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Cyclin-dependent kinase 4/6 inhibitor (CDKI) is an oral targeted drug that has been approved in combination with endocrine therapy as the first-line or second-line treatment for hormone receptor-positive, HER2-negative advanced or metastatic breast cancer
.
Jennifer J Gao et al.
Breast cancer.
In this exploratory analysis, the researchers compiled patient data from three phase 3 trials of CDKI or placebo combined with fulvestrant in the treatment of breast cancer that were approved before August 1, 2020
.
All analyzed patients were 18 years of age or older, ECOG performance status 0-1, hormone receptor positive, HER2 negative, advanced or metastatic breast cancer patients, all received at least one dose of CDKI or placebo combined with fulvestrant treatment
Aggregated overall survival analysis
From October 7, 2013 to June 10, 2016, a total of 1960 patients in the three trials were randomized (12 patients did not receive study treatment, 1296 [66%] were assigned to the CDKI group, and 652 [33 %] was assigned to the placebo group)
.
Among all the treated patients (n=1948), the median follow-up was 43.
Among all the treated patients (n=1948), the median follow-up was 43.
Among patients receiving CDKI or placebo combined with fulvestrant as second-line or late-line systemic endocrine therapy (three trials; n=1552), the median follow-up was 45.
1 months, and the estimated overall survival HR was 0.
77 (95 % CI 0.
67-0.
89)
.
812 (52%) patients died
Among patients receiving CDKI or placebo combined with fulvestrant as second-line or late-line systemic endocrine therapy (three trials; n=1552), the median follow-up was 45.
Fulvestrant combined with CDKI, whether as a first-line treatment or a second-line or later-line treatment, can make patients obtain significant survival prolonging effects
Original source:
Jennifer J Gao, et al.
Overall survival in patients with hormone receptor- positive, HER2-negative, advanced or metastatic breast cancer treated with a cyclin-dependent kinase 4/6 inhibitor plus fulvestrant: a US Food and Drug Administration pooled analysis in this message
