by B. Porte, M. Carton, F. Lerebours, E. Brain, D. Loirat,
L. Haroun, A. Bellesoeur, S. Bach Hamba, Y. Kirova, P. Cottu
The Breast: Open
Access, November 13, 2020
Highlights
• Efficacy and safety of palbociclib in the treatment of
advanced breast cancer in real-life are very close to those from the pivotal
trials.
• In the endocrine naive and endocrine sensitive population,
we have highlighted three poor prognostic factors ECOG performance status 2,
previous endocrine therapy for advanced breast cancer and three metastatic
sites or more.
ABSTRACT
Background Palbociclib is indicated for the treatment of
hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer
(ABC), in combination with endocrine therapy. Emerging real-life data suggest
that the efficacy of a palbociclib-based therapy is highly conserved. We report
the Institut Curie hospital experience.Patients and methods We
retrospectively reviewed all patients with HR+ HER2- ABC treated with a
palbociclib-based therapy as first or second line for ABC, with an initial
prescription from November 2016 to December 2018. Clinical, laboratory and
imaging data were retrieved from electronic records. Data lock was December 31st,
2019. Descriptive analyses, univariate and multivariate Cox regression analyses
were performed. Results We included 310 consecutive patients. Median
age was 61.8 years old. Palbociclib was prescribed in first line in 225
patients (72.6%). Before palbociclib-based therapy initiation, 122 patients
(39.3%) were endocrine naive, 96 (31.0%) endocrine sensitive and 92 (29.7%)
endocrine resistant. Median follow-up was 20.7 months. Median progression free
survival (PFS) was 23.4 months (95%CI: 21.6-NR) in endocrine naive patients,
22.7 months (95%CI: 14.7-NR) in endocrine sensitive, and 13.4 months (95%CI:
10.7-20.8) in endocrine resistant. At 12 months from the initiation of
palbociclib, 94.5% of patients were alive. By multivariate analysis, poor
prognosis factors for PFS were identified in the endocrine naive/sensitive
population: initial ECOG status 2, previous endocrine therapy for ABC, 3
metastatic sites or more. Toxicity profile was similar to previously published
data.Conclusion In a non-selected population of patients with HR+ HER2-
ABC, the efficacy and safety data are strikingly similar to those previously
reported.
