Abstract | PURPOSE: The 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). 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. RESULTS: 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 13.1 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. CONCLUSION: The planned continuation of bevacizumab during a second-line treatment, BBP strategy, is feasible for the Japanese mCRC patients.
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Authors | Goro Nakayama, Keisuke Uehara, Kiyoshi Ishigure, Hiroyuki Yokoyama, Akiharu Ishiyama, Takehiko Eguchi, Kenji Tsuboi, Norifumi Ohashi, Tsutomu Fujii, Hiroyuki Sugimoto, Masahiko Koike, Michitaka Fujiwara, Yuich Ando, Yasuhiro Kodera |
Journal | Cancer chemotherapy and pharmacology
(Cancer Chemother Pharmacol)
Vol. 70
Issue 4
Pg. 575-81
(Oct 2012)
ISSN: 1432-0843 [Electronic] Germany |
PMID | 22886005
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
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Chemical References |
- Antibodies, Monoclonal, Humanized
- Organoplatinum Compounds
- Bevacizumab
- Leucovorin
- Fluorouracil
- Camptothecin
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Topics |
- Adult
- Aged
- Antibodies, Monoclonal, Humanized
(administration & dosage, adverse effects)
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Bevacizumab
- Camptothecin
(analogs & derivatives, therapeutic use)
- Colorectal Neoplasms
(drug therapy, pathology)
- Disease Progression
- Female
- Fluorouracil
(therapeutic use)
- Humans
- Leucovorin
(therapeutic use)
- Male
- Middle Aged
- Organoplatinum Compounds
(therapeutic use)
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