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Most patients with metastatic castration-resistant prostate cancer (mCRPC) are fatal once the disease progresses
.
mCRPC is driven by both activated androgen receptors and elevated intratumoral androgens; however, the current standard therapy is the treatment of a single androgen signaling mechanism
The ACIS study is a randomized, double-blind, placebo-controlled phase 3 trial conducted in 167 hospitals in 17 countries.
It aims to study the combination therapy of apalutamide and abiraterone acetate and the standard treatment of mCRPC Compared with the efficacy and safety in newly treated mCRPC patients
.
The study recruited 18-year-old mCRPC patients who had not undergone chemotherapy, and who had not been treated with androgen biosynthesis signaling inhibitors, and were receiving continuous androgen deprivation treatment.
They were randomly divided into two groups 1:1 and received oral administration.
Apalutamide (240 mg/day) + abiraterone acetate (1000 mg/day) + prednisone (5 mg*2 times/day) or placebo + abiraterone acetate + prednisone for 28 days As a course of treatment
.
The primary endpoint is progression-free survival
Radiological progression-free survival
Radiological progression-free survivalFrom October 10, 2014 to August 30, 2016, a total of 982 patients were recruited and randomly divided into two groups: 492 patients in the apalutamide group and 490 patients in the placebo group
.
After a median follow-up of 25.
After a median follow-up of 25.
Partial adverse reactions
Partial adverse reactionsThe most common grade 3-4 adverse reaction requiring emergency treatment is hypertension (apalutamide group vs placebo group: 17% vs 10%)
.
There were 195 (40%) and 181 (37%) patients in the apalutamide group and placebo group, respectively, who had serious adverse events requiring emergency treatment.
In summary, compared with standard therapies, apalutamide combined with abiraterone-prednisone can improve the radiological progression-free survival of newly treated mCRPC patients
.
Further research is needed to determine the subgroup of patients that may benefit the most from this combination therapy to further improve the treatment plan for mCRPC
Compared with standard therapy, apalutamide combined with abiraterone-prednisone can improve the radiological progression-free survival of newly treated mCRPC patients.
Original source:
Fred Saad, et al.
Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 study in this message