A multicentre, randomised, open-label, parallel-group Phase 2b study of belotecan versus topotecan for recurrent ovarian cancer

• Published in: British journal of cancer Vol. 124; no. 2; pp. 375 - 382
• Main Authors: Kim, Hee Seung, Park, Sang-Yoon, Park, Chan-Yong, Kim, Young Tae, Kim, Beob-Jong, Song, Yong Jung, Kim, Byoung-Gie, Kim, Yong Beom, Cho, Chi-Heum, Kim, Jong-Hyeok, Song, Yong Sang
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 19-01-2021; Nature Publishing Group
• Subjects: 631/67/1517/1709; 692/4028/67/1059/99; Adult; Aged; Antineoplastic Agents - therapeutic use; Biomedical and Life Sciences; Biomedicine; Camptothecin - analogs & derivatives; Camptothecin - therapeutic use; Cancer Research; Carcinoma, Ovarian Epithelial - drug therapy; Carcinoma, Ovarian Epithelial - mortality; Drug Resistance; Epidemiology; Female; Humans; Middle Aged; Molecular Medicine; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - mortality; Oncology; Ovarian cancer; Platinum; Progression-Free Survival; Survival; Topotecan; Topotecan - therapeutic use; Toxicity
• ISSN: 0007-0920; 1532-1827; 1532-1827
• DOI: 10.1038/s41416-020-01098-8

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/m
2
or topotecan 1.5 mg/m
2
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.