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Sandy Srinivas, MD
Sandy Srinivas, MD
Posted: Monday, November 7, 2022
Treatment with radium-223 has shown activity and an acceptable safety profile in patients with metastatic castration-resistant prostate cancer and asymptomatic bone metastases whose disease had progressed on novel hormonal therapies, according to findings presented in the European Journal of Cancer. The patients in the phase IIa EXCAAPE trial had previously received abiraterone acetate or enzalutamide, noted Joan Carles, MD, PhD, of Vall d’Hebron University Hospital, Barcelona, and colleagues.
“We aim for our findings to establish the use of radium-223 in the patient population considered here and to drive development of further studies,” the authors reported.
In this multicenter, single-arm, open-label, noncontrolled trial, the authors enrolled 52 patients with metastatic castration-resistant prostate cancer and asymptomatic bone metastases whose disease had progressed on first-line treatment with abiraterone acetate or enzalutamide. Patients received up to one cycle every 4 weeks for no more than six cycles of intravenous radium-223 at 55 kBq/kg of body weight.
After a median follow-up of 6.6 months, patients with androgen receptor splice variant 7 (AR-V7)-negative circulating tumor cells (CTCs) had longer radiographic progression-free survival rates (5.5 months) compared with those with AR-V7–positive CTCs (2.2 months). This difference was not statistically significant (P = .398). Median overall survival was 14.8 months, and overall survival was significantly longer for patients with AR-V7–CTCs (14.8 months) compared with those with AR-V7–positive CTCs (3.5 months).
There were 46 incidences of adverse events, with serious adverse events reported in 11 patients. The most common adverse events were asthenia (26.9%) and arthralgia (25.0%). Treatment was discontinued by 2 patients because of adverse events, and disease progression or death occurred in 31 of 52 patients (59.6%). No treatment-related deaths were reported.
Disclosure: For full disclosures of the study authors, visit ejcancer.com.
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