Inoue Masayoshi, Kusumoto Hidenori, Shiono Hiroyuki, Shintani Yasushi, Ose Naoko, Sakamaki Yasushi, Okami Jiro, Higashiyama Masahiko, Takeuchi Yukiyasu
Division of Thoracic Surgery, Department of Surgery , Kyoto Prefectural University of Medicine , Kyoto , Japan.
General Thoracic Surgery , Nara Hospital, Kindai University School of Medicine , Osaka , Japan.
J Chemother. 2019 Oct;31(6):343-348. doi: 10.1080/1120009X.2019.1651002. Epub 2019 Aug 14.
Feasibility is one of the major concerns during adjuvant chemotherapy in patients with completely resected non-small cell lung cancer. A phase II clinical trial of adjuvant chemotherapy with four courses of carboplatin (AUC 5 at day 1) and S-1 (80 mg/m/day for 2 weeks followed by a 2-week rest) was performed to evaluate the feasibility (UMIN 9101). The primary endpoint was the completion rate and the secondary endpoints were adverse events, 2-year overall survival and disease-free rates. Thirty-five non-small cell lung cancer patients were enrolled. The adjuvant chemotherapy completion rate was 85.3% (29/34); 17/34 (50%) patients completed 4 courses without dose reduction. There were no treatment-related deaths, and Grade 3/4 adverse events included neutropenia (38.2%), leukocytopenia (14.7%), anemia (20.6%), thrombocytopenia (20.6%), anorexia (5.9%), fatigue (5.9%), and oral mucositis (2.9%). Two-year overall and disease-free survival rates were 96.3% and 53.3%, respectively. Adjuvant chemotherapy with carboplatin plus S-1 is safe and feasible.
在完全切除的非小细胞肺癌患者的辅助化疗中，可行性是主要关注点之一。开展了一项II期临床试验，采用四个疗程的卡铂（第1天AUC 5）加S-1（80mg/m²/天，持续2周，随后休息2周）进行辅助化疗，以评估其可行性（UMIN 9101）。主要终点是完成率，次要终点是不良事件、2年总生存率和无病生存率。纳入了35例非小细胞肺癌患者。辅助化疗完成率为85.3%（29/34）；17/34（50%）的患者完成了4个疗程且未减量。无治疗相关死亡，3/4级不良事件包括中性粒细胞减少（38.2%）、白细胞减少（14.7%）、贫血（20.6%）、血小板减少（20.6%）、厌食（5.9%）、疲劳（5.9%）和口腔黏膜炎（2.9%）。2年总生存率和无病生存率分别为96.3%和53.3%。卡铂加S-1辅助化疗安全可行。
