Keisuke Miwa1, Eiji Oki2, Yasunori Emi3, Hiroshi Saeki2, Tetsuya Kusumoto4, Yoshito Akagi5, Yutaka Ogata6, Hironori Samura7, Shoji Tokunaga8, Hiroshi Ishikawa9, Takaho Tanaka10, Susumu Sueyoshi11, Hidefumi Higashi12, Hiroyuki Matsuda13, Tetsuo Touyama14, Yoshihiko Maehara2. 1. Multidisciplinary Treatment Cancer Center, Kurume University Hospital, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan. miwakeisuke@gmail.com. 2. Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 3. Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan. 4. Department of Gastroenterological Surgery/Clinical Research Institute Cancer Research Division, National Kyushu Medical Center, Fukuoka, Japan. 5. Department of Surgery, Kurume University School of Medicine, Kurume, Japan. 6. Department of Surgery, Kurume University Medical Center, Kurume, Japan. 7. Department of Surgery I, Ryukyu University, Okinawa, Japan. 8. Medical Information Center, Kyushu University Hospital, Fukuoka, Japan. 9. Department of Surgery, Sasebo City General Hospital, Sasebo, Japan. 10. Department of Surgery, Social Insurance Tagawa Hospital, Tagawa, Japan. 11. Department of Surgery, Omuta City Hospital, Omuta, Japan. 12. Department of Surgery, Steel Memorial Yawata Hospital, Kitakyushu, Japan. 13. Department of Surgery, Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital, Hiroshima, Japan. 14. Department of Surgery, Nakagami Hospital, Okinawa, Japan.
Abstract
OBJECTIVES: The purpose of this phase II study was to explore the efficacy and safety of an alternating regimen consisting of folinic acid, 5-fluorouracil (5-FU) and oxaliplatin (mFOLFOX6) plus bevacizumab, and folinic acid, 5-FU and irinotecan (FOLFIRI) plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer. METHODS: Fifty-two patients with metastatic colorectal cancer received an alternating regimen consisting of four cycles of mFOLFOX6 plus bevacizumab followed by four cycles of FOLFIRI plus bevacizumab until disease progression. The primary endpoint was progression-free survival. RESULTS: The median age was 60 years (range 37-75 years). Median progression-free survival was 14.2 months (95 % confidence interval [CI] 10.6-16.3) and median overall survival was 28.4 months (95 % CI 22.6-39.1). The overall response rate was 60.0 % (95 % CI 45.2-73.6). Regarding toxicity, the commonest grade 3-4 hematological adverse events were neutropenia (34.6 %) and leukopenia (7.7 %), and the commonest grade 3-4 non-hematological adverse events were anorexia (13.5 %), fatigue (9.6 %), nausea (9.6 %), and vomiting (9.6 %). Bevacizumab-related grade 3-4 adverse events included hypertension (1.9 %) and thrombosis (1.9 %). CONCLUSIONS: An alternating regimen consisting of mFOLFOX6 plus bevacizumab and FOLFIRI plus bevacizumab is an effective and well-tolerated first-line chemotherapy combination for patients with metastatic colorectal cancer.
OBJECTIVES: The purpose of this phase II study was to explore the efficacy and safety of an alternating regimen consisting of folinic acid, 5-fluorouracil (5-FU) and oxaliplatin (mFOLFOX6) plus bevacizumab, and folinic acid, 5-FU and irinotecan (FOLFIRI) plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer. METHODS: Fifty-two patients with metastatic colorectal cancer received an alternating regimen consisting of four cycles of mFOLFOX6 plus bevacizumab followed by four cycles of FOLFIRI plus bevacizumab until disease progression. The primary endpoint was progression-free survival. RESULTS: The median age was 60 years (range 37-75 years). Median progression-free survival was 14.2 months (95 % confidence interval [CI] 10.6-16.3) and median overall survival was 28.4 months (95 % CI 22.6-39.1). The overall response rate was 60.0 % (95 % CI 45.2-73.6). Regarding toxicity, the commonest grade 3-4 hematological adverse events were neutropenia (34.6 %) and leukopenia (7.7 %), and the commonest grade 3-4 non-hematological adverse events were anorexia (13.5 %), fatigue (9.6 %), nausea (9.6 %), and vomiting (9.6 %). Bevacizumab-related grade 3-4 adverse events included hypertension (1.9 %) and thrombosis (1.9 %). CONCLUSIONS: An alternating regimen consisting of mFOLFOX6 plus bevacizumab and FOLFIRI plus bevacizumab is an effective and well-tolerated first-line chemotherapy combination for patients with metastatic colorectal cancer.
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