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Published on: October 27, 2014
Utidelone Plus Bevacizumab for ERBB2-Negative Metastatic Breast Cancer and Active Brain Metastases: The U-BOMB Phase
Min Yan1, Huimin Lv1, Xinlan Liu2
1Department of Breast Disease, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
Importance:
Patients with ERBB2 (formerly HER2 or HER2/neu)-negative metastatic breast cancer (MBC) and brain metastases have poor prognosis, and effective treatment options are limited.
Objective:
To investigate the activity and safety of utidelone plus bevacizumab in patients with ERBB2-negative MBC and active brain metastases.
Design, Setting, And Participants:
This nonrandomized clinical trial was conducted at 5 hospitals in China. Adult patients with ERBB2-negative MBC who had untreated or progressive brain metastases were enrolled between May 5, 2022, and October 25, 2023. The data cutoff date was May 20, 2024; data were analyzed from September 15, 2022, to July 20, 2024.
Interventions:
Patients received bevacizumab (15 mg/kg on day 1) and utidelone (30 mg/m2 on days 1-5) every 3 weeks until disease progression or unacceptable toxic effects.
Main Outcomes And Measures:
The primary end point was central nervous system (CNS) objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Results:
A total of 47 female patients (median age, 53 years [IQR, 45-59 years]) were recruited. Of these, 35 patients had untreated brain metastases and 12 had brain metastases that had progressed after local radiotherapy. The CNS ORR was 42.6% (95% CI, 28.3%-57.8%) per RECIST version 1.1 and 40.4% (95% CI, 26.4%-55.7%) per Response Assessment in Neuro-Oncology Brain Metastases criteria. The median follow-up duration was 11.0 months (range, 2.3-23.6 months). The median progression-free survival (PFS) was 7.7 months (95% CI, 5.6-9.7), median CNS-PFS was 10.6 months (95% CI, 8.4 months to not reached), and median overall survival was 15.1 months (95% CI, 12.0 months to not reached). The most common grade 3 or higher treatment-emergent adverse events were decreased lymphocyte count in 5 patients (10.6%) and decreased white blood cell count in 3 patients (6.4%). No serious or fatal adverse events occurred.
Conclusions And Relevance:
The findings of this nonrandomized clinical trial suggest the potential of utidelone plus bevacizumab for the treatment of patients with ERBB2-negative MBC and active brain metastases. This treatment approach warrants further validation in a randomized clinical trial.
Trial Registration:
ClinicalTrials.gov Identifier: NCT05357417.
Insights
Utidelone plus bevacizumab shows promise for ERBB2-negative metastatic breast cancer with brain metastases. This combination therapy demonstrated a 42.6% CNS objective response rate with manageable side effects.
Area of Science:
- Oncology
- Medical Research
- Clinical Trials
Background:
- Metastatic breast cancer (MBC) that is ERBB2-negative and involves brain metastases presents a significant clinical challenge with limited effective treatment options.
- Patients with ERBB2-negative MBC and active brain metastases often experience a poor prognosis.
Purpose of the Study:
- To evaluate the efficacy and safety of combining utidelone with bevacizumab in patients diagnosed with ERBB2-negative metastatic breast cancer and active brain metastases.
- To determine the central nervous system (CNS) objective response rate (ORR) as the primary outcome measure.
Main Methods:
- A nonrandomized clinical trial involving 47 adult female patients with ERBB2-negative MBC and untreated or progressive brain metastases.
- Patients received a combination regimen of bevacizumab (15 mg/kg) and utidelone (30 mg/m2) administered every 3 weeks.
- The primary endpoint was assessed using RECIST version 1.1 criteria for CNS ORR.
Main Results:
- The study reported a CNS ORR of 42.6% (95% CI, 28.3%-57.8%) per RECIST 1.1.
- Median progression-free survival (PFS) was 7.7 months, and median CNS-PFS was 10.6 months.
- The most frequent grade 3 or higher adverse events included decreased lymphocyte count (10.6%) and decreased white blood cell count (6.4%), with no serious or fatal events reported.
Conclusions:
- The combination of utidelone and bevacizumab demonstrates potential as a treatment strategy for ERBB2-negative metastatic breast cancer with active brain metastases.
- Further investigation and validation of this therapeutic approach are recommended through a randomized clinical trial.
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