BETHLEHEM, Pa.--(BUSINESS WIRE)--Saladax Biomedical, Inc., recently presented a study on the value of adjusting paclitaxel doses at two leading conferences. The results show that serious side effects such as neutropenia, and neuropathy are greatly reduced when oncologists personalize each patient’s chemotherapy dose using a simple blood test. “Open-Label Randomized Study of Individualized Pharmacokinetically (PK) – Guided Dosing versus Body Surface Area (BSA) Dosing of Paclitaxel (PTX) in Advanced Non-Small Cell Lung Cancer (NSCLC)” was presented at: the European Society for Medical Oncology (ESMO) in Madrid, Spain, and the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) in Kyoto, Japan. At IATDMCT Saladax received the Best Poster Presentation Award for TDM. The study was conducted in China by investigators at the Department of Oncology at Shanghai Pulmonary Hospital. Saladax’s MyPaclitaxel assay (licensed to Fosun Long March Diagnostics) was used to measure the level of drug in the patients’ blood.
ESMO is the most prestigious and influential oncology organization in Europe, respected by healthcare professionals, key opinion leaders, and patient advocacy associations. IATDMCT is the leading organization that promotes therapeutic drug monitoring and clinical toxicology worldwide. Therapeutic drug monitoring or PK-guided dosing maximize a drug's clinical and economic benefits to patients.
Paclitaxel (PTX) (Taxol®) is commonly used to treat several cancers, including ovarian cancer, breast cancer, and non-small cell lung cancer. The current study expands on previously published works, demonstrating that dosing by measuring drug levels in a patient's blood is superior to the current practice of dosing by Body Surface Area (BSA). This approach improves outcomes by lowering toxicity, such as neuropathy and neutropenia, while maintaining or improving efficacy.
The presentation was based on a large, two-arm, randomized study; with a total of 275 patients. Levels of paclitaxel in blood showed that most patients dosed by BSA were over-exposed to PTX. Patients in the dose-adjusted arm had their doses individualized based on the results of the paclitaxel blood test. Dose individualization resulted in a statistically significant lowering of the relative toxicity in the individualized dosing arm compared to the BSA arm: 38% reduction in grade 4 hematological toxicity, 34% reduction in severe neutropenia, and a 53% reduction in neuropathy grade ≥ 2. The study demonstrates that using blood levels to individualize dosing (TDM), chemotherapy can be personalized to reduce neutropenia and neuropathy while still maintaining or improving efficacy.
“More and more studies are being reported that show the benefits of TDM in oncology, and we hope that more oncologists will use this tool to improve patient care,” stated Dr. Salamone, CEO and President of Saladax, at the ESMO Conference. “This study demonstrated the superiority of individualized patient dosing compared to standard BSA dosing methods.”
About Saladax Biomedical, Inc.
Saladax Biomedical is a leader in the development high-value diagnostic products. Saladax products deliver actionable data to help physicians select and optimize the use of pharmaceutical products to improve health and positively impact the economics of care. Saladax diagnostics make a difference.
Headquartered in Ben Franklin TechVentures®, Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003-certified. For more information visit: www.saladax.com.