Paclitaxel

Ovarian cancer: Subsequent therapy for metastatic ovarian carcinoma after failure of first-line or subsequent chemotherapy. Breast cancer: Adjuvant treatment of node-positive breast cancer after standard doxorubicin-containing combination chemotherapy; metastatic breast cancer after failure of combination chemotherapy or relapse within 6 months of adjuvant therapy. NSCLC: First-line treatment in combination with cisplatin for NSCLC in patients who are not candidates for curative surgery or radiation therapy. AIDS-related Kaposi's sarcoma: Second-line therapy.

Ovarian cancer: 135 mg/m² or 175 mg/m² IV over 3 hours every 3 weeks.
Breast cancer (adjuvant): 175 mg/m² IV over 3 hours every 3 weeks for 4 courses (administered sequentially to doxorubicin combination).
Breast cancer (metastatic): 175 mg/m² IV over 3 hours every 3 weeks.
NSCLC: 135 mg/m² IV over 24 hours, then cisplatin 75 mg/m² on Day 1, every 3 weeks.
Kaposi's sarcoma: 135 mg/m² IV over 3 hours every 3 weeks or 100 mg/m² IV over 3 hours every 2 weeks.
Premedicate with corticosteroids, diphenhydramine, and H2 antagonists to prevent hypersensitivity reactions.

Injection: 6 mg/mL solution (30 mg/5 mL, 100 mg/16.7 mL, 300 mg/50 mL vials) — in polyoxyethylated castor oil/dehydrated alcohol

Baseline neutrophil count <1,500 cells/mm³ (or <1,000 cells/mm³ for Kaposi's sarcoma patients). History of severe hypersensitivity reactions to paclitaxel or Cremophor EL (polyoxyethylated castor oil).

• Hypersensitivity Reactions: Severe reactions including anaphylaxis occurred in 2–4% of patients receiving premedication. Premedicate all patients and monitor during infusion; have resuscitative equipment available.
• Myelosuppression: Severe (neutropenia <500 cells/mm³) occurred in 28% of patients. Monitor CBCs frequently.
• Peripheral Neuropathy: Cumulative, dose-dependent peripheral neuropathy in 60% of patients. Dose reduction recommended for severe symptoms.
• Cardiac Conduction Abnormalities: Bradycardia and AV block reported. Monitor heart rate during infusion.
• Injection Site Reactions: Extravasation can cause tissue injury.
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise effective contraception.

Peripheral Neuropathy (60%), Neutropenia (90%), Alopecia (87%), Arthralgia/Myalgia (60%), Nausea/Vomiting (52%), Diarrhea (38%), Mucositis (31%), Hypersensitivity (41%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

CYP2C8 and CYP3A4 inhibitors (ketoconazole, ritonavir): Increase paclitaxel exposure; use with caution.
CYP2C8 and CYP3A4 inducers (rifampin): Decrease paclitaxel exposure.
Cisplatin: When administered before paclitaxel, more profound myelosuppression occurs; administer paclitaxel before cisplatin.
Anthracyclines: Paclitaxel inhibits doxorubicin clearance; increased cardiotoxicity risk.

Can cause fetal harm. Advise females of reproductive potential to use effective contraception. Consult the full prescribing information for pregnancy risk details.

Advise women not to breastfeed during treatment and for a period after the last dose. Refer to prescribing information for duration guidance.

Safety and effectiveness in pediatric patients have not been established unless otherwise noted in the full prescribing information.

Dose modifications for organ impairment are specified in the complete prescribing information.

Paclitaxel promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability inhibits the normal dynamic reorganization of the microtubule network essential for vital interphase and mitotic cellular functions. Paclitaxel induces abnormal arrays (bundles) of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis, leading to cell cycle arrest at G2/M and apoptosis.

Tmax: End of infusion. Protein binding: 89–98%. Volume of distribution: 227–688 L/m². Hepatic metabolism by CYP2C8 (major) and CYP3A4 to hydroxylated metabolites. Biphasic/triphasic elimination with terminal half-life of 13–52 hours. Fecal elimination ~71%, renal ~14%. Accumulates in peripheral tissues.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• CA-139-209 — Paclitaxel vs doxorubicin in patients with previously treated advanced breast cancer. Phase III.
  📄 Primary Publication ↗
• CALGB 9344 — Adjuvant paclitaxel after AC chemotherapy in node-positive breast cancer. Phase III, n=3121.
  📄 Primary Publication ↗

Paclitaxel has FDA-approved indications across the following cancer types covered on CancerDrugEvidence: