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A multicenter, open-label, phase II trial of S-1 plus carboplatin in advanced non-small cell lung cancer patients with interstitial lung disease
- Source :
- Lung Cancer. 125:93-99
- Publication Year :
- 2018
- Publisher :
- Elsevier BV, 2018.
-
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).
- Subjects :
- Male
Pulmonary and Respiratory Medicine
Oncology
Cancer Research
medicine.medical_specialty
Lung Neoplasms
Phases of clinical research
Disease-Free Survival
Carboplatin
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Usual interstitial pneumonia
Carcinoma, Non-Small-Cell Lung
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Clinical endpoint
Humans
Prospective Studies
Lung cancer
Survival rate
Aged
Tegafur
business.industry
Interstitial lung disease
Middle Aged
medicine.disease
respiratory tract diseases
Survival Rate
Drug Combinations
Oxonic Acid
Regimen
030228 respiratory system
chemistry
030220 oncology & carcinogenesis
Carcinoma, Squamous Cell
Female
Neoplasm Recurrence, Local
Lung Diseases, Interstitial
business
Subjects
Details
- ISSN :
- 01695002 and 00001104
- Volume :
- 125
- Database :
- OpenAIRE
- Journal :
- Lung Cancer
- Accession number :
- edsair.doi.dedup.....e3cf9cc0998243a6923c97b1de53e4d5