Efficacy and safety of utidelone in pretreated patients with metastatic breast cancer in China: a multicenter, real-world study.

BACKGROUND

Utidelone (UTD1), a genetically engineered epothilone derivative, has been approved in China for use in combination with capecitabine in treating metastatic breast cancer (MBC) patients previously treated with anthracyclines or taxanes.

OBJECTIVES

To evaluate the real-world efficacy and safety of UTD1 in Chinese patients with MBC and to explore potential predictors of therapeutic effectiveness.

DESIGN

A multicenter, retrospective, real-world study.

METHODS

MBC patients who received UTD1 between March 2021 and August 2023 were identified using an electronic database. Outcome variables included progression-free survival (PFS), overall survival (OS), time to treatment failure (TTF), objective response rate (ORR), clinical benefit rate (CBR), and adverse events (AEs).

RESULTS

A total of 270 MBC patients were included, with 81.1% presenting with visceral metastasis and 23.7% with brain metastasis. The median number of treatment lines for UTD1 was 3. UTD1 showed a median PFS of 3.97 months (95% confidence interval (CI) 3.33-4.61) and a median OS of 20.63 months (95% CI 16.72-24.54). Among the patients, 17.4% received UTD1 monotherapy, and 82.6% received UTD1-based combination therapy. The median TTF was 2.80 months (95% CI 2.31-3.29). The ORR was 8.4%, and the CBR was 33.5%. The most common AE was peripheral neuropathy (PN, 55.2%). Patients with unresolved PN from previous therapy or receiving UTD1 through intravenous infusion on days 1-5 were more likely to develop ⩾grade 3 PN.

CONCLUSION

UTD1 is a new option for patients who have previously received taxanes and anthracyclines, with its clinical toxicity controllable.