Carboplatin, S-1 and concurrent thoracic radiotherapy for elderly patients with locally advanced non-small cell lung cancer: a multicenter Phase I/II study.

Abstract

OBJECTIVES:

We conducted a Phase I/II study of carboplatin, S-1 and concurrent thoracic radiotherapy (TRT) for elderly patients (71 years or older) with unresectable stage III non-small cell lung cancer (NSCLC).

MATERIALS AND METHODS:

Patients received carboplatin (AUC 3-5) on Day 1 and S-1 (30-40 mg/m2 two times daily) on Days 1-14, every 2 weeks, for up to four cycles, plus concurrent TRT at a total dose of 60 Gy. The primary endpoint for the Phase II study was the 1-year progression-free survival (PFS) rate.

RESULTS:

Eighteen patients were enrolled in the Phase I study. Febrile neutropenia, a decreased platelet count and esophagitis were dose-limiting toxicities. The recommended doses for the Phase II study were determined to be an AUC of 3 for carboplatin, 40 mg/m2 twice daily for S-1. Twenty-eight patients were evaluated in the Phase II study. The 1-year PFS rate was 57.1% (90% CI 41.6-71.4%), and the median PFS was 16.8 months (95% CI 7.8-not assessable [NA]). The lower limit of the 90% CI for 1-year PFS exceeded the prespecified threshold value of 30%; therefore, the primary endpoint was met. Grades 3-4 toxicities included thrombocytopenia (21%) and hyponatremia (11%). Grade 3 radiation pneumonitis was observed in 18% of patients. No treatment-related deaths were observed.

CONCLUSION:

Combination chemotherapy consisting of carboplatin plus S-1 and concurrent TRT had a promising efficacy in elderly patients with locally advanced NSCLC; however, radiation pneumonitis was frequently observed.

• Authors: Seiji Niho, Yukio Hosomi, Hiroaki Okamoto, Keiji Nihei, Hiroshi Tanaka, Toyoaki Hida, Shigeki Umemura, Koichi Goto, Tetsuo Akimoto, Yuichiro Ohe
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 49 Issue 7 Pg. 614-619 (Jul 01 2019) ISSN: 1465-3621 [Electronic] England
• PMID: 30916304 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: © The Author(s) 2019. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: [email protected].

Chemical References

• Drug Combinations
• S 1 (combination)
• Tegafur
• Oxonic Acid
• Carboplatin
• Paclitaxel

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carboplatin (administration & dosage, adverse effects, therapeutic use)
• Carcinoma, Non-Small-Cell Lung (drug therapy, pathology, radiotherapy)
• Chemoradiotherapy
• Drug Combinations
• Female
• Humans
• Leukopenia (chemically induced)
• Lung Neoplasms (drug therapy, pathology, radiotherapy)
• Male
• Neoplasm Staging
• Oxonic Acid (adverse effects, therapeutic use)
• Paclitaxel (administration & dosage)
• Progression-Free Survival
• Radiation Pneumonitis (etiology)
• Tegafur (adverse effects, therapeutic use)
• Treatment Outcome