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Saladax Biomedical, Inc., recently presented a study on the value of adjusting paclitaxel doses.  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 two conferences: the European Society for Medical Oncology (ESMO), and the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT).  At IATDMCT Saladax received the Best Poster Award based upon the study’s originality, significance, scientific and technical challenges, and presentation.  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) 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 organization that promotes therapeutic drug monitoring and clinical toxicology worldwide. Therapeutic drug monitoring or PK-guided dosing maximize a drugs’ clinical and economic benefits to patients.

Paclitaxel (PTX) (Taxolâ) 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 in a patients’ blood is superior to the current practice of dosing by Body Surface Area (BSA), because it improves outcomes by lowering toxicity, such as neuropathy and neutropenia, without impacting efficacy.1

The presentation was on a large, two-arm, randomized study; with a total of 275 patients. [JC1]  Levels of paclitaxel in blood showed that patients dosed by BSA were over-exposed to PTX.  Patients in the dose-adjusted/individualized arm had their doses lowered based on the results of the paclitaxel blood test.  Patients in the BSA arm did not have their doses adjusted, except for toxicity.  Of those who received individualized dosing (PK-guided/TDM), 96% received lower doses in cycle 4 compared to cycle 1.2Dose reduction 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.  While lower toxicity could be expected with reduced doses, the efficacy of the regimen was not impacted.  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, 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.”