Title:TC > 0.05 as a Pharmacokinetic Parameter of Paclitaxel for Therapeutic Efficacy and Toxicity in Cancer Patients
Volume: 13
Issue: 3
Author(s): D.S. Xin, L. Zhou, C.Z. Li, S.Q. Zhang, H.Q. Huang, G.D. Qiu, L.F. Lin, Y.Q. She, J.T. Zheng, C. Chen, L. Fang, Z.S. Chen*S.Y. Zhang*
Affiliation:
- Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, St. John`s University, 8000 Utopia Parkway, Queens, NY 11439,United States
- Department of Pharmacy, Cancer Hospital of Shantou University Medical College, Raoping Rd, Shantou 515041, Guangdong,China
Keywords:
Cancer treatment, paclitaxel, pharmacokinetics, TC > 0.05, therapeutic efficacy, toxicity.
Abstract: Background: Paclitaxel (PTX) has remarkable anti-tumor activity, but it causes severe
toxicities. There is an urgent need to seek an appropriate pharmacokinetic parameter of PTX to improve
treatment efficacy and reduce adverse effects.
Objective: To evaluate the association of pharmacokinetic parameter TC > 0.05 of paclitaxel (PTX) and
its therapeutic efficacy and toxicity in patients with solid tumors.
Methods: A total of 295 patients with ovarian cancer, esophageal cancer, breast cancer, and non-small
cell lung cancer (NSCLC), who were admitted to the Tumor Hospital of Shantou University Medical
College, China, were recruited for this study. Patients received 3 weeks of PTX chemotherapy. The
plasma concentrations of PTX were examined using the MyPaclitaxel™ kit. The patients’ PTX
TC > 0.05 (the time during which PTX plasma concentration exceed 0.05µmol/L) were calculated based
on pharmacokinetic analysis.
Results: The results showed that: (1) the concentrations of PTX in these 295 patients ranged from
0.0358-0.127 µmol/L; (2) the PTX TC > 0.05 ranged from 14 to 38h with a median time of 27h; (3)
among all treatment cycles, there was a statistically significant difference in the PTX TC > 0.05 between
CR+PR and SD+PD; (4) with the increasing value of TC > 0.05, level of leukopenia and leukopenic fever
increased; (5) high PTX TC > 0.05 led to the occurrence of neutropenia, neutropenic fever, severe
anemia, and severe peripheral neurotoxicity. Taken together, our results indicated that the pharmacokinetic
parameter PTX TC > 0.05 was an effective measure of treatment efficacy and toxicity in patients
with solid tumors. Maintaining PTX TC > 0.05 at 26 to 30h could improve its efficacy and reduce
the incidence of leukopenia, neutropenia, anemia, and peripheral neurotoxicity in these patients.
Conclusion: PTX TC > 0.05 is a key pharmacokinetic parameter of PTX which should be monitored to
optimize individual treatment in patients with solid tumors.
