Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan.
Int J Clin Oncol. 2013 Apr;18(2):279-84. doi: 10.1007/s10147-012-0374-z. Epub 2012 Feb 25.
An oxaliplatin-based regimen as the adjuvant treatment for stage III colon cancer demonstrated a survival advantage over fluorouracil (FU) and leucovorin (LV) in the MOSAIC and NSABP C-07 trials. For adjuvant treatment after the resection of metastases from colorectal cancer), active chemotherapy regimens such as FOLFOX are recommended. However, the safety data of FOLFOX are insufficient for its use after metastasectomy of colorectal cancer in Japanese patients. The aim of this study was to evaluate the safety of mFOLFOX6 for adjuvant treatment after the resection of metastases from colorectal cancer.
Among 67 consecutive patients who received mFOLFOX6 as the adjuvant treatment after resection of metastases from colorectal cancer between September 2002 and March 2009 in our institution, 51 patients who had not received preoperative chemotherapy were reviewed. The mFOLFOX6 treatment comprised oxaliplatin 85 mg/m(2) and l-leucovorin 200 mg/m(2) given intravenously over a 2-h period on day 1, followed by a 5-FU bolus of 400 mg/m(2) and a 46-h infusion of 5-FU 2400 mg/m(2), every 2 weeks for up to 12 cycles.
National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTC) grade 3-4 toxicities per patient were: peripheral neuropathy 8%, allergic reaction 4%, aspartate transaminase (AST) 4%, febrile neutropenia 4%, nausea 2%, anorexia 2%, fatigue 2%, alanine transaminase (ALT) 2%, bilirubin 2%, neutrophils 49%, leukocytes 6%, and hemoglobin 2%; 71% of the patients completed the scheduled 12 cycles.
Adjuvant therapy with mFOLFOX6 after resection of metastases from colorectal cancer is feasible for Japanese patients.
MOSAIC 和 NSABP C-07 试验表明，奥沙利铂为基础的方案作为 III 期结肠癌的辅助治疗，与氟尿嘧啶（FU）和亚叶酸（LV）相比具有生存优势。对于结直肠癌转移灶切除后的辅助治疗，推荐使用 FOLFOX 等活性化疗方案。然而，对于日本患者结直肠癌转移灶切除后使用 FOLFOX 的安全性数据尚不充分。本研究旨在评估 mFOLFOX6 用于结直肠癌转移灶切除后辅助治疗的安全性。
在我院 2002 年 9 月至 2009 年 3 月期间，67 例接受 mFOLFOX6 作为结直肠癌转移灶切除后辅助治疗的连续患者中，对未接受术前化疗的 51 例患者进行了回顾性分析。mFOLFOX6 治疗方案包括奥沙利铂 85mg/m²静脉滴注 2 小时，第 1 天给予 l-亚叶酸 200mg/m²，随后给予氟尿嘧啶 400mg/m² 推注，5-FU 2400mg/m² 持续输注 46 小时，每 2 周 1 次，最多 12 个周期。
按美国国立癌症研究所不良事件通用术语标准 3.0 版（NCI-CTC），每例患者的 3-4 级毒性为：周围神经病变 8%，过敏反应 4%，天冬氨酸转氨酶（AST）4%，发热性中性粒细胞减少症 4%，恶心 2%，厌食 2%，乏力 2%，丙氨酸转氨酶（ALT）2%，胆红素 2%，中性粒细胞 49%，白细胞 6%，血红蛋白 2%；71%的患者完成了计划的 12 个周期。
mFOLFOX6 用于结直肠癌转移灶切除后的辅助治疗对日本患者是可行的。
