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Title: A New Loading Dose Schedule Gets Herceptin Patients To Steady State Immediately: Presented at AACR-NCI-EORTC

"A New Loading Dose Schedule Gets Herceptin Patients To Steady State Immediately: Presented at AACR-NCI-EORTC"

By Maggie Schwarz PHILADELPHIA, PA -- November 18, 2005 -- A loading dose schedule of Herceptin (trastuzumab) given weekly for 3 weeks, then once every 3 weeks overcomes the problem of an 18-week wait until steady state is reached, researchers reported here. The findings were obtained from a pharmacokinetic simulation performed in an attempt to achieve early high levels of Herceptin, said lead researcher Brian Leyland-Jones, MD, PhD, Minda de Guzburg Professor and Founding Chairman, Department of Oncology, McGill University, Montreal, Quebec, Canada. He presented the preliminary data from the first six patients evaluable for pharmacokinetic analysis on November 16[^th at the International Conference on Molecular Targets and Cancer Therapeutics.

The conference is organized by the American Association for Cancer Research - National Cancer Institute - European Organisation for Research and Treatment of Cancer (AACR-NCI-EORTC).

Achieving high Herceptin levels, similar to those seen at steady state, early in the course of therapy may allow for earlier responses, as well as maximizing the synergistic effects when Herceptin is used in combination with chemotherapy. This would be of particular benefit in the neoadjuvant setting, where patients have a relatively short time to derive optimum benefit from prior to surgical resection.

For their study, Dr. Leyland-Jones and colleagues studied women with human epidermal growth factor receptor 2 (Her 2)-positive metastatic breast cancer. They received IV Herceptin monotherapy at a loading dose of 6 mg/kg over 90 minutes on days 1, 8 and 15, followed b y a maintenance dose of 6 mg/kg every 3 weeks from day 22.

Blood samples for pharmacokinetic analysis were collected at different time points and serum concentrations of Herceptin determined by enzyme-linked immunosorbent assay.

Preliminary data from the first six patients evaluable for pharmacokinetic analysis demonstrate the suitability of the loading regimen on the basis of both pharmacokinetics and preliminary indications of safety.

The safety profile of Herceptin using the novel loading schedule was similar to that seen normally using the registered dosing schedule (4 mg/kg on day 1, followed by 2 mg/kg weekly).

Dr. Leyland-Jones said he is satisfied that this simple and convenient schedule achieved higher serum concentrations that were comparable to those achieved at steady state of Herceptin during early stages of treatment without compromising patient safety.

"The loading regimen not only holds the potential of improved efficacy but is also especially desirable in the neoadjuvant setting and in terms of maximizing the potential for synergy with chemotherapy," he concluded.

[Presentation title: A Novel Loading Regimen for Herceptin(R) (Trastuzumab) in Metastatic Breast Cancer Boosts Serum Levels in Early Cycles without Compromising Safety: Preliminary Results. Abstract B169]

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