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Clin Cancer Res. 2015 Dec 1;21(23):5245-52. doi: 10.1158/1078-0432.CCR-14-3160. Epub 2015 Aug 7.

Randomized Phase II Study of Adjuvant Chemotherapy with Long-term S-1 versus Cisplatin+S-1 in Completely Resected Stage II-IIIA Non-Small Cell Lung Cancer.

Author information

1
Department of Medical Oncology, Hiroshima City Hospital, Hiroshima, Japan.
2
Department of Thoracic Surgery, Kinki University Faculty of Medicine, Osakasayama, Japan. mitsudom@surg.med.kindai.ac.jp.
3
Department of Genome Biology, Kinki University Faculty of Medicine, Osakasayama, Japan.
4
Department of Biostatistics, Yokohama City University, Yokohama, Japan.
5
Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
6
Department of General Thoracic Surgery, Osaka City General Hospital, Osaka, Japan.
7
Department of Thoracic Surgery, Hyogo Cancer Center, Akashi, Japan.
8
Department of General Thoracic Surgery, Chiba University Graduate School of Medicine, Chiba, Japan.
9
Department of Medical Oncology, Kinki University Faculty of Medicine, Osakasayama, Japan.
10
Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
11
Department of Respiratory Medicine, Graduate School of Medicine, Osaka City University, Osaka, Japan.
12
Division of Thoracic Oncology, Shizuoka Cancer Center, Shuntougun, Japan.
13
Department of Thoracic Surgery, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Habikino, Japan.
14
Clinical Research Institute, National Kyushu Cancer Center, Fukuoka, Japan.
15
Department of Thoracic Oncology, Kinki-chuo Chest Medical Center, Sakai, Japan.
16
Department of Surgical Oncology, Hiroshima University Graduate School of Medicine, Hiroshima, Japan.
17
Department of Medical Oncology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
18
Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Abstract

PURPOSE:

The aims of this study were to evaluate the efficacy and safety of S-1 versus cisplatin (CDDP)+S-1 in patients with completely resected stage II and IIIA non-small cell lung cancer, and to identify predictive biomarkers whose expression in the tumors was significantly associated with patient outcome.

EXPERIMENTAL DESIGN:

A total of 200 patients were randomly assigned to receive either S-1 (40 mg/m(2) twice per day) for 2 consecutive weeks repeated every 3 weeks for 1 year (S group) or CDDP (60 mg/m(2)) on day 1 plus oral S-1 (40 mg/m(2) twice per day) for 2 consecutive weeks repeated every 3 weeks for four cycles (CS group) within 8 weeks after surgery. The primary endpoints were relapse-free survival (RFS) at 2 years and identification of predictive biomarkers whose expressions have been reported to be associated with CDDP or fluoropyrimidine sensitivity.

RESULTS:

The RFS rate at 2 years was 65.6% (95% confidence intervals; CI, 55.3-74.0%) in the S group and 58.1% (95% CI, 47.7-67.2%) in the CS group. The only gene with interaction of P < 0.05 was uridine monophosphate synthase (UMPS; P = 0.0348). The benefit that members of the S group had over members of the CS group was higher expression of UMPS. In vitro and in vivo experiments confirmed that overexpression of UMPS enhanced the antitumor effect of fluoropyrimidine.

CONCLUSIONS:

Adjuvant S-1 monotherapy might be preferable to CDDP+S-1 for patients with completely resected NSCLC. UMPS expression may define a patient subset that would benefit from long-term postoperative S-1 monotherapy.

PMID:
26253869
DOI:
10.1158/1078-0432.CCR-14-3160
[Indexed for MEDLINE]
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