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Jpn J Clin Oncol. 2016 Aug;46(8):741-7. doi: 10.1093/jjco/hyw062. Epub 2016 May 20.

Randomized feasibility study of S-1 for adjuvant chemotherapy in completely resected Stage IA non-small-cell lung cancer: results of the Setouchi Lung Cancer Group Study 0701.

Author information

1
Department of Thoracic, Breast and Endocrinological Surgery, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama soh-j@cc.okayama-u.ac.jp.
2
Department of Thoracic Surgery, Kurashiki Central Hospital, Kurashiki, Okayama.
3
Department of General Thoracic Surgery, Kawasaki Medical School, Kurashiki, Okayama.
4
Division of General Thoracic Surgery, Tottori University Hospital, Yonago, Tottori.
5
Second Department of Internal Medicine, Nagasaki University Hospital, Nagasaki Clinical Oncology Center, Nagasaki University Hospital, Nagasaki.
6
Department of Surgery, Okayama Saiseikai General Hospital, Okayama.
7
Department of Surgery, Uwajima City Hospital, Uwajima, Ehime.
8
Center of Chest Medicine and Surgery, Ehime University, Toon, Ehime.
9
Department of Surgery, Kagawa Prefectural Central Hospital, Takamatsu, Kagawa.
10
Department of Thoracic Surgery, National Hospital Organization Iwakuni Clinical Center, Iwakuni, Yamaguchi.
11
Department of Hematology, Oncology and Respiratory Medicine, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama.
12
Division of Molecular Medicine, Aichi Cancer Center Research Institute, Nagoya, Aichi.
13
Department of Thoracic, Breast and Endocrinological Surgery, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama Department of Clinical Genomic Medicine, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama.
14
Department of Thoracic Surgery, Kyoto University, Kyoto, Japan.

Abstract

OBJECTIVE:

The aim of this multicenter study was to determine the appropriate administration schedule for S-1, an oral fluoropyrimidine, for adjuvant chemotherapy in patients with completely resected pathological-Stage IA (tumor diameter, 2-3 cm) non-small-cell lung cancer.

METHODS:

Patients were randomly assigned to receive adjuvant chemotherapy consisting of either the 4-week oral administration of S-1 (80-120 mg/body/day) followed by a 2-week rest (Group A), or the 2-week oral administration of S-1 (80-120 mg/body/day) followed by a 1-week rest (Group B). The duration of adjuvant chemotherapy was 1 year in both arms. The primary endpoint was compliance, namely drug discontinuation-free survival, which was calculated using the Kaplan-Meier method with log-rank test.

RESULTS:

Eighty patients were enrolled in this study, and 76 patients actually received S-1 treatment. The drug discontinuation-free survival rates at 1 year were 49.1% in Group A and 52.7% in Group B (P = 0.373). The means of the relative dose intensities were 55.3% in Group A and 64.6% in Group B (P = 0.237). There were no treatment-related deaths. Patients with grade 3/4 toxicities were significantly more frequent in Group A (40.5%) than in Group B (15.4%, P = 0.021). The 2-year relapse-free survival rates were 97.5% in Group A and 92.5% in Group B, and the 2-year overall survival rates were 100% in both groups.

CONCLUSIONS:

The feasibility showed no significant difference between the two groups among patients with completely resected Stage IA (tumor diameter, 2-3 cm) non-small-cell lung cancer.

KEYWORDS:

S-1; adjuvant chemotherapy; clinical trials; non–small-cell lung cancer

PMID:
27207886
PMCID:
PMC5025397
DOI:
10.1093/jjco/hyw062
[Indexed for MEDLINE]
Free PMC Article

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