Posted on August 9th, 2013 by
Xofigo® (radium-223) significantly improved overall survival in men with metastatic, hormone-refractory prostate cancer that has spread to bones (but not other organs), according to the results of a study published in the New England Journal of Medicine
Prostate cancer is a hormonally sensitive disease that can often be controlled for long periods with androgen-deprivation therapy (ADT). When prostate cancer stops responding to this treatment, it is referred to as hormone-refractory prostate cancer. Metastatic hormone-refractory prostate cancer is a challenging form of the disease to treat because the cancer has spread to distant sites in the body and does not respond to treatment with standard hormonal therapy.
Xofigo is a radiopharmaceutical agent that binds with minerals in the bone to deliver radiation directly to bone tumors, thereby limiting the damage to the surrounding normal tissues. The U.S. Food and Drug Administration (FDA) approved the drug in May 2013 after a trial known as Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) was stopped early after an interim analysis showed that treatment with Xofigo significantly improved survival, compared with placebo.
Now the updated results from the phase 3, randomized, double-blind, placebo-controlled study have confirmed the advantage. Men in the study were randomly assigned to receive Xofigo or placebo—six injections administered four weeks apart. The interim analysis involved 809 patients and showed that Xofigo significantly improved overall survival—men who received Xofigo lived a median of 14 months, compared to a median of 11.2 months for the men in the placebo group. The updated analysis includes 921 men and confirmed the survival benefit—median overall survival in the Xofigo group was 14.9 months compared to 11.3 months in the placebo group.
Adverse events were consistently lower in the Xofigo group than in the placebo group and there was no clinically meaningful difference in the frequency of grade 3/4 adverse events between the Xofigo and placebo groups. Quality of life was better in the Xofigo group.
The researchers concluded that Xofigo improves overall survival in men with metastatic, hormone-refractory prostate cancer with spread to bones.
Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. New England Journal of Medicine. 2013; 369:213-223.
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