Palbociclib and endocrine therapy in heavily pretreated hormone receptor-positive HER2-negative advanced breast cancer: the UK Compassionate Access Programme experience.
Howell, Sacha J
AffiliationDepartment of Medicine, Breast Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK
MetadataShow full item record
AbstractPURPOSE: 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.
CitationBattisti 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.
JournalBreast Cancer Research and Treatment.
- Efficacy and safety of palbociclib in combination with letrozole as first-line treatment of ER-positive, HER2-negative, advanced breast cancer: expanded analyses of subgroups from the randomized pivotal trial PALOMA-1/TRIO-18.
- Authors: Finn RS, Crown JP, Ettl J, Schmidt M, Bondarenko IM, Lang I, Pinter T, Boer K, Patel R, Randolph S, Kim ST, Huang X, Schnell P, Nadanaciva S, Bartlett CH, Slamon DJ
- Issue date: 2016 Jun 28
- A single institution experience with palbociclib toxicity requiring dose modifications.
- Authors: Gong J, Cho M, Yu KW, Waisman J, Yuan Y, Mortimer J
- Issue date: 2018 Apr
- Palbociclib Combined with Fulvestrant in Premenopausal Women with Advanced Breast Cancer and Prior Progression on Endocrine Therapy: PALOMA-3 Results.
- Authors: Loibl S, Turner NC, Ro J, Cristofanilli M, Iwata H, Im SA, Masuda N, Loi S, André F, Harbeck N, Verma S, Folkerd E, Puyana Theall K, Hoffman J, Zhang K, Bartlett CH, Dowsett M
- Issue date: 2017 Sep
- Palbociclib in highly pretreated metastatic ER-positive HER2-negative breast cancer.
- Authors: Hoste G, Punie K, Wildiers H, Beuselinck B, Lefever I, Van Nieuwenhuysen E, Han SN, Berteloot P, Concin N, Salihi R, Vergote I, Neven P
- Issue date: 2018 Aug
- Systematic review and network meta-analysis comparing palbociclib with chemotherapy agents for the treatment of postmenopausal women with HR-positive and HER2-negative advanced/metastatic breast cancer.
- Authors: Wilson FR, Varu A, Mitra D, Cameron C, Iyer S
- Issue date: 2017 Nov