Retrospective analysis on the efficacy of bevacizumab with FOLFOX as a first-line treatment in Japanese patients with metastatic colorectal cancer

Asia Pac J Clin Oncol. 2014 Dec;10(4):322-9. doi: 10.1111/ajco.12094. Epub 2013 Aug 5.

Abstract

Aims: Past reports have suggested that the addition of bevacizumab (BV) to oxaliplatin combined with 5-fluorouracil (5-FU) and folinic acid (leucovorin) (FOLFOX4) provides a limited survival benefit in metastatic colorectal cancer (mCRC). Our study aimed to evaluate the survival benefits of a FOLFOX4 + BV regimen.

Methods: Patients with mCRC who started treatment between April 2005 and July 2008 were evaluated in this retrospective cohort study. Patients received FOLFOX4, or FOLFOX4 + BV after the approval of BV in 2007. The two cohorts treated before and after BV approval were compared. Primary end-points were progression-free survival (PFS), overall survival (OS) and response rate (RR).

Results: A total of 213 patients received either FOLFOX4 (n = 128) or FOLFOX4 + BV (n = 85). For FOLFOX4 and FOLFOX4 + BV respectively, median PFS was 9.9 and 17.0 months (HR, 0.58; 95% CI, 0.42-0.82; P = 0.002), median OS was 20.5 and 38.8 months (HR, 0.49; 95% CI, 0.34-0.71; P < 0.001), respectively. Patients who received 5-fluorouracil plus leucovorin (FL) as maintenance therapy during oxaliplatin suspension in both FOLFOX4 (n = 6) and FOLFOX4 + BV (n = 46) groups showed a trend to improved median PFS and median OS.

Conclusions: The additive effect and potential survival benefits of adding BV to the FOLFOX4 regimen in first-line treatment of mCRC were demonstrated. Maintenance FL during suspension of oxaliplatin appeared to be an important factor in better survival.

Keywords: FOLFOX4; bevacizumab; metastatic colorectal cancer; overall survival; progression-free survival.

Publication types

  • Comparative Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Angiogenesis Inhibitors / administration & dosage*
  • Angiogenesis Inhibitors / adverse effects
  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Bevacizumab
  • Colorectal Neoplasms / drug therapy*
  • Colorectal Neoplasms / pathology
  • Disease-Free Survival
  • Electronic Health Records
  • Female
  • Fluorouracil / administration & dosage
  • Fluorouracil / adverse effects
  • Humans
  • Japan
  • Leucovorin / administration & dosage
  • Leucovorin / adverse effects
  • Male
  • Middle Aged
  • Neoplasm Metastasis / drug therapy
  • Organoplatinum Compounds / administration & dosage
  • Organoplatinum Compounds / adverse effects
  • Proportional Hazards Models
  • Retrospective Studies
  • Treatment Outcome
  • Young Adult

Substances

  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal, Humanized
  • Organoplatinum Compounds
  • Bevacizumab
  • Leucovorin
  • Fluorouracil

Supplementary concepts

  • Folfox protocol