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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, JH | - |
dc.contributor.author | Lee, KH | - |
dc.contributor.author | Kim, DW | - |
dc.contributor.author | Kim, SW | - |
dc.contributor.author | Kim, HR | - |
dc.contributor.author | Kim, JH | - |
dc.contributor.author | Choi, JH | - |
dc.contributor.author | An, HJ | - |
dc.contributor.author | Kim, JS | - |
dc.contributor.author | Jang, JS | - |
dc.contributor.author | Kim, BS | - |
dc.contributor.author | Kim, HT | - |
dc.date.accessioned | 2022-10-28T05:29:00Z | - |
dc.date.available | 2022-10-28T05:29:00Z | - |
dc.date.issued | 2021 | - |
dc.identifier.issn | 0007-0920 | - |
dc.identifier.uri | http://repository.ajou.ac.kr/handle/201003/22491 | - |
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.iso | en | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Camptothecin | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Infusions, Intravenous | - |
dc.subject.MESH | Lung Neoplasms | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Neoplasm Recurrence, Local | - |
dc.subject.MESH | Prognosis | - |
dc.subject.MESH | Small Cell Lung Carcinoma | - |
dc.subject.MESH | Topoisomerase I Inhibitors | - |
dc.subject.MESH | Topotecan | - |
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.identifier.pmid | 33191408 | - |
dc.identifier.url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7884704/ | - |
dc.subject.keyword | Small-cell lung cancer | - |
dc.subject.keyword | Lung cancer | - |
dc.contributor.affiliatedAuthor | Choi, JH | - |
dc.type.local | Journal Papers | - |
dc.identifier.doi | 10.1038/s41416-020-01055-5 | - |
dc.citation.title | British journal of cancer | - |
dc.citation.volume | 124 | - |
dc.citation.number | 4 | - |
dc.citation.date | 2021 | - |
dc.citation.startPage | 713 | - |
dc.citation.endPage | 720 | - |
dc.identifier.bibliographicCitation | British journal of cancer, 124(4). : 713-720, 2021 | - |
dc.identifier.eissn | 1532-1827 | - |
dc.relation.journalid | J000070920 | - |
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