Abstract P5-21-24: Retrospective assessment of treatment patterns and outcomes associated with palbociclib plus letrozole for postmenopausal women with HR+/HER2– advanced breast cancer enrolled in an early access program
Authors: Brufsky A , Davis K , Mitra D , Nagar S , McRoy L , Cotter M , Stearns V 
Published: February 2018

Abstract
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.
Citation Format: Brufsky A, Davis K, Mitra D, Nagar S, McRoy L, Cotter M, Stearns V. Retrospective assessment of treatment patterns and outcomes associated with palbociclib plus letrozole for postmenopausal women with HR+/HER2– advanced breast cancer enrolled in an early access program [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P5-21-24.