07 Jun 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
Zhang P. et al., 2017, The Lancet
Utidelone, a genetically engineered epothilone analogue, has emerged as a potential treatment for breast cancer in phase 1 and 2 trials. This phase III multicentre, open- label, randomized controlled trial was planned to compare the efficacy and safety of utidelone-capecitabine combination versus capecitabine alone in 270 patients with metastatic breast cancer. Patients were randomly assigned (2:1) to a 21-day cycle of either utidelone (30 mg/m2 IV once per day on days 1–5) plus capecitabine (1000 mg/m2 orally twice per day on days 1–14), or capecitabine alone (1250 mg/m2 orally twice per day on days 1–14), until disease progression or unacceptable toxicity occurred. PFS (progression free survival) was assessed as the primary end- point. Median PFS in the combination group was 8·44 months (95% CI 7·95–9·92) compared with 4·27 months (3·22–5·68) in the capecitabine alone group. Peripheral neuropathy and Palmar-plantar erythrodysaesthesia were the most prominent grade 3 adverse event in the combination and monotherapy group respectively. 155 patients died (99 in combination therapy, 56 in monotherapy). All deaths, except one in each group were due to disease progression. This study has demonstrated that the combination was more efficacious compared to capecitabine alone, with mild toxicity and a longer PFS; thus making it an effective option for patients with metastatic breast cancer.