Phase II Study of S‐1 and Paclitaxel Combination Therapy in Patients with Previously Treated Non‐Small Cell Lung Cancer

Lessons Learned In terms of efficacy and safety, good results were obtained with S‐1 and paclitaxel (PTX) combination therapy. The findings suggest that S‐1 and PTX combination therapy is a feasible treatment option in patients with previously treated non‐small cell lung cancer. Background Although monotherapy with cytotoxic agents, including docetaxel and pemetrexed, is recommended for patients with previously treated advanced non‐small cell lung cancer (NSCLC), its outcomes are unsatisfactory. S‐1 is an oral fluoropyrimidine agent that consists of tegafur, 5‐ chloro‐2, 4‐dihydroxypyridine, and potassium oxonate. S‐1 is approved for patients with gastric cancer in 7 Asian countries and 15 European countries. It is also approved for patients with eight type of cancers, including NSCLC, in Japan. We evaluated the efficacy and toxicity of S‐1 and paclitaxel (PTX) combination therapy in patients with previously treated NSCLC. Methods Oral S‐1 was administered thrice weekly on days 1–14 at 80, 100, and 120 mg/day in patients with body surface areas of 1.5 m2, respectively. PTX was administered at 80 mg/m2 on days 1 and 8. Primary endpoint was response rate, and secondary endpoints were progression‐free survival (PFS), overall survival (OS), and safety. Results Forty patients were enrolled, with response and disease control rates of 27.5% and 75.0%, respectively (Fig. 1). Median PFS and OS were 6.5 and 20.7 months, respectively. Grade 3/4 anemia and thrombocytopenia were seen in five (12%) and one (2%) patients, respectively. Febrile neutropenia occurred in three patients (7%). Common grade 3/4 nonhematological toxicities were stomatitis (5% of patients), diarrhea (7% of patients), and interstitial lung disease (one patient). No treatment‐related deaths were observed. Conclusion This S‐1 and PTX cotherapy dose and schedule showed satisfactory efficacy, with mild toxicities, in patients with previously treated advanced NSCLC. 经验总结 • 在疗效和安全性方面，S‐1 联合紫杉醇 (PTX) 治疗效果良好。 • 研究结果表明，S‐1 联合 PTX 治疗经治非小细胞肺癌是一种可行的治疗方案。 摘要 背景。虽然对于既往经治的晚期非小细胞肺癌 (NSCLC) 的治疗，建议使用多烯紫杉醇和培美曲塞等细胞毒性药物单药疗法，但其结果并不令人满意。S‐1 是一种口服氟尿嘧啶制剂，由替加氟、5‐氯‐ 2、4 ‐二羟基吡啶和氧酸钾组成。S‐1 已在 7 个亚洲国家和 15 个欧洲国家获批用于胃癌患者的治疗。而且，日本已批准 S‐1 用于包括NSCLC在内的八种癌症患者的治疗。本研究评估了 S‐1 联合紫杉醇 (PTX) 治疗既往经治 NSCLC 的疗效和毒性。 方法。对于体表面积 1.5 m2 的患者，在第 1‐14 天口服 S‐1，每周三次，每次分别80 mg/天、100 mg/天、120 mg/天。在第 1 天和第 8 天按照PTX 80 mg/m2 的剂量给药。主要终点为缓解率，次要终点为无进展生存期 (PFS)、总生存期 (OS) 和安全性。 结果。共入组 40 例患者，缓解率为 27.5%，疾病控制率为 75.0%(图 1)。中