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04.03.2019 | Original Article | Ausgabe 5/2019 Open Access

International Journal of Clinical Oncology 5/2019

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

Zeitschrift:
International Journal of Clinical Oncology > Ausgabe 5/2019
Autoren:
Shunichi Sugawara, Kazuhiko Nakagawa, Nobuyuki Yamamoto, Hiroshi Nokihara, Yuichiro Ohe, Makoto Nishio, Toshiaki Takahashi, Koichi Goto, Makoto Maemondo, Yukito Ichinose, Takashi Seto, Hiroshi Sakai, Akihiko Gemma, Fumio Imamura, Masato Shingyoji, Hideo Saka, Akira Inoue, Koji Takeda, Isamu Okamoto, Katsuyuki Kiura, Satoshi Morita, Tomohide Tamura
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The online version of this article (https://​doi.​org/​10.​1007/​s10147-019-01396-z) contains supplementary material, which is available to authorized users.

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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.

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