Abiraterone plus ADT boosts prostate cancer survival

The investigators enrolled 1,917 patients with either newly diagnosed node-positive or metastatic prostate cancer, high-risk locally advanced disease, or relapsed, high-risk disease following radical surgery or radiotherapy.

In all, 95% of patients had newly diagnosed disease; 52% had metastatic disease, 20% had node-positive or node-indeterminate nonmetastatic disease, and 28% had node-negative nonmetastatic disease.

After a median follow-up of 40 months, there had been 184 deaths among the 960 patients assigned to received ADT plus abiraterone and prednisolone, compared with 262 deaths among 957 patients assigned to ADT alone. The respective 3-year survival rates were 83% vs. 76%, translating into a HR of 0.63 (P less than .001) favoring abiraterone. The respective hazard ratios for abiraterone in patients with metastatic and nonmetastatic disease were 0.75 and 0.61, respectively.

Failure-free survival (no radiologic, clinical, or prostate-specific antigen progression or prostate cancer death) also favored abiraterone, with a HR of 0.29, compared with ADT alone (P less than .001). The respective hazard ratios for patients with nonmetastatic disease and metastatic disease were 0.21 and 0.31, respectively.

Grade 3 or greater adverse events occurred in 47% of patients on abiraterone, and in 33% of patients treated with ADT alone. There nine deaths on treatment in the abiraterone group, including two cases of pneumonia (one with sepsis), two strokes, and one case each of dyspnea, lower respiratory tract infection, liver failure, pulmonary hemorrhage, and chest infections.

There were three deaths in the ADT alone group, two from myocardial infarctions and one from bronchopneumonia.

LATITUDE was supported by Janssen Research and Development. Dr. Fizazi reported having no relevant conflicts of interest. Multiple coauthors reported personal fees or other support from Janssen and other companies. STAMPEDE was supported by Cancer Research UK, Medical Research Council, Astellas Pharma, Clovis Oncology, Janssen, Novartis, Pfizer, and Sanofi-Aventis. Lead author Nicholas D. James, PhD, reports receiving support, fees, grants and/or other considerations from Astellas Pharma, Novartis, Pfizer, Clovis Oncology, and Sanofi-Aventis. Multiple coauthors reported similar relationships with various entities.