What is the recommended administration protocol for Docetaxel (generic name: Docetaxel)?

Docetaxel Administration Protocol

Docetaxel should be administered as a 1-hour intravenous infusion at doses ranging from 60-100 mg/m² every 3 weeks, with the specific dose determined by the cancer type, treatment setting, and patient risk factors. 1

Standard Dosing by Indication

Breast Cancer

• Metastatic/locally advanced after prior chemotherapy: 60-100 mg/m² IV over 1 hour every 3 weeks 1
• Adjuvant node-positive disease: 75 mg/m² IV administered 1 hour after doxorubicin 50 mg/m² and cyclophosphamide 500 mg/m² every 3 weeks for 6 courses 1
• Prophylactic G-CSF may be used to mitigate hematological toxicity in the adjuvant setting 1

Non-Small Cell Lung Cancer

• After platinum failure (monotherapy): 75 mg/m² IV over 1 hour every 3 weeks 1
• Chemotherapy-naive (combination): 75 mg/m² IV over 1 hour followed immediately by cisplatin 75 mg/m² over 30-60 minutes every 3 weeks 1
• Critical warning: 100 mg/m² in previously treated patients is associated with increased hematologic toxicity, infection, and treatment-related mortality 1

Prostate Cancer (Metastatic Castration-Resistant)

• Standard regimen: 75 mg/m² IV over 1 hour every 3 weeks 1
• Must be combined with prednisone 5 mg orally twice daily continuously 1, 2
• Six doses administered every 3 weeks is the appropriate regimen 2

Gastric Adenocarcinoma

• Combination regimen: 75 mg/m² IV over 1 hour on day 1, followed by cisplatin 75 mg/m² over 1-3 hours, followed by fluorouracil 750 mg/m²/day as continuous infusion for 5 days 1
• Repeat every 3 weeks 1
• Premedication with antiemetics and appropriate hydration required 1

Head and Neck Cancer (Induction)

• TAX323/TAX324 regimen: 75 mg/m² IV over 1 hour followed by cisplatin 75 mg/m² over 1 hour on day 1, then fluorouracil 750 mg/m²/day continuous infusion for 5 days 1
• Administer every 3 weeks for 4 cycles, followed by radiotherapy 1
• Prophylactic antibiotics required for all patients 1

Ovarian Cancer (Alternative to Paclitaxel)

• Standard regimen: 60-75 mg/m² IV over 1 hour followed by carboplatin AUC 5-6 IV over 1 hour on day 1, every 3 weeks for 6 cycles 2
• This regimen is particularly useful for patients at high risk for neuropathy (e.g., diabetics) 2

Alternative Weekly Dosing Schedule

Weekly docetaxel is an option for patients where myelosuppression risk is unacceptable, including elderly patients, those with poor performance status, or heavily pretreated patients 3, 4:

• Dose: 30-40 mg/m² IV weekly for 6 of 8 weeks, or 40 mg/m² weekly for 6 weeks followed by 2-week rest 2, 4
• Advantages: Significantly less myelotoxic than 3-weekly dosing 3, 4
• Disadvantages: Increased cumulative hyperlacrimation, skin/nail toxicity, and fatigue that negatively affects quality of life 3, 4
• Efficacy: Comparable to 3-weekly dosing across disease types 3

Critical Administration Requirements

Facility and Monitoring

• Must administer in a facility equipped to manage anaphylaxis 1
• Hypersensitivity reactions require immediate discontinuation and appropriate therapy 1

Premedication Protocol

• Dexamethasone premedication is mandatory to prevent fluid retention and hypersensitivity reactions 1
• Despite premedication, severe fluid retention occurred in 6.5% of patients, characterized by poorly tolerated peripheral edema, pleural effusion, dyspnea at rest, cardiac tamponade, or pronounced ascites 1

Pharmacokinetics

• Infusion duration: 1 hour for most indications (3-hour infusion used in some paclitaxel comparisons but not standard) 5
• Disposition: Three-compartment model with terminal half-life of 12.2 hours 5
• Clearance: Mean 22 L/h/m² via hepatic CYP3A4 metabolism and biliary excretion 5
• Renal excretion: Minimal (<5%) 5

Dose Modifications and Contraindications

Hepatic Impairment

• Patients with elevated bilirubin and/or transaminases have 12-27% decreased clearance and require dose reduction 5
• Docetaxel is >90% metabolized hepatically 5

Drug Interactions

• Avoid CYP3A4 inhibitors (erythromycin, ketoconazole, cyclosporin) as they may increase toxicity 5
• CYP3A4 inducers (anticonvulsants) may require dose increases 5

Hematologic Toxicity

• Neutropenia is dose-limiting: Grade 3-4 neutropenia occurs in 61% of courses at 100 mg/m² 6
• The docetaxel/carboplatin regimen has increased neutropenia risk compared to paclitaxel regimens 2

Common Pitfalls to Avoid

• Never use 100 mg/m² in previously treated NSCLC patients due to excessive mortality risk 1
• Do not assess treatment response too early in prostate cancer: PSA response should be evaluated at approximately 12 weeks, not earlier, to avoid misinterpreting initial PSA flare 7
• Maintain androgen deprivation therapy continuously during docetaxel treatment for prostate cancer 7
• Weekly dosing requires careful monitoring for cumulative toxicities (hyperlacrimation, nail changes) that may necessitate schedule alterations 3, 4
• Ensure adequate premedication and hydration when combining with cisplatin 1