Open-Label, Randomized Study Of Individualized, Pharmacokinetically (PK)-Guided Dosing Of Paclitaxel Combined With Carboplatin In Advanced Non-Small Cell Lung Cancer (NSCLC) Patients.
This study was one of the largest studies (n=304) ever done for therapeutic dose management compared to dosing by BSA. In the PK-guided arm patient’s doses were adjusted according to their drug level (pharmacokinetic parameter was time above threshold concentration Tc>0.05) from the previous cycle. PK guided dosing significantly reduced grade 4 neutropenia (29%), and grades of neutropenia ≥2 (48%) and ≥3 (88%). Survival was similar in both arms. Patients whose doses were adjusted with TDM had an improved risk-benefit profile.