Pharmacokinetics of Trastuzumab After Subcutaneous and Intravenous Administration in Obese Patients.

Subcutaneous trastuzumab (T-SC) administration does not allow the historical target concentration of 20 µg/mL for efficacy to be reached, from the start of treatment in patients with a body mass index (BMI) >30 kg/m. To analyze the influence of the strategy of dosification (fixed vs adjusted patient's body weight dose) on the initial minimum plasma concentration () of trastuzumab in obese patients. This was an observational, prospective study, which included patients with HER2-positive nonmetastatic breast cancer treated with trastuzumab.

Influence of Anthropometric Characteristics in Patients With Her2-Positive Breast Cancer on Initial Plasma Concentrations of Trastuzumab.

Background: Plasma concentrations of trastuzumab <20 µg/mL in patients with gastric cancer are associated with reduced progression-free and overall survival. In breast cancer treatment, this relationship has not yet been studied, but a suboptimal pharmacodynamic exposure to trastuzumab could be a reason for therapeutic failure of treatment of HER2-positive breast cancer.

Objective: The objective of the present study was to determine the proportion of nonmetastatic HER2-positive breast cancers that do not reach a minimum plasma concentration ( C) of 20 µg/mL after first drug administration, established as therapeutically effective in clinical trials.

Application of capability indices and control charts in the analytical method control strategy.

In this study, we assessed the usefulness of control charts in combination with the process capability indices, C and C , in the control strategy of an analytical method. The traditional X-chart and moving range chart were used to monitor the analytical method over a 2-year period. The results confirmed that the analytical method is in-control and stable.