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Tyrosine kinase inhibitors (TKIs), especially when combined with capecitabine, may improve the survival outcome of patients with HER2-positive (HER2+) breast cancer with brain metastases, according to the results of a meta-analysis presented at the 17th St. Gallen International Breast Cancer Conference 2021.
Chuangui Song, PhD, from the Fujian Medical University Union Hospital in China, and colleagues searched PubMed, the Cochrane Library, and Embase for clinical trials to assess the efficacy and safety of TKIs in patients with HER2+ breast cancer with brain metastases.
Progression-free survival (PFS) and the CNS objective response rate (CNS ORR) were the study’s primary outcome measures. Secondary outcomes were CNS time to progression, 6-month PFS, 6-month overall survival (OS), 12-month OS, median PFS, median OS, and adverse events of grade 3 or greater.
A total of 15 clinical trials — 7 randomized controlled trials and 8 single-arm trials — with 1031 patients with HER2+ breast cancer with brain metastases were included in the analysis. The researchers found that PFS in the TKI-containing arm was significantly longer (hazard ratio [HR], 0.35; 95% CI, 0.23-0.46; P =.000) compared with the non-TKI-containing arm. The pooled CNS ORR was 18% (95% CI, 6.0-35.0), the pooled median PFS was 4.88 months (95% CI, 3.67-6.08), and the pooled OS was 10.41 months (95% CI, 7.61-13.20).
The researchers also conducted a subgroup analysis that demonstrated the combined regimen of TKI with capecitabine to have a more substantial benefit with a more favorable CNS ORR of 40% (95% CI, 16-66) compared with TKI monotherapy (3% [95% CI, 0-8]) or TKI combined with other drugs (7% [95% CI, 2-15]).
Hepatic toxicity (20.5%), diarrhea (18.9%), neutropenia (14.0%), thrombocytopenia (9.1%), and stomatitis mucositis (8.3%) were the most frequently reported adverse events of grade 3 or greater.
“The therapy TKI improves the survival outcome of [patients with HER2+ breast cancer with brain metastases], especially when combined with capecitabine,” Dr Song’s group concluded.
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Yu Y, Zhang J, Huang K, Lin Y, Song C. The efficacy and safety of tyrosine kinase inhibitors in HER-2 positive breast cancer with brain metastases: a systematic review and meta-analysis. Presented at: 17th St. Gallen International Breast Cancer Conference 2021; March 17-20, 2021. Abstract P057.