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 topote

SUBMITTER: Kim HS 

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

REPOSITORIES: biostudies-literature