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Overall Survival With Palbociclib Plus Endocrine Therapy vs Capecitabine in Postmenopausal Patients With HR+/HER2− Metastatic Breast Cancer
TAKE-HOME MESSAGE
- This final overall survival (OS) analysis of the phase III PEARL study comparing the efficacy of palbociclib combined with endocrine therapy (ET) versus capecitabine in postmenopausal patients with aromatase inhibitor–resistant metastatic breast cancer showed that OS and second progression–free survival (time from randomization to the end of the first subsequent therapy or death from any cause) were similar among patients taking palbociclib plus ET and those taking capecitabine. In addition, in patients with wild-type ESR1 tumours, palbociclib plus ET and capecitabine were associated with similar OS rates.
- In this study, OS was similar among women taking palbociclib plus ET and and those taking capecitabine, and these results were independent of the ESR1 mutational status.
abstract
This abstract is available on the publisher's site.
Access this abstract now Full Text Available for ClinicalKey SubscribersBACKGROUND
An earlier analysis of the PEARL phase III study showed that palbociclib plus endocrine therapy (ET) does not improve progression-free survival (PFS) over capecitabine in aromatase inhibitor-resistant, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (MBC) patients. Here, we report the final overall survival (OS) analysis.
METHODS
Postmenopausal patients (N = 601) were randomized 1:1 to capecitabine or palbociclib plus ET (exemestane, Cohort 1; fulvestrant, Cohort 2). OS was analysed in Cohort 2, the wild-type ESR1 population and the overall population. Additionally, we analysed subsequent systemic therapies and explored PFS2 (time from randomization to the end of the first subsequent therapy/death).
RESULTS
OS was 31.1 months for palbociclib plus fulvestrant and 32.8 months for capecitabine (adjusted hazard ratio [aHR] 1.10, 95% confidence interval [CI] 0.81-1.50, P = 0.550). In the wild-type ESR1 population, OS was 37.2 months for palbociclib plus ET and 34.8 months for capecitabine (aHR 1.06, 95% CI 0.81-1.37, P = 0.683). In OS analyses, no subgroup showed superiority for palbociclib plus ET over capecitabine. OS in the overall population was 32.6 months for palbociclib plus ET and 30.9 months for capecitabine (P = 0.995). Subsequent systemic therapy was given to 79.8% and 82.9% of patients with palbociclib plus ET and capecitabine, respectively. Median PFS2 was similar between study arms (Cohort 2, P = 0.941; wild-type ESR1 population, P = 0.827). No new safety findings were observed.
CONCLUSIONS
Palbociclib plus ET did not show a statistically superior OS compared to capecitabine in MBC patients progressing on aromatase inhibitors.
Additional Info
Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study
Eur. J. Cancer 2022 Jun 01;168(xx)12-24, M Martín, C Zielinski, M Ruiz-Borrego, E Carrasco, EM Ciruelos, M Muñoz, B Bermejo, M Margelí, T Csöszi, A Antón, N Turner, MI Casas, S Morales, E Alba, L Calvo, J de la Haba-Rodríguez, M Ramos, L Murillo, A Santaballa, JL Alonso-Romero, P Sánchez-Rovira, M Corsaro, X Huang, C Thallinger, Z Kahan, M Gil-GilFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.