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Basch, E., Reeve, B., Mitchell, S., Clauser, S.B., Minasian, L.M., Dueck, A.C., et al. (2014) Development of the National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Journal of the National Cancer Institute, 106, dju244.
https://doi.org/10.1093/jnci/dju244

has been cited by the following article:

• TITLE: Treatment Outcome of Pharmacokinetics-Based Dosing of Docetaxel and Fluorouracil in Advanced Head and Neck Cancer Patients

  AUTHORS: Abdelhamid M. Fouad, Magdy M. Saber, Yahia M. Ismail, Yasser A. Sallam, Tarek M. Shouman, Reham A. A. Elshimy, Ahmed Abo Gabal

  KEYWORDS: Head and Neck Cancer, DPF, Docetaxel, Fluorouracil, Pharmacokinetics Dose Adjustment

  JOURNAL NAME: Journal of Cancer Therapy, Vol.9 No.12, December 18, 2018

  ABSTRACT: Introduction: Docetaxel, Cisplatin and 5-Fluorouracil (DPF) became the standard induction chemotherapy in advanced Head and Neck Cancer (HNC) but associated with high toxicity rate. Several studies reported higher response rates with better tolerability when chemotherapy dose is calculated based on Pharmacokinetics (PK) versus conventional Body Surface Area (BSA). Patients and Methods: Thirty nine patients with stage III and IV HNC who received induction DPF were included in the study. Dose of cycle 1 was BSA-based then Docetaxel and 5-FU doses were PK-adjusted starting from cycle 2 whereas Cisplatin dose was BSA-based throughout the study. Results: After median follow up period of 14 months the median overall survival (OS) and progression free survival (PFS) were 15.1 and 10.6 months respectively. Twenty nine patients were available for response assessment. Seven patients (24.1%) achieved complete response while partial response encountered in 19 patients (65.5%) with and Overall response rate of 89.6%. Both treatment related side effects and mortality significantly decreased after the application of PK dose adjustments (p-value 0.007 and 0.01 respectively). Conclusion: PK-guided dose adjustments of 5-FU and Docetaxel in DPF regimen can significantly decrease the treatment related side effects and mortality without compromising the tumor response rate. A randomized clinical trial is needed to compare the PK-guided dose adjustment with the standard BSA based protocol.