Background
CHAARTED (Androgen Ablation With or Without Chemotherapy in Metastatic Prostate Cancer). Phase III RCT; 790 men with metastatic hormone-sensitive prostate cancer, stratified by high- versus low-volume disease.
Interventions and follow up
Arm A: Docetaxel 75mg/m2 q3wk x6 cycles + ADT.
Arm B: ADT alone.
Primary endpoint: Overall survival.
mFollow up: 28.9mo.
Arm B: ADT alone.
Primary endpoint: Overall survival.
mFollow up: 28.9mo.
Results
mOS: 57.6mo vs 44.0mo, arm A vs B; HR 0.61, 95%CI 0.47–0.80; P<.001.
Time to castration-resistant disease: 20.2mo vs 11.7mo, arm A vs B; HR 0.61, 95%CI 0.51–0.72; P<.001.
Time to clinical progression: 33.0mo vs 19.8mo, arm A vs B; HR 0.61, 95%CI 0.50–0.75; P<.001.
Time to castration-resistant disease: 20.2mo vs 11.7mo, arm A vs B; HR 0.61, 95%CI 0.51–0.72; P<.001.
Time to clinical progression: 33.0mo vs 19.8mo, arm A vs B; HR 0.61, 95%CI 0.50–0.75; P<.001.
Adverse events
Overall: Grade ≥3 events 29.6% in the docetaxel arm.
Hematologic/infectious: Neutropenia, febrile neutropenia, and infection with neutropenia were the principal grade ≥3 toxicities; fatigue also common with docetaxel.
Hematologic/infectious: Neutropenia, febrile neutropenia, and infection with neutropenia were the principal grade ≥3 toxicities; fatigue also common with docetaxel.
Conclusions
Adding docetaxel to ADT significantly prolonged overall survival in metastatic hormone-sensitive prostate cancer, with the greatest benefit observed in high-volume disease.
Key Limitations
Survival benefit driven by high-volume subgroup; updated/long-term analyses suggested attenuated benefit in low-volume disease. Predates routine ADT + androgen-receptor pathway inhibitor and triplet therapy.
Clinical Context
CHAARTED, with STAMPEDE, established docetaxel intensification of ADT as a standard for metastatic hormone-sensitive prostate cancer (particularly high volume) in ASCO/ESMO guidelines, and forms the chemotherapy backbone of modern triplet regimens.