MONDAY, Sept. 27, 2021 (HealthDay News) — For patients with high-risk nonmetastatic (M0) prostate cancer, abiraterone acetate plus prednisone (AAP) added to androgen deprivation therapy (ADT) improves metastasis-free survival, while standard of care (SOC) plus abiraterone improves overall survival for men with de novo metastatic castration-sensitive prostate cancer (mCSPC), according to two studies presented at the annual meeting of the European Society for Medical Oncology, held virtually from Sept. 16 to 21.

In the STAMPEDE study, Gerhardt Attard, M.D., Ph.D., from the University College London Cancer Institute, and colleagues randomly assigned prostate cancer patients with M0 node-positive or high-risk node-negative in a 1:1 ratio to receive ADT versus ADT with AAP or ADT versus ADT with AAP and enzalutamide (ENZ). Data were included for 1,974 patients at 113 sites who were randomly assigned to ADT +/− AAP (914 patients) and ADT +/− AAP + ENZ (1,060 patients). The researchers found that metastasis-free survival and survival improved with AAP-based therapy (hazard ratios, 0.53 and 0.60, respectively). Six-year metastasis-free survival improved from 69 to 82 percent, and six-year overall survival improved from 77 to 86 percent.

In the PEACE-1 study, Karim Fizazi, M.D., Ph.D., from the Institute Gustave Roussy in Villejuif, France, and colleagues randomly assigned 1,173 men with de novo mCSPC to SOC, SOC + abiraterone, SOC + radiation to the primary tumor (RXT), or SOC + abiraterone + RXT. Patients were followed for a median of 4.4 years. The researchers found that in the overall population and in the population treated with ADT + docetaxel, overall survival was improved with abiraterone (hazard ratios, 0.83 and 0.75, respectively).

“PEACE-1 is the first trial to establish that triplet treatment should be offered to these men, especially those with the most aggressive cancers,” Fizazi said in a statement.

Several authors from both studies disclosed financial ties to pharmaceutical companies, including Janssen, which manufactures abiraterone acetate and provided funding for the studies.

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