JFMC37 - 0801试验的预先计划的安全性分析：一项关于卡培他滨6个月与12个月作为III期结肠癌辅助化疗的随机III期研究。
Preplanned safety analysis of the JFMC37-0801 trial: a randomized phase III study of six months versus twelve months of capecitabine as adjuvant chemotherapy for stage III colon cancer.
作者信息
Suto Takeshi, Ishiguro Megumi, Hamada Chikuma, Kunieda Katsuyuki, Masuko Hiroyuki, Kondo Ken, Ishida Hideyuki, Nishimura Genichi, Sasaki Kazuaki, Morita Takayuki, Hazama Shoichi, Maeda Koutarou, Mishima Hideyuki, Ike Hideyuki, Sadahiro Sotaro, Sugihara Kenichi, Okajima Masazumi, Saji Shigetoyo, Sakamoto Junichi, Tomita Naohiro
机构信息
Department of Gastroenterological Surgery, Yamagata Prefectural Central Hospital, 1800 Aoyagi, Yamagata-shi, Yamagata, 990-2214, Japan.
Department of Translational Oncology, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.
出版信息
Int J Clin Oncol. 2017 Jun;22(3):494-504. doi: 10.1007/s10147-016-1083-9. Epub 2017 Jan 11.
BACKGROUND
Six months of adjuvant chemotherapy is regarded as the standard of care for patients with stage III colon cancer. However, whether longer treatment can improve prognosis has not been fully investigated. We conducted a phase III study comparing 6 and 12 months of adjuvant capecitabine chemotherapy for stage III colon cancer, and report here the results of our preplanned safety analysis.
METHODS
Patients aged 20-79 years with curatively resected stage III colon cancer were randomly assigned to receive 8 cycles (6 months) or 16 cycles (12 months) of capecitabine (2500 mg/m/day on days 1-14 of each 21-day cycle). Treatment exposure and adverse events (AEs) were evaluated.
RESULTS
A total of 1304 patients (642 and 636 in the 6-month and 12-month groups, respectively) were analyzed. The most common AE was hand-foot syndrome (HFS). HFS, leukocytopenia, neutropenia, and hyperbilirubinemia (any grade) occurred more frequently in the 12-month group than in the 6-month group. HFS was the only grade ≥3 AE to have a significantly higher incidence in the 12-month group (23 vs 17%, p = 0.011). The completion rate for 8 cycles was 72% in both groups, while that for 16 cycles was 46% in the 12-month group. HFS was the most common AE requiring dose reduction and treatment discontinuation.
CONCLUSIONS
Twelve months of adjuvant capecitabine demonstrated a higher cumulative incidence of HFS compared to the standard 6-month treatment period, while toxicities after 12 months of capecitabine were clinically acceptable.
TRIAL REGISTRATION
UMIN-CTR, UMIN000001367.
背景
六个月的辅助化疗被视为III期结肠癌患者的标准治疗方案。然而，更长时间的治疗是否能改善预后尚未得到充分研究。我们开展了一项III期研究，比较III期结肠癌患者接受6个月和12个月的卡培他滨辅助化疗的情况，并在此报告我们预先计划的安全性分析结果。
方法
年龄在20 - 79岁、接受了根治性切除的III期结肠癌患者被随机分配接受8个周期（6个月）或16个周期（12个月）的卡培他滨治疗（每21天周期的第1 - 14天，剂量为2500 mg/m²/天）。评估治疗暴露情况和不良事件（AE）。
结果
共分析了1304例患者（6个月组642例，12个月组636例）。最常见的AE是手足综合征（HFS）。HFS、白细胞减少、中性粒细胞减少和高胆红素血症（任何级别）在12个月组中的发生频率高于6个月组。HFS是唯一在12个月组中发生率显著更高的≥3级AE（23%对17%，p = 0.011）。两组8个周期的完成率均为72%，而12个月组16个周期的完成率为46%。HFS是最常见的需要降低剂量和停止治疗的AE。
结论
与标准的6个月治疗期相比，12个月的卡培他滨辅助化疗显示HFS的累积发生率更高，而卡培他滨治疗12个月后的毒性在临床上是可接受的。
试验注册
UMIN - CTR，UMIN000001367。
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