Jun Higashijima1, Takuya Tokunaga2, Toshiaki Yoshimoto2, Shohei Eto2, Hideya Kashihara2, Chie Takasu2, Masaaki Nishi2, Kozo Yoshikawa2, Hiroshi Okitsu3,4, Masashi Ishikawa5, Hidenori Miyake6, Toshiyuki Yagi7, Toru Kono8, Mitsuo Shimada2. 1. Department of Surgery, Institute of Health Biosciences, The University of Tokushima, Kuramoto 3-18-15, Tokushima, 770-8503, Japan. higashijima.jun@tokushima-u.ac.jp. 2. Department of Surgery, Institute of Health Biosciences, The University of Tokushima, Kuramoto 3-18-15, Tokushima, 770-8503, Japan. 3. Department of Surgery, Tokushima Red Cross Hospital, Tokushima, Japan. 4. Department of Surgery, Taoka Hospital, Tokushima, Japan. 5. Department of Surgery, Shikoku Central Hospital, Ehime, Japan. 6. Department of Surgery, Tokushima Municipal Hospital, Tokushima, Japan. 7. Department of Surgery, Tokushima Prefectural Central Hospital, Tokushima, Japan. 8. Advanced Surgery Center, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan.
Abstract
BACKGROUND: We clarified the safety and efficacy of preoperative chemoradiotherapy for locally advanced rectal cancer using a multidrug regimen (S-1 + oxaliplatin + bevacizumab). METHODS: This multicenter phase II trial involved 47 patients with locally advanced rectal cancer. All patients received S-1 orally (80 mg/m2/day on days 1-5, 8-12, 15-19, and 22-26) and infusions of oxaliplatin (50 mg/m2 on days 1, 8, 15, and 22) and bevacizumab (5 mg/kg on days 1 and 15). The total radiation dose was 40 Gy delivered in daily fractions of 2 Gy via the four-field technique. The primary endpoint was the pathological complete response rate. The secondary endpoints were safety (incidence of adverse events) and clinical response, relapse-free survival, overall survival, local recurrence, R0 resection, downstaging, and treatment completion rates. RESULTS: All 47 patients received chemoradiotherapy, and 44 patients underwent curative resection. Two patients refused surgery and selected a watch-and-wait strategy. The pathological complete response rate was 18.2% in patients who underwent curative resection. The clinical response rate was 91.3% in 46 patients. Concerning hematotoxicity, there was one grade 4 adverse event (2.1%) and seven grade 3 events (14.9%). Diarrhea was the most frequent non-hematotoxic event, and the grade 3 event rate was 25.5%. CONCLUSIONS: Although preoperative chemoradiotherapy for patients with locally advanced rectal cancer using the S-1 + oxaliplatin + bevacizumab regimen did not achieve the expected pathological complete response rate, this regimen led to an improved clinical response rate.
BACKGROUND: We clarified the safety and efficacy of preoperative chemoradiotherapy for locally advanced rectal cancer using a multidrug regimen (S-1 + oxaliplatin + bevacizumab). METHODS: This multicenter phase II trial involved 47 patients with locally advanced rectal cancer. All patients received S-1 orally (80 mg/m2/day on days 1-5, 8-12, 15-19, and 22-26) and infusions of oxaliplatin (50 mg/m2 on days 1, 8, 15, and 22) and bevacizumab (5 mg/kg on days 1 and 15). The total radiation dose was 40 Gy delivered in daily fractions of 2 Gy via the four-field technique. The primary endpoint was the pathological complete response rate. The secondary endpoints were safety (incidence of adverse events) and clinical response, relapse-free survival, overall survival, local recurrence, R0 resection, downstaging, and treatment completion rates. RESULTS: All 47 patients received chemoradiotherapy, and 44 patients underwent curative resection. Two patients refused surgery and selected a watch-and-wait strategy. The pathological complete response rate was 18.2% in patients who underwent curative resection. The clinical response rate was 91.3% in 46 patients. Concerning hematotoxicity, there was one grade 4 adverse event (2.1%) and seven grade 3 events (14.9%). Diarrhea was the most frequent non-hematotoxic event, and the grade 3 event rate was 25.5%. CONCLUSIONS: Although preoperative chemoradiotherapy for patients with locally advanced rectal cancer using the S-1 + oxaliplatin + bevacizumab regimen did not achieve the expected pathological complete response rate, this regimen led to an improved clinical response rate.
Authors: T Shirasaka; K Nakano; T Takechi; H Satake; J Uchida; A Fujioka; H Saito; H Okabe; K Oyama; S Takeda; N Unemi; M Fukushima Journal: Cancer Res Date: 1996-06-01 Impact factor: 12.701
Authors: C G Lee; M Heijn; E di Tomaso; G Griffon-Etienne; M Ancukiewicz; C Koike; K R Park; N Ferrara; R K Jain; H D Suit; Y Boucher Journal: Cancer Res Date: 2000-10-01 Impact factor: 12.701