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)
Cancer Chemotherapy and Pharmacology, 08/16/2012
Nakayama G et al. – The planned continuation of bevacizumab during a second–line treatment, bevacizumab beyond first progression (BBP) strategy, is feasible for the Japanese metastatic colorectal cancer (mCRC) patients.Methods
- Previously 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.
- In the first–line setting, 47 patients treated with mFOLFOX6 plus bevacizumab achieved RR of 61.7 %, DCR of 89.4 %, and median PFS of 13.1months (95 % CI, 8.7–17.5months).
- 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 7.3months (95 % CI, 5.0–9.6months).
- Median 2nd PFS was 18.0months (95 % CI, 13.7–22.3months).
- The median OS and SBP were 30.8months (95 % CI, 27.6–34.0months) and 19.6months (95 % CI, 13.5–25.7months), respectively.
- No critical events associated with bevacizumab were observed during the second–line therapy.