title: Final quality of life and safety data for patients with metastatic castration-resistant prostate cancer treated with cabazitaxel in the UK Early Access Programme (EAP) (NCT01254279).
abstract: OBJECTIVE
  To compile the safety profile and quality of life (QoL) data for patients with metastatic castration-resistant prostate cancer (mCRPC) treated with cabazitaxel in the UK Early Access Programme (UK EAP).
  
  
  METHODS
  A total of 112 patients participated at 12 UK cancer centres. All had mCRPC with disease progression during or after docetaxel. Patients received cabazitaxel 25 mg/m(2) every 3 weeks with prednisolone 10 mg daily for up to 10 cycles. Safety assessments were performed before each cycle and QoL was recorded at alternate cycles using the EQ-5D-3L questionnaire and visual analogue scale (VAS). The safety profile was compiled after completion of the UK EAP and QoL measures were analysed to record trends. No formal statistical analysis was carried out.
  
  
  RESULTS
  The incidences of neutropenic sepsis (6.3%), grade 3 and 4 diarrhoea (4.5%) and grade 3 and 4 cardiac toxicity (0%) were low. Neutropenic sepsis episodes, though low, occurred only in patients who did not receive prophylactic granulocyte-colony stimulating factor. There were trends towards improved VAS and EQ-5D-3L pain scores during treatment.
  
  
  CONCLUSIONS
  The UK EAP experience indicates that cabazitaxel might improve QoL in mCRPC and represents an advance and a useful addition to the armamentarium of treatment for patients whose disease has progressed during or after docetaxel. In view of the potential toxicity, careful patient selection is important.
authors: Bristol Haematology and Oncology Centre, Bristol, UK.
authors: Amit
authors: A
authors: Bahl
authors: Bristol Haematology and Oncology Centre, Bristol, UK.
authors: Susan
authors: S
authors: Masson
authors: Clatterbridge Centre for Oncology, Wirral, UK.
authors: Zafar
authors: Z
authors: Malik
authors: Rosemere Cancer Centre, Royal Preston Hospital, Preston, UK.
authors: Alison J
authors: AJ
authors: Birtle
authors: Nottingham University Hospitals NHS Trust, Nottingham, UK.
authors: Santhanam
authors: S
authors: Sundar
authors: University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, UK.
authors: Rob J
authors: RJ
authors: Jones
authors: School of Cancer Sciences, University of Birmingham, Birmingham, UK.
authors: Nicholas D
authors: ND
authors: James
authors: Velindre Hospital, Cardiff, UK.
authors: Malcolm D
authors: MD
authors: Mason
authors: Velindre Hospital, Cardiff, UK.
authors: Satish
authors: S
authors: Kumar
authors: St James's University Hospital, Leeds, UK.
authors: David
authors: D
authors: Bottomley
authors: South Devon Healthcare NHS Foundation Trust, Torquay, UK.
authors: Anna
authors: A
authors: Lydon
authors: Guy's and St. Thomas' NHS Foundation Trust, London, UK.
authors: Simon
authors: S
authors: Chowdhury
authors: The Christie NHS Foundation Trust, Manchester, UK.
authors: James
authors: J
authors: Wylie
authors: The Institute for Cancer Research and Royal Marsden Hospital, Sutton, UK.
authors: Johann S
authors: JS
authors: de Bono
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000453:epidemiology*; D011788:Quality of Life; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use*; D006113:United Kingdom / Q000453:epidemiology
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; C552428:cabazitaxel
keywords: cabazitaxel; quality of life; useful addition