医学
危险系数
内科学
临床终点
化疗
随机对照试验
养生
胰腺癌
化疗方案
外科
不利影响
置信区间
胃肠病学
癌症
作者
Hiroto Kuwabara,Shinji Itoh,Mototsugu Shimokawa,Hiromitsu Hayashi,Hiroshi Takahashi,Kengo Fukuzawa,Mizuki Ninomiya,Kenichiro Araki,Yo‐ichi Yamashita,Keizō Sugimachi,Hideaki Uchiyama,Yuji Morine,Tohru Utsunomiya,Tadashi Uwagawa,Takashi Maeda,Hideo Baba,Tomoharu Yoshizumi
标识
DOI:10.1007/s10147-023-02399-7
摘要
Six-month adjuvant chemotherapy with S-1 is standard care for resected pancreatic cancer in Japan; however, the optimal duration has not been established. We aimed to evaluate the impact of duration of adjuvant chemotherapy with S-1.We performed a multicenter, randomized, open-label, phase II study. Patients with histologically proven invasive pancreatic ductal carcinoma, pathological stage I-III, and no local residual or microscopic residual tumor were eligible. Patients were randomized 1:1 to receive 6- or 12-month adjuvant chemotherapy with S-1. The primary endpoint was 2-year overall survival (OS). Secondary endpoints were disease-free survival (DFS) and feasibility.A total of 170 patients were randomized (85 per group); the full analysis set was 82 in both groups. Completion rates were 64.7% (6-month group) and 44.0% (12-month group). Two-year OS was 71.5% (6-month group) and 65.4% (12-month group) (hazard ratio (HR): 1.143; 80% confidence interval CI 0.841-1.553; P = 0.5758). Two-year DFS was 46.4% (6-month group) and 44.9% (12-month group) (HR: 1.069; 95% CI 0.727-1.572; P = 0.6448). In patients who completed the regimen, 2-year DFS was 56.5% (6-month group) and 75.0% (12-month group) (HR: 0.586; 95% CI 0.310-1.105; P = 0.0944). Frequent (≥ 5%) grade ≥ 3 adverse events comprised anorexia (10.5% in the 6-month group) and diarrhea (5.3% vs. 5.1%; 6- vs. 12-month group, respectively).In patients with resected pancreatic cancer, 12-month adjuvant chemotherapy with S-1 was not superior to 6-month therapy regarding OS and DFS.
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