Efficacy of utidelone plus capecitabine versus capecitabine for heavily pretreated, anthracycline- and taxane-refractory metastatic breast cancer: final analysis of overall survival in a phase III randomised controlled trial.
Abstract | BACKGROUND: Primary analysis of the phase III trial BG01-1323L demonstrated that utidelone plus capecitabine significantly improved progression-free survival (PFS) and overall response rate (ORR) versus capecitabine alone in heavily-pretreated patients with metastatic breast cancer (MBC). Here, we report the final overall survival (OS) analysis and updates of other endpoints. PATIENTS AND METHODS: In total, 405 patients were randomised 2:1 to receive utidelone (30 mg/m2 IV daily, days 1-5, over 90 min) plus capecitabine (1000 mg/m2 orally b.i.d., days 1-14) or capecitabine alone (1250 mg/m2 orally b.i.d., days 1-14) every 21 days. The secondary endpoint, OS, was estimated using the Kaplan-Meier product-limit approach at a two-sided alpha level of 0.05 after the prespecified 310 death events had been reached. Exploratory analyses of the primary endpoint, PFS, and the secondary endpoint, ORR, were also done. Safety was analysed in patients who had at least one dose of study drug. RESULTS: At the final OS analysis, the median duration of follow-up was 19.6 months in the utidelone plus capecitabine group and 15.4 months in the capecitabine alone group. In the intention-to-treat population, 313 deaths had occurred at data cut-off, 203 of 270 patients in the combination group and 110 of 135 in the monotherapy group. Median OS in the combination group was 19.8 months compared with 16.0 months in the monotherapy group [hazard ratio (HR) = 0.75, 95% confidence intervals (CI) 0.59-0.94, P = 0.0142]. The updated analysis of PFS and ORR showed that the combination therapy remained superior to monotherapy. Safety results were similar to those previously reported with respect to incidence, severity and specificity. No late-emerging toxicities or new safety concerns occurred. CONCLUSIONS:
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Authors | B Xu, T Sun, Q Zhang, P Zhang, Z Yuan, Z Jiang, X Wang, S Cui, Y Teng, X-C Hu, J Yang, H Pan, Z Tong, H Li, Q Yao, Y Wang, Y Yin, P Sun, H Zheng, J Cheng, J Lu, B Zhang, C Geng, J Liu, K Shen, S Yu, H Li, L Tang, R Qiu, study group of BG01-1323L |
Journal | Annals of oncology : official journal of the European Society for Medical Oncology
(Ann Oncol)
Vol. 32
Issue 2
Pg. 218-228
(02 2021)
ISSN: 1569-8041 [Electronic] England |
PMID | 33188874
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2020 European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved. |
Chemical References |
- Anthracyclines
- Taxoids
- Capecitabine
- Fluorouracil
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Topics |
- Anthracyclines
(therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects)
- Breast Neoplasms
(drug therapy)
- Capecitabine
(therapeutic use)
- Disease-Free Survival
- Fluorouracil
(therapeutic use)
- Humans
- Taxoids
(therapeutic use)
- Treatment Outcome
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