|
|||||
|
|
Phase II clinical trial of second-line FOLFIRI plus bevacizumab for patients with metastatic colorectal cancer: AVASIRI trial |
|
| Authors: | Yosuke Horita Yasuhide Yamada Ken Kato Yoshinori Hirashima Kouhei Akiyoshi Kengo Nagashima Takako Nakajima Tetsuya Hamaguchi Yasuhiro Shimada |
| Institution: | 1. Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo, Japan 2. Department of Chemotherapy, Toyama Prefectural Central Hospital, Nishinagae 2-2-78, Toyama, Toyama, 930-8550, Japan 3. Department of Medical Oncology, Faculty of Medicine, Oita University, Oita, Japan 4. Laboratory of Biostatistics, Faculty of Pharmaceutical Sciences, Josai University, Saitama, Japan |
| Abstract: | ObjectiveFOLFIRI is a standard chemotherapy regimen for the treatment of metastatic colorectal cancer. Although some studies have shown its efficacy in combination with bevacizumab as first-line chemotherapy, there are no data to support FOLFIRI plus bevacizumab as second-line chemotherapy in patients with this form of cancer. The aim of this study was to evaluate the efficacy and safety of FOLFIRI and bevacizumab as second-line chemotherapy in patients with metastatic colorectal cancer.MethodsEligible patients were ??20?years old, previously treated (except with irinotecan CPT-11] and bevacizumab), with an Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and adequate organ function. Twenty-five eligible patients received FOLFIRI with bevacizumab at a dose of 10?mg/kg given intravenously on day 1. All therapy was administered every 2?weeks until disease progression. The primary endpoint was the response rate.ResultsTwenty-five patients were enrolled between February 2008 and March 2009. The median age was 62 (range 38?C73) years, the male/female distribution was 20/5, 16 patients had performance status 0 and 9 had performance status 1, and the proportion of patients who were oxaliplatin pretreated/untreated was 16/9. The overall response rate was 32% (90% confidence interval CI]: 17.0?C50.4%), with 8 patients showing partial responses, 15 with stable disease, and 2 with disease progression. Median progression-free survival was 11.6?months (95% CI: 6.9?C16.4). Median overall survival was 21.4?months (95% CI: 12.0?C30.8). The grade 3/4 adverse events with treatment were neutropenia (64%), leukopenia (16%), diarrhea (8%), anorexia (8%), and febrile neutropenia (8%). The bevacizumab-related grade 3/4 adverse event was hypertension, which was observed in 12% of patients.ConclusionsThe FOLFIRI plus bevacizumab regimen is an active, well-tolerated second-line chemotherapy treatment for patients with metastatic colorectal cancer. |
| Keywords: | |
| 本文献已被 SpringerLink 等数据库收录！ | |