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ID 47019
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Author
Nogami, Naoyuki
Kuyama, Shoichi
Kiura, Katsuyuki Kakenhi
Takigawa, Nagio
Chikamori, Kenichi
Shibayama, Takuo
Kishino, Daizo
Hosokawa, Shinobu
Tamaoki, Akihiko
Harita, Shingo
Ueoka, Hiroshi
Shinkai, Tetsu
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 (35 mg/m(2)) and topotecan (0.75 mg/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.
Keywords
Lung cancer
Topotecan
Amrubicin
Chemo-naive
Sensitive relapse
Refractory relapse
Published Date
2011-10
Publication Title
Lung Cancer
Volume
volume74
Issue
issue1
Publisher
Elsevier Ireland Ltd.
Start Page
80
End Page
84
ISSN
0169-5002
NCID
AA10785743
Content Type
Journal Article
language
英語
Copyright Holders
© 2011 Elsevier Ireland Ltd. All rights reserved.
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Refereed
True
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