A Phase II Study of S‐1 and Paclitaxel Combination Therapy as a First‐Line Treatment in Elderly Patients with Advanced Non‐Small Cell Lung Cancer

Lessons Learned Coadministration of S‐1 and paclitaxel in elderly patients with advanced non‐small cell lung cancer showed favorable efficacy. Coadministration of S‐1 and paclitaxel in elderly patients with advanced non‐small lung cancer showed tolerable toxicity. Background Although monotherapy with cytotoxic agents including docetaxel or vinorelbine are recommended for elderly patients with advanced non‐small cell lung cancer (NSCLC), the outcome is not satisfactory. We evaluated the efficacy and safety of S‐1 and paclitaxel (PTX) as a first‐line cotreatment in elderly patients with advanced NSCLC. Methods Oral S‐1 was administered on days 1–14 every 3 weeks at 80, 100, and 120 mg per day for patients with body surface area < 1.25 m2, 1.25–1.5 m2, and > 1.5 m2, respectively. PTX was administered at 80 mg/m2 on days 1 and 8. The primary endpoint was response rate, and secondary endpoints were progression‐free survival (PFS), overall survival (OS), and safety. Results Seventeen patients were enrolled with response and disease control rates of 47.1% and 88.2%, respectively. Median PFS and OS were 5.6 and 35.0 months, respectively. Hematological grade 3 or 4 toxicities included leukopenia (55.8%), neutropenia (52.9%), febrile neutropenia (11.8%), and anemia (11.8%). Nonhematological grade 3 toxicities included stomatitis (23.5%), diarrhea (5.9%), and interstitial lung disease (5.9%), and grade 5 toxicities included interstitial lung disease (5.9%). Conclusion This S‐1 and PTX cotherapy dose and schedule showed satisfactory efficacy with mild toxicities in elderly patients with advanced NSCLC. 经验获取 • 在晚期非小细胞肺癌老年患者中同时使用 S‐1 和紫杉醇进行治疗显示出良好的疗效。 • 在晚期非小细胞肺癌老年患者中同时使用 S‐1 和紫杉醇进行治疗显示出可耐受的毒性。 摘要 背景。虽然晚期非小细胞肺癌 (NSCLC) 老年患者推荐采用含多西他赛或长春瑞滨的细胞毒制剂单药治疗，但是，预后并不令人满意。我们评估了将 S‐1 和紫杉醇(PTX)作为晚期 NSCLC 老年患者的一线联合治疗的有效性和安全性。 方法。在每 3 周的第 1–14 天，体表面积 < 1.25 m2、1.25–1.5 m2，以及 > 1.5 m2的患者分别按照每天 80 mg、100 mg 以及 120 mg 的剂量口服 S‐1。患者在第 1 天和第 8 天按照PTX 80 mg/m2 的剂量给药。主要终点为反应率，次要终点为无进展生存期 (PFS)、总生存期 (OS) 以及安全性。 结果。17 名入组患者的反应率和疾病控制率分别为 47.1% 和 88.2%。中位 PFS 和 OS 分别为 5.6 和 35.0 个月。3 或 4 级血液毒性包括白细胞减少症 (55.8%)、嗜中性粒细胞减少症 (52.9%)、发热性嗜中性粒细胞减少症 (11.8%) 以及贫血 (11.8%)。3 级非血液毒性包括口腔炎 (23.5%)、腹泻 (5.9%) 以及间质性肺病 (5.9%)，5 级毒性包括间质性肺病 (5.9%)。 结论。本次 S‐1 和 PTX 协同治疗的剂量和时间表在晚期 NSCLC 老年患者中显示出令人满意的疗效以及轻微毒性。