Department of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto-cho, Tokushima, 770-8503, Japan.
Department of Medical Oncology, Tokushima Municipal Hospital, 2-34 Kitajosanjima-cho, Tokushima, 770-0812, Japan.
Lung Cancer. 2018 Nov;125:93-99. doi: 10.1016/j.lungcan.2018.09.007. Epub 2018 Sep 12.
The clinical benefit of chemotherapy and the appropriate regimen for non-small-cell lung cancer (NSCLC) patients with interstitial lung disease (ILD) remain unclear. To fulfill this unmet medical need, we conducted a phase II study to elucidate the efficacy of S-1 in combination with carboplatin (CBDCA) in NSCLC patients with ILD.
A total of 33 advanced or recurrent NSCLC patients with ILD were prospectively enrolled in this multicenter, open-label, phase II study. Every 4 weeks, CBDCA at a dose of AUC 5 on day 1 and S-1 at a dose of 80 mg/m daily for 14 days were administered. The primary endpoint was the investigator-assessed objective response rate.
The median age at initiating chemotherapy was 70. Sixteen patients (48.5%) had squamous cell carcinoma histology. With respect to the types of ILD, the usual interstitial pneumonia pattern was dominant (66.7%). The median number of cycles administered was 3, and the overall response rate and disease control rate were 33.3% and 78.8%, respectively. The median progression-free survival, the median survival time and the 1-year survival rate were 4.8 months, 12.8 months and 51.4%, respectively. Acute exacerbation of ILD caused by chemotherapy was noted in 2 patients (6.1%).
This is the first prospective study designed to evaluate the efficacy of a specific chemotherapeutic regimen as the primary endpoint in patients with advanced NSCLC with ILD. The combination of S-1 with CBDCA may be a treatment option for advanced NSCLC patients with ILD (The clinical trial registration number: UMIN000011046).
化疗的临床获益以及间质性肺病（ILD）非小细胞肺癌（NSCLC）患者的合适治疗方案仍不明确。为满足这一未满足的医疗需求，我们开展了一项 II 期研究，以阐明 S-1 联合卡铂（CBDCA）治疗 NSCLC 合并ILD 患者的疗效。
本多中心、开放标签、II 期前瞻性研究共纳入 33 例ILD 进展或复发的 NSCLC 患者。每 4 周，第 1 天给予 CBDCA 剂量 AUC5，S-1 剂量 80mg/m2 每天连用 14 天。主要终点为研究者评估的客观缓解率。
开始化疗时的中位年龄为 70 岁。16 例患者（48.5%）为鳞状细胞癌组织学类型。ILD 的类型方面，以寻常型间质性肺炎模式为主（66.7%）。中位治疗周期数为 3 个，总缓解率和疾病控制率分别为 33.3%和 78.8%。中位无进展生存期、中位总生存期和 1 年生存率分别为 4.8 个月、12.8 个月和 51.4%。2 例（6.1%）患者出现化疗引起的ILD 急性加重。
这是第一项旨在评估特定化疗方案疗效的前瞻性研究，该方案将作为 ILD 晚期 NSCLC 患者的主要终点。S-1 联合 CBDCA 可能是 ILD 晚期 NSCLC 患者的一种治疗选择（临床试验注册号：UMIN000011046）。
