In this large study, men with advanced prostate cancer that no longer responded to hormone therapy were treated with one of two drugs: docetaxel or mitoxantrone (both with prednisone). Docetaxel given once every three weeks helped patients live about 2.4 months longer on average than mitoxantrone, and also did better at improving pain, PSA levels and quality of life. On the other hand, side effects were more common with docetaxel, so the treatment should be chosen with your treating doctor.
mCRPC; in TAX327, Karnofsky performance status 60 or higher
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Docetaxel | 75 mg/m² | IV, 1-h infusion | Day 1, every 21 days |
| Prednisone | 5 mg twice daily | Oral | Continuous |
| ADT (GnRH agonist or antagonist, or prior orchiectomy) | Per formulation | — | Continuous |
Per the FDA label and the trial.
Metastatic castration-resistant prostate cancer
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Docetaxel | 75 mg/m² | IV over 1 hour | Day 1 |
| Prednisone | 5 mg twice a day | Oral | Daily |
As in TAX 327.
Dose source:.
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.
Mitoxantrone 12 mg/m² IV every 3 weeks for 10 cycles, with prednisone 5 mg orally twice daily continuously.
Docetaxel 75 mg/m² IV over 1 hour every 3 weeks for 10 cycles, with prednisone 5 mg orally twice daily continuously. Premedication per the FDA label: oral dexamethasone 8 mg at 12, 3 and 1 hours before the infusion.
Docetaxel 30 mg/m² IV weekly for 5 of every 6 weeks for 5 cycles, with prednisone 5 mg twice daily.
Source of the regimen details: FDA label for docetaxel (DailyMed, Clinical Studies section, TAX327) and the abstract of the paper
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.
1006 men with metastatic hormone-refractory prostate cancer and a Karnofsky performance status of 60 or more (March 2000 to June 2002).
Primary endpoint: overall survival. Secondary endpoints: pain, prostate-specific antigen (PSA) level and quality of life. All statistical comparisons were against mitoxantrone.
According to the FDA label (docetaxel every 3 weeks, 332 patients, versus mitoxantrone, 335 patients): grade 3-4 neutropenia 32% versus 22%; febrile neutropenia 3% versus 2%; infection 32% (grade 3-4: 6%) versus 20% (4%); sensory neuropathy 30% (grade 3-4: 2%) versus 7%; treatment-related fluid retention 24% versus 5%; alopecia 65% versus 13%. In the abstract, adverse events were more common in the docetaxel groups.
Based on this study, docetaxel every three weeks with prednisone showed better survival than mitoxantrone and can be an effective option in metastatic hormone-refractory prostate cancer. The weekly docetaxel schedule did not show a significant survival advantage. The current status of this regimen in guidelines and drug approvals should be checked separately, as the abstract does not mention them.
The abstract does not mention the study's limitations. Adverse events were more common in the docetaxel groups, and details should be checked in the full text.
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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