BETHLEHEM, Pa.--(BUSINESS WIRE)--Saladax Biomedical, Inc. recently presented results from the largest, randomized, prospective dose adjustment-therapeutic drug monitoring (TDM) trial ever conducted in oncology: evaluating 304 patients over six years (abstract # 8051). The CEPAC-TDM phase III study in advanced Non-Small Cell Lung Cancer (NSCLC) patients (ClinicalTrials.gov Identifier NCT01326767) compared two arms – one with dose optimization [pharmacokinetically (PK)-guided] to one with standard dosing. The results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2015 taking place in Chicago, Illinois. The presentation is available on the Saladax website at www.saladax.com.
CEPAC-TDM was a study of paclitaxel (PTX) dosing in NSCLC patients receiving PTX in combination with carboplatin on a 3-weekly schedule. Standard dosing of chemotherapy does not account for the many differences between patients that make drug exposure highly variable, and variability of exposure can lead to severe toxicity and/or shorter survival.
Patients with advanced NSCLC receiving PTX/carboplatin chemotherapy were enrolled at nine German and one Swiss institution. In the PK-Guided Arm the majority of patients saw a significant reduction in the dose with fewer toxic side effects and the same survival as the standard arm. This well controlled, randomized study showed that using PK-Guided dosing with 3-weekly PTX in NSCLC patients, results in a clinically significant reduction of both neutropenia and neuropathy compared to standard dosing. The reduction in neuropathy is particularly important because it is impossible to treat or prevent this often debilitating side effect. The lower average PTX doses only reduced toxicity and did not reduce efficacy, confirming the value of PK-guided dosing with chemotherapy patients.
At the same conference, interim study results from a similar randomized study in NSCLC (ClinicalTrials.gov Identifier NCT02058433) reported from Shanghai Pulmonary Hospital in China presented very consistent trends further demonstrating the value of PK-Guided dosing (abstract # 8052).
About Saladax Biomedical, Inc.:
Saladax Biomedical is a leader in the development high-value diagnostic services and products. Products that deliver actionable data to help physicians select and optimize the use of current and new pharmaceutical products to improve health and positively impact the economics of care: diagnostics that make a difference. Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified. For more information visit: www.saladax.com.