Gemcitabine plus bevacizumab compared with gemcitabine plus placebo in patients with advanced pancreatic cancer: Phase III trial of the Cancer and Leukemia Group B (CALGB 80303)

Hedy Lee Kindler, Donna Niedzwiecki, Donna Hollis, Susan Sutherland, Deborah Schrag, Herbert Hurwitz, Federico Innocenti, Mary Frances Mulcahy, Eileen O'Reilly, Timothy F. Wozniak, Joel Picus, Pankaj Bhargava, Robert J. Mayer, Richard L. Schilsky, Richard M. Goldberg

Research output: Contribution to journalArticlepeer-review

671 Scopus citations

Abstract

Purpose: The combination of gemcitabine plus bevacizumab produced a 21% response rate and a median survival of 8.8 months in a multicenter phase II trial in patients with metastatic pancreatic cancer. These encouraging data led Cancer and Leukemia Group B (CALGB) to conduct a double-blind, placebo-controlled, randomized phase III trial of gemcitabine/bevacizumab versus gemcitabine/ placebo in advanced pancreatic cancer patients. Patients and Methods: Eligible patients had no prior therapy for advanced disease, Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2, no tumor invasion of adjacent organs, and no increased bleeding risk. The primary end point was overall survival. Patients were stratified by performance status, extent of disease, and prior radiotherapy. Patients received gemcitabine at 1,000 mg/m2 over 30 minutes on days 1, 8, and 15 every 28 days and bevacizumab at 10 mg/kg or placebo on days 1 and 15 every 28 days. Results: Between June 2004 and April 2006, 602 patients were enrolled onto the study and 535 were treated. Median overall survival was 5.8 months for gemcitabine/bevacizumab and 5.9 months for gemcitabine/placebo (P = .95). Median progression-free survival was 3.8 and 2.9 months, respectively (P = .07). Overall response rates were 13% and 10%, respectively. Patients with a performance status of 0, 1, and 2 survived a median of 7.9, 4.8, and 2.4 months, respectively. The only statistically significant differences in grades 3 and 4 toxicity occurred for hypertension (10% v 3%; P <.001) and proteinuria (5% v 1%; P =.002); venous thrombosis grade ≥ 3 was equivalent in both arms (14% and 15%, respectively). Conclusion: The addition of bevacizumab to gemcitabine does not improve survival in advanced pancreatic cancer patients.

Original languageEnglish (US)
Pages (from-to)3617-3622
Number of pages6
JournalJournal of Clinical Oncology
Volume28
Issue number22
DOIs
StatePublished - Aug 1 2010

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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