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Título

RADIUM-223 IN METASTATIC PROSTATE CANCER. CLINICAL EXPERIENCE OF A BRAZILIAN INSTITUTION AND ITS COMPARISON TO PIVOTAL STUDY.

Introdução, Material, Método, Resultados, Discussão e Conclusões

Background: In castration-resistant prostate cancer (CRPC), the skeleton is the most common metastatic site, decreasing patients ‘quality of life and survival. Radium-223 is an alpha particles emitter which are selectively accumulated in the bone, producing a palliative anti-tumor effect on these metastases, improving overall survival and the time to first symptomatic skeletal event in these patients. Our main objective is to compare our experience with Radium-223 with ALSYMPCA trial data. Patients and Methods: This retrospective study describes the experience with radium-233 in patients with mCRPC and no known visceral involvement at an oncology reference hospital in São Paulo, Brazil. Were enrolled all the patients who received Radium-223 between January 2017 and July 2019. Results: This study involved 45 patients, of whom 33 were selected. The main age of prostate cancer diagnostic was 64 years. The most common prognostic stages were III (18%) and IV (42%). All patients had used androgen deprivation therapy (ADT), 63% chemotherapy and 60% was submitted to bone metastases radiotherapy before Radium-223. Most of the patients (57%) received 6 cycles of Radium-223, like ALSYMPCA study (63%), and the main cause of discontinuation before it was bone disease progression (43%). Bone pain control was achieved in 72% and 36% needed bone metastases radiotherapy after Radium-223. Twenty one percent progressed bone disease during Radium-223. Other 18% progressed after the treatment, in which the median time to first skeletal symptomatic event was 6 months, less than in pivotal trial (15,6 months). Thirty percent did not progress bone disease and 27% died during the treatment or less than 30 days after the cycles, none of them related to Radium-223. A 30% or more reduction in prostate-specific antigen (PSA) and alkaline phosphatase (AP) blood levels after 12 weeks of Radium-223 was achieved in 10% and 15%, respectively, less than in reference study (16 and 37%, respectively). The main adverse events were anemia (70%; 9% grade 3), fatigue (51%) and diarrhea (39%), more than in ALSYMPCA trial (31%, 26% and 25%, respectively). In both, 36% had nausea. Conclusion: Radium-223 showed a clinical benefit, reducing bone metastases pain, and was well tolerated in patients with mCRPC. We observed less median time to first skeletal symptomatic event, more adverse events and less time to increased PSA and AP, in comparison to ALSYMPCA trial.

Palavras Chave

Prostate cancer. Radium-223. Bone metastases.