A randomised phase II trial of S-1 plus cisplatin versus vinorelbine plus cisplatin with concurrent thoracic radiotherapy for unresectable, locally advanced non-small cell lung cancer: WJOG5008L

Tomonari Sasaki, Takashi Seto, Takeharu Yamanaka, Naonobu Kunitake, Junichi Shimizu, Takeshi Kodaira, Makoto Nishio, Takuyo Kozuka, Toshiaki Takahashi, Hideyuki Harada, Naruo Yoshimura, Shinichi Tsutsumi, Hiromoto Kitajima, Masaaki Kataoka, Yukito Ichinose, Kazuhiko Nakagawa, Yasumasa Nishimura, Nobuyuki Yamamoto, Yoichi Nakanishi

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: Cisplatin-based chemoradiotherapy is the standard treatment for unresectable, locally advanced non-small-cell lung cancer (NSCLC). This trial evaluated two experimental regimens that combine chemotherapy with concurrent radiotherapy. Methods: Eligible patients with unresectable stage III NSCLC were randomised to either the SP arm (S-1 and cisplatin) or VP arm (vinorelbine and cisplatin), with early concurrent thoracic radiotherapy of 60 Gy, comprising 2 Gy per daily fraction. The primary endpoint was the overall survival rate at 2 years (2-year overall survival (OS)) (Study ID: UMIN000002420). Results: From September 2009 to September 2012, 112 patients were enroled. Of the 108 eligible patients, the 2-year OS was 75.6% (80% confidence interval (CI), 67–82%) in the SP arm and 68.5% (80% CI: 60–76%) in the VP arm. The hazard ratio (HR) for death between the two arms was 0.85 (0.48–1.49). The median progression-free survival was 14.8 months for the SP arm and 12.3 months for the VP arm with an HR of 0.92 (0.58–1.44). There were four treatment-related deaths in the SP arm and five in the VP arm. Conclusions: The null hypotheses for 2-year OS were rejected in both arms. The West Japan Oncology Group will employ the SP arm as the investigational arm in a future phase III study.

Original languageEnglish
Pages (from-to)675-682
Number of pages8
JournalBritish journal of cancer
Volume119
Issue number6
DOIs
Publication statusPublished - Sep 11 2018

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Non-Small Cell Lung Carcinoma
Cisplatin
Radiotherapy
Thorax
Survival
Confidence Intervals
Chemoradiotherapy
Disease-Free Survival
Japan
Survival Rate
Drug Therapy
Therapeutics
vinorelbine

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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A randomised phase II trial of S-1 plus cisplatin versus vinorelbine plus cisplatin with concurrent thoracic radiotherapy for unresectable, locally advanced non-small cell lung cancer : WJOG5008L. / Sasaki, Tomonari; Seto, Takashi; Yamanaka, Takeharu; Kunitake, Naonobu; Shimizu, Junichi; Kodaira, Takeshi; Nishio, Makoto; Kozuka, Takuyo; Takahashi, Toshiaki; Harada, Hideyuki; Yoshimura, Naruo; Tsutsumi, Shinichi; Kitajima, Hiromoto; Kataoka, Masaaki; Ichinose, Yukito; Nakagawa, Kazuhiko; Nishimura, Yasumasa; Yamamoto, Nobuyuki; Nakanishi, Yoichi.

In: British journal of cancer, Vol. 119, No. 6, 11.09.2018, p. 675-682.

Research output: Contribution to journalArticle

Sasaki, T, Seto, T, Yamanaka, T, Kunitake, N, Shimizu, J, Kodaira, T, Nishio, M, Kozuka, T, Takahashi, T, Harada, H, Yoshimura, N, Tsutsumi, S, Kitajima, H, Kataoka, M, Ichinose, Y, Nakagawa, K, Nishimura, Y, Yamamoto, N & Nakanishi, Y 2018, 'A randomised phase II trial of S-1 plus cisplatin versus vinorelbine plus cisplatin with concurrent thoracic radiotherapy for unresectable, locally advanced non-small cell lung cancer: WJOG5008L', British journal of cancer, vol. 119, no. 6, pp. 675-682. https://doi.org/10.1038/s41416-018-0243-2
Sasaki, Tomonari ; Seto, Takashi ; Yamanaka, Takeharu ; Kunitake, Naonobu ; Shimizu, Junichi ; Kodaira, Takeshi ; Nishio, Makoto ; Kozuka, Takuyo ; Takahashi, Toshiaki ; Harada, Hideyuki ; Yoshimura, Naruo ; Tsutsumi, Shinichi ; Kitajima, Hiromoto ; Kataoka, Masaaki ; Ichinose, Yukito ; Nakagawa, Kazuhiko ; Nishimura, Yasumasa ; Yamamoto, Nobuyuki ; Nakanishi, Yoichi. / A randomised phase II trial of S-1 plus cisplatin versus vinorelbine plus cisplatin with concurrent thoracic radiotherapy for unresectable, locally advanced non-small cell lung cancer : WJOG5008L. In: British journal of cancer. 2018 ; Vol. 119, No. 6. pp. 675-682.
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abstract = "Background: Cisplatin-based chemoradiotherapy is the standard treatment for unresectable, locally advanced non-small-cell lung cancer (NSCLC). This trial evaluated two experimental regimens that combine chemotherapy with concurrent radiotherapy. Methods: Eligible patients with unresectable stage III NSCLC were randomised to either the SP arm (S-1 and cisplatin) or VP arm (vinorelbine and cisplatin), with early concurrent thoracic radiotherapy of 60 Gy, comprising 2 Gy per daily fraction. The primary endpoint was the overall survival rate at 2 years (2-year overall survival (OS)) (Study ID: UMIN000002420). Results: From September 2009 to September 2012, 112 patients were enroled. Of the 108 eligible patients, the 2-year OS was 75.6{\%} (80{\%} confidence interval (CI), 67–82{\%}) in the SP arm and 68.5{\%} (80{\%} CI: 60–76{\%}) in the VP arm. The hazard ratio (HR) for death between the two arms was 0.85 (0.48–1.49). The median progression-free survival was 14.8 months for the SP arm and 12.3 months for the VP arm with an HR of 0.92 (0.58–1.44). There were four treatment-related deaths in the SP arm and five in the VP arm. Conclusions: The null hypotheses for 2-year OS were rejected in both arms. The West Japan Oncology Group will employ the SP arm as the investigational arm in a future phase III study.",
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T1 - A randomised phase II trial of S-1 plus cisplatin versus vinorelbine plus cisplatin with concurrent thoracic radiotherapy for unresectable, locally advanced non-small cell lung cancer

T2 - WJOG5008L

AU - Sasaki, Tomonari

AU - Seto, Takashi

AU - Yamanaka, Takeharu

AU - Kunitake, Naonobu

AU - Shimizu, Junichi

AU - Kodaira, Takeshi

AU - Nishio, Makoto

AU - Kozuka, Takuyo

AU - Takahashi, Toshiaki

AU - Harada, Hideyuki

AU - Yoshimura, Naruo

AU - Tsutsumi, Shinichi

AU - Kitajima, Hiromoto

AU - Kataoka, Masaaki

AU - Ichinose, Yukito

AU - Nakagawa, Kazuhiko

AU - Nishimura, Yasumasa

AU - Yamamoto, Nobuyuki

AU - Nakanishi, Yoichi

PY - 2018/9/11

Y1 - 2018/9/11

N2 - Background: Cisplatin-based chemoradiotherapy is the standard treatment for unresectable, locally advanced non-small-cell lung cancer (NSCLC). This trial evaluated two experimental regimens that combine chemotherapy with concurrent radiotherapy. Methods: Eligible patients with unresectable stage III NSCLC were randomised to either the SP arm (S-1 and cisplatin) or VP arm (vinorelbine and cisplatin), with early concurrent thoracic radiotherapy of 60 Gy, comprising 2 Gy per daily fraction. The primary endpoint was the overall survival rate at 2 years (2-year overall survival (OS)) (Study ID: UMIN000002420). Results: From September 2009 to September 2012, 112 patients were enroled. Of the 108 eligible patients, the 2-year OS was 75.6% (80% confidence interval (CI), 67–82%) in the SP arm and 68.5% (80% CI: 60–76%) in the VP arm. The hazard ratio (HR) for death between the two arms was 0.85 (0.48–1.49). The median progression-free survival was 14.8 months for the SP arm and 12.3 months for the VP arm with an HR of 0.92 (0.58–1.44). There were four treatment-related deaths in the SP arm and five in the VP arm. Conclusions: The null hypotheses for 2-year OS were rejected in both arms. The West Japan Oncology Group will employ the SP arm as the investigational arm in a future phase III study.

AB - Background: Cisplatin-based chemoradiotherapy is the standard treatment for unresectable, locally advanced non-small-cell lung cancer (NSCLC). This trial evaluated two experimental regimens that combine chemotherapy with concurrent radiotherapy. Methods: Eligible patients with unresectable stage III NSCLC were randomised to either the SP arm (S-1 and cisplatin) or VP arm (vinorelbine and cisplatin), with early concurrent thoracic radiotherapy of 60 Gy, comprising 2 Gy per daily fraction. The primary endpoint was the overall survival rate at 2 years (2-year overall survival (OS)) (Study ID: UMIN000002420). Results: From September 2009 to September 2012, 112 patients were enroled. Of the 108 eligible patients, the 2-year OS was 75.6% (80% confidence interval (CI), 67–82%) in the SP arm and 68.5% (80% CI: 60–76%) in the VP arm. The hazard ratio (HR) for death between the two arms was 0.85 (0.48–1.49). The median progression-free survival was 14.8 months for the SP arm and 12.3 months for the VP arm with an HR of 0.92 (0.58–1.44). There were four treatment-related deaths in the SP arm and five in the VP arm. Conclusions: The null hypotheses for 2-year OS were rejected in both arms. The West Japan Oncology Group will employ the SP arm as the investigational arm in a future phase III study.

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