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 .
Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III randomized Intergroup study 0099.
PURPOSE The Southwest Oncology Group ( SWOG ) coordinated an Intergroup study with the participation of Radiation Therapy Oncology Group ( RTOG ) , and Eastern Cooperative Oncology Group ( ECOG ) . This r and omized phase III trial compared chemoradiotherapy versus radiotherapy alone in patients with nasopharyngeal cancers . MATERIAL S AND METHODS Radiotherapy was administered in both arms : 1.8- to 2.0-Gy/d fractions Monday to Friday for 35 to 39 fractions for a total dose of 70 Gy . The investigational arm received chemotherapy with cisplatin 100 mg/m2 on days 1 , 22 , and 43 during radiotherapy ; postradiotherapy , chemotherapy with cisplatin 80 mg/m2 on day 1 and fluorouracil 1,000 mg/m2/d on days 1 to 4 was administered every 4 weeks for three courses . Patients were stratified by tumor stage , nodal stage , performance status , and histology . RESULTS Of 193 patients registered , 147 ( 69 radiotherapy and 78 chemoradiotherapy ) were eligible for primary analysis for survival and toxicity . The median progression-free survival ( PFS ) time was 15 months for eligible patients on the radiotherapy arm and was not reached for the chemo-radiotherapy group . The 3-year PFS rate was 24 % versus 69 % , respectively ( P < .001 ) . The median survival time was 34 months for the radiotherapy group and not reached for the chemo-radiotherapy group , and the 3-year survival rate was 47 % versus 78 % , respectively ( P = .005 ) . One hundred eighty-five patients were included in a secondary analysis for survival . The 3-year survival rate for patients r and omized to radiotherapy was 46 % , and for the chemoradiotherapy group was 76 % ( P < .001 ) . CONCLUSION We conclude that chemoradiotherapy is superior to radiotherapy alone for patients with advanced nasopharyngeal cancers with respect to PFS and overall survival
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 .