Neoadjuvant FOLFIRI+bevacizumab in patients with resectable liver metastases from colorectal cancer: A phase 2 trial

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Abstract

Background: Preoperative treatment of resectable liver metastases from colorectal cancer (CRC) is a matter of debate. The aim of this study was to assess the feasibility and activity of bevacizumab plus FOLFIRI in this setting.Methods:Patients aged 18-75 years, PS 0-1, with resectable liver-confined metastases from CRC were eligible. They received bevacizumab 5 mg kg-1 followed by irinotecan 180 mg m-2, leucovorin 200 mg m-2, 5-fluorouracil 400 mg m-2 bolus and 5-fluorouracil 2400 mg m-2 46-h infusion, biweekly, for 7 cycles. Bevacizumab was stopped at cycle 6. A single-stage, single-arm phase 2 study design was applied with 1-year progression-free rate as the primary end point, and 39 patients required.Results:From October 2007 to December 2009, 39 patients were enrolled in a single institution. Objective response rate was 66.7% (95% exact CI: 49.8-80.9). Of these, 37 patients (94.9%) underwent surgery, with a R0 rate of 84.6%. Five patients had a pathological complete remission (14%). Out of 37 patients, 16 (43.2%) had at least one surgical complication (most frequently biloma). At 1 year of follow-up, 24 patients were alive and free from disease progression (61.6%, 95% CI: 44.6-76.6). Median PFS and OS were 14 (95% CI: 11-24) and 38 (95% CI: 28-NA) months, respectively.Conclusion:Preoperative treatment of patients with resectable liver metastases from CRC with bevacizumab plus FOLFIRI is feasible, but further studies are needed to define its clinical relevance.

Original languageEnglish
Pages (from-to)1566-1570
Number of pages5
JournalBritish Journal of Cancer
Volume108
Issue number8
DOIs
Publication statusPublished - Apr 30 2013

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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