The addition of utidelone to capecitabine significantly prolonged progression-free survival with manageable toxicity in patients with metastatic breast cancer refractory to previous chemotherapies, a study published in The Lancet Oncology has shown.1

This open-label, phase 3 superiority trial ( Identifier: NCT02253459) enrolled 270 women aged 18 to 70 years with metastatic breast cancer refractory to anthracycline and taxane chemotherapy regimens. Patients had received no more than 4 prior regimens.

Investigators randomly assigned participants 2:1 to receive intravenous utidelone daily on days 1 to 5 plus oral capecitabine twice daily on days 1 to 14 or capecitabine alone until disease progression or unacceptable toxicity.

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After a median follow-up of 6.77 months for the utidelone group and 4.55 months for the capecitabine alone group, results showed that adding utidelone was associated with a significant 54% reduction in the risk of progression or death compared with capecitabine alone (hazard ratio, 0.46; 95% CI, 0.36-0.59; P < .0001).

Median progression-free survival was 8.44 months (95% CI, 7.95-9.92) with utidelone plus capecitabine vs 4.27 months (95% CI, 3.22-5.68) with capecitabine alone.

Twenty-two percent of the 267 patients in the utidelone arm experienced grade 3 peripheral neuropathy vs only 1 patient in capecitabine alone arm. Seven percent of utidelone-treated patients reported grade 3 palmar-plantar erythrodysesthesia compared with 8% of those who received capecitabine only.

Investigators observed 16 serious adverse events, the most common being diarrhea in 3 patients, in the combination group and 14 serious adverse events in the monotherapy arm. One patient in each arm died potentially related to treatment.

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Given its mild toxicity and progression-free survival benefit, the findings ultimately support the use of utidelone in combination with capecitabine in patients with advanced breast cancer.

Utidelone is an investigational genetically engineered epothilone analogue that has demonstrated promising activity in breast cancer in phase 1 and 2 trials. Similar to taxanes, epothilones inhibit microtubule function, an essential component for cell division.


  1. Zhang P, Sun T, Zhang Q, et al. Utidelone plus capecitabine versus capecitabine alone for heavily pretreated metastatic breast cancer refractory to anthracyclines and taxanes: a multicentre, open-label, superiority, phase 3, randomised controlled trial. Lancet Oncol. 2017 Feb 10. doi: 10.1016/S1470-2045(17)30088-8 [Epub ahead of print]