Randomized controlled trial comparing docetaxel-cisplatin combination with weekly docetaxel alone in elderly patients with advanced non-small-cell lung cancer: Japan Clinical Oncology Group (JCOG) 0207

Hiroko Tsukada, Akira Yokoyama, Koichi Goto, Tetsu Shinkai, Masao Harada, Masahiko Ando, Taro Shibata, Yuichiro Ohe, Tomohide Tamura, Nagahiro Saijo, N. Yamamoto, Y. Nishiwaki, K. Kubota, Y. Segawa, H. Isobe, H. Eguchi, S. Yoneda, H. Sakai, T. Sawa, T. IshiguroK. Nakagawa, Isamu Okamoto, M. Kawahara, S. Atagi, T. Nakano, M. Miyake, T. Kaburaki, Y. Fujita, S. Fujiuchi, K. Kudo, Y. Takeda, T. Hida, H. Senba, S. Fujii, T. Tsukamoto, M. Nagasawa, K. Minato, R. Yoshino, K. Watanabe, H. Kunikane, H. Saito, M. Okuno, M. Ito, S. Yokota

Research output: Contribution to journalArticle

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Abstract

Objective: Prospective trials specifically designed for elderly patients with advanced non-small-cell lung cancer demonstrating the benefit of platinum-based therapies are still lacking. This trial was designed to clarify whether the addition of cisplatin to monotherapy could improve survival for elderly patients. Methods: Elderly patients (age ≥70 years, ECOG performance Status 0-1) with advanced non-small-cell lung cancer were randomized to receive docetaxel 20 mg/m2 plus cisplatin 25 mg/m2 on Day 1, 8 and 15 (docetaxel plus cisplatin) or docetaxel 25 mg/m2 on the same schedule (docetaxel). Both regimens were repeated every 4 weeks until disease progression. Results: One hundred and twenty-six patients were enrolled. Sixty-three were randomly assigned docetaxel plus cisplatin and 63 docetaxel monotherapy. Median age was 76 years (range 70-88). The second planned interim analysis was performed on 112 assessable patients (docetaxel/docetaxel plus cisplatin: 56/56). Although the formal criterion for stopping the trial was not met, the Data and Safety Monitoring Committee recommended study termination on ethical grounds based on the interaction (two-sided P = 0.077, hazard ratios for ≤74/≥75: 0.23/0.72) between age and subgroup and treatment arm, which suggested that docetaxel may not represent an adequate control arm regimen for the age subgroup of 70-74 years. Conclusions: The interpretation of study results is limited due to early stopping. Further study is needed to confirm survival benefit of platinum-based chemotherapy for elderly non-small-cell lung cancer [UMIN-CTR (www.umin.ac.jp/ctr/) ID: C000000146].

Original languageEnglish
Article numberhyu176
Pages (from-to)88-95
Number of pages8
JournalJapanese journal of clinical oncology
Volume45
Issue number1
DOIs
Publication statusPublished - Jan 1 2015
Externally publishedYes

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docetaxel
Medical Oncology
Non-Small Cell Lung Carcinoma
Cisplatin
Japan
Randomized Controlled Trials
Platinum
Clinical Trials Data Monitoring Committees
Survival

All Science Journal Classification (ASJC) codes

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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Randomized controlled trial comparing docetaxel-cisplatin combination with weekly docetaxel alone in elderly patients with advanced non-small-cell lung cancer : Japan Clinical Oncology Group (JCOG) 0207. / Tsukada, Hiroko; Yokoyama, Akira; Goto, Koichi; Shinkai, Tetsu; Harada, Masao; Ando, Masahiko; Shibata, Taro; Ohe, Yuichiro; Tamura, Tomohide; Saijo, Nagahiro; Yamamoto, N.; Nishiwaki, Y.; Kubota, K.; Segawa, Y.; Isobe, H.; Eguchi, H.; Yoneda, S.; Sakai, H.; Sawa, T.; Ishiguro, T.; Nakagawa, K.; Okamoto, Isamu; Kawahara, M.; Atagi, S.; Nakano, T.; Miyake, M.; Kaburaki, T.; Fujita, Y.; Fujiuchi, S.; Kudo, K.; Takeda, Y.; Hida, T.; Senba, H.; Fujii, S.; Tsukamoto, T.; Nagasawa, M.; Minato, K.; Yoshino, R.; Watanabe, K.; Kunikane, H.; Saito, H.; Okuno, M.; Ito, M.; Yokota, S.

In: Japanese journal of clinical oncology, Vol. 45, No. 1, hyu176, 01.01.2015, p. 88-95.

Research output: Contribution to journalArticle

Tsukada, H, Yokoyama, A, Goto, K, Shinkai, T, Harada, M, Ando, M, Shibata, T, Ohe, Y, Tamura, T, Saijo, N, Yamamoto, N, Nishiwaki, Y, Kubota, K, Segawa, Y, Isobe, H, Eguchi, H, Yoneda, S, Sakai, H, Sawa, T, Ishiguro, T, Nakagawa, K, Okamoto, I, Kawahara, M, Atagi, S, Nakano, T, Miyake, M, Kaburaki, T, Fujita, Y, Fujiuchi, S, Kudo, K, Takeda, Y, Hida, T, Senba, H, Fujii, S, Tsukamoto, T, Nagasawa, M, Minato, K, Yoshino, R, Watanabe, K, Kunikane, H, Saito, H, Okuno, M, Ito, M & Yokota, S 2015, 'Randomized controlled trial comparing docetaxel-cisplatin combination with weekly docetaxel alone in elderly patients with advanced non-small-cell lung cancer: Japan Clinical Oncology Group (JCOG) 0207', Japanese journal of clinical oncology, vol. 45, no. 1, hyu176, pp. 88-95. https://doi.org/10.1093/jjco/hyu176
Tsukada, Hiroko ; Yokoyama, Akira ; Goto, Koichi ; Shinkai, Tetsu ; Harada, Masao ; Ando, Masahiko ; Shibata, Taro ; Ohe, Yuichiro ; Tamura, Tomohide ; Saijo, Nagahiro ; Yamamoto, N. ; Nishiwaki, Y. ; Kubota, K. ; Segawa, Y. ; Isobe, H. ; Eguchi, H. ; Yoneda, S. ; Sakai, H. ; Sawa, T. ; Ishiguro, T. ; Nakagawa, K. ; Okamoto, Isamu ; Kawahara, M. ; Atagi, S. ; Nakano, T. ; Miyake, M. ; Kaburaki, T. ; Fujita, Y. ; Fujiuchi, S. ; Kudo, K. ; Takeda, Y. ; Hida, T. ; Senba, H. ; Fujii, S. ; Tsukamoto, T. ; Nagasawa, M. ; Minato, K. ; Yoshino, R. ; Watanabe, K. ; Kunikane, H. ; Saito, H. ; Okuno, M. ; Ito, M. ; Yokota, S. / Randomized controlled trial comparing docetaxel-cisplatin combination with weekly docetaxel alone in elderly patients with advanced non-small-cell lung cancer : Japan Clinical Oncology Group (JCOG) 0207. In: Japanese journal of clinical oncology. 2015 ; Vol. 45, No. 1. pp. 88-95.
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title = "Randomized controlled trial comparing docetaxel-cisplatin combination with weekly docetaxel alone in elderly patients with advanced non-small-cell lung cancer: Japan Clinical Oncology Group (JCOG) 0207",
abstract = "Objective: Prospective trials specifically designed for elderly patients with advanced non-small-cell lung cancer demonstrating the benefit of platinum-based therapies are still lacking. This trial was designed to clarify whether the addition of cisplatin to monotherapy could improve survival for elderly patients. Methods: Elderly patients (age ≥70 years, ECOG performance Status 0-1) with advanced non-small-cell lung cancer were randomized to receive docetaxel 20 mg/m2 plus cisplatin 25 mg/m2 on Day 1, 8 and 15 (docetaxel plus cisplatin) or docetaxel 25 mg/m2 on the same schedule (docetaxel). Both regimens were repeated every 4 weeks until disease progression. Results: One hundred and twenty-six patients were enrolled. Sixty-three were randomly assigned docetaxel plus cisplatin and 63 docetaxel monotherapy. Median age was 76 years (range 70-88). The second planned interim analysis was performed on 112 assessable patients (docetaxel/docetaxel plus cisplatin: 56/56). Although the formal criterion for stopping the trial was not met, the Data and Safety Monitoring Committee recommended study termination on ethical grounds based on the interaction (two-sided P = 0.077, hazard ratios for ≤74/≥75: 0.23/0.72) between age and subgroup and treatment arm, which suggested that docetaxel may not represent an adequate control arm regimen for the age subgroup of 70-74 years. Conclusions: The interpretation of study results is limited due to early stopping. Further study is needed to confirm survival benefit of platinum-based chemotherapy for elderly non-small-cell lung cancer [UMIN-CTR (www.umin.ac.jp/ctr/) ID: C000000146].",
author = "Hiroko Tsukada and Akira Yokoyama and Koichi Goto and Tetsu Shinkai and Masao Harada and Masahiko Ando and Taro Shibata and Yuichiro Ohe and Tomohide Tamura and Nagahiro Saijo and N. Yamamoto and Y. Nishiwaki and K. Kubota and Y. Segawa and H. Isobe and H. Eguchi and S. Yoneda and H. Sakai and T. Sawa and T. Ishiguro and K. Nakagawa and Isamu Okamoto and M. Kawahara and S. Atagi and T. Nakano and M. Miyake and T. Kaburaki and Y. Fujita and S. Fujiuchi and K. Kudo and Y. Takeda and T. Hida and H. Senba and S. Fujii and T. Tsukamoto and M. Nagasawa and K. Minato and R. Yoshino and K. Watanabe and H. Kunikane and H. Saito and M. Okuno and M. Ito and S. Yokota",
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T1 - Randomized controlled trial comparing docetaxel-cisplatin combination with weekly docetaxel alone in elderly patients with advanced non-small-cell lung cancer

T2 - Japan Clinical Oncology Group (JCOG) 0207

AU - Tsukada, Hiroko

AU - Yokoyama, Akira

AU - Goto, Koichi

AU - Shinkai, Tetsu

AU - Harada, Masao

AU - Ando, Masahiko

AU - Shibata, Taro

AU - Ohe, Yuichiro

AU - Tamura, Tomohide

AU - Saijo, Nagahiro

AU - Yamamoto, N.

AU - Nishiwaki, Y.

AU - Kubota, K.

AU - Segawa, Y.

AU - Isobe, H.

AU - Eguchi, H.

AU - Yoneda, S.

AU - Sakai, H.

AU - Sawa, T.

AU - Ishiguro, T.

AU - Nakagawa, K.

AU - Okamoto, Isamu

AU - Kawahara, M.

AU - Atagi, S.

AU - Nakano, T.

AU - Miyake, M.

AU - Kaburaki, T.

AU - Fujita, Y.

AU - Fujiuchi, S.

AU - Kudo, K.

AU - Takeda, Y.

AU - Hida, T.

AU - Senba, H.

AU - Fujii, S.

AU - Tsukamoto, T.

AU - Nagasawa, M.

AU - Minato, K.

AU - Yoshino, R.

AU - Watanabe, K.

AU - Kunikane, H.

AU - Saito, H.

AU - Okuno, M.

AU - Ito, M.

AU - Yokota, S.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - Objective: Prospective trials specifically designed for elderly patients with advanced non-small-cell lung cancer demonstrating the benefit of platinum-based therapies are still lacking. This trial was designed to clarify whether the addition of cisplatin to monotherapy could improve survival for elderly patients. Methods: Elderly patients (age ≥70 years, ECOG performance Status 0-1) with advanced non-small-cell lung cancer were randomized to receive docetaxel 20 mg/m2 plus cisplatin 25 mg/m2 on Day 1, 8 and 15 (docetaxel plus cisplatin) or docetaxel 25 mg/m2 on the same schedule (docetaxel). Both regimens were repeated every 4 weeks until disease progression. Results: One hundred and twenty-six patients were enrolled. Sixty-three were randomly assigned docetaxel plus cisplatin and 63 docetaxel monotherapy. Median age was 76 years (range 70-88). The second planned interim analysis was performed on 112 assessable patients (docetaxel/docetaxel plus cisplatin: 56/56). Although the formal criterion for stopping the trial was not met, the Data and Safety Monitoring Committee recommended study termination on ethical grounds based on the interaction (two-sided P = 0.077, hazard ratios for ≤74/≥75: 0.23/0.72) between age and subgroup and treatment arm, which suggested that docetaxel may not represent an adequate control arm regimen for the age subgroup of 70-74 years. Conclusions: The interpretation of study results is limited due to early stopping. Further study is needed to confirm survival benefit of platinum-based chemotherapy for elderly non-small-cell lung cancer [UMIN-CTR (www.umin.ac.jp/ctr/) ID: C000000146].

AB - Objective: Prospective trials specifically designed for elderly patients with advanced non-small-cell lung cancer demonstrating the benefit of platinum-based therapies are still lacking. This trial was designed to clarify whether the addition of cisplatin to monotherapy could improve survival for elderly patients. Methods: Elderly patients (age ≥70 years, ECOG performance Status 0-1) with advanced non-small-cell lung cancer were randomized to receive docetaxel 20 mg/m2 plus cisplatin 25 mg/m2 on Day 1, 8 and 15 (docetaxel plus cisplatin) or docetaxel 25 mg/m2 on the same schedule (docetaxel). Both regimens were repeated every 4 weeks until disease progression. Results: One hundred and twenty-six patients were enrolled. Sixty-three were randomly assigned docetaxel plus cisplatin and 63 docetaxel monotherapy. Median age was 76 years (range 70-88). The second planned interim analysis was performed on 112 assessable patients (docetaxel/docetaxel plus cisplatin: 56/56). Although the formal criterion for stopping the trial was not met, the Data and Safety Monitoring Committee recommended study termination on ethical grounds based on the interaction (two-sided P = 0.077, hazard ratios for ≤74/≥75: 0.23/0.72) between age and subgroup and treatment arm, which suggested that docetaxel may not represent an adequate control arm regimen for the age subgroup of 70-74 years. Conclusions: The interpretation of study results is limited due to early stopping. Further study is needed to confirm survival benefit of platinum-based chemotherapy for elderly non-small-cell lung cancer [UMIN-CTR (www.umin.ac.jp/ctr/) ID: C000000146].

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U2 - 10.1093/jjco/hyu176

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JF - Japanese Journal of Clinical Oncology

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