Niraparib With Abiraterone Acetate Plus Prednisone as First-Line Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Repair Gene Alterations: Final Analysis of the Asian Subgroup From the MAGNITUDE Study.
1/5 보강
PICO 자동 추출 (휴리스틱, conf 2/4)
유사 논문P · Population 대상 환자/모집단
35 participants with BRCA + mCRPC (all BRCA2+).
I · Intervention 중재 / 시술
추출되지 않음
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
[CONCLUSIONS] In this final exploratory analysis of the Asian subgroup, participants with BRCA + mCRPC continued to benefit from first-line treatment with niraparib + AAP in comparison to placebo + AAP, with efficacy and toxicity profiles consistent with the global study population. [TRIAL REGISTRATION] United States National Library of Medicine (https://clinicaltrials.gov); NCT03748641.
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[OBJECTIVES] Patients with homologous recombination repair gene altered (HRR+) metastatic castration-resistant prostate cancer (mCRPC) have a poor prognosis but achieved clinical benefits when treated
- 95% CI 0.13-0.83
APA
Ye D, Saad M, et al. (2026). Niraparib With Abiraterone Acetate Plus Prednisone as First-Line Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Repair Gene Alterations: Final Analysis of the Asian Subgroup From the MAGNITUDE Study.. International journal of urology : official journal of the Japanese Urological Association, 33(4), e70455. https://doi.org/10.1111/iju.70455
MLA
Ye D, et al.. "Niraparib With Abiraterone Acetate Plus Prednisone as First-Line Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Repair Gene Alterations: Final Analysis of the Asian Subgroup From the MAGNITUDE Study.." International journal of urology : official journal of the Japanese Urological Association, vol. 33, no. 4, 2026, pp. e70455.
PMID
42015879 ↗
Abstract 한글 요약
[OBJECTIVES] Patients with homologous recombination repair gene altered (HRR+) metastatic castration-resistant prostate cancer (mCRPC) have a poor prognosis but achieved clinical benefits when treated with first-line niraparib and abiraterone acetate plus prednisone (niraparib + AAP) in the MAGNITUDE trial. We report final exploratory results from MAGNITUDE for the subgroup of patients with Breast Cancer gene-positive (BRCA+) mCRPC enrolled in Asia (NCT03748641).
[METHODS] Participants with HRR + mCRPC were randomized 1:1 to treatment with niraparib + AAP or placebo + AAP. The primary endpoint of radiographic progression-free survival (rPFS) by blinded independent central review (BICR) and secondary survival endpoints were calculated for the BRCA+ Asian subgroup. Safety was assessed in the Asian HRR+ population.
[RESULTS] The Asian subgroup included 35 participants with BRCA + mCRPC (all BRCA2+). After 34.99 months of follow-up, median rPFS by BICR was 38.6 months in the niraparib + AAP group versus 8.3 months in the placebo+AAP group (hazard ratio [HR] 0.33, 95% confidence interval [CI] 0.13-0.83, nominal p-value = 0.0141). Clinically relevant benefits were also observed in time to PSA progression (HR 0.32, 95% CI 0.13-0.83), and time to cytotoxic chemotherapy (HR 0.098, 95% CI 0.01-0.68). Median overall survival was not reached in the niraparib+AAP group and was 24.0 months in the placebo+AAP group (HR 0.67, 95% CI 0.27-1.71). The safety profile of niraparib+AAP was consistent with the main study population.
[CONCLUSIONS] In this final exploratory analysis of the Asian subgroup, participants with BRCA + mCRPC continued to benefit from first-line treatment with niraparib + AAP in comparison to placebo + AAP, with efficacy and toxicity profiles consistent with the global study population.
[TRIAL REGISTRATION] United States National Library of Medicine (https://clinicaltrials.gov); NCT03748641.
[METHODS] Participants with HRR + mCRPC were randomized 1:1 to treatment with niraparib + AAP or placebo + AAP. The primary endpoint of radiographic progression-free survival (rPFS) by blinded independent central review (BICR) and secondary survival endpoints were calculated for the BRCA+ Asian subgroup. Safety was assessed in the Asian HRR+ population.
[RESULTS] The Asian subgroup included 35 participants with BRCA + mCRPC (all BRCA2+). After 34.99 months of follow-up, median rPFS by BICR was 38.6 months in the niraparib + AAP group versus 8.3 months in the placebo+AAP group (hazard ratio [HR] 0.33, 95% confidence interval [CI] 0.13-0.83, nominal p-value = 0.0141). Clinically relevant benefits were also observed in time to PSA progression (HR 0.32, 95% CI 0.13-0.83), and time to cytotoxic chemotherapy (HR 0.098, 95% CI 0.01-0.68). Median overall survival was not reached in the niraparib+AAP group and was 24.0 months in the placebo+AAP group (HR 0.67, 95% CI 0.27-1.71). The safety profile of niraparib+AAP was consistent with the main study population.
[CONCLUSIONS] In this final exploratory analysis of the Asian subgroup, participants with BRCA + mCRPC continued to benefit from first-line treatment with niraparib + AAP in comparison to placebo + AAP, with efficacy and toxicity profiles consistent with the global study population.
[TRIAL REGISTRATION] United States National Library of Medicine (https://clinicaltrials.gov); NCT03748641.
🏷️ 키워드 / MeSH 📖 같은 키워드 OA만
- Humans
- Male
- Prostatic Neoplasms
- Castration-Resistant
- Prednisone
- Aged
- Abiraterone Acetate
- Antineoplastic Combined Chemotherapy Protocols
- Middle Aged
- Piperidines
- Indazoles
- Progression-Free Survival
- Recombinational DNA Repair
- Double-Blind Method
- BRCA2 Protein
- Asia
- niraparib
- prostate cancer
- safety
- survival
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