BACKGROUND: Cabazitaxel is a novel taxoid developed to overcome resistance to other taxanes.
The 2010 TROPIC trial demonstrated improved survival for cabazitaxel compared with mitoxantrone in metastatic castration resistant prostate cancer (mCRPC) after previous docetaxel chemotherapy. However, concerns regarding safety (particularly neutropenic and cardiac complications) remained and quality of life (QOL) was not assessed.
OBJECTIVE: The UK Early Access Programme (EAP) was part of an international phase IIIb/IV trial set up to facilitate access to cabazitaxel and to record detailed safety data. In the UK a specific amendment enabled formal QOL evaluation.
DESIGN, SETTING AND PARTICIPANTS: 112 patients participated at 12 UK Cancer Centres. All had mCRPC with disease progression during or after docetaxel.
INTERVENTION: Patients received cabazitaxel 25mg/m2 every 3 weeks with prednisolone 10mg daily for up to 10 cycles. Safety assessments were performed prior to each cycle and QOL recorded at alternate cycles using the EQ5D-3L questionnaire and visual analogue scale (VAS).
OUTCOME MEASURES AND STATISTICAL ANALYSIS: Safety profile was compiled following completion of the EAP and QOL measures analysed to record trends. No formal statistical analysis was carried out.
RESULTS AND LIMITATIONS: 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 G-CSF. There were trends to improved VAS and EQ5D-3L pain scores during treatment.
CONCLUSIONS: The UK EAP experience indicates that cabazitaxel may improve QOL in mCRPC and represents an advance and 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.
PATIENT SUMMARY: We recorded detailed information about side effects and quality of life in 112 patients with advanced prostate cancer receiving cabazitaxel chemotherapy. We found that side effects were less severe than expected and, importantly, many patients' quality of life and pain symptoms improved during treatment.
Written by:
Bahl A, Masson S, Malik Z, Birtle A, Sundar S, Jones R, James N, Mason M, Kumar S, Bottomley D, Lydon A, Chowdhury S, Wylie J, de Bono J. Are you the author?
Bristol Haematology and Oncology Centre, Bristol, United Kingdom.
Reference: BJU Int. 2015 Jan 30. Epub ahead of print.
doi: 10.1111/bju.13069
PubMed Abstract
PMID: 25639506