BACKGROUND: The objective of this study was to evaluate treatment patterns and clinical outcomes among patients who received palbociclib in combination with letrozole (P+L) for the treatment of HR+/HER2–advanced breast cancer (ABC) as part of an Expanded Access Program (EAP) in the United States.
METHODS: Data were obtained by a retrospective chart review of patients previously enrolled in the EAP. Complete data from time of initial diagnosis of ABC until the date of chart abstraction (end of follow-up), including the post-EAP period, were obtained. Clinical outcomes assessed included clinical benefit rate (CBR), defined as complete response, partial response, or stable disease for ≥24 weeks from P + L initiation, progression free survival (PFS) and overall survival (OS). Survival outcomes were assessed using the Kaplan-Meier statistical analysis.
RESULTS: Data from 126 patients were included in this analysis. Median age was 62.5 years at EAP enrollment, and a majority of patients were Caucasian (83%). Approximately 25% of patients had de novo metastatic disease. A majority of patients had a performance status of ECOG 0 (56%) or 1 (37%) at EAP enrollment. Visceral disease was present in 71% of patients and 16% had bone-only disease. The majority of patients in this cohort from the EAP were heavily pre-treated, having had up to 5 prior lines of therapy in the metastatic setting prior to initiating P + L therapy; nearly 59% received 3+ prior lines before initiating P + L. Only 11% of patients received P + L as their initial regimen for MBC. At the time of the last available record, 12 patients were still on P + L therapy, an average of 21 months after the start of the EAP program. Nearly 80% of patients had prior AI exposure and 69% had prior chemotherapy. CBR was 33% for the overall sample of patients treated with P + L and 22% in those with 3+ prior lines of treatment. Patients with prior AI exposure in the ABC setting (n=100) had a CBR of 27% while those without prior AI exposure had CBR of 58%. Patients with prior chemotherapy (n=87) had a CBR of 28% and those without prior chemotherapy had CBR of 46%. For the entire cohort, 6- and 12-month PFS rates were 40% and 25% respectively; 12- and 24-month OS rates were 66% and 44%, respectively. Patients receiving 3+ lines of prior therapy had 6- and 12-month PFS rates of 28% and 19%, respectively, and 12- and 24-month OS rates of 59% and 34% respectively.
CONCLUSIONS: Our results suggest that the majority of patients enrolled in the EAP program derived benefit from receiving treatment with P + L despite multiple prior lines of treatment and prior endocrine-based therapy, including prior AI. These findings further demonstrate the benefit of treatment with palbociclib combination therapy in HR+/HER2– MBC.
