A phase II study of amrubicin and topotecan combination therapy in patients with relapsed or extensive-disease small-cell lung cancer

Okayama Lung Cancer Study Group Trial 0401

Naoyuki Nogami, Katsuyuki Hotta, Shoichi Kuyama, Katsuyuki Kiura, Nagio Takigawa, Kenichi Chikamori, Takuo Shibayama, Daizo Kishino, Shinobu Hosokawa, Akihiko Tamaoki, Shingo Harita, Masahiro Tabata, Hiroshi Ueoka, Tetsu Shinkai, Mitsune Tanimoto

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Backgrounds: Chemotherapy is a mainstay in the treatment of extensive-disease small-cell lung cancer (ED-SCLC), although the survival benefit remains modest. We conducted a phase II trial of amrubicin (a topoisomerase II inhibitor) and topotecan (a topoisomerase I inhibitor) in chemotherapy-naïve and relapsed SCLC patients. Methods: Amrubicin (35mg/m 2) and topotecan (0.75mg/m 2) were administered on days 3-5 and 1-5, respectively. The objective response rate (ORR) was set as the primary endpoint, which was assessed separately in chemotherapy-naïve and relapsed cases. Results: Fifty-nine patients were enrolled (chemotherapy-naïve 31, relapsed 28). The ORRs were 74% and 43% in the chemotherapy-naïve and relapsed cases, respectively. Survival data were also promising, with a median progression-free survival time and median survival time of 5.3 and 14.9 months and 4.7 and 10.2 months in the chemotherapy-naïve and relapsed cases, respectively. Even refractory-relapsed cases responded to the treatment favorably (27% ORR). The primary toxicity was myelosuppression with grades 3 or 4 neutropenia in 97% of the patients, which led to grades 3 or 4 febrile neutropenia in 41% of the patients and two toxic deaths. Conclusion: This phase II study showed the favorable efficacy and moderate safety profiles of a topotecan and amrubicin two-drug combination especially in relapsed patients with ED-SCLC.

Original languageEnglish
Pages (from-to)80-84
Number of pages5
JournalLung Cancer
Volume74
Issue number1
DOIs
Publication statusPublished - Oct 2011

Fingerprint

Topotecan
Small Cell Lung Carcinoma
Lung Neoplasms
Drug Therapy
Survival
Therapeutics
Topoisomerase I Inhibitors
Topoisomerase II Inhibitors
Febrile Neutropenia
Poisons
Drug Combinations
Neutropenia
Disease-Free Survival
amrubicin
Safety

Keywords

  • Amrubicin
  • Chemo-naive
  • Lung cancer
  • Refractory relapse
  • Sensitive relapse
  • Topotecan

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

A phase II study of amrubicin and topotecan combination therapy in patients with relapsed or extensive-disease small-cell lung cancer : Okayama Lung Cancer Study Group Trial 0401. / Nogami, Naoyuki; Hotta, Katsuyuki; Kuyama, Shoichi; Kiura, Katsuyuki; Takigawa, Nagio; Chikamori, Kenichi; Shibayama, Takuo; Kishino, Daizo; Hosokawa, Shinobu; Tamaoki, Akihiko; Harita, Shingo; Tabata, Masahiro; Ueoka, Hiroshi; Shinkai, Tetsu; Tanimoto, Mitsune.

In: Lung Cancer, Vol. 74, No. 1, 10.2011, p. 80-84.

Research output: Contribution to journalArticle

Nogami, N, Hotta, K, Kuyama, S, Kiura, K, Takigawa, N, Chikamori, K, Shibayama, T, Kishino, D, Hosokawa, S, Tamaoki, A, Harita, S, Tabata, M, Ueoka, H, Shinkai, T & Tanimoto, M 2011, 'A phase II study of amrubicin and topotecan combination therapy in patients with relapsed or extensive-disease small-cell lung cancer: Okayama Lung Cancer Study Group Trial 0401', Lung Cancer, vol. 74, no. 1, pp. 80-84. https://doi.org/10.1016/j.lungcan.2011.01.018
Nogami, Naoyuki ; Hotta, Katsuyuki ; Kuyama, Shoichi ; Kiura, Katsuyuki ; Takigawa, Nagio ; Chikamori, Kenichi ; Shibayama, Takuo ; Kishino, Daizo ; Hosokawa, Shinobu ; Tamaoki, Akihiko ; Harita, Shingo ; Tabata, Masahiro ; Ueoka, Hiroshi ; Shinkai, Tetsu ; Tanimoto, Mitsune. / A phase II study of amrubicin and topotecan combination therapy in patients with relapsed or extensive-disease small-cell lung cancer : Okayama Lung Cancer Study Group Trial 0401. In: Lung Cancer. 2011 ; Vol. 74, No. 1. pp. 80-84.
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abstract = "Backgrounds: Chemotherapy is a mainstay in the treatment of extensive-disease small-cell lung cancer (ED-SCLC), although the survival benefit remains modest. We conducted a phase II trial of amrubicin (a topoisomerase II inhibitor) and topotecan (a topoisomerase I inhibitor) in chemotherapy-na{\"i}ve and relapsed SCLC patients. Methods: Amrubicin (35mg/m 2) and topotecan (0.75mg/m 2) were administered on days 3-5 and 1-5, respectively. The objective response rate (ORR) was set as the primary endpoint, which was assessed separately in chemotherapy-na{\"i}ve and relapsed cases. Results: Fifty-nine patients were enrolled (chemotherapy-na{\"i}ve 31, relapsed 28). The ORRs were 74{\%} and 43{\%} in the chemotherapy-na{\"i}ve and relapsed cases, respectively. Survival data were also promising, with a median progression-free survival time and median survival time of 5.3 and 14.9 months and 4.7 and 10.2 months in the chemotherapy-na{\"i}ve and relapsed cases, respectively. Even refractory-relapsed cases responded to the treatment favorably (27{\%} ORR). The primary toxicity was myelosuppression with grades 3 or 4 neutropenia in 97{\%} of the patients, which led to grades 3 or 4 febrile neutropenia in 41{\%} of the patients and two toxic deaths. Conclusion: This phase II study showed the favorable efficacy and moderate safety profiles of a topotecan and amrubicin two-drug combination especially in relapsed patients with ED-SCLC.",
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AU - Nogami, Naoyuki

AU - Hotta, Katsuyuki

AU - Kuyama, Shoichi

AU - Kiura, Katsuyuki

AU - Takigawa, Nagio

AU - Chikamori, Kenichi

AU - Shibayama, Takuo

AU - Kishino, Daizo

AU - Hosokawa, Shinobu

AU - Tamaoki, Akihiko

AU - Harita, Shingo

AU - Tabata, Masahiro

AU - Ueoka, Hiroshi

AU - Shinkai, Tetsu

AU - Tanimoto, Mitsune

PY - 2011/10

Y1 - 2011/10

N2 - Backgrounds: Chemotherapy is a mainstay in the treatment of extensive-disease small-cell lung cancer (ED-SCLC), although the survival benefit remains modest. We conducted a phase II trial of amrubicin (a topoisomerase II inhibitor) and topotecan (a topoisomerase I inhibitor) in chemotherapy-naïve and relapsed SCLC patients. Methods: Amrubicin (35mg/m 2) and topotecan (0.75mg/m 2) were administered on days 3-5 and 1-5, respectively. The objective response rate (ORR) was set as the primary endpoint, which was assessed separately in chemotherapy-naïve and relapsed cases. Results: Fifty-nine patients were enrolled (chemotherapy-naïve 31, relapsed 28). The ORRs were 74% and 43% in the chemotherapy-naïve and relapsed cases, respectively. Survival data were also promising, with a median progression-free survival time and median survival time of 5.3 and 14.9 months and 4.7 and 10.2 months in the chemotherapy-naïve and relapsed cases, respectively. Even refractory-relapsed cases responded to the treatment favorably (27% ORR). The primary toxicity was myelosuppression with grades 3 or 4 neutropenia in 97% of the patients, which led to grades 3 or 4 febrile neutropenia in 41% of the patients and two toxic deaths. Conclusion: This phase II study showed the favorable efficacy and moderate safety profiles of a topotecan and amrubicin two-drug combination especially in relapsed patients with ED-SCLC.

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KW - Amrubicin

KW - Chemo-naive

KW - Lung cancer

KW - Refractory relapse

KW - Sensitive relapse

KW - Topotecan

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