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Re-treatment with radium-223: first experience from an international, open-label, phase I/II study in patients with castration-resistant prostate cancer and bone metastases.


ABSTRACT: Background:Six radium-223 injections at 4-week intervals is indicated for patients with castration-resistant prostate cancer and symptomatic bone metastases. However, patients usually develop disease progression after initial treatment. This prospective phase I/II study assessed re-treatment safety and efficacy of up to six additional radium-223 injections. Patients and methods:Patients had castration-resistant prostate cancer and bone metastases and six initial radium-223 injections with no on-treatment bone progression; all had subsequent radiologic or clinical progression. Concomitant agents were allowed at investigator discretion, excluding chemotherapy and initiation of new abiraterone or enzalutamide. The primary endpoint was safety; additional exploratory endpoints included time to radiographic bone progression, time to total alkaline phosphatase and prostate-specific antigen progression, radiographic progression-free survival, overall survival, time to first symptomatic skeletal event (SSE), SSE-free survival, and time to pain progression. Results:Among 44 patients, 29 (66%) received all six re-treatment injections. Median time from end of initial radium-223 treatment was 6?months. Forty-one (93%) reported??1 treatment-emergent adverse event. No grade 4-5 hematologic treatment-emergent adverse events occurred. Only one (2%) patient had radiographic bone progression; eight (18%) had radiographic soft tissue tumor progression (three lymph node and five visceral metastases). Median times to total alkaline phosphatase and prostate-specific antigen progression were not reached and 2.2?months, respectively. Median radiographic progression-free survival was 9.9?months (12.8-month maximum follow-up). Five (11%) patients died and eight (18%) experienced first SSEs. Median overall survival, time to first SSE, and SSE-free survival were not reached. Five (14%) of 36 evaluable patients (baseline worst pain score??7) had pain progression. After 2?years of follow-up, 28 (64%) patients died, and the median overall survival was 24.4?months. Conclusions:Re-treatment with a second course of six radium-223 injections after disease progression is well tolerated, with minimal hematologic toxicity and low radiographic bone progression rates in this small study with limited follow-up. Favorable safety and early effects on disease progression indicate that radium-223 re-treatment is feasible and warrants further evaluation in larger prospective trials.

SUBMITTER: Sartor O 

PROVIDER: S-EPMC5834059 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Re-treatment with radium-223: first experience from an international, open-label, phase I/II study in patients with castration-resistant prostate cancer and bone metastases.

Sartor O O   Heinrich D D   Mariados N N   Méndez Vidal M J MJ   Keizman D D   Thellenberg Karlsson C C   Peer A A   Procopio G G   Frank S J SJ   Pulkkanen K K   Rosenbaum E E   Severi S S   Trigo Perez J M JM   Wagner V V   Li R R   Nordquist L T LT  

Annals of oncology : official journal of the European Society for Medical Oncology 20171001 10


<h4>Background</h4>Six radium-223 injections at 4-week intervals is indicated for patients with castration-resistant prostate cancer and symptomatic bone metastases. However, patients usually develop disease progression after initial treatment. This prospective phase I/II study assessed re-treatment safety and efficacy of up to six additional radium-223 injections.<h4>Patients and methods</h4>Patients had castration-resistant prostate cancer and bone metastases and six initial radium-223 injecti  ...[more]

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