ID | 47019 |
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Author |
Nogami, Naoyuki
Kuyama, Shoichi
Takigawa, Nagio
Chikamori, Kenichi
Shibayama, Takuo
Kishino, Daizo
Hosokawa, Shinobu
Tamaoki, Akihiko
Harita, Shingo
Tabata, Masahiro
Kaken ID
researchmap
Ueoka, Hiroshi
Shinkai, Tetsu
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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-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.
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Keywords | Lung cancer
Topotecan
Amrubicin
Chemo-naive
Sensitive relapse
Refractory relapse
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Published Date | 2011-10
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Publication Title |
Lung Cancer
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Volume | volume74
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Issue | issue1
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Publisher | Elsevier Ireland Ltd.
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Start Page | 80
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End Page | 84
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ISSN | 0169-5002
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NCID | AA10785743
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Content Type |
Journal Article
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language |
English
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Copyright Holders | © 2011 Elsevier Ireland Ltd. All rights reserved.
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File Version | author
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Refereed |
True
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DOI | |
PubMed ID | |
Web of Science KeyUT |