LATITUDE Trial: Survival Benefit With Combination Therapy for Prostate Cancer
Posted: Wednesday, March 20, 2019
No surprises emerged from the final analysis of the phase III LATITUDE study in patients with newly diagnosed high-risk metastatic castration-naive prostate cancer, presented at the 2019 Genitourinary Cancers Symposium in San Francisco (Abstract 141) and published in the Journal of Clinical Oncology. As in the first two interim analyses, the latest results indicate that abiraterone acetate + prednisone (AA+P) added to androgen-deprivation therapy (ADT) offers a survival advantage and “reinforce” the combination therapy as a standard of care in this patient population.
Just about 1,200 patients were randomly assigned 1:1 to treatment with either AA+P and ADT or placebo and ADT, reported Karim Fizazi, MD, PhD, of Gustave Roussy Cancer Campus, Paris-Sud University, Villejuif, France, and colleagues. After a median follow-up of 51.8 months, 275 patients (46%) in the AA+P group versus 343 patients (57%) in the placebo group had died (overall survival: hazard ratio = 0.7; 95% confidence interval = 0.6–0.8; P < .0001).
Grade 3 or 4 adverse effects did occur more often in the AA+P group. Those of special interest, noted by Dr. Fizazi and his team, included hypertension (21.9% with AA+P vs. 10.5% with placebo), hypokalemia (11.7% vs. 1.7%), and hepatotoxicity (8.9% vs. 3.5%). Nonetheless, these adverse effects were similar to what was expected given the two interim analyses.
Also, reported the investigators, the other co-primary endpoint in addition to overall survival, radiographic progression-free survival, “showed a significant benefit” with the combination therapy versus placebo.
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.