A Gonçalves1, M Gilabert2, E François3, L Dahan4, H Perrier5, R Lamy6, D Re7, R Largillier8, M Gasmi9, X Tchiknavorian10, B Esterni11, D Genre11, L Moureau-Zabotto2, M Giovannini2, J-F Seitz4, J-R Delpero12, O Turrini13, P Viens12, J-L Raoul14. 1. Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Cancer Research Center of Marseille, U1068 INSERM, CNRS UMR7258; Aix-Marseille University, Marseille; Clinical Investigation Center 9502, Marseille. Electronic address: goncalvesa@marseille.fnclcc.fr. 2. Department of Medical Oncology, Institut Paoli-Calmettes, Marseille. 3. Department of Medical Oncology, Centre Antoine Lacassagne, Nice. 4. Aix-Marseille University, Marseille; Clinical Investigation Center 9502, Marseille; Department of Digestive Oncology, Hôpital de le Timone, Assistance Publique-Hôpitaux de Marseille, Marseille. 5. Digestive Oncology Unit, Hôpital Saint-Joseph, Marseille. 6. Department of Oncology, Centre Hospitalier Bretagne Sud (Lorient), Lorient. 7. Medicine Unit, Centre Hospitalier Antibes Juan-les-Pins, Antibes. 8. Department of Oncology, Centre azuréen de cancérologie, Mougins. 9. Department of Gastro-enterology, Hôpital Nord APHM, Marseille. 10. Department of Medical Oncology, Centre Hospitalier Toulon, Toulon, France. 11. Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Clinical Investigation Center 9502, Marseille. 12. Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Cancer Research Center of Marseille, U1068 INSERM, CNRS UMR7258; Aix-Marseille University, Marseille; Clinical Investigation Center 9502, Marseille. 13. Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Cancer Research Center of Marseille, U1068 INSERM, CNRS UMR7258; Aix-Marseille University, Marseille. 14. Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Cancer Research Center of Marseille, U1068 INSERM, CNRS UMR7258.
Abstract
BACKGROUND:Sorafenib is an oral anticancer agent targeting Ras-dependent signaling and angiogenic pathways. A phase I trial demonstrated that the combination of gemcitabine and sorafenib was well tolerated and had activity in advanced pancreatic cancer (APC) patients. The BAYPAN study was a multicentric, placebo-controlled, double-blind, randomized phase III trial comparing gemcitabine/sorafenib and gemcitabine/placebo in the treatment of APC. PATIENTS AND METHODS: The patient eligibility criteria were locally advanced or metastatic pancreatic adenocarcinoma, no prior therapy for advanced disease and a performance status of zero to two. The primary end point was progression-free survival (PFS). The patients received gemcitabine 1000 mg/m(2) i.v., weekly seven times followed by 1 rest week, then weekly three times every 4 weeks plus sorafenib 200 mg or placebo, two tablets p.o., twice daily continuously. RESULTS:Between December 2006 and September 2009, 104 patients were enrolled on the study (52 pts in each arm) and 102 patients were treated. The median and the 6-month PFS were 5.7 months and 48% for gemcitabine/placebo and 3.8 months and 33% for gemcitabine/sorafenib (P = 0.902, stratified log-rank test), respectively. The median overall survivals were 9.2 and 8 months, respectively (P = 0.231, log-rank test). The overall response rates were similar (19 and 23%, respectively). CONCLUSION: The addition of sorafenib to gemcitabine does not improve PFS in APC patients.
RCT Entities:
BACKGROUND:Sorafenib is an oral anticancer agent targeting Ras-dependent signaling and angiogenic pathways. A phase I trial demonstrated that the combination of gemcitabine and sorafenib was well tolerated and had activity in advanced pancreatic cancer (APC) patients. The BAYPAN study was a multicentric, placebo-controlled, double-blind, randomized phase III trial comparing gemcitabine/sorafenib and gemcitabine/placebo in the treatment of APC. PATIENTS AND METHODS: The patient eligibility criteria were locally advanced or metastatic pancreatic adenocarcinoma, no prior therapy for advanced disease and a performance status of zero to two. The primary end point was progression-free survival (PFS). The patients received gemcitabine 1000 mg/m(2) i.v., weekly seven times followed by 1 rest week, then weekly three times every 4 weeks plus sorafenib 200 mg or placebo, two tablets p.o., twice daily continuously. RESULTS: Between December 2006 and September 2009, 104 patients were enrolled on the study (52 pts in each arm) and 102 patients were treated. The median and the 6-month PFS were 5.7 months and 48% for gemcitabine/placebo and 3.8 months and 33% for gemcitabine/sorafenib (P = 0.902, stratified log-rank test), respectively. The median overall survivals were 9.2 and 8 months, respectively (P = 0.231, log-rank test). The overall response rates were similar (19 and 23%, respectively). CONCLUSION: The addition of sorafenib to gemcitabine does not improve PFS in APCpatients.
Authors: Davendra P S Sohal; Pamela B Mangu; Alok A Khorana; Manish A Shah; Philip A Philip; Eileen M O'Reilly; Hope E Uronis; Ramesh K Ramanathan; Christopher H Crane; Anitra Engebretson; Joseph T Ruggiero; Mehmet S Copur; Michelle Lau; Susan Urba; Daniel Laheru Journal: J Clin Oncol Date: 2016-05-31 Impact factor: 44.544
Authors: Joanne W Chiu; Hilda Wong; Roland Leung; Roberta Pang; Tan-To Cheung; Sheung-Tat Fan; Ronnie Poon; Thomas Yau Journal: Oncologist Date: 2014-08-12
Authors: Jean-Luc Van Laethem; Hanno Riess; Jacek Jassem; Michael Haas; Uwe M Martens; Colin Weekes; Marc Peeters; Paul Ross; John Bridgewater; Bohuslav Melichar; Stefano Cascinu; Piotr Saramak; Patrick Michl; David Van Brummelen; Alberto Zaniboni; Wollf Schmiegel; Svein Dueland; Marius Giurescu; Vittorio L Garosi; Katrin Roth; Anke Schulz; Henrik Seidel; Prabhu Rajagopalan; Michael Teufel; Barrett H Childs Journal: Target Oncol Date: 2017-02 Impact factor: 4.493