A multicentre, randomised, open-label, parallel-group Phase 2b study of belotecan versus topotecan for recurrent ovarian cancer
- Authors
- Kim, H.S.; Park, S.-Y.; Park, C.-Y.; Kim, Y.T.; Kim, B.-J.; Song, Y.J.; Kim, B.-G.; Kim, Y.B.; Cho, C.-H.; Kim, J.-H.; Song, Y.S.
- Issue Date
- Jan-2021
- Publisher
- Springer Nature
- Citation
- British Journal of Cancer, v.124, no.2, pp.375 - 382
- Journal Title
- British Journal of Cancer
- Volume
- 124
- Number
- 2
- Start Page
- 375
- End Page
- 382
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/79793
- DOI
- 10.1038/s41416-020-01098-8
- ISSN
- 0007-0920
- 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.
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