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.

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.

• Authors: 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
• Journal: International journal of clinical oncology (Int J Clin Oncol) Vol. 24 Issue 5 Pg. 485-493 (May 2019) ISSN: 1437-7772 [Electronic] Japan
• PMID: 30830659 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antimetabolites, Antineoplastic
• Drug Combinations
• S 1 (combination)
• Tegafur
• Docetaxel
• Oxonic Acid

Topics

• Adult
• Aged
• Aged, 80 and over
• Antimetabolites, Antineoplastic (adverse effects, therapeutic use)
• Carcinoma, Non-Small-Cell Lung (drug therapy, mortality, pathology)
• Disease-Free Survival
• Docetaxel (adverse effects, therapeutic use)
• Drug Combinations
• Female
• Humans
• Japan
• Lung Neoplasms (drug therapy, mortality, pathology)
• Male
• Middle Aged
• Neutropenia (chemically induced)
• Oxonic Acid (adverse effects, therapeutic use)
• Quality of Life
• Tegafur (adverse effects, therapeutic use)
• Treatment Outcome