Efficacy and safety of abiraterone acetate plus prednisone in Japanese patients with newly diagnosed, metastatic hormone-naive prostate cancer: final subgroup analysis of LATITUDE, a randomized, double-blind, placebo-controlled, phase 3 study

Autor: Suneel Mundle, Namphuong Tran, Toshitaka Shin, Kazuhiro Shibayama, Satoshi Fukasawa, Nobuaki Matsubara, Hiroyoshi Suzuki, Noriyuki Ohtake, Sumiko Kitani, Katsuyoshi Hashine, Karim Fizazi
Rok vydání: 2020
Předmět:
Male
0301 basic medicine
Cancer Research
medicine.medical_specialty
Population
Abiraterone Acetate
Antineoplastic Agents
Subgroup analysis
Placebo
Gastroenterology
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Double-Blind Method
Japan
Prednisone
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
AcademicSubjects/MED00300
metastatic hormone-naïve prostate cancer
Radiology
Nuclear Medicine and imaging
Progression-free survival
Neoplasm Metastasis
education
Aged
education.field_of_study
business.industry
Hazard ratio
Abiraterone acetate
Prostatic Neoplasms
General Medicine
Middle Aged
Interim analysis
Survival Analysis
030104 developmental biology
Oncology
chemistry
030220 oncology & carcinogenesis
Original Article
business
medicine.drug
Zdroj: Japanese Journal of Clinical Oncology
ISSN: 1465-3621
DOI: 10.1093/jjco/hyaa030
Popis: Background LATITUDE was a randomized, double-blind, international and phase 3 study of abiraterone acetate plus prednisone in patients with high-risk metastatic hormone-naïve prostate cancer. In the first interim analysis of LATITUDE (clinical cutoff date: 31 October 2016), significant prolongation in overall survival and radiographic progression-free survival (co-primary endpoints) was observed when compared with placebo. The results of the Japanese subgroup analysis of LATITUDE first interim analysis were consistent with those of the overall population. In this study, overall survival and safety results from the final analysis of the Japanese subgroup of the LATITUDE study are presented (clinical cutoff date: 15 August 2018). Methods Abiraterone acetate (1000 mg/day) and prednisone (5 mg/day) were administered orally in the abiraterone acetate plus prednisone group, and matching placebos in the placebo group. Results Of the 1199 patients included in LATITUDE, 70 constituted the Japanese subgroup (abiraterone acetate plus prednisone: n = 35, placebo: n = 35). Following a median (range) follow-up of 56.6 (2.5, 64.2) months, the median overall survival was not reached in both the treatment arms of the Japanese subgroup (hazard ratio: 0.61; 95% confidence interval: 0.27–1.42; nominal P = 0.2502). A total of 23 deaths (abiraterone acetate plus prednisone: 9 [25.7%], placebo group: 14 [40.0%]) were reported in Japanese subgroup. Grade 3/4 adverse events were reported in 24 (68.6%) and 9 (25.7%) patients in the abiraterone acetate plus prednisone and placebo groups, respectively. Conclusions In this Japanese subgroup analysis, addition of abiraterone acetate plus prednisone to androgen-deprivation therapy demonstrated favorable efficacy and safety outcomes in patients with newly diagnosed, high-risk metastatic hormone-naïve prostate cancer. Survival benefits observed in the Japanese subgroup first interim analysis were sustained long-term and were consistent with the overall population.
In this Japanese subpopulation analysis of LATITUDE, addition of abiraterone acetate plus prednisone to androgen-deprivation therapy demonstrated favorable long-term efficacy and safety in patients with high-risk metastatic hormone-naïve prostate cancer.
Databáze: OpenAIRE
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