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Pharmacologic synergy versus independent action in androgen receptor-axis-targeted agent-docetaxel triplet therapy for metastatic hormone-sensitive prostate cancer: a copula-based analysis.

Urologic oncology 2026 Vol.44(4) p. 110990

Chen W, Yoshida S, Yajima S, Sato H, Hirakawa A, Tanabe K, Fukushima H, Yasuda Y, Tanaka H, Masuda H, Fujii Y

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[BACKGROUND] Triplet therapy combining androgen deprivation therapy (ADT), docetaxel, and androgen receptor-axis-targeted agents (ARATs) has exhibited survival benefits in metastatic hormone-sensitive

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  • 95% CI 0.93-1.44

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BibTeX ↓ RIS ↓
APA Chen W, Yoshida S, et al. (2026). Pharmacologic synergy versus independent action in androgen receptor-axis-targeted agent-docetaxel triplet therapy for metastatic hormone-sensitive prostate cancer: a copula-based analysis.. Urologic oncology, 44(4), 110990. https://doi.org/10.1016/j.urolonc.2025.110990
MLA Chen W, et al.. "Pharmacologic synergy versus independent action in androgen receptor-axis-targeted agent-docetaxel triplet therapy for metastatic hormone-sensitive prostate cancer: a copula-based analysis.." Urologic oncology, vol. 44, no. 4, 2026, pp. 110990.
PMID 41570781

Abstract

[BACKGROUND] Triplet therapy combining androgen deprivation therapy (ADT), docetaxel, and androgen receptor-axis-targeted agents (ARATs) has exhibited survival benefits in metastatic hormone-sensitive prostate cancer (mHSPC). Whether these benefits originate from pharmacologic synergy or independent drug action (IDA) remains unclear.

[METHODS] Using reconstructed individual patient data from phase III trials, we applied a copula-based independent-action model to compare observed triplet outcomes with counterfactual predictions derived from docetaxel- and ARAT-based doublets. The primary analysis used weak positive dependence (θ = 0.24), with sensitivity analyses across a plausible range.

[RESULTS] The triplet, docetaxel-doublet, and ARAT-doublet cohorts comprised 138/355, 206/355, and 637/1,667 events/patients for rPFS, respectively. The observed triplet outcomes did not exceed independent-action predictions (observed/predicted Hazard ration [HR] 1.39; 95% Confidence Interval [95% CI] 1.12-1.74), with excellent concordance in curve shape (r = 0.99) and a difference of restricted mean survival time (ΔRMST) of 4.47 months favoring the prediction. Drug-matched analyses using abiraterone further reduced the discrepancy (HR 1.16; 95% CI 0.93-1.44; ΔRMST 2.93 months). Across the full plausible dependence range (θ = 0.08-0.40), findings remained consistent (HR 1.35-1.44). For overall survival, observed/predicted differences were larger (HR 1.87; 95% CI 1.61-2.17; r = 0.97; ΔRMST 7.59 months), but these results were considered exploratory due to substantial confounding from postprogression therapies.

[CONCLUSIONS] These findings did not identify any population-level benefit of triplet therapy that clearly exceeded predictions under an independent-action model, although synergistic effects at the individual-patient level cannot be excluded. These findings support selective or sequential treatment strategies to optimize the benefit-toxicity balance in appropriate patient populations.

MeSH Terms

Humans; Male; Docetaxel; Prostatic Neoplasms; Antineoplastic Combined Chemotherapy Protocols; Receptors, Androgen; Drug Synergism; Androgen Antagonists; Neoplasm Metastasis; Taxoids; Aged

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