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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) ( NCT 01254279)
Author(s) -
Bahl Amit,
Masson Susan,
Malik Zafar,
Birtle Alison J.,
Sundar Santhanam,
Jones Rob J.,
James Nicholas D.,
Mason Malcolm D.,
Kumar Satish,
Bottomley David,
Lydon Anna,
Chowdhury Simon,
Wylie James,
Bono Johann S.
Publication year - 2015
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/bju.13069
Subject(s) - cabazitaxel , docetaxel , medicine , prostate cancer , quality of life (healthcare) , visual analogue scale , oncology , cancer , surgery , androgen deprivation therapy , nursing
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 ). 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 s afety 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.