, W. Weder20 1 Clinic of Oncology, Universitätsspital Zürich, Zurich, SWITZERLAND 2 Radio-onkologie, Universitätsspital Zürich, Zurich, SWITZERLAND 3 Biostatistics, SAKK Cordination Center, Bern, SWITZERLAND 4 Thoracic Surgery, University Hospital Zurich, Zurich, SWITZERLAND 5 SAKK Coordination Center, Bern, SWITZERLAND 6 Medical Oncology, Inselspital Bern, Bern, SWITZERLAND 7 Medical Oncology, Kantonsspital St. Gallen, St. Gallen, SWITZERLAND 8 Medizinische Onkologie, Kantonsspital Graubünden, Chur, SWITZERLAND 9 Respiratory Oncology Unit, Univ Hospital Leuven, Leuven, BELGIUM 10 Oncology, Centre Hospitalier Universitaire Vaudois - CHUV, Lausanne, SWITZERLAND 11 Medical Oncology, Kantonsspital Aarau, Aarau, SWITZERLAND 12 Medical Oncology, University Hospital Basel, Basel, SWITZERLAND 13 Onkologie, Tifenau Spital, Bern, SWITZERLAND 14 Onkologie, Kantonsspital Baden, Baden, SWITZERLAND 15 SAKK Coordination Center, Bern, SWITZERLAND 16 Thoracic Surgery, Inselspital Bern, Bern, SWITZERLAND
Aim: We have previously documented the feasibility of neoadjuvant chemotherapy and EPP in a multicenter trial of MPM (Weder, Ann Oncol 18: 1196, 2007). The objectives of the trimodality trial SAKK17/04 (NCT00334594) were to evaluate the time to loco-regional relapse with or without high dose hemithoracic radiotherapy in a prospective multicenter randomized phase II trial in patients with R0 and R1 resection after neoadjuvant chemotherapy and EPP. Methods: Eligible patients had pathologically confirmed MPM, surgically resectable TNM stage (T1-3 N0-2 M0), PS0-1, ages 18-70 years. Part 1 had a phase II design, and included neoadjuvant chemotherapy with 3 cycles of cisplatin and pemetrexed, followed by restaging and EPP. The primary endpoint of part 1 was complete macroscopic resection (R0-1). Part 2 randomized consenting patients with R0-1 resection into two parallel phase II arms (control arm A and radiotherapy arm B). The primary endpoint for part 2 was loco-regional relapse-free survival (RFS). To detect a 1 year increase with 80% power and 10% alpha, 37 patients were needed for arm B. Secondary endpoints included operability, tolerability of chemotherapy and radiotherapy, survival, and translational research Results: Because accrual of part 2 was slower than planned, the trial was stopped in 2013. Overall, 153 patients entered the trial, of whom 125 underwent surgery and 99 had a complete macroscopic resection ( primary endpoint part 1). Of the later patients, 54 could be randomized 1:1 into each arm. Reasons for non-randomization included patient refusal in 24 and ineligibility or protocol deviations in 21. Of the 27 patients randomized to hemithoracic radiotherapy, 25 completed the treatment as planned. For part 1 the median RFS was 8.8 (95%CI: 7.3–10.7) and median OS was 15.0 (95% CI: 12.1–19.3) months. For part 2 the median local RFS for group A was 7.6 (95%CI: 5.5–10.7) and for group B 9.4 (95%CI: 6.5-11.9) months ( primary endpoint part 2), while the overall RFS and OS for group A were 5.7 (95%CI: 3.5-8.8) and 16.9 (95%CI:
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/mdu438.65/1746545 by guest on 26 October 2019
NEOADJUVANT CHEMOTHERAPY AND EXTRAPLEURAL PNEUMONECTOMY (EPP) OF MALIGNANT PLEURAL MESOTHELIOMA (MPM) WITH OR WITHOUT HEMITHORACIC RADIOTHERAPY: FINAL RESULTS OF THE RANDOMIZED MULTICENTER PHASE II TRIAL SAKK17/04
19
© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].