Objectives

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.

Materials and methods

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/m² daily for 14 days were administered. The primary endpoint was the investigator-assessed objective response rate.

Results

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%).

Conclusion

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).

中文翻译：

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S-1加卡铂在间质性肺疾病的晚期非小细胞肺癌患者中进行的多中心，开放标签，II期临床试验

目标

对于患有间质性肺病（ILD）的非小细胞肺癌（NSCLC）患者，化学疗法的临床益处和适当的治疗方案仍不清楚。为了满足这一尚未满足的医疗需求，我们进行了II期研究，以阐明S-1联合卡铂（CBDCA）在NSCLC患有ILD的患者中的疗效。

材料和方法

这项多中心，开放标签的II期研究共纳入了33位晚期或复发性ICL NSCLC患者。每4周，在第1天给予ABD 5剂量的CBDCA和每天80 mg / m ²剂量的S-1，持续14天。主要终点是研究者评估的客观反应率。

结果

开始化疗的中位年龄为70岁。16例（48.5％）患有鳞状细胞癌组织学。关于ILD的类型，通常以间质性肺炎为主（66.7％）。给予的中位周期数为3，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，中位生存时间和1年生存率分别为4.8个月，12.8个月和51.4％。2例（6.1％）观察到化疗引起的ILD急性加重。

结论

这是第一项旨在评估特定化疗方案作为晚期ICL伴NSD的患者主要终点的疗效的前瞻性研究。S-1与CBDCA的组合可能是ILD晚期NSCLC患者的治疗选择（临床试验注册号：UMIN000011046）。