BACKGROUND: This phase III study investigated the addition of aflibercept to gemcitabine, in patients with advanced pancreatic cancer. PATIENTS AND METHODS: Patients with metastatic pancreatic cancer were randomly assigned to receive either intravenous (i.v.) aflibercept, 4 mg/kg every 2 weeks, or matching placebo combined with gemcitabine, 1000 mg/m(2) i.v. weekly for 7 weeks out of 8, then weekly for 3 weeks out of 4 until progressive disease, unacceptable toxicity or withdrawal of consent. The primary objective was to demonstrate an improvement in overall survival (OS) between the treatment arms. RESULTS: The study was stopped for futility following a planned interim analysis of OS in 427 randomised patients. With a median follow-up of 7.9 months, based on the 546 patients at study termination, median OS was 7.8 months in the gemcitabine plus placebo arm (n=275) versus 6.5 months in the gemcitabine plus aflibercept arm (n=271), which was not significant (hazard ratio 1.165, 95% confidence interval (CI) 0.921-1.473, p=0.2034). Median progression-free survival was 3.7 months in both arms. Treatment discontinuations due to adverse events were more frequent in the aflibercept than in the placebo-containing arm (23% versus 12%). CONCLUSION: Adding aflibercept to gemcitabine did not improve OS in patients with metastatic pancreatic cancer.
RCT Entities:
BACKGROUND: This phase III study investigated the addition of aflibercept to gemcitabine, in patients with advanced pancreatic cancer. PATIENTS AND METHODS: Patients with metastatic pancreatic cancer were randomly assigned to receive either intravenous (i.v.) aflibercept, 4 mg/kg every 2 weeks, or matching placebo combined with gemcitabine, 1000 mg/m(2) i.v. weekly for 7 weeks out of 8, then weekly for 3 weeks out of 4 until progressive disease, unacceptable toxicity or withdrawal of consent. The primary objective was to demonstrate an improvement in overall survival (OS) between the treatment arms. RESULTS: The study was stopped for futility following a planned interim analysis of OS in 427 randomised patients. With a median follow-up of 7.9 months, based on the 546 patients at study termination, median OS was 7.8 months in the gemcitabine plus placebo arm (n=275) versus 6.5 months in the gemcitabine plus aflibercept arm (n=271), which was not significant (hazard ratio 1.165, 95% confidence interval (CI) 0.921-1.473, p=0.2034). Median progression-free survival was 3.7 months in both arms. Treatment discontinuations due to adverse events were more frequent in the aflibercept than in the placebo-containing arm (23% versus 12%). CONCLUSION: Adding aflibercept to gemcitabine did not improve OS in patients with metastatic pancreatic cancer.
Authors: Christoforos Kosmidis; Konstantinos Sapalidis; Efstathios Kotidis; Nikolaos Mixalopoulos; Paul Zarogoulidis; Drosos Tsavlis; Sofia Baka; Yan-Gao Man; John Kanellos Journal: Ann Transl Med Date: 2016-05
Authors: Maeve A Lowery; Ryan Ptashkin; Emmet Jordan; Michael F Berger; Ahmet Zehir; Marinela Capanu; Nancy E Kemeny; Eileen M O'Reilly; Imane El-Dika; William R Jarnagin; James J Harding; Michael I D'Angelica; Andrea Cercek; Jaclyn F Hechtman; David B Solit; Nikolaus Schultz; David M Hyman; David S Klimstra; Leonard B Saltz; Ghassan K Abou-Alfa Journal: Clin Cancer Res Date: 2018-05-30 Impact factor: 12.531
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