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

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    Authors
    Battisti, N
    Kingston, B
    King, J
    Denton, A
    Waters, S
    Sita-Lumsden, A
    Rehman, F
    Stavraka, C
    Kristeleit, H
    Sawyer, E
    Houghton, D
    Davidson, N
    Howell, Sacha J
    Choy, J
    Harper, P
    Roylance, R
    Fharat, R
    Mohammed, K
    Ring, A
    Johnston, S
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    Affiliation
    Department of Medicine, Breast Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK
    Issue Date
    2019
    
    Metadata
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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, ?2 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.
    Citation
    Battisti NML, Kingston B, King J, Denton A, Waters S, Sita-Lumsden A, et al. Palbociclib and endocrine therapy in heavily pretreated hormone receptor-positive HER2-negative advanced breast cancer: the UK Compassionate Access Programme experience. Breast Cancer Res Treat. 2019 Jan 17.
    Journal
    Breast Cancer Research and Treatment.
    URI
    http://hdl.handle.net/10541/621569
    DOI
    10.1007/s10549-019-05134-x
    PubMed ID
    30656459
    Additional Links
    https://dx.doi.org/10.1007/s10549-019-05134-x
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1007/s10549-019-05134-x
    Scopus Count
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