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Breast Cancer Research and Treatment
Published in: Breast Cancer Research and Treatment 3/2019

01-04-2019 | Breast Cancer | Clinical trial

Palbociclib and endocrine therapy in heavily pretreated hormone receptor-positive HER2-negative advanced breast cancer: the UK Compassionate Access Programme experience

Authors: Nicolò Matteo Luca Battisti, Belinda Kingston, Judy King, Arshi Denton, Simon Waters, Ailsa Sita-Lumsden, Farah Rehman, Chara Stavraka, Hartmut Kristeleit, Elinor Sawyer, David Houghton, Neville Davidson, Sacha Howell, Julia Choy, Peter Harper, Rebecca Roylance, Raja Fharat, Kabir Mohammed, Alistair Ring, Stephen Johnston

Published in: Breast Cancer Research and Treatment | Issue 3/2019

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Abstract

Purpose

Palbociclib is approved in 1st line for hormone receptor (HR)-positive HER2-negative advanced breast cancer (ABC). A Compassionate Access Programme previously allowed patients to receive it in 4th line. However, Palbociclib has not been specifically tested in this population. We aimed to determine the safety and efficacy profile of Palbociclib within the Programme across ten institutions in the United Kingdom.

Methods

We retrospectively identified HR-positive HER2-negative ABC patients on the Programme between December 2015 and September 2017. Demographics, disease characteristics, prior treatments, blood tests, toxicities, treatment delays and responses were recorded. Simple statistics, Fisher’s exact test, χ2 method and Cox regression were used.

Results

118 patients identified had a median age of 59. 82.2% were postmenopausal and 92.4% performance status 0–1. 81.4% had visceral involvement and 6.8% bone-only disease after a median of 5 prior treatments and 3 prior chemotherapies. Clinical benefit rate was 47.5%, overall response rate 15.8%, median PFS 4.5 months and median OS 15.8 months. Longer progression-free survival on prior endocrine therapy was a predictor of longer PFS and OS. 89.7% developed neutropenia (grade ≥ 3 in 56.8%). 5.1% experienced febrile neutropenia. 48.3% had dose reductions and 3.4% discontinued Palbociclib following toxicity. No statistically significant difference in grade ≥ 3 neutropenia was observed according to metastatic sites nor previous treatments.

Conclusions

This is the most extensive analysis of palbociclib in ≥ 4th-line setting. Clinical benefit was confirmed particularly for endocrine-sensitive, predominantly bony disease and in earlier lines of treatment. Safety was similar to PALOMA trials with higher febrile neutropenia rate.
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Metadata
Title
Palbociclib and endocrine therapy in heavily pretreated hormone receptor-positive HER2-negative advanced breast cancer: the UK Compassionate Access Programme experience
Authors
Nicolò Matteo Luca Battisti
Belinda Kingston
Judy King
Arshi Denton
Simon Waters
Ailsa Sita-Lumsden
Farah Rehman
Chara Stavraka
Hartmut Kristeleit
Elinor Sawyer
David Houghton
Neville Davidson
Sacha Howell
Julia Choy
Peter Harper
Rebecca Roylance
Raja Fharat
Kabir Mohammed
Alistair Ring
Stephen Johnston
Publication date
01-04-2019
Publisher
Springer US
Published in
Breast Cancer Research and Treatment / Issue 3/2019
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI
https://doi.org/10.1007/s10549-019-05134-x

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