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4CPS-181 Triplet versus doublet therapies in the treatment of de novo metastatic hormone-sensitive prostate cancer according to tumour burden

ejhpharm · 2026-03-18 · canonical JSON source

19 visible annotations · policy: published · automated confidence ≥ 75.00%

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Background and Importance Triplet therapies combining darolutamide (ARASENS) or abiraterone (PEACE-1) with docetaxel and androgen deprivation therapy (ADT) have shown improved survival versus doublet therapies in metastatic hormone-sensitive prostate cancer (mHSPC), particularly in de novo cases. However, subgroup analyses showed survival benefit mainly in patients with high tumour burden (CHAARTED criteria: ≥4 bone metastases, ≥1 outside the axial skeleton or visceral metastases), with no statistical differences compared to low tumour burden.Aim and Objectives To compare the effectiveness of triplet therapies versus doublet therapies in de novo mHSPC, both overall and in high and low tumour burden subgroups (CHAARTED criteria).Material and Methods We conducted a retrospective, observational, multicentre study at two tertiary hospitals (September 2015–September 2025). Patients with de novo mHSPC were included. Baseline variables included age, tumour burden, Gleason score, ECOG status, PSA, and treatment. Progression-free survival (PFS) and overall survival (OS) were analysed using log-rank tests and Cox regression for subgroup analyses (SPSS ).Results 114 patients were included: 74 received doublet therapies and 40 triplet therapies. Baseline characteristics were: age of 71 (65–78) vs 65 (59–71) years (p=0,041); high tumour burden in 69% vs 70% (p=0.91); Gleason ≥8 in 63% vs 79% (p=0.086); ECOG ≥2 in 12% vs 0% (p=0.025); baseline PSA of 73 (31-261) vs 48 (17-133) ng/mL (p=0.97). Among triplets, 73% received abiraterone and 27% darolutamide. Among doublets, 32% received abiraterone, 31% apalutamide, 26% enzalutamide, and 11% docetaxel. Median PFS and OS were 32 and 50 months, respectively, in the doublet group and were not reached in the triplet group. No significant differences were observed in OS (p=0.658) or PFS (p=0.285) between groups. Cox regression revealed no differences between high and low-burden subgroups (OS p=0.52; PFS p=0.277).Conclusion and Relevance In this cohort, no significant differences in PFS or OS were observed between triplet and doublet therapies, nor between high and low-burden subgroups. Therefore the benefit of triplet therapy in low-burden disease cannot be excluded. However, limited follow-up among triplet-treated patients is the main study limitation. Longer-term observational studies are warranted to further evaluate this hypothesis.Conflict of Interest No conflict of interest