First Italian Multicentre Experience in using Ra-223 in patients with metastatic castration resistant prostate cancer (mCRPC)

Abstract

Aim: Radium‐223 is a novel bone‐targeted α‐emitter associated with a survival benefit. We present first Italian multicentre experience in using Ra‐223 in mCRPC patients . Material and methods: Data from mCRPC patients submitted to Ra‐223 treatment over 3 years (August 2013 ‐ February 2016) were retrospectively collected. Information included Gleason score, age, prior treatments, bone symptoms, analgesic requirements, imaging and blood results. Ra‐223 (50 kBq/kg) was administered every 4 weeks, up to the recommended 6 therapy cycles. Endpoints assessed included Overall Survival, pain score using Visual Analog scale (VAS), side effects, skeletal related events (SREs), disease biomarkers (PSA & ALP levels) and haematological parameters. Results: 90 patients received Ra‐223 in three Italian Radiotherapy/Nuclear Medicine Departments. Up to April 2016 only Pisa Nuclear Medicine Department data are available, while analysis of data from other centres is still ongoing. Median age was 69 yr (range 52‐85 yr). Median follow‐up was 8,6 months (range 1‐18 months). Mean Gleason score was 7. All patients received 3 previous lines of treatment on average. All bone scans showed foci of abnormal uptake. CT scans was used to exclude visceral involvement and the presence of pathologic lymph nodes with a diameter ≥ 3 cm. 16/32 pts completed the recommended 6 cycles, of whom: 5 had bone pain reduction, 3 had worsening, 8 had absence of bone pain, remaining stable and not requiring analgesia. 16 pts stopped treatment : 3 cases of delay due to lack in radiopharmaceutical supplies, 9 developed extra skeletal disease/skeletal progression, 3 deteriorated clinically, 1 experienced SRE during treatment. About non‐haematological toxicity we observed 3 cases of G3 anorexia, 3 cases of G1 diarrhoea, 2 cases of G2 asthenia. No patients developed SREs during follow‐up. Concerning haematological toxicity, bone marrow failure resulted in 8 cases of G2 anaemia, 6 cases of G3 anaemia, 2 cases of G2 leucopoenia, 1 case of G2 thrombocytopenia. Regarding biomarkers, median ALP decline was 50%, median LDH decline was ‐5%, 32% of pts showed a reduction in PSA level. OSmean is at the present date about 8months, and median OS has not been achieved yet. Conclusion: Ra‐223 has a major impact on serum ALP levels, with negligible effect on PSA levels. Therefore, ALP appears to be a useful biomarker of therapy response. Haematological and non‐haematological side effects were acceptable. Stability in pain or palliative effects occurred in the majority of pts.