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Related Experiment Videos

Dose scheduling--Herceptin.

B Leyland-Jones1

  • 1Department of Oncology, McGill University, Montreal, Que., Canada. leylandj@med.mcgill.ca

Oncology
|November 6, 2001
PubMed
Summary
This summary is machine-generated.

New Herceptin (trastuzumab) dosing strategies show promise for breast cancer treatment. Increased doses and less frequent administration, including with paclitaxel and capecitabine, are being explored for improved efficacy and convenience.

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Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Previous studies of Herceptin (trastuzumab) revealed a dose-related, non-linear pharmacokinetic profile.
  • A dose-finding study recommended an initial intravenous (i.v.) dose of 4 mg/kg followed by weekly 2 mg/kg doses.
  • Pharmacokinetic and safety data suggested feasibility of increased dosing and reduced frequency.

Purpose of the Study:

  • To evaluate a phase I/II trial of Herceptin (trastuzumab) at an 8 mg/kg initial dose and 6 mg/kg maintenance dose, combined with paclitaxel, administered every 3 weeks.
  • To explore 3-weekly Herceptin as first-line monotherapy for metastatic breast cancer.
  • To investigate 3-weekly Herceptin in combination with capecitabine (Xeloda).

Main Methods:

  • A phase I/II trial was conducted using a 3-weekly regimen of Herceptin (8 mg/kg initial, 6 mg/kg maintenance) plus paclitaxel.

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  • Serum trough Herceptin concentrations and AUC were compared between weekly and 3-weekly regimens.
  • Further trials were proposed for 3-weekly Herceptin monotherapy and combination with capecitabine.

    • Main Results:

    • Preliminary results of the 3-weekly Herceptin plus paclitaxel regimen are promising.
    • Serum trough Herceptin concentrations were similar, while AUC was greater compared to weekly Herceptin plus 3-weekly paclitaxel.
    • Subcutaneous (s.c.) administration of Herceptin is under clinical evaluation for simplified administration.

    Conclusions:

    • Increased dosing and reduced frequency of Herceptin administration are feasible.
    • The combination of Herceptin and paclitaxel demonstrates additive antitumor efficacy and clinical benefits.
    • Future breast cancer therapies may involve combinations of oral taxanes, capecitabine, and 3-weekly or subcutaneous Herceptin.