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Int J Clin Oncol. 2019 Mar 4. doi: 10.1007/s10147-019-01396-z. [Epub ahead of print]

Japanese subgroup analysis of a phase III study of S-1 versus docetaxel in non-small cell lung cancer patients after platinum-based treatment: EAST-LC.

Author information

1
Department of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan.
2
Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan.
3
Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
4
Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
5
Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
6
Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
7
Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
8
Department of Respiratory Medicine, Miyagi Cancer Center, Miyagi, Japan.
9
Department of Cancer Information Research, National Kyushu Cancer Center, Clinical Research Institute, Fukuoka, Japan.
10
Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan.
11
Department of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan.
12
Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
13
Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan.
14
Division of Respirology, Chiba Cancer Center, Chiba, Japan.
15
Department of Respiratory Medicine and Medical Oncology, National Hospital Organization Nagoya Medical Center, Aichi, Japan.
16
Department of Palliative Medicine, Tohoku University School of Medicine, Miyagi, Japan.
17
Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.
18
Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
19
Department of Hematology, Oncology, and Respiratory Medicine, Okayama University Graduate School of Medicine, Okayama, Japan.
20
Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
21
Thoracic Center, St Luke's International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo, 104-8560, Japan. tamuratomohide@gmail.com.

Abstract

INTRODUCTION:

The East Asia S-1 Trial in Lung Cancer (EAST-LC) was a randomized phase III study conducted in East Asia that demonstrated the non-inferiority of S-1 to docetaxel in previously treated patients with advanced non-small cell lung cancer (NSCLC). Here, we reported the results of the Japanese subgroup treated with docetaxel 60 mg/m2, the standard dosage in Japan.

PATIENTS AND METHODS:

Patients were randomized 1:1 to receive either S-1 or docetaxel. The primary endpoint was overall survival (OS); the secondary endpoints included progression-free survival (PFS), response rate (RR), quality of life (QOL), and safety.

RESULTS:

Patient characteristics in the Japanese subgroup (n = 724) were similar to those in the overall EAST-LC population. Median OS was 13.4 months in the S-1 group and 12.6 months in the docetaxel group. In pemetrexed-pretreated patients, OS with S-1 was similar to that with docetaxel. Median PFS was 2.9 and 3.0 months in the S-1 and docetaxel groups, respectively. RR was 9.4% and 10.3% in the S-1 and docetaxel groups, respectively. The QOL of patients treated with S-1 was better compared with that of patients treated with docetaxel. Decreased appetite and diarrhea were more common in the S-1 group, whereas the frequency of neutropenia and febrile neutropenia was markedly higher in the docetaxel group.

CONCLUSIONS:

This Japanese subgroup analysis showed that S-1 had similar efficacy to docetaxel in patients with previously treated advanced NSCLC. These results are similar to those of the overall EAST-LC population.

KEYWORDS:

Chemotherapy; Japan; Phase III; Second line; Tegafur–gimeracil–oteracil; Third line

PMID:
30830659
DOI:
10.1007/s10147-019-01396-z

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