Hee Seung Kim1, Sang-Yoon Park2, Chan-Yong Park3, Young Tae Kim4, Beob-Jong Kim5, Yong Jung Song6, Byoung-Gie Kim7, Yong Beom Kim8, Chi-Heum Cho9, Jong-Hyeok Kim10, Yong Sang Song11. 1. Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, 03080, Republic of Korea. 2. Center for Uterine Cancer, Research Institute and Hospital, National Cancer Center, Goyang, 10408, Republic of Korea. 3. Department of Obstetrics and Gynecology, Gil Medical Center, Gachon University of Medicine and Science, Incheon, 21565, Republic of Korea. 4. Department of Obstetrics and Gynecology, Institute of Women's Medical Life Science, Yonsei University College of Medicine, Seoul, 03722, Republic of Korea. 5. Department of Obstetrics and Gynecology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, 01812, Republic of Korea. 6. Department of Obstetrics and Gynecology, Pusan National University School of Medicine, Yangsan, 50612, Republic of Korea. 7. Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, Republic of Korea. 8. Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam, 13620, Republic of Korea. 9. Department of Obstetrics and Gynecology, Dongsan Medical Center, Keimyung University, Daegu, 42601, Republic of Korea. 10. Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, 05505, Republic of Korea. 11. Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, 03080, Republic of Korea. yssong@snu.ac.kr.
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.
RCT Entities:
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.
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