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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).

AbstractOBJECTIVE:
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).
PATIENTS AND 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.
AuthorsAmit Bahl, Susan Masson, Zafar Malik, Alison J Birtle, Santhanam Sundar, Rob J Jones, Nicholas D James, Malcolm D Mason, Satish Kumar, David Bottomley, Anna Lydon, Simon Chowdhury, James Wylie, Johann S de Bono
JournalBJU international (BJU Int) Vol. 116 Issue 6 Pg. 880-7 (Dec 2015) ISSN: 1464-410X [Electronic] England
PMID25639506 (Publication Type: Clinical Trial, Phase III, Journal Article)
Copyright© 2015 The Authors BJU International © 2015 BJU International Published by John Wiley & Sons Ltd.
Chemical References
  • Antineoplastic Agents
  • Taxoids
  • cabazitaxel
Topics
  • Aged
  • Antineoplastic Agents (adverse effects, therapeutic use)
  • Humans
  • Male
  • Middle Aged
  • Patient Safety
  • Prostatic Neoplasms, Castration-Resistant (drug therapy, epidemiology)
  • Quality of Life
  • Taxoids (adverse effects, therapeutic use)
  • United Kingdom (epidemiology)

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