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 .
Epirubicin increases long-term survival in adjuvant chemotherapy of patients with poor-prognosis, node-positive, early breast cancer: 10-year follow-up results of the French Adjuvant Study Group 05 randomized trial.
PURPOSE The French Adjuvant Study Group 05 ( FASG-05 ) showed that fluorouracil 500 mg/m2 , cyclophosphamide 500 mg/m2 , and epirubicin 100 mg/m2 ( FEC 100 ) was superior to the same regimen with epirubicin 50 mg/m2 ( FEC 50 ) in terms of disease-free survival ( DFS ) and overall survival ( OS ) in adjuvant treatment of early breast cancer . We report 10-year data on efficacy , and long-term side effects for FASG-05 . PATIENTS AND METHODS We r and omly assigned 565 patients to treatment with FEC 50 or FEC 100 after surgery . Postmenopausal patients also received tamoxifen for 3 years , and almost all patients ( 96 % ) also received radiotherapy . RESULTS Median follow-up was 110 months . The 10-year DFS was 45.3 % ( 95 % CI , 41.9 % to 48.7 % ) with FEC 50 and 50.7 % ( 95 % CI , 47.3 % to 54.1 % ) with FEC 100 ( Wilcoxon P = .036 ; log-rank P = .08 ) . The 10-year OS was 50.0 % ( 95 % CI , 46.7 % to 53.3 % ) with FEC 50 and 54.8 % ( 95 % CI , 51.3 % to 58.3 % ) with FEC 100 ( Wilcoxon P = .038 ; log-rank P = .05 ) . Delayed cardiac toxicity ( before relapse ) occurred in four patients ( 1.5 % ) in the FEC 50 arm and three patients ( 1.1 % ) in the FEC 100 arm . Cardiac toxicity after relapse occurred in six ( 4.3 % ) and five ( 4.1 % ) patients treated with FEC 50 and FEC 100 , respectively . CONCLUSION Treatment with adjuvant FEC 100 demonstrated superior DFS and OS versus FEC 50 at 10 years of follow-up . This survival advantage was not offset by long-term complications such as cardiac toxicity and second malignancy . Given the risk-benefit ratio , FEC 100 is a more optimal regimen for long-term survival in patients with poor prognosis
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 .