In the ALSYMPCA study a survival benefit of Radium-223 (Ra-223) treated metastasized Castration Resistant Prostate Cancer (mCRPC) patients with bone disease was established. However, the effect of Ra-223 treatment on pain and Quality of Life (QoL) was not explored. 200 mCRPC patients treated with Ra-223 in 20 Dutch hospitals were included in the prospective ROTOR registry.
QoL (FACT-P) and pain (BPI-S) were recorded at Base-Line (BL) and at every Ra-223 cycle. Patients with complete questionnaires at BL and at least one on treatment were included in the analysis. Patients with a BPI-S Pain At Its Worst (PAIW) of ≥ 4 were considered symptomatic. A decrease of FACT-P and BPI-S PAIW of ≥ 6 points and ≥2 points, respectively, were considered clinically meaningfull.
Currently, data is collected from 244 patients. In 101 (41%) patients QoL and pain could be evaluated. Mean age was 72.9 (range 47.8-89.8) years, 85 (83%) had ≥6 bone metastases, an average of 4.8 (CI 4.6-5.1) cycles were administered and 51 (50%) were treated with 6 cycles. The mean total FACT-P in was 70.6 (CI 68.4-72.8). The lowest FACT-P score was at cycle 3 (67.6; CI65.0-70.1) and was 67.0 (CI 66.3-73.6) at cycle 6, which were 3.0 and 3.6 points lower than BL, respectively. The mean total BPI-S score was 43.5 (CI 38.9-48.0) at baseline. Asymptomatic patients (57; 56%) had a PAIW score of 2.1 (CI 1.8-2.5) and a mean total score of 31.0 (CI 25.9-36.0) at base line. The lowest PAIW score was at cycle 5 (1.7; CI 1.1-2.2) and mean total score of 23.4 (CI 16.2-30.6). Symptomatic patients (54; 53%) had a PAIW of 6.9 (CI 6.5-7.2) and a mean total score of 56.0 (CI 51.0-60.9). The lowest PAIW score was at cycle 2 (6.1; CI 5.6-6.6) and mean total score of 53.2 (CI 44.9-59.4) which were 0.8 and 2.8 points lower than base line, respectively. Patients treated with 6 cycles of Ra-223 had a PAIW of 7.1 (CI 6.1-8.2) and a mean score of 56.1 (CI 35.5-67.7).
QoL and pain remained stable during Ra-223 treatment. The lack of pain response might be related to opiate use, which will be analyzed.
Clinical trial identification
Legal entity responsible for the study
Netherlands Cancer Institute-Antoni van Leeunwenhoek hospital.
A. Bergman: Grants: Bayer BV. All other authors have declared no conflicts of interest.