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Central European Society for Anticancer Drug Research Announces Start of Enrollment in First Randomized Trial of Pharmacokinetic-Guided Dose Adjustment of Paclitaxel in Non-Small Cell Lung Cancer
Date:4/26/2011

ing conventional dosing of paclitaxel at 200 mg/m2 every three weeks (conventional treatment Arm A) with paclitaxel blood level testing and subsequent individual dose adjustments (experimental treatment Arm B), with the primary objective to significantly reduce grade 4 neutropenia in patients within treatment Arm B, without adversely affecting chemotherapy efficacy in terms of progression-free survival (PFS) and overall survival (OS).

About non-small cell lung cancer (NSCLC)

Lung cancer is the most common cancer in the world today, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of all cases.  According to the Centers for Disease Control and Prevention (CDC), about 90% of lung cancer deaths in men and almost 80% of lung cancer deaths in women are due to smoking.  Treatment for NSCLC varies depending on the stage of the cancer, though combinations of taxanes are routinely used as part of first-line therapy treatment regimens.  Common side effects of taxanes include polyneuropathy and bone marrow suppression which results in severe neutropenia.

About pharmacokinetic-guided dosing

There is increasing evidence for the relationship between paclitaxel plasma concentrations, drug-associated toxicity, especially neutropenia and clinical outcome.  These data are derived from various pharmacological studies in patients with solid tumors, including lung cancer, ovarian cancer, breast cancer and less frequent cancer types.  The aim of TDM is to decrease toxicity while maintaining or improving treatment efficacy as compared to the standard of care.  Prospective pharmacokinetic studies with dose adjustments are important to evaluate the value of paclitaxel TDM.

About the CESAR Central European Society for Anticancer Drug Research-EWIV  

In the context of the pan-European Early Drug Development Network, CESAR represents the Central European platform for n
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SOURCE Saladax Biomedical, Inc.
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