A newer report of this study has been published: Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial (2018)
This study showed that in men with prostate cancer that has spread, giving six cycles of docetaxel chemotherapy at the same time as starting hormone therapy adds more than a year of life on average. The greatest benefit was seen in patients with a high volume of disease.
Metastatic hormone-sensitive prostate cancer, especially high-volume
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Docetaxel | 75 mg/m² | IV | Day 1 |
| Hormone therapy (ADT) | Continuous |
As in CHAARTED. Today it is usually given with a newer hormonal tablet (darolutamide or abiraterone).
Dose source:.
Metastatic hormone-sensitive prostate cancer (outside the FDA label)
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Docetaxel | 75 mg/m² | IV | Day 1, every 21 days |
| Androgen deprivation therapy (ADT) | As scheduled | Continuous |
Dose from the CHAARTED trial. In ARASENS, darolutamide 600 mg twice daily was added to ADT and docetaxel.
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
ADT (LHRH agonist or antagonist, or surgical castration) with docetaxel 75 mg/m² IV over 1 hour on day 1 every 3 weeks (21 days) for 6 cycles, with oral dexamethasone premedication 8 mg at 12, 3 and 1 hours before the infusion; daily prednisone was not required and growth factor was at the physician's discretion.
ADT (LHRH agonist or antagonist, or surgical castration) alone.
Source of the regimen details: Full text of the paper (PMC4562797) and ClinicalTrials.gov NCT00309985
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
790 men with metastatic hormone-sensitive prostate cancer who had started ADT no more than 120 days before randomisation (without evidence of progression); ECOG performance status 0 to 2 (2 only if due to cancer), neutrophils ≥1500, platelets ≥100 thousand, bilirubin ≤ upper limit of normal, ALT ≤2.5 times the upper limit, creatinine clearance ≥30 mL/min. Prior adjuvant ADT (no more than 24 months and completed at least 12 months earlier) was allowed. Stratified by disease volume; high volume = visceral metastases or 4 or more bone lesions with at least one outside the vertebral column and pelvis.
Primary endpoint: overall survival (hypothesis: a 33.3% increase in median overall survival). Secondary endpoints: time to biochemical, symptomatic or radiographic progression; PSA response.
In the combination group: grade 3 or 4 febrile neutropenia in 6.2%, grade 3 or 4 infection with neutropenia in 2.3%, and grade 3 sensory and motor neuropathy in 0.5% each.
CHAARTED (together with STAMPEDE) laid the foundation for "treatment intensification" in mHSPC and ended the era of ADT alone. Today docetaxel is used mostly as part of triplet therapy (ADT + docetaxel + abiraterone or darolutamide) in high-volume disease.
The trial was open-label; the benefit was concentrated mainly in high-volume disease (subgroup analysis); the control group is ADT alone, which is no longer standard.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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