Masaki Hanibuchi1, Soji Kakiuchi2, Shinji Atagi3, Fumitaka Ogushi4, Eiji Shimizu5, Takashi Haku6, Yuko Toyoda1, Masahiko Azuma1, Mayo Kondo1, Hiroshi Kawano1, Kenji Otsuka1, Satoshi Sakaguchi1, Hiroshi Nokihara1, Hisatsugu Goto1, Yasuhiko Nishioka7. 1. Department of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto-cho, Tokushima, 770-8503, Japan. 2. Department of Medical Oncology, Tokushima Municipal Hospital, 2-34 Kitajosanjima-cho, Tokushima, 770-0812, Japan. 3. Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, 1180 Nagasone-cho, Kita-ku, Sakai, 591-8025, Japan. 4. Department of Respiratory Medicine, National Hospital Organization Kochi National Hospital, 1-2-25 Asakuranishi-cho, Kochi, 780-8077, Japan. 5. Department of Respiratory Medicine and Rheumatology, Tottori University Hospital, 36-1 Nishi-cho, Yonago, 683-8504, Japan. 6. Department of Respiratory Medicine, Tokushima Prefectural Central Hospital, 1-10-3 Kuramoto-cho, Tokushima, 770-8539, Japan. 7. Department of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto-cho, Tokushima, 770-8503, Japan. Electronic address: yasuhiko@tokushima-u.ac.jp.
Abstract
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).
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 NSCLCpatients with ILD. MATERIALS AND METHODS: A total of 33 advanced or recurrent NSCLCpatients 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 NSCLCpatients with ILD (The clinical trial registration number: UMIN000011046).
Authors: Xie Xiaohong; Wang Liqiang; Li Na; Lin Xinqing; Qin Yinyin; Liu Ming; Ouyang Ming; Han Qian; Luo Qun; Li Shiyue; Li Chunyan; Wang Xiaoqian; Yang Shuanying; Huang Wei; Liu Mei; Wang Ping; Zhou Chengzhi Journal: Front Mol Biosci Date: 2021-03-31