Nicolò Matteo Luca Battisti1, Belinda Kingston2, Judy King3, Arshi Denton4, Simon Waters5, Ailsa Sita-Lumsden6, Farah Rehman6, Chara Stavraka7, Hartmut Kristeleit7, Elinor Sawyer7, David Houghton8, Neville Davidson8, Sacha Howell9, Julia Choy10, Peter Harper10, Rebecca Roylance11, Raja Fharat12, Kabir Mohammed13, Alistair Ring14, Stephen Johnston15. 1. Department of Medicine, Breast Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. nicolo.battisti@rmh.nhs.uk. 2. Department of Medicine, Breast Unit, The Royal Marsden NHS Foundation Trust, 203 Fulham Rd, Chelsea, London, SW3 6JJ, UK. belinda.kingston@icr.ac.uk. 3. Royal Free Hospital NHS Foundation Trust, 17 Lyndhurst Gardens, Hampstead, London, NW3 5NU, UK. 4. Mount Vernon Cancer Centre and London North West University Healthcare NHS Trust, Rickmansworth Rd, Northwood, HA6 2RN, UK. 5. Velindre Cancer Centre, Cardiff, CF14 2TL, UK. 6. Imperial College Healthcare NHS Trust, The Bays, S Wharf Rd, Paddington, London, W2 1NY, UK. 7. Department of Medical Oncology, Guy's and St Thomas' NHS Foundation Trust, Great Maze Pond, London, SE1 9RT, UK. 8. Ramsay Healthcare UK -Rivers Hospital, High Wych Rd, Sawbridgeworth, Hertfordshire, CM21 0HH, UK. 9. The Christie NHS Foundation Trust, Wilmslow Rd, Manchester, M20 4BX, UK. 10. Leaders in Oncology Care, HCA Healthcare, 95-97 Harley Street, London, W1G 6AF, UK. 11. Hospitals Biomedical Research Centre, NIHR University College London, University College London Hospitals NHS Foundation Trust, 235 Euston Rd, Fitzrovia, London, NW1 2BU, UK. 12. University College London Hospitals NHS Foundation Trust, 235 Euston Rd, Fitzrovia, London, NW1 2BU, UK. 13. Research and Development Department, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. 14. Department of Medicine, Breast Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. 15. Department of Medicine, Breast Unit, The Royal Marsden NHS Foundation Trust, 203 Fulham Rd, Chelsea, London, SW3 6JJ, UK.
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.
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.
Entities:
Keywords:
Advanced stage; Breast cancer; ER-positive; Palbociclib; Pretreated
Authors: Luis Manso; Cristina Hernando; María Galán; Mafalda Oliveira; Miguel A Cabrera; Raquel Bratos; César A Rodríguez; Manuel Ruiz-Borrego; Salvador Blanch; Antonio Llombart-Cussac; Juan I Delgado-Mingorance; Iñaki Álvarez-Busto; Isabel Gallegos; Lucía González-Cortijo; Serafín Morales; Elena Aguirre; Blanca A Hernando; Ana Ballesteros; José E Alés-Martínez; Cristina Reboredo; Amparo Oltra; María González-Cao; Marta Santisteban; Diego Malón; Isabel Echeverría; Elisa García-Garre; Estela Vega; Sònia Servitja; Raquel Andrés; Carlos E Robles; Rafael López; Elena Galve; María J Echarri; Marta Legeren; Fernando Moreno Journal: Breast Date: 2020-11-13 Impact factor: 4.380