Dataset Information

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

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.

SUBMITTER: Kim HS

PROVIDER: S-EPMC7853132 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

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

Kim Hee Seung HS Park Sang-Yoon SY Park Chan-Yong CY Kim Young Tae YT Kim Beob-Jong BJ Song Yong Jung YJ Kim Byoung-Gie BG Kim Yong Beom YB Cho Chi-Heum CH Kim Jong-Hyeok JH Song Yong Sang YS

British journal of cancer 20200930 2

<h4>Background</h4>This Phase 2b study compared the efficacy and toxicity of belotecan and topotecan in recurrent ovarian cancer.<h4>Methods</h4>Patients with platinum-sensitive recurrent or platinum-resistant recurrent ovarian cancer (PRROC) were randomised 1:1 to receive belotecan 0.5 mg/m<sup>2</sup> or topotecan 1.5 mg/m<sup>2</sup> for five consecutive days every 3 weeks. The primary endpoint was overall response rate (ORR); secondary endpoints were progression-free survival (PFS), overall ...[more]

PMID: 32994466

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Dataset Information

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

Background

Methods

Results

Conclusions

Clinical trial registration

Publications

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

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