A multicentre, randomised, open-label, parallel-group Phase 2b study of belotecan versus topotecan for recurrent ovarian cancer
DC Field | Value | Language |
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dc.contributor.author | Kim, H.S. | - |
dc.contributor.author | Park, S.-Y. | - |
dc.contributor.author | Park, C.-Y. | - |
dc.contributor.author | Kim, Y.T. | - |
dc.contributor.author | Kim, B.-J. | - |
dc.contributor.author | Song, Y.J. | - |
dc.contributor.author | Kim, B.-G. | - |
dc.contributor.author | Kim, Y.B. | - |
dc.contributor.author | Cho, C.-H. | - |
dc.contributor.author | Kim, J.-H. | - |
dc.contributor.author | Song, Y.S. | - |
dc.date.available | 2021-01-21T02:40:07Z | - |
dc.date.created | 2020-10-05 | - |
dc.date.issued | 2021-01 | - |
dc.identifier.issn | 0007-0920 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/79793 | - |
dc.description.abstract | Background: This Phase 2b study compared the efficacy and toxicity of belotecan and topotecan in recurrent ovarian cancer. Methods: Patients with platinum-sensitive recurrent or platinum-resistant recurrent ovarian cancer (PRROC) were randomised 1:1 to receive belotecan 0.5 mg/m2 or topotecan 1.5 mg/m2 for five consecutive days every 3 weeks. The primary endpoint was overall response rate (ORR); secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity. Results: A total of 140 (belotecan, n = 71; topotecan, n = 69) and 130 patients (belotecan, n = 66; topotecan, n = 64) were included in the intention-to-treat (ITT) and per-protocol (PP) populations. ORR did not differ significantly between the belotecan and topotecan groups (ITT, 29.6% versus 26.1%; PP, 30.3% versus 25%). Although PFS did not differ between the groups, belotecan was associated with improved OS compared with topotecan in the PP population (39.7 versus 26.6 months; P = 0.034). In particular, belotecan showed longer OS in PRROC and non-high-grade serous carcinoma (non-HGSC; PP, adjusted hazard ratios, 0.499 and 0.187; 95% confidence intervals 0.255–0.977 and 0.039–0.895). Furthermore, there were no differences in toxicities between the two groups. Conclusions: Belotecan was not inferior to topotecan in terms of overall response for recurrent ovarian cancer. Clinical trial registration: NCT01630018. © 2020, The Author(s), under exclusive licence to Cancer Research UK. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | Springer Nature | - |
dc.relation.isPartOf | British Journal of Cancer | - |
dc.title | A multicentre, randomised, open-label, parallel-group Phase 2b study of belotecan versus topotecan for recurrent ovarian cancer | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000573766500001 | - |
dc.identifier.doi | 10.1038/s41416-020-01098-8 | - |
dc.identifier.bibliographicCitation | British Journal of Cancer, v.124, no.2, pp.375 - 382 | - |
dc.description.isOpenAccess | N | - |
dc.identifier.scopusid | 2-s2.0-85091691488 | - |
dc.citation.endPage | 382 | - |
dc.citation.startPage | 375 | - |
dc.citation.title | British Journal of Cancer | - |
dc.citation.volume | 124 | - |
dc.citation.number | 2 | - |
dc.contributor.affiliatedAuthor | Park, C.-Y. | - |
dc.type.docType | Article | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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