This review shows that a significant proportion of patients in curative-intent clinical trials experience toxicities that result in dose modifications-dose reduction , dose delays or missed doses-despite strict selection criteria and intense monitoring .
Toxicities of systemic cancer therapies are often less frequently observed in clinical trials than in clinical practice , due to the careful selection of patients with fewer comorbidities .
Although guidelines exist for the estimation of chemotherapy dose , clinical factors like age , comorbid illness and extremes of body habitus are not considered in the method of dose calculation , which can result in significant toxicity .
Induction chemotherapy with docetaxel, cisplatin, fluorouracil and l-leucovorin for locally advanced head and neck cancers: a modified regimen for Japanese patients
Combination chemotherapy with docetaxel ( T ) , cisplatin ( P ) , fluorouracil ( 5-FU ) and leucovorin has been reported to have major activity against squamous cell carcinoma of the head and neck ( SCCHN ) administered as a 4-day ( TPFL4 ) or 5-day ( TPFL5 ) regimen . The purpose of this study was to evaluate the efficacy and toxicity of a modified TPFL regimen ( m-TPFL ) for locally advanced SCCHN , consisting of a modified dosage with docetaxel , cisplatin , 5-FU and l-leucovorin ( l-LV ) design ed for Japanese patients . Organ preservation of the primary tumor site was also assessed . Thirty-four Japanese patients with locally advanced SCCHN were eligible .  Docetaxel was administered as a 1-h i.v . infusion at 48 mg/m2 on day 1 ; cisplatin , 24 mg/m2/day ; 5-FU , 560 mg/m2/day and l-LV , 125 mg/body/day were delivered on days 1–4 by continuous i.v . infusion . This regimen was administered every 28 days . Patients who achieved a complete response ( CR ) after induction chemotherapy underwent radiation therapy alone . Ninety-one cycles were administered . The main hematological toxicity was neutropenia , classified as grade III or IV in 18.7 % of cycles . The most common non-hematologic toxicities included anorexia , stomatitis and alopecia . The clinical overall response rate to m-TPFL was 88.2 % , with 58.8 % CRs and 29.4 % partial responses . After definitive locoregional therapy , 25 of 34 patients were disease-free with preserved primary tumor site anatomy . Overall and progression-free survival rates at the 2-year follow-up are 92.8 and 75.3 % , respectively . Our m-TPFL regimen design ed for Japanese patients yielded excellent response rates with an acceptable toxicity profile in good-performance-status patients
This review shows that a significant proportion of patients in curative-intent clinical trials experience toxicities that result in dose modifications-dose reduction , dose delays or missed doses-despite strict selection criteria and intense monitoring .
Toxicities of systemic cancer therapies are often less frequently observed in clinical trials than in clinical practice , due to the careful selection of patients with fewer comorbidities .
Although guidelines exist for the estimation of chemotherapy dose , clinical factors like age , comorbid illness and extremes of body habitus are not considered in the method of dose calculation , which can result in significant toxicity .