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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 | 김혜련 | - |
dc.date.accessioned | 2022-11-24T00:51:11Z | - |
dc.date.available | 2022-11-24T00:51:11Z | - |
dc.date.issued | 2021-02 | - |
dc.identifier.issn | 0007-0920 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/191039 | - |
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/m2) or belotecan (0.5 mg/m2), 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. Trial registration: ClinicalTrials.gov NCT01497873. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English | - |
dc.publisher | Nature Publishing Group on behalf of Cancer Research UK | - |
dc.relation.isPartOf | BRITISH JOURNAL OF CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Camptothecin / adverse effects | - |
dc.subject.MESH | Camptothecin / analogs & derivatives* | - |
dc.subject.MESH | Camptothecin / therapeutic use | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Infusions, Intravenous | - |
dc.subject.MESH | Lung Neoplasms / drug therapy* | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Neoplasm Recurrence, Local / drug therapy* | - |
dc.subject.MESH | Prognosis | - |
dc.subject.MESH | Small Cell Lung Carcinoma / drug therapy* | - |
dc.subject.MESH | Topoisomerase I Inhibitors / adverse effects | - |
dc.subject.MESH | Topoisomerase I Inhibitors / therapeutic use | - |
dc.subject.MESH | Topotecan / adverse effects | - |
dc.subject.MESH | Topotecan / therapeutic use* | - |
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.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Jin-Hyoung Kang | - |
dc.contributor.googleauthor | Ki-Hyeong Lee | - |
dc.contributor.googleauthor | Dong-Wan Kim | - |
dc.contributor.googleauthor | Sang-We Kim | - |
dc.contributor.googleauthor | Hye Ryun Kim | - |
dc.contributor.googleauthor | Joo-Hang Kim | - |
dc.contributor.googleauthor | Jin-Hyuk Choi | - |
dc.contributor.googleauthor | Ho Jung An | - |
dc.contributor.googleauthor | Jin-Soo Kim | - |
dc.contributor.googleauthor | Joung-Soon Jang | - |
dc.contributor.googleauthor | Bong-Seog Kim | - |
dc.contributor.googleauthor | Heung Tae Kim | - |
dc.identifier.doi | 10.1038/s41416-020-01055-5 | - |
dc.contributor.localId | A01166 | - |
dc.relation.journalcode | J00406 | - |
dc.identifier.eissn | 1532-1827 | - |
dc.identifier.pmid | 33191408 | - |
dc.contributor.alternativeName | Kim, Hye Ryun | - |
dc.contributor.affiliatedAuthor | 김혜련 | - |
dc.citation.volume | 124 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 713 | - |
dc.citation.endPage | 720 | - |
dc.identifier.bibliographicCitation | BRITISH JOURNAL OF CANCER, Vol.124(4) : 713-720, 2021-02 | - |
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