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

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Colorectal Neoplasms
Neoplasm Metastasis
Liver
irinotecan
Fluorouracil
Leucovorin
Bevacizumab
Disease Progression
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

@article{4135bc470c6141acb1cbd65b231c7a25,
title = "Neoadjuvant FOLFIRI+bevacizumab in patients with resectable liver metastases from colorectal cancer: A phase 2 trial",
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.",
author = "G. Nasti and Piccirillo, {M. C.} and F. Izzo and A. Ottaiano and V. Albino and P. Delrio and C. Romano and P. Giordano and S. Lastoria and C. Carac{\`o} and {De Lutio Di Castelguidone}, E. and R. Palaia and G. Daniele and L. Aloj and G. Romano and Iaffaioli, {R. V.}",
year = "2013",
month = "4",
day = "30",
doi = "10.1038/bjc.2013.140",
language = "English",
volume = "108",
pages = "1566--1570",
journal = "British Journal of Cancer",
issn = "0007-0920",
publisher = "Nature Publishing Group",
number = "8",

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TY - JOUR

T1 - Neoadjuvant FOLFIRI+bevacizumab in patients with resectable liver metastases from colorectal cancer

T2 - A phase 2 trial

AU - Nasti, G.

AU - Piccirillo, M. C.

AU - Izzo, F.

AU - Ottaiano, A.

AU - Albino, V.

AU - Delrio, P.

AU - Romano, C.

AU - Giordano, P.

AU - Lastoria, S.

AU - Caracò, C.

AU - De Lutio Di Castelguidone, E.

AU - Palaia, R.

AU - Daniele, G.

AU - Aloj, L.

AU - Romano, G.

AU - Iaffaioli, R. V.

PY - 2013/4/30

Y1 - 2013/4/30

N2 - 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.

AB - 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.

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U2 - 10.1038/bjc.2013.140

DO - 10.1038/bjc.2013.140

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VL - 108

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EP - 1570

JO - British Journal of Cancer

JF - British Journal of Cancer

SN - 0007-0920

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