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

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 & 2 others Satoshi Morita, Tomohide Tamura

Research output: Contribution to journalArticle

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/m 2 , 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.

Original languageEnglish
Pages (from-to)485-493
Number of pages9
JournalInternational Journal of Clinical Oncology
Volume24
Issue number5
DOIs
Publication statusPublished - May 15 2019

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docetaxel
Far East
Platinum
Non-Small Cell Lung Carcinoma
Lung Neoplasms
Therapeutics
Disease-Free Survival
Pemetrexed
Survival
Quality of Life
Febrile Neutropenia

All Science Journal Classification (ASJC) codes

  • Surgery
  • Hematology
  • Oncology

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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. / Sugawara, Shunichi; Nakagawa, Kazuhiko; Yamamoto, Nobuyuki; Nokihara, Hiroshi; Ohe, Yuichiro; Nishio, Makoto; Takahashi, Toshiaki; Goto, Koichi; Maemondo, Makoto; Ichinose, Yukito; Seto, Takashi; Sakai, Hiroshi; Gemma, Akihiko; Imamura, Fumio; Shingyoji, Masato; Saka, Hideo; Inoue, Akira; Takeda, Koji; Okamoto, Isamu; Kiura, Katsuyuki; Morita, Satoshi; Tamura, Tomohide.

In: International Journal of Clinical Oncology, Vol. 24, No. 5, 15.05.2019, p. 485-493.

Research output: Contribution to journalArticle

Sugawara, S, Nakagawa, K, Yamamoto, N, Nokihara, H, Ohe, Y, Nishio, M, Takahashi, T, Goto, K, Maemondo, M, Ichinose, Y, Seto, T, Sakai, H, Gemma, A, Imamura, F, Shingyoji, M, Saka, H, Inoue, A, Takeda, K, Okamoto, I, Kiura, K, Morita, S & Tamura, T 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', International Journal of Clinical Oncology, vol. 24, no. 5, pp. 485-493. https://doi.org/10.1007/s10147-019-01396-z
Sugawara, Shunichi ; Nakagawa, Kazuhiko ; Yamamoto, Nobuyuki ; Nokihara, Hiroshi ; Ohe, Yuichiro ; Nishio, Makoto ; Takahashi, Toshiaki ; Goto, Koichi ; Maemondo, Makoto ; Ichinose, Yukito ; Seto, Takashi ; Sakai, Hiroshi ; Gemma, Akihiko ; Imamura, Fumio ; Shingyoji, Masato ; Saka, Hideo ; Inoue, Akira ; Takeda, Koji ; Okamoto, Isamu ; Kiura, Katsuyuki ; Morita, Satoshi ; Tamura, Tomohide. / 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. In: International Journal of Clinical Oncology. 2019 ; Vol. 24, No. 5. pp. 485-493.
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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/m 2 , 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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T1 - Japanese subgroup analysis of a phase III study of S-1 versus docetaxel in non-small cell lung cancer patients after platinum-based treatment

T2 - EAST-LC

AU - Sugawara, Shunichi

AU - Nakagawa, Kazuhiko

AU - Yamamoto, Nobuyuki

AU - Nokihara, Hiroshi

AU - Ohe, Yuichiro

AU - Nishio, Makoto

AU - Takahashi, Toshiaki

AU - Goto, Koichi

AU - Maemondo, Makoto

AU - Ichinose, Yukito

AU - Seto, Takashi

AU - Sakai, Hiroshi

AU - Gemma, Akihiko

AU - Imamura, Fumio

AU - Shingyoji, Masato

AU - Saka, Hideo

AU - Inoue, Akira

AU - Takeda, Koji

AU - Okamoto, Isamu

AU - Kiura, Katsuyuki

AU - Morita, Satoshi

AU - Tamura, Tomohide

PY - 2019/5/15

Y1 - 2019/5/15

N2 - 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/m 2 , 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.

AB - 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/m 2 , 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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