Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
Okino Medical Clinic, Sendai, Japan.
Thorac Cancer. 2023 Sep;14(27):2804-2810. doi: 10.1111/1759-7714.15076. Epub 2023 Aug 17.
This phase II trial was designed to evaluate the efficacy and safety of S-1 combined with weekly irinotecan as a second- or third-line treatment for patients with advanced or recurrent squamous cell lung cancer.
Patients with a body surface area <1.25, 1.25-1.50, and >1.50 m received oral S-1 on days 1-14 at 80, 100, and 120 mg/day, respectively, and irinotecan on days 1 and 8 at 70 mg/m every 3 weeks. The primary endpoint was the overall response rate, and the secondary endpoints were progression-free survival, overall survival, and the incidence and severity of adverse effects.
Between September 2011 and December 2014, 30 patients were enrolled in this study. The overall response rate was 6.7% (95% confidence interval [CI]: 0.8%-22.1%), and the disease control rate was 73.3%. The median progression-free survival was 3.0 months (95% CI: 2.5-3.4 months), and the median overall survival was 10.5 months (95% CI: 5.6-13.7 months). Grade 3/4 treatment-related adverse events were reported in ≥10% of the patients, including leukopenia (21%), neutropenia (21%), anemia (17%), anorexia (10%), and hypokalemia (10%).
Although the treatment-related adverse events were manageable, the combination of weekly irinotecan and S-1 did not have the expected effect.
本 II 期临床试验旨在评估 S-1 联合每周伊立替康作为二线或三线治疗晚期或复发性鳞状细胞肺癌患者的疗效和安全性。
体表面积<1.25、1.25-1.50 和>1.50m 的患者分别在第 1-14 天口服 S-1，剂量为 80、100 和 120mg/天，第 1 和 8 天给予伊立替康 70mg/m，每 3 周一次。主要终点是总缓解率，次要终点是无进展生存期、总生存期以及不良反应的发生率和严重程度。
2011 年 9 月至 2014 年 12 月期间，共纳入 30 例患者。总缓解率为 6.7%（95%置信区间[CI]：0.8%-22.1%），疾病控制率为 73.3%。中位无进展生存期为 3.0 个月（95%CI：2.5-3.4 个月），中位总生存期为 10.5 个月（95%CI：5.6-13.7 个月）。≥10%的患者出现 3/4 级治疗相关不良反应，包括白细胞减少症（21%）、中性粒细胞减少症（21%）、贫血（17%）、厌食症（10%）和低钾血症（10%）。
虽然治疗相关不良反应可管理，但每周伊立替康联合 S-1 并未产生预期效果。
