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

Fukasawa, Satoshi; Suzuki, Hiroyoshi; Kawaguchi, Kazushiro; Noguchi, Hidehisa; Enjo, Kentaro; Tran, Namphuong; Todd, Mary B.; Fizazi, Karim; Matsubara, Nobuaki

doi:10.1093/jjco/hyy129

Cited by 25 publications

(55 citation statements)

References 40 publications

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“…In particular, with respect to response to initial ADT, our cohort showed longer PFS (12.3 months) than that of the CHAARTED study cohort (8.6 months) 7,13 . Due to the high survival rate, no OS benefit was discernable in the Japanese subgroup analysis of the LATITUDE study 12 . A racial difference may thus exist in response to hormonal therapy.…”

Section: Discussionmentioning

confidence: 65%

“…In addition, a meta‐analysis revealed that the administration of docetaxel and abiraterone acetate combination with ADT did not improve OS compared with ADT alone in patients >70 years old 16 . Patients with de novo metastatic PCa tend to be relatively old at diagnosis (median age was 73 years in our study and 70 years in a Japanese prospective cohort study) 12 . Considering these issues, selection should be more discussed to those patients requiring potent upfront treatment in mCNPC.…”

Section: Discussionmentioning

confidence: 69%

“…In particular, a favorable response to ADT treatment has been reported in Asian populations compared with other ethnic groups 3,10,11 . No significant improvement in overall survival (OS) was observed from a Japanese subgroup analysis in the LATITUDE study 12 . In addition, combined androgen blockade (CAB) therapy using bicalutamide as an antiandrogen agent and testosterone‐suppressing therapy (orchiectomy or luteinizing hormone‐releasing hormone agonist/antagonist) remains the standard treatment for mCNPC in Japan.…”

Section: Introductionmentioning

confidence: 99%

“…3,10,11 No significant improvement in overall survival (OS) was observed from a Japanese subgroup analysis in the LATITUDE study. 12 In addition, combined androgen blockade (CAB) therapy using bicalutamide as an antiandrogen agent and testosterone-suppressing therapy (orchiectomy or luteinizing hormone-releasing hormone agonist/antagonist) remains the standard treatment for mCNPC in Japan. Notably, the criteria for high tumor burden with respect to the number of bone metastases differed between CHAARTED (≥4) and LATITUDE (≥3) criteria, and the legitimacy of these thresholds has not been fully validated.…”

Section: Introductionmentioning

confidence: 99%

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How many bone metastases may be defined as high‐volume metastatic prostate cancer in Asians: A retrospective multicenter cohort study

et al. 2020

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Background Recent landmark randomized trials (CHAARTED and LATITUDE studies) have highlighted potent upfront therapy for “high‐volume” and “high‐risk” metastatic castration‐naïve prostate cancer (mCNPC). However, treatment response shows racial differences. We aimed to propose a novel definition for “high‐volume” prostate cancer in Asians. Methods We retrospectively pursued 426 patients with de novo mCNPC from multiple institutions between 1999 and 2017. All patients received androgen deprivation therapy alone as initial treatment. We evaluated the number of bone metastases at diagnosis to clarify the clinical significance for progression‐free survival and overall survival (OS). Statistical analyses were conducted using the Mann‐Whitney U test, Cox proportional hazard models, and Kaplan‐Meier methods. Results Median age and prostate‐specific antigen level were 73 years and 266.2 ng/ml, respectively. Median OS was 55.5 months in patients who met the CHAARTED high criteria (vs 33.1 months in the trial). We evaluated 5 thresholds in the number of bone metastases (≥4, ≥6, ≥11, ≥16, and ≥21) to investigate the prognostic values. Patients with ≥11 bone metastases showed the highest HR for OS (2.766). Patients with 11 to 20 bone metastases had a significantly shorter OS than those with ≤10 metastases (P = .0001). We, therefore, proposed modified CHAARTED and LATITUDE high criteria (extending bone metastases ≥11). In multivariate analysis, the modified criteria were the only independent prognostic factors for OS (P = .0272 and P = .042, respectively). Conversely, no significant differences in OS were seen between patients with 1 to 3 bone metastases and 4 to 10 (P = .7513). Conclusion Our exploratory study suggested ≥11 bone metastases as a suitable definition for “high‐volume” prostate cancer in Asians. A larger, prospective study is warranted to verify our findings.

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Section: Discussionmentioning

confidence: 65%

Section: Discussionmentioning

confidence: 69%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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How many bone metastases may be defined as high‐volume metastatic prostate cancer in Asians: A retrospective multicenter cohort study

et al. 2020

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“…Some retrospective studies have found greater OS in Japanese men with de novo mHSPC, compared with other races. Recently, a subgroup analysis of the LATITUDE trial in Japanese patients also showed that the progression‐free survival in the Japanese subgroup was superior to that of the overall population, in both the androgen deprivation therapy plus abiraterone and androgen deprivation therapy only arms . Differences in ethnicities and treatment environments might influence hormonal therapy treatment outcomes; however, the precise mechanisms that affect these differences remain unknown, and further genetic analyses are required to elucidate these issues in the future.…”

mentioning

confidence: 99%

Editorial Comment to Prognostic significance of risk stratification in CHAARTED and LATITUDE studies among Japanese men with de novo metastatic prostate cancer

Inoue

2018

Int J of Urology

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Comparison of Systemic Treatments for Metastatic Castration-Sensitive Prostate Cancer

et al. 2021

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IMPORTANCE Multiple systemic treatments are available for metastatic castration-sensitive prostate cancer (mCSPC), with unclear comparative effectiveness and safety and widely varied costs.OBJECTIVE To compare the effectiveness and safety determined in randomized clinical trials of systemic treatments for mCSPC. DATA SOURCES Bibliographic databases (MEDLINE, Embase, and Cochrane Central), regulatory documents (US Food and Drug Administration and European Medicines Agency), and trial registries (ClinicalTrials.gov and European Union clinical trials register) were searched from inception through November 5, 2019.STUDY SELECTION, DATA EXTRACTION, AND SYNTHESIS Eligible studies were randomized clinical trials evaluating the addition of docetaxel, abiraterone acetate, apalutamide, or enzalutamide to androgen-deprivation therapy (ADT) for treatment of mCSPC. Two investigators independently performed screening. Discrepancies were resolved through consensus. A Cochrane risk-of-bias tool was used to assess trial quality. Relative effects of competing treatments were assessed by bayesian network meta-analysis and survival models. The Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline was used. MAIN OUTCOMES AND MEASURESOverall survival, radiographic progression-free survival, and serious adverse events (SAEs).RESULTS Seven trials with 7287 patients comparing 6 treatments (abiraterone acetate, apalutamide, docetaxel, enzalutamide, standard nonsteroidal antiandrogen, and placebo/no treatment) were identified. Ordered from the most to the least effective determined by results of clinical trials, treatments associated with improved overall survival when added to ADT included abiraterone acetate (hazard ratio [HR], 0.61; 95% credible interval [CI], 0.54-0.70), apalutamide (HR, 0.67; 95% CI, 0.51-0.89), and docetaxel (HR, 0.79; 95% CI, 0.71-0.89); treatments associated with improved radiographic progression-free survival when added to ADT included enzalutamide (HR, 0.39; 95% CI, 0.30-0.50), apalutamide (HR, 0.48; 95% CI, 0.39-0.60), abiraterone acetate (HR, 0.51; 95% CI, 0.45-0.58), and docetaxel (HR, 0.67; 95% CI 0.60-0.74). Docetaxel was associated with substantially increased SAEs (odds ratio, 23.72; 95% CI,), abiraterone acetate with slightly increased SAEs (odds ratio, 1.42; 95% CI, 1.10-1.83), and other treatments with no significant increase in SAEs. Risk of bias was noted for 4 trials with open-label design, 3 trials with missing data, and 2 trials with potential unprespecified analyses. CONCLUSIONS AND RELEVANCEIn this network meta-analysis, as add-on treatments to ADT, abiraterone acetate and apalutamide may provide the largest overall survival benefits with relatively low SAE risks. Although enzalutamide may improve radiographic progression-free survival to the greatest extent, longer follow-up is needed to examine the overall survival benefits associated with enzalutamide.

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

Abstract: Abiraterone acetate plus prednisone in addition to androgen-deprivation therapy (ADT) was efficacious versus ADT alone in Japanese men with metastatic hormone-naïve prostate cancer. No new safety concerns were identified.

Cited by 25 publications

References 40 publications

How many bone metastases may be defined as high‐volume metastatic prostate cancer in Asians: A retrospective multicenter cohort study

How many bone metastases may be defined as high‐volume metastatic prostate cancer in Asians: A retrospective multicenter cohort study

Editorial Comment to Prognostic significance of risk stratification in CHAARTED and LATITUDE studies among Japanese men with de novo metastatic prostate cancer

Comparison of Systemic Treatments for Metastatic Castration-Sensitive Prostate Cancer

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