The efficacy and safety of bevacizumab beyond first progression in patients treated with first-line mFOLFOX6 followed by second-line FOLFIRI in advanced colorectal cancer: a multicenter, single-arm, phase II trial CCOG-0801Report as inadecuate




The efficacy and safety of bevacizumab beyond first progression in patients treated with first-line mFOLFOX6 followed by second-line FOLFIRI in advanced colorectal cancer: a multicenter, single-arm, phase II trial CCOG-0801 - Download this document for free, or read online. Document in PDF available to download.

Cancer Chemotherapy and Pharmacology

, Volume 70, Issue 4, pp 575–581

First Online: 12 August 2012Received: 24 May 2012Accepted: 29 July 2012

Abstract

PurposeThe aim of this study was to evaluate the efficacy and safety of the planned continuation of bevacizumab beyond first progression BBP in Japanese patients with metastatic colorectal cancer mCRC.

MethodsPreviously untreated patients with assessable disease were treated with mFOLFOX6 plus bevacizumab until tumor progression, followed by FOLFIRI plus bevacizumab. The primary endpoint of the study was the second progression-free survival 2nd PFS, defined as duration from enrollment until progression after the second-line therapy. Secondary endpoints of the study were overall survival OS, survival beyond first progression SBP, progression-free survival PFS, response rate RR, disease control rate DCR, and safety.

ResultsIn the first-line setting, 47 patients treated with mFOLFOX6 plus bevacizumab achieved RR of 61.7 %, DCR of 89.4 %, and median PFS of 13.1 months 95 % CI, 8.7–17.5 months. Thirty-one patients went on to receive a second-line therapy with FOLFIRI plus bevacizumab and achieved RR of 27.6 %, DCR of 62.1 %, and median PFS of 7.3 months 95 % CI, 5.0–9.6 months. Median 2nd PFS was 18.0 months 95 % CI, 13.7–22.3 months. The median OS and SBP were 30.8 months 95 % CI, 27.6–34.0 months and 19.6 months 95 % CI, 13.5–25.7 months, respectively. No critical events associated with bevacizumab were observed during the second-line therapy.

ConclusionThe planned continuation of bevacizumab during a second-line treatment, BBP strategy, is feasible for the Japanese mCRC patients.

KeywordsColorectal cancer Chemotherapy Bevacizumab beyond progression BBP Trial registration This trial was registered in University Hospital Medical Information Network UMIN, UMIN000006818.

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Author: Goro Nakayama - Keisuke Uehara - Kiyoshi Ishigure - Hiroyuki Yokoyama - Akiharu Ishiyama - Takehiko Eguchi - Kenji Tsuboi -

Source: https://link.springer.com/







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