What is the optimal method for prescribing cancer chemotherapy? At this time this is usually done on the basis op the patient body surface area (BSA) in meter squared.

But a BSA dose unit will provide small individuals with too much chemotherapy and large individuals with not enough chemotherapy. Therefore we need to examine other prescription units, such at the bodyweight (BW) of the patient.

In this P2T study we will attempt to define the highest possible therapeutic ratio: High efficacy for cancer eradication, low incidence of side effects. P2T wants to decrease the side effects and increase cure rates for patients with breast cancer, who currently receive prophylactic, ‘adjuvant’ chemotherapy for many months.

THE NETHERLANDS

101214
Annual number of patients diagnosed with cancer
14428
Annual number of patients diagnosed with breast cancer
3128
Annual deaths due to breast cancer
STUDY DESIGN

A selected group of women with breast cancer will be divided in two groups. All chemotherapy will be administered intravenously.

For three months group 1 receives chemotherapy dosed per kg bodyweight (kg being a 3D unit). The second group receives chemotherapy dosed per m2 body surface area (m2 – a 2D unit). Later, the two groups will change to the other prescription method; an example of the so-called staggered wedge approach.

The null hypothesis is that women receiving chemotherapy per kg bodyweight will have similar serum levels of chemotherapy and that small women will have less side effects and that large women will have less cancer recurrences.

PROJECT MANAGEMENT

Project managers for P2T
Rob Vriesendorp & Hans Nortier

Preliminary discussions have been held with investigators/medical oncologists/ pharmacokinetic experts in the Leiden University Medical Center and the Medical Center Haaglanden in The Hague.

POTENTIAL BENEFITS

Patients with an early stage of non-metastasized breast cancer after standard surgery and external beam irradiation can be given a higher chance for cure and a lower chance for serious side effects of chemotherapy.

PUBLICATIONS

Comparison of BSA and BW prescriptions for cancer chemotherapy

By: Huib M. Vriesendorp This is an introduction to a fourth P2T project, a study in patients with a favorable stage of Breast cancer, stage 1 and 2, after complete local regional control with surgery and radiotherapy, but a high chance of fatal, metastatic disease within with a year. (1) These patients are called ‘triple negatives’ because their tumors lack receptors for estrogens, progesterone and epidermal growth factor receptors.

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