VEGF remains an interesting target in advanced pancreas cancer (APCA): Results of a multi-institutional phase II study of bevacizumab, gemcitabine, and infusional 5-fluorouracil in patients with APCA

L. K. Martin, X. Li, B. Kleiber, E. C. Ellison, M. Bloomston, M. Zalupski, T. S. Bekaii-Saab

Research output: Contribution to journalArticle

18 Scopus citations

Abstract

Background: We investigated the safety and efficacy of bevacizumab combined with gemcitabine followed by infusional 5-fluorouracil (5-FU) in patients with advanced pancreas cancer (APCA). Design: Patients with untreated APCA received bevacizumab 10 mg/kg, gemcitabine 1000 mg/m. 2 over 100 min, and 5-FU 2400 mg/m. 2 over 48 h on days 1 and 15 of each 28-day cycle. The primary end point was the proportion of patients with progression-free survival (PFS) at 6 months from initiation of therapy. If PFS at 6 months was ≥41%, the regimen would be considered promising. Results: Forty-two patients were enrolled in the study; of which, 39 were evaluable for primary end point. PFS at 6 months was 49% (95% CI 34% to 64%). Median PFS was 5.9 months (95% CI 3.5 to 8.1) and median overall survival (OS) was 7.4 months (95% CI 4.7 to 11.2). Partial response and stable disease occurred in 30% and 45% of patients, respectively. Treatment-related hypertension and normal baseline albumin correlated with an improved response rate, PFS and OS. Grade 3 to 4 toxicities included fatigue (14%), hypertension (5%), and venous thrombosis (5%). Conclusions: The study met its primary end point. Further investigation of anti-VEGF therapy in combination with fluoropyrimidine-based therapy is warranted in APCA. Treatment-related hypertension and normal baseline albumin may predict for the efficacy of bevacizumab and should be investigated in prospective studies.

Original languageEnglish (US)
Article numbermds134
Pages (from-to)2812-2820
Number of pages9
JournalAnnals of Oncology
Volume23
Issue number11
DOIs
StatePublished - Nov 1 2012

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Keywords

  • 5-fluorouracil
  • Bevacizumab
  • Gemcitabine
  • Pancreas cancer
  • VEGF

ASJC Scopus subject areas

  • Hematology
  • Oncology

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