Neoadjuvant FOLFIRI+bevacizumab in patients with resectable liver metastases from colorectal cancer: a phase 2 trial.
de Lutio di Castelguidone, E
Br J Cancer
Springer Science and Business Media LLC
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Nasti, G., Piccirillo, M., Izzo, F., Ottaiano, A., Albino, V., Delrio, P., Romano, C., et al. (2013). Neoadjuvant FOLFIRI+bevacizumab in patients with resectable liver metastases from colorectal cancer: a phase 2 trial.. Br J Cancer, 108 (8), 1566-1570. https://doi.org/10.1038/bjc.2013.140
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.
Humans, Colorectal Neoplasms, Liver Neoplasms, Camptothecin, Fluorouracil, Leucovorin, Antineoplastic Combined Chemotherapy Protocols, Disease-Free Survival, Chemotherapy, Adjuvant, Neoadjuvant Therapy, Survival Rate, Adult, Aged, Middle Aged, Female, Male, Kaplan-Meier Estimate, Antibodies, Monoclonal, Humanized, Bevacizumab
External DOI: https://doi.org/10.1038/bjc.2013.140
This record's URL: https://www.repository.cam.ac.uk/handle/1810/287412
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