Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer.
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Embargo End Date
ICR Authors
Authors
Turner, NC
Slamon, DJ
Ro, J
Bondarenko, I
Im, S-A
Masuda, N
Colleoni, M
DeMichele, A
Loi, S
Verma, S
Iwata, H
Harbeck, N
Loibl, S
André, F
Puyana Theall, K
Huang, X
Giorgetti, C
Huang Bartlett, C
Cristofanilli, M
Slamon, DJ
Ro, J
Bondarenko, I
Im, S-A
Masuda, N
Colleoni, M
DeMichele, A
Loi, S
Verma, S
Iwata, H
Harbeck, N
Loibl, S
André, F
Puyana Theall, K
Huang, X
Giorgetti, C
Huang Bartlett, C
Cristofanilli, M
Document Type
Journal Article
Date
2018-11-15
Date Accepted
2018-10-20
Abstract
BACKGROUND: The cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor palbociclib, in combination with fulvestrant therapy, prolongs progression-free survival among patients with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. We report the results of a prespecified analysis of overall survival. METHODS: We randomly assigned patients with hormone-receptor-positive, HER2-negative advanced breast cancer who had progression or relapse during previous endocrine therapy to receive palbociclib plus fulvestrant or placebo plus fulvestrant. We analyzed overall survival; the effect of palbociclib according to the prespecified stratification factors of presence or absence of sensitivity to endocrine therapy, presence or absence of visceral metastatic disease, and menopausal status; the efficacy of subsequent therapies after disease progression; and safety. RESULTS: Among 521 patients who underwent randomization, the median overall survival was 34.9 months (95% confidence interval [CI], 28.8 to 40.0) in the palbociclib-fulvestrant group and 28.0 months (95% CI, 23.6 to 34.6) in the placebo-fulvestrant group (hazard ratio for death, 0.81; 95% CI, 0.64 to 1.03; P=0.09; absolute difference, 6.9 months). CDK4/6 inhibitor treatment after the completion of the trial regimen occurred in 16% of the patients in the placebo-fulvestrant group. Among 410 patients with sensitivity to previous endocrine therapy, the median overall survival was 39.7 months (95% CI, 34.8 to 45.7) in the palbociclib-fulvestrant group and 29.7 months (95% CI, 23.8 to 37.9) in the placebo-fulvestrant group (hazard ratio, 0.72; 95% CI, 0.55 to 0.94; absolute difference, 10.0 months). The median duration of subsequent therapy was similar in the two groups, and the median time to the receipt of chemotherapy was 17.6 months in the palbociclib-fulvestrant group, as compared with 8.8 months in the placebo-fulvestrant group (hazard ratio, 0.58; 95% CI, 0.47 to 0.73; P<0.001). No new safety signals were observed with 44.8 months of follow-up. CONCLUSIONS: Among patients with hormone-receptor-positive, HER2-negative advanced breast cancer who had sensitivity to previous endocrine therapy, treatment with palbociclib-fulvestrant resulted in longer overall survival than treatment with placebo-fulvestrant. The differences in overall survival in the entire trial group were not significant. (Funded by Pfizer; PALOMA-3 ClinicalTrials.gov number, NCT01942135 .).
Citation
The New England journal of medicine, 2018, 379 (20), pp. 1926 - 1936
Source Title
Publisher
MASSACHUSETTS MEDICAL SOC
ISSN
0028-4793
eISSN
1533-4406
Collections
Research Team
Molecular Oncology