954 - Quality of life of patients with metastatic castration-resistant prostate cancer: results from an observational study in 6 European countries

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Supportive measures
Prostate Cancer
Presenter Ramesh Dass
Authors R.N. Dass1, P. Hamberg2, M. Spencer3, P. Wheatley Price3
  • 1Janssen-Cilag Ltd, London/UK
  • 2Internal Medicine, St Franciscus Gasthuis, NL-3045 PM - Rotterdam/NL
  • 3Hemar (health Economics, Market Access And Reimbursement), Janssen-Cilag Ltd, London/UK



Despite advances in prostate cancer (PC) therapy, treatment options for metastatic castration-resistant prostate cancer (mCRPC) are limited. However, studies on health-related quality of life (HRQoL) for mCRPC patients are rare and although HRQoL is considered as a key outcome of mCRPC treatments, patient utilities are not measured routinely.


To assess QoL outcomes in mCRPC patients. Methodology Observational, cross-sectional, prospective year-long study conducted in 47 centres specialised in PC treatment in 6 countries: Belgium, France, Germany, Sweden, the Netherlands, and the United Kingdom. Patients with confirmed diagnosis of PC, presenting with metastatic castration-resistant disease were eligible. At inclusion, clinical and therapeutic data were collected by physicians, and EQ-5D and FACT-P questionnaires were completed by patients. Interim results based on 200 patients, of a target of 900, are presented below.


Mean age was 72.8 years. Mean time since diagnosis of PC was 6.6 years. At diagnosis, 34.5% of patients had metastases, and 79.2% had a Gleason score ≥ 7. At inclusion, 34.2% of the patients had never been treated with any prior cytotoxic chemotherapy (CT), 35.3% had been treated with CT in the past and 30.5% were undergoing CT (respective mean times since PC diagnosis: 7.3, 6.4 and 5.7 years). Mean (SD) EQ-5D single index utility score was 0.7 (0.3). 65.3% of patients had moderate or extreme pain or discomfort, 53.2% had problems performing daily activities and 51,3% had mobility problems. Mean (SD) EQ-5D VAS score was 55.7 (22.7). Although not statistically significant (NS), a trend for patients without any prior CT to have higher mean EQ-5D single index utility and VAS scores, was observed. Mean (SD) FACT-P total score was 102.8 (24.1) and 107.2 (25.8), 103.2 (23.7) and 98.1 (21.9) respectively in patients without any prior CT, undergoing CT and treated with CT in the past (NS). Subscale scores were: physical well being: 20.3 (6.1), social/family well being: 20.4 (5.4), emotional well being: 16.9 (4.7), functional well being: 16.0 (6.3) and PC subscale: 29.4 (8.3).


The interim analysis was insufficiently powered to detect a significant impact of CT on HRQoL in mCRPC patients. The final analysis is expected to adequately highlight determinants of HRQoL.


R.N. Dass: Janssen Cilag employee,

P. Hamberg: Study investigator,

M. Spencer: Janssen Cilag employee,

P. Wheatley Price: Janssen Cilag employee