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Phase II study of tailored S-1 monotherapy with a 1-week interval after a 2-week dosing period in elderly patients with advanced non-small cell lung cancer.
- Source :
-
Respiratory investigation [Respir Investig] 2018 Jan; Vol. 56 (1), pp. 80-86. Date of Electronic Publication: 2017 Oct 21. - Publication Year :
- 2018
-
Abstract
- Background: S-1 is an oral fluoropyrimidine that is active in the treatment of non-small cell lung cancer (NSCLC); however, an optimal treatment schedule and appropriate dose adjustments of S-1 in elderly patients have not yet been established.<br />Methods: We conducted a phase II trial to evaluate the efficacy and safety of a 2-week S-1 monotherapy treatment followed by a 1-week interval as a first-line treatment of elderly NSCLC patients, by adjusting the dose based on the individual creatinine clearance (Ccr) and body surface area (BSA). The primary endpoint was the disease control rate.<br />Results: Forty patients were enrolled. The disease control and response rates were 89.5% (95% confidence interval [CI] = 79.8-99.2) and 7.9% (95% CI = 0.0-16.4), respectively. The median progression-free survival and overall survival times were 4.4 months (95% CI = 4.2-8.5) and 17.0 months (95% CI = 11.2-18.7), respectively. Neutropenia, anorexia, hyponatremia, hypokalemia, and pneumonia of grade ≥ 3 occurred in 5.0%, 7.5%, 5.0%, 2.5%, and 2.5% of patients, respectively. Among the patient-reported outcomes, most of the individual factors in the patients' quality of life, including upper intestine-related symptoms improved with the treatment, except for dyspnea, which slightly albeit continuously worsened throughout the study.<br />Conclusions: In elderly patients with previously untreated advanced NSCLC, a 2-week S-1 monotherapy treatment, tailored to both the Ccr and BSA, with a 1-week interval was well tolerated and demonstrated promising efficacy. This study was registered at the University Hospital Medical Information Network (UMIN) Center (ID: UMIN000002035), Japan.<br /> (Copyright © 2017 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.)
- Subjects :
- Administration, Oral
Aged
Aged, 80 and over
Body Surface Area
Carcinoma, Non-Small-Cell Lung mortality
Creatinine
Drug Administration Schedule
Drug Combinations
Female
Humans
Lung Neoplasms mortality
Male
Metabolic Clearance Rate
Survival Rate
Treatment Outcome
Antimetabolites, Antineoplastic administration & dosage
Carcinoma, Non-Small-Cell Lung drug therapy
Lung Neoplasms drug therapy
Oxonic Acid administration & dosage
Precision Medicine
Tegafur administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 2212-5353
- Volume :
- 56
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Respiratory investigation
- Publication Type :
- Academic Journal
- Accession number :
- 29325686
- Full Text :
- https://doi.org/10.1016/j.resinv.2017.09.003