Okumura Norihito, Sonobe Makoto, Okabe Kazunori, Nakamura Hiroshige, Kataoka Masafumi, Yamashita Motohiro, Nakata Masao, Kataoka Kazuhiko, Yamashita Yoshinori, Soh Junichi, Yoshioka Hiroshige, Hotta Katsuyuki, Matsuo Keitaro, Sakamoto Junichi, Toyooka Shinichi, Date Hiroshi
Department of Thoracic Surgery, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama, 710-8602, Japan.
Department of Thoracic Surgery, Kyoto University Graduate School of Medicine, 54 Shogoinkawara-cho, Sakyo-ku, Kyoto, Japan.
Int J Clin Oncol. 2017 Apr;22(2):274-282. doi: 10.1007/s10147-016-1067-9. Epub 2016 Dec 5.
This multicenter study evaluated the feasibility of novel adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent, long-term maintenance with S-1 in patients with completely resected stage II-IIIA non-small-cell lung cancer (NSCLC).
Patients received four cycles of S-1 (80 mg/m/day for 2 weeks, followed by 2 weeks rest) plus carboplatin (area under the curve 5, day 1) followed by S-1 (80 mg/m/day for 2 weeks, followed by a 1-week rest). Patients unable to continue S-1 plus carboplatin because of severe toxicity converted to single-agent S-1 maintenance. The duration of adjuvant chemotherapy was 10 months in both situations. The primary endpoint was feasibility, defined as the proportion of patients who completed four cycles of S-1 plus carboplatin and single-agent S-1 maintenance for 10 months. The treatment completion rate was determined; treatment was considered feasible if the lower 90% confidence interval (CI) was ≥50%.
Eighty-nine patients were enrolled, of whom 87 were eligible and assessable. Seventy-eight patients (89.7%) completed four cycles of S-1 plus carboplatin and 55 (63.2%) completed the following S-1 maintenance therapy for a total of 10 months. The treatment completion rate was 63.2% (90% CI, 54.4-71.2%), indicating feasibility. There were no treatment-related deaths. Grade 3/4 toxicities included neutropenia (13.8%), thrombocytopenia (11.5%), and anorexia (4.6%). The 2-year relapse-free survival rate was 59.8%.
We concluded that adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent maintenance therapy with S-1 is feasible and tolerable in patients with completely resected NSCLC.
UMIN000005041.
这项多中心研究评估了对于完全切除的II-IIIA期非小细胞肺癌（NSCLC）患者，采用S-1联合卡铂进行新型辅助化疗，随后使用S-1单药长期维持治疗的可行性。
患者接受四个周期的S-1（80mg/m²/天，持续2周，随后休息2周）联合卡铂（曲线下面积为5，第1天给药），之后给予S-1（80mg/m²/天，持续2周，随后休息1周）。因严重毒性而无法继续接受S-1联合卡铂治疗的患者改为S-1单药维持治疗。两种情况下辅助化疗的持续时间均为10个月。主要终点为可行性，定义为完成四个周期S-1联合卡铂治疗以及10个月S-1单药维持治疗的患者比例。确定治疗完成率；如果90%置信区间下限≥50%，则认为治疗可行。
共入组89例患者，其中87例符合条件且可评估。78例患者（89.7%）完成了四个周期的S-1联合卡铂治疗，55例患者（63.2%）完成了后续共10个月的S-1维持治疗。治疗完成率为63.2%（90%置信区间，54.4-71.2%），表明具有可行性。无治疗相关死亡病例。3/4级毒性反应包括中性粒细胞减少（13.8%）、血小板减少（11.5%）和厌食（4.6%）。2年无复发生存率为59.8%。
我们得出结论，对于完全切除的NSCLC患者，S-1联合卡铂辅助化疗后序贯S-1单药维持治疗是可行且可耐受的。
UMIN000005041。
