Abstract
BackgroundThis Phase 2b study compared the efficacy and toxicity of belotecan and topotecan in recurrent ovarian cancer.MethodsPatients 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.ResultsA 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.ConclusionsBelotecan was not inferior to topotecan in terms of overall response for recurrent ovarian cancer.Clinical trial registrationNCT01630018.
Highlights
Ovarian cancer has a poor prognosis, with a 5-year survival rate of
Population A total of 141 patients were enrolled between January 2011 and June 2014, of whom 140 and 130 patients were included in ITT and PP populations after exclusion of 10 patients due to the protocol violation such as failure of dose reduction (n = 7) and withdrawal of consent (n = 3) (Fig. 1)
Additional chemotherapy up to nine cycles was given in eight patients (5.7%) with high-grade serous carcinoma (HGSC)
Summary
Among patients showing disease recurrence, those with who relapse >6 months after the completion of primary chemotherapy are classified as platinum-sensitive recurrent ovarian cancer (PSROC), and platinum-based chemotherapy remains effective for them, with a response rate of up to 65%.3. Belotecan is a semi-synthetic camptothecin analogue with the water-solubilising group at position 7 unlike topotecan, which inhibits the relegation of single-stranded DNA breaks by blocking topoisomerase I, and thereby disrupting DNA replication and inducing apoptosis of tumour cells.[5,6] In preclinical studies, camptothecin including belotecan showed the inhibition of type This Phase 2b study compared the efficacy and toxicity of belotecan and topotecan in recurrent ovarian cancer.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
