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A randomised phase 2b study comparing the efficacy and safety of belotecan vs. topotecan as monotherapy for sensitive-relapsed small-cell lung cancer
DC Field | Value | Language |
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dc.contributor.author | Kang, Jin-Hyoung | - |
dc.contributor.author | Lee, Ki-Hyeong | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Kim, Sang-We | - |
dc.contributor.author | Kim, Hye Ryun | - |
dc.contributor.author | Kim, Joo-Hang | - |
dc.contributor.author | Choi, Jin-Hyuk | - |
dc.contributor.author | An, Ho Jung | - |
dc.contributor.author | Kim, Jin-Soo | - |
dc.contributor.author | Jang, Joung-Soon | - |
dc.contributor.author | Kim, Bong-Seog | - |
dc.contributor.author | Kim, Heung Tae | - |
dc.date.accessioned | 2022-04-20T10:27:53Z | - |
dc.date.available | 2022-04-20T10:27:53Z | - |
dc.date.created | 2021-03-05 | - |
dc.date.created | 2021-03-05 | - |
dc.date.issued | 2021-02-16 | - |
dc.identifier.citation | British Journal of Cancer, Vol.124 No.4, pp.713-720 | - |
dc.identifier.issn | 0007-0920 | - |
dc.identifier.other | 124790 | - |
dc.identifier.uri | https://hdl.handle.net/10371/179093 | - |
dc.description.abstract | Background This study compared the efficacy/safety of the camptothecin analogues belotecan and topotecan for sensitive-relapsed small-cell lung cancer (SCLC). Methods One-hundred-and-sixty-four patients were randomised (1:1) to receive five consecutive daily intravenous infusions of topotecan (1.5 mg/m(2)) or belotecan (0.5 mg/m(2)), every 3 weeks, for six cycles. Main outcomes were objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), tolerability and toxicity. The study statistical plan was non-inferiority design with ORR as the endpoint. Results In the belotecan vs. topotecan groups, ORR (primary endpoint) was 33% vs. 21% (p = 0.09) and DCR was 85% vs. 70% (p = 0.030). PFS was not different between groups. Median OS was significantly longer with belotecan than with topotecan (13.2 vs. 8.2 months, HR = 0.69, 95% CI: 0.48-0.99), particularly in patients aged <65 years, with more advanced disease (i.e., extensive-stage disease, time to relapse: 3-6 months), or Eastern Cooperative Oncology Group performance status 1 or 2. More belotecan recipients completed all treatment cycles (53% vs. 35%; p = 0.022). Conclusions The efficacy/safety of belotecan warrants further evaluation in Phase 3 trials. Belotecan potentially offers an alternative to topotecan for sensitive-relapsed SCLC, particularly in patients aged <65 years, with more advanced disease, or poor performance. | - |
dc.language | 영어 | - |
dc.publisher | Nature Publishing Group | - |
dc.title | A randomised phase 2b study comparing the efficacy and safety of belotecan vs. topotecan as monotherapy for sensitive-relapsed small-cell lung cancer | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 김동완 | - |
dc.identifier.doi | 10.1038/s41416-020-01055-5 | - |
dc.citation.journaltitle | British Journal of Cancer | - |
dc.identifier.wosid | 000590411200002 | - |
dc.identifier.scopusid | 2-s2.0-85096015877 | - |
dc.citation.endpage | 720 | - |
dc.citation.number | 4 | - |
dc.citation.startpage | 713 | - |
dc.citation.volume | 124 | - |
dc.identifier.sci | 000590411200002 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | PROGRESSION-FREE SURVIVAL | - |
dc.subject.keywordPlus | 2ND-LINE TREATMENT | - |
dc.subject.keywordPlus | IMPACT | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | IRINOTECAN | - |
dc.subject.keywordPlus | THERAPIES | - |
dc.subject.keywordPlus | ETOPOSIDE | - |
dc.subject.keywordPlus | TOXICITY | - |
dc.subject.keywordPlus | ANEMIA | - |
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