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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

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dc.contributor.authorKang, JH-
dc.contributor.authorLee, KH-
dc.contributor.authorKim, DW-
dc.contributor.authorKim, SW-
dc.contributor.authorKim, HR-
dc.contributor.authorKim, JH-
dc.contributor.authorChoi, JH-
dc.contributor.authorAn, HJ-
dc.contributor.authorKim, JS-
dc.contributor.authorJang, JS-
dc.contributor.authorKim, BS-
dc.contributor.authorKim, HT-
dc.date.accessioned2022-10-28T05:29:00Z-
dc.date.available2022-10-28T05:29:00Z-
dc.date.issued2021-
dc.identifier.issn0007-0920-
dc.identifier.urihttp://repository.ajou.ac.kr/handle/201003/22491-
dc.description.abstractBACKGROUND: 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.
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dc.language.isoen-
dc.subject.MESHAged-
dc.subject.MESHCamptothecin-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHInfusions, Intravenous-
dc.subject.MESHLung Neoplasms-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHNeoplasm Recurrence, Local-
dc.subject.MESHPrognosis-
dc.subject.MESHSmall Cell Lung Carcinoma-
dc.subject.MESHTopoisomerase I Inhibitors-
dc.subject.MESHTopotecan-
dc.titleA randomised phase 2b study comparing the efficacy and safety of belotecan vs. topotecan as monotherapy for sensitive-relapsed small-cell lung cancer-
dc.typeArticle-
dc.identifier.pmid33191408-
dc.identifier.urlhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7884704/-
dc.subject.keywordSmall-cell lung cancer-
dc.subject.keywordLung cancer-
dc.contributor.affiliatedAuthorChoi, JH-
dc.type.localJournal Papers-
dc.identifier.doi10.1038/s41416-020-01055-5-
dc.citation.titleBritish journal of cancer-
dc.citation.volume124-
dc.citation.number4-
dc.citation.date2021-
dc.citation.startPage713-
dc.citation.endPage720-
dc.identifier.bibliographicCitationBritish journal of cancer, 124(4). : 713-720, 2021-
dc.identifier.eissn1532-1827-
dc.relation.journalidJ000070920-
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Hematology-Oncology
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