Abstract P5-21-22: Palbociclib in highly pretreated metastatic ER-positive HER-2 negative breast cancer
Authors: Hoste G , Punie K , Wildiers H , Neven P , Berteloot P , Van Nieuwenhuysen E , Han S , Concin N , Salihi R , Lefever I , Vergote I 
Published: February 2018

Abstract
Palbociclib, a first-in-class CDK 4/6 inhibitor, in combination with letrozole or fulvestrant is now licensed for the first or second line treatment of postmenopausal women with hormone-sensitive HER-2 negative metastatic breast cancer (MBC), but its activity in later lines is unknown. In Belgium, a compassionate Use Program (CUP) was temporarily established to provide palbociclib after at least 4 lines of systemic treatment for MBC.
The UZ Leuven Multidisciplinary Breast Center included 82 patients in this CUP from September 28th 2015 to March 14th 2017. This analysis describes retrospectively collected efficacy (Revised RECIST guideline, version 1.1) and safety data from 68 patients with at least 6 months follow-up at the data cut-off point. The primary endpoint was clinical benefit, defined as being on treatment for at least 6 months (CR + PR + SD). Most of the patients (89.7%) used palbociclib in combination with letrozole. Other combinations are with tamoxifen (2.9%), fulvestrant (2.9%), exemestane (1.5%), anastrazole (1.5%) and megestrol (1.5%).
At the data cut-off point, 18 patients are still on-treatment with palbociclib. The average duration of treatment is 5.7 months [range 2m- 17m]. The mean age of the patients was 66.3 years [range 34.8y – 85.9y] at the time of inclusion. Patients had had an average of 5.7 lines of systemic therapy [range 4 – 11 lines] before starting palbociclib, which was in 61.8% at least one line of chemotherapy. In this highly pretreated setting, 29 patients experienced stable disease lasting ≥ 6 months, resulting in an overall clinical benefit rate of 42.6%. 19.1% (13/68) showed stable disease for ≥ 9 months and 8% for ≥ 12 months. The subjective tolerance of the combination treatment was good, with 38% (26/68) of the patients discontinuing or delaying treatment following adverse events which were in the vast majority hematologic but asymptomatic. No factors predicting clinical benefit could be identified: use of chemotherapy before starting Palbociclib (p = 0.4644), age (p = 0.7029), time between primary breast cancer diagnosis and starting palbociclib (p = 0.1919) or time between first metastasis and starting palbociclib (p = 0.1108) and bone-only disease (p = 1,0000) were not significantly associated with clinical benefit at 6 months.
These data not only support the findings of the PALOMA studies, but also show unexpectedly high clinical benefit and safety of palbociclib in heavily pretreated endocrine-resistant hormone receptor positive HER-2 negative advanced breast cancer.
An update of these data will be presented.
Citation Format: Hoste G, Punie K, Wildiers H, Neven P, Berteloot P, Van Nieuwenhuysen E, Han S, Concin N, Salihi R, Lefever I, Vergote I. Palbociclib in highly pretreated metastatic ER-positive HER-2 negative breast cancer [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 P5-21-22.