Paclitaxel
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ADIS DRUG PROFILE
© 2004 Adis Data Information BV. All rights reserved.
Paclitaxel As Adjuvant or Neoadjuvant Therapy in Early Breast Cancer Dene Simpson and Greg L. Plosker Adis International Limited, Auckland, New Zealand
Contents Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1839 1. Pharmacodynamic Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1840 2. Pharmacokinetic Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1840 3. Therapeutic Efficacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1841 4. Tolerability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1844 5. Dosage and Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1846 6. Paclitaxel: Current Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1846
Features and properties of paclitaxel (Taxol®) Indication
Abstract ▲ Paclitaxel is a antimicrotubule agent with established antitumour activity in a variety of cancers including breast cancer. ▲ The efficacy of intravenous paclitaxel as adjuvant therapy for early breast cancer has been investigated in two large, randomised trials; it was administered sequentially to standard doxorubicin-cyclophosphamide (AC) combination therapy and compared with cycles of AC alone. ▲ In both trials, the addition of sequentially administered paclitaxel to the AC regimen significantly improved disease-free survival at 5 years compared with AC alone. In one of the trials, women who received paclitaxel also had a significant improvement in overall 5-year survival time. ▲ In randomised trials of neoadjuvant therapy for women with early breast cancer, paclitaxel or paclitaxel-containing regimens showed efficacy in terms of response/remission rates, local breast tumour recurrence and proportion of patients eligible for breast-conserving surgery. ▲ The most frequently reported grade 3–4 adverse events with paclitaxel administered sequentially to AC were haematological events (neutropenia, thrombocytopenia, anaemia) and nausea/vomiting.
Focus of this profile
Adjuvant and neoadjuvant therapy of early breast cancer
Mechanism of action Antimicrotubule agent
Promotes microtubule assembly and induces formation of stable, nonfunctioning microtubules
Dosage and administration when administered sequentially to a doxorubicin-cyclophosphamide regimen for early, node-positive breast cancer Dose
175 mg/m2
Duration and route of administration
3h intravenous infusion
Freq
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