Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): A randomised, controlled, open-label, phase 3 trial

The Lancet

Volumn 387, Issue 10026, 2016, Pages 1405-1414

  Zalcman, Gérard ^a,b   Mazieres, Julien ^c   Margery, Jacques ^d   Greillier, Laurent ^e   Audigier Valette, Clarisse ^f   Moro Sibilot, Denis ^g   Molinier, Olivier ^h   Corre, Romain ⁱ   Monnet, Isabelle ^j   Gounant, Valérie ^k   Rivière, Frédéric ^l   Janicot, Henri ^m   Gervais, Radj ⁿ   Locher, Chrystèle ^o   Milleron, Bernard ^p   Tran, Quan ^p   Lebitasy, Marie Paule ^p   Morin, Franck ^p   Creveuil, Christian ^q,r   Parienti, Jean Jacques ^q,r   Scherpereel, Arnaud ^s   more..

^a UNIVERSITÉ DE CAEN   (France)

^b INSERM   (France)

^c SERVICE DE PNEUMOLOGIE   (France)

^d INSTITUT GUSTAVE ROUSSY   (France)

^e ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE   (France)

^f Centre Hospitalier Intercommunal   (France)

^g UNIV GRENOBLE ALPES   (France)

^h CENTRE HOSPITALIER DU MANS   (France)

ⁱ RENNES UNIVERSITY HOSPITAL   (France)

^j CENTRE HOSPITALIER INTERCOMMUNAL DE CRÉTEIL   (France)

^k ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^l PERCY MILITARY HOSPITAL   (France)

^m SERVICE DE RHUMATOLOGIE   (France)

ⁿ Centre de Lutte Contre le Cancer Franois Baclesse   (France)

^o CENTRE HOSPITALIER DE MEAUX   (France)

^p French Cooperative Thoracic Group   (France)

^q CHU CÔTE DE NACRE   (France)

^r UNIVERSITÉ DE CAEN   (France)

^s LILLE UNIVERSITY HOSPITAL   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANTIVITAMIN K; BEVACIZUMAB; CARBOPLATIN; CISPLATIN; CLOPIDOGREL; CYANOCOBALAMIN; DIPYRIDAMOLE; FOLIC ACID; LIVER ENZYME; LOW MOLECULAR WEIGHT HEPARIN; PEMETREXED; ANTINEOPLASTIC AGENT; CREATININE; VASCULOTROPIN A;

ADD ON THERAPY; ADULT; ADVANCED CANCER; AGED; ANOREXIA; ARTERIAL THROMBOEMBOLISM; ARTICLE; ASTHENIA; BLEEDING; BRAIN HEMORRHAGE; CANCER SURGERY; CARDIOTOXICITY; CENTRAL NERVOUS SYSTEM; COMORBIDITY; COMPUTER ASSISTED TOMOGRAPHY; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DIGESTIVE SYSTEM PERFORATION; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FRANCE; HEALTH CARE QUALITY; HUMAN; HYPERTENSION; INTENTION TO TREAT ANALYSIS; LIFE EXPECTANCY; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEPHROTOXICITY; NEUTROPENIA; ORAL MUCOSITIS; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PLEURA EFFUSION; PLEURA MESOTHELIOMA; PRIORITY JOURNAL; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SEPSIS; SMOKING; THROMBOCYTOPENIA; THROMBOSIS; VEIN THROMBOSIS; VENOUS THROMBOEMBOLISM; VOMITING; BLOOD; CLINICAL TRIAL; LUNG NEOPLASMS; MESOTHELIOMA; MIDDLE AGED; MORTALITY; PATHOLOGY; PLEURAL NEOPLASMS;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BEVACIZUMAB; CISPLATIN; CREATININE; FEMALE; HUMANS; HYPERTENSION; LUNG NEOPLASMS; MALE; MESOTHELIOMA; MIDDLE AGED; PEMETREXED; PLEURAL NEOPLASMS; PROTEINURIA; THROMBOSIS; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 84951085442     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(15)01238-6     Document Type: Article

References (35)

1. JC Wagner, CA Sleggs, P Marchand Diffuse pleural mesothelioma and asbestos exposure in the North Western Cape Province Br J Ind Med 17 1960 260 271
2. JP Steele Prognostic factors for mesothelioma Hematol Oncol Clin North Am 19 2005 1041 1052
3. SM Gelvez-Zapata, D Gaffney, M Scarci, AS Coonar What is the survival after surgery for localized malignant pleural mesothelioma? Interact Cardiovasc Thorac Surg 16 2013 533 537
4. NJ Vogelzang, JJ Rusthoven, J Symanowski et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma J Clin Oncol 21 2003 2636 2644
5. GL Ceresoli, PA Zucali, AG Favaretto et al. Phase II study of pemetrexed plus carboplatin in malignant pleural mesothelioma J Clin Oncol 24 2006 1443 1538
6. Y Ohta, V Shridhar, RK Bright et al. VEGF and VEGF type C play an important role in angiogenesis and lymphangiogenesis in human malignant mesothelioma tumours Br J Cancer 81 1999 54 61
7. L Strizzi, A Catalano, G Vianale et al. Vascular endothelial growth factor is an autocrine growth factor in human malignant mesothelioma J Pathol 193 2001 468 475
8. LL Garland, K Chansky, AJ Wozniak et al. Phase II study of cediranib in patients with malignant pleural mesothelioma: SWOG S0509 J Thorac Oncol 11 2011 1938 1945
9. S Dubey, PA Jänne, L Krug et al. A phase II study of sorafenib in malignant mesothelioma: results of Cancer and Leukemia Group B 30307 J Thorac Oncol 5 2010 1655 1661
10. AK Nowak, MJ Millward, J Creaney et al. A phase II study of intermittent sunitinib malate as second-line therapy in progressive malignant pleural mesothelioma J Thorac Oncol 9 2012 1449 1456
11. WA Buikhuisen, JA Burgers, AD Vincent et al. Thalidomide versus active supportive care for maintenance in patients with malignant mesothelioma after first-line chemotherapy (NVALT 5): an open-label, multicentre, randomised phase 3 study Lancet Oncol 14 2013 543 551
12. HL Kindler, TG Karrison, DR Gandara et al. Multicenter, double-blind, placebo-controlled, randomized phase II trial of gemcitabine/cisplatin plus bevacizumab or placebo in patients with malignant mesothelioma J Clin Oncol 30 2012 2509 2515
13. ZE Labby, SG Armato 3rd, HL Kindler, JJ Dignam, A Hasani, AK Nowak Optimization of response classification criteria for patients with malignant pleural mesothelioma J Thorac Oncol 7 2012 1728 1734
14. MJ Byrne, AK Nowak Modified RECIST criteria for assessment of response in malignant pleural mesothelioma Ann Oncol 15 2004 257 260
15. G Zalcman, J Margery, A Scherpereel et al. IFCT-GFPC-0701 MAPS trial, a multicenter randomized phase II/III trial of pemetrexed-cisplatin with or without bevacizumab in patients with malignant pleural mesothelioma J Clin Oncol 28 suppl 15S 2010 abstract 7020.
16. C Boutin, F Rey, JR Viallat Prevention of malignant seeding after invasive diagnostic procedures in patients with pleural mesothelioma. A randomized trial of local radiotherapy Chest 108 1995 754 758
17. A Scherpereel, P Astoul, P Baas et al. Guidelines of the European Respiratory Society and the European Society of Thoracic Surgeons for the management of malignant pleural mesothelioma Eur Respir J 35 2010 479 495
18. PJ Hollen, RJ Gralla, AM Liepa, JT Symanowski, JJ Rusthoven Adapting the Lung Cancer Symptom Scale (LCSS) to mesothelioma: using the LCSS-Meso conceptual model for validation Cancer 101 2004 587 595
19. D Osoba, G Rodrigues, J Myles, B Zee, J Pater Interpreting the significance of changes in health-related quality-of-life scores J Clin Oncol 16 1998 139 144
20. P Bauer Multiple testing in clinical trials Stat Med 10 1991 871 889
21. BC Kahan, TP Morris Improper analysis of trials randomised using stratified blocks or minimisation Stat Med 31 2012 328 340
22. PC O'Brien, TR Fleming A multiple testing procedure for clinical trials Biometrics 35 1979 549 556
23. D Curran, T Sahmoud, P Therasse, J van Meerbeeck, PE Postmus, G Giaccone Prognostic factors in patients with pleural mesothelioma: the European Organization for Research and Treatment of Cancer experience J Clin Oncol 16 1998 145 152
24. DM Jackman, H Kindler, BY Yeap et al. Erlotinib plus bevacizumab in previously treated patients with malignant pleural mesothelioma Cancer 113 2008 808 814
25. JE Dowell, FR Dunphy, RN Taub et al. A multicenter phase II study of cisplatin, pemetrexed, and bevacizumab in patients with advanced malignant mesothelioma Lung Cancer 77 2012 567 571
26. GL Ceresoli, PA Zucali, M Mencoboni et al. Phase II study of pemetrexed and carboplatin plus bevacizumab as first-line therapy in malignant pleural mesothelioma Br J Cancer 109 2013 552 558
27. M Reck, J von Pawel, P Zatloukal et al. Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAiL J Clin Oncol 27 2009 1227 1234
28. H Hurwitz, L Fehrenbacher, W Novotny et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer N Engl J Med 350 2004 2335 2342
29. B Giantonio, P Catalano, N Meropol et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group study E3200 J Clin Oncol 25 2007 1539 1544
30. X Zhu, W Shenbong, W Dahut et al. Risks of proteinuria and hypertension with bevacizumab, an antibody against vascular endothelial growth factor: systematic review and meta-analysis Am J Kidney Dis 49 2007 186 193
31. R Gray, S Bhattacharya, C Bowden et al. Independent review of E2100: a phase III trial of bevacizumab plus paclitaxel versus paclitaxel in women with metastatic breast cancer J Clin Oncol 27 2009 4966 4972
32. VM Montori, PJ Devereaux, NK Adhikari et al. Randomized trials stopped early for benefit: a systematic review JAMA 294 2005 2203 2209
33. PE Van Schil, P Baas, R Gaafar et al. Trimodality therapy for malignant pleural mesothelioma: results from an EORTC phase II multicentre trial Eur Respir J 36 2010 1362 1369
34. T Treasure, L Lang-Lazdunski, D Waller et al. Extra-pleural pneumonectomy versus no extra-pleural pneumonectomy for patients with malignant pleural mesothelioma: clinical outcomes of the Mesothelioma and Radical Surgery (MARS) randomised feasibility study Lancet Oncol 12 2011 763 772
35. United States Patent and Trademark Office April 25, 2000. Application of extension of patent term under 35 U.S.C. § 156 http://www.fda.gov/ohrms/dockets/dailys/04/sep04/090304/04e-0402-app0001-01-vol1.pdf (accessed Dec 17, 2015).