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


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-04

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

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. More... »

PAGES

731-740

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10549-019-05134-x

DOI

http://dx.doi.org/10.1007/s10549-019-05134-x

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1111500963

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30656459


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