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Palbociclib Plus Exemestane and Ovarian Function Suppression for HR-Positive, HER2-Negative Breast Cancer
According to updated survival outcomes from the phase 2 Young-PEARL study, palbociclib plus exemestane with ovarian function suppression prolonged the progression-free survival (PFS), but not the overall survival (OS), when compared to capecitabine among premenopausal patients with HR-positive, HER2-negative metastatic breast cancer.
These data will be presented by Yeon Hee Park, MD, Sungkyunkwan University, Seoul, South Korea, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
The Young-PEARL study enrolled 184 premenopausal patients with HR-positive, HER2-negative metastatic breast cancer who had relapsed or progressed during a previous tamoxifen therapy. Patients were randomized on a 1-to-1 basis to receive either exemestane plus palbociclib with ovarian function suppression (experimental arm, n = 92) or capecitabine (n = 92). The primary end point was PFS with a key secondary end point of OS, with 174 patients included in the final analysis.
After a median follow-up duration of 54.8 months, the updated median PFS was 19.5 months in the experimental arm vs 14.0 months in the capecitabine arm (hazard ratio [HR], 0.75; P = .04). The median OS was 54.8 months in the experimental arm vs 57.8 months in the capecitabine arm. Confirmed objective response rate was 33.3% and 33.7%, respectively. The most common grade ≥3 treatment-emergent adverse event in the experimental arm was asymptomatic neutropenia, and hand-foot syndrome and neutropenia in the capecitabine arm.
Source:
Park YH, Lee KH, Kim GM, et al. Palbociclib plus exemestane with GnRH agonist vs capecitabine in premenopausal patients with HR+/HER2- metastatic breast cancer: Updated survival results of the randomized phase 2 study Young-PEARL. Presented at the ASCO Annual Meeting. May 31 – June 4, 2024; Chicago, IL. Abstract #LBA1002
