A Multicenter Randomized Controlled Study of Paclitaxel plus Carboplatin versus Oral Uracil-Tegafur as the Adjuvant Chemotherapy in Resected Non-Small Cell Lung Cancer

作者：Toyooka Shinichi; Okumura Norihito; Nakamura Hiroshige; Nakata Masao; Yamashita Motohiro; Tada Hirohito; Kajiwara Shinsuke; Watanabe Naoki; Okada Morihito; Sakamoto Junichi; Aoe Motoi; Soh Junichi; Miyoshi Shinichiro; Hotta Katsuyuki; Matsuo Keitaro; Date Hiroshi

来源：Journal of Thoracic Oncology, 2018, 13(5): 699-706.

DOI：10.1016/j.jtho.2018.02.015

• Non-small cell lung cancer
• adjuvant chemotherapy
• paclitaxel
• carboplatin
• uracil-tegafur

Introduction: We conducted a randomized controlled study to compare the survival benefit of paclitaxel plus carboplatin and oral uracil-tegafur (UFT) as adjuvant chemotherapy in resected NSCLC.
Methods: In an open-label multicenter trial, patients with pathological stage IB to IIIA NSCLC were randomized into a group receiving paclitaxel (175 mg/m(2)) plus carboplatin (area under the curve 5) every 3 weeks for four cycles (arm A) or a group receiving orally administered UFT (250 mg/m(2)) daily for 2 years (arm B). The primary and secondary end points were overall survival and relapse-free survival and toxicity, respectively.
Results: Between November 2004 and November 2010, 402 patients from 40 institutions were included (201 in each arm). The median follow-up period was 6.5 years. The 5-year overall survival rate was 70% (95% confidential interval [CI]: 63-76] in arm A versus 73% (95% CI: 66-78) in arm B (hazard ratio = 0.92, 95% CI: 0.55-1.41, p = 0.69). There was no significant difference in the 5-year relapsefree survival rate between arms A and B (56% versus 57% [hazard ratio = 0.92, 95% CI: 0.63-1.34, p = 0.50]). Toxicities were well tolerated and there was no treatment-related death. Toxicities of any grade or grade 4 were significantly more frequent in the paclitaxel plus carboplatin group (95.7% and 22.1%, respectively) than in the UFT group (76.5% and 1.0%, respectively [p < 0.0001 in both]).
Conclusions: As adjuvant chemotherapy, paclitaxel plus carboplatin was no better than UFT in terms of survival among patients with stage IB to IIIA NSCLC tumors who underwent complete resection (UMIN000000810).

• 出版日期2018-5