Phase III study of adjuvant gemcitabine compared with adjuvant uracil-tegafur in patients with completely resected pathological stage IB–IIIA non-small cell lung cancer (WJTOG0101)

医学 吉西他滨 内科学 危险系数 特加福 阶段(地层学) 临床终点 胃肠病学 肺癌 佐剂 肿瘤科 辅助治疗 不利影响 置信区间 外科 癌症 临床试验 生物 古生物学
作者
Masafumi Yamaguchi,Hirohito Tada,Tetsuya Mitsudomi,Takashi Seto,Kohei Yokoi,Nobuyuki Katakami,Kazuhiko Nakagawa,Makoto Oda,Mitsunori Ohta,Toshiyuki Sawa,Motohiro Yamashita,Norihiko Iked,Hideo Saka,Masahiko Higashiyama,Hiroaki Nomori,Hiroshi Semba,Shunichi Negoro,Yasutaka Chiba,Mototsugu Shimokawa,Masahiro Fukuoka,Yoichi Nakanishi
出处
期刊:International Journal of Clinical Oncology [Springer Science+Business Media]
卷期号:26 (12): 2216-2223 被引量:6
标识
DOI:10.1007/s10147-021-02012-9
摘要

Adjuvant oral uracil-tegafur (UFT) has led to significantly longer postoperative survival among patients with non-small-cell lung cancer (NSCLC). Gemcitabine (GEM) monotherapy is also reportedly effective for NSCLC and has minor adverse events (AEs). This study compared the efficacy of GEM- versus UFT-based adjuvant regimens in patients with completely resected pathological stage (p-stage) IB–IIIA NSCLC. Patients with completely resected p-stage IB–IIIA NSCLC were randomly assigned to GEM or UFT. The primary endpoint was overall survival (OS); secondary endpoints were disease-free survival (DFS), and AEs. We assigned 305 patients to the GEM group and 303 to the UFT group. Baseline factors were balanced between the arms. Of the 608 patients, 293 (48.1%) had p-stage IB disease, 195 (32.0%) had p-stage II disease and 121 (19.9%) had p-stage IIIA disease. AEs were generally mild in both groups, and only one death occurred, in the GEM group. After a median follow-up of 6.8 years, the two groups did not significantly differ in survival: 5 year OS rates were GEM: 70.0%, UFT: 68.8% (hazard ratio 0.948; 95% confidence interval 0.73–1.23; P = 0.69). Although GEM-based adjuvant therapy for patients with completely resected stage IB–IIIA NSCLC was associated with acceptable toxicity, it did not provide longer OS than did UFT.
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