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 .
Outcomes and toxicity in african-american and caucasian patients in a randomized adjuvant chemotherapy trial for colon cancer.
BACKGROUND Previous studies have demonstrated that African-Americans with colon cancer have worse overall and stage-specific survival rates than Caucasians . Such differences could reflect variation in access to health care , in tumor biology , or in treatment efficacy . Little is known about potential differences in chemotherapy-related toxicities between African-Americans and Caucasians . In this study , we examined survival and toxic effects among African-American and Caucasian patients enrolled in a large , r and omized phase III trial of adjuvant chemotherapy for resected colon cancer . METHODS We analyzed data on 3380 patients ( 344 African-Americans and 3036 Caucasians ) enrolled in a r and omized trial of adjuvant 5-fluorouracil-based chemotherapy in patients with stage II ( high risk ) and stage III colon cancer to evaluate differences in outcomes and toxicity . We compared disease-free survival ( DFS ) and overall survival ( OS ) between African-Americans and Caucasians by the Kaplan-Meier method , computed Cox proportional hazards by multivariable analysis , and compared treatment-related toxicity rates by Fisher 's exact test . All statistical tests were two-sided . RESULTS We found no differences in DFS or OS between African-American and Caucasian patients . Five-year DFS was 57 % ( 95 % confidence interval [ CI ] = 52 % to 62 % ) for African-Americans and 58 % ( 95 % CI = 56 % to 60 % ) for Caucasians ( P = .15 ) , and 5-year OS was 65 % ( 95 % CI = 60 % to 70 % ) for African-Americans and 66 % ( 95 % CI = 64 % to 68 % ) for Caucasians ( P = .38 ) . On multivariable analysis , no statistically significant difference in disease recurrence or death was detected between the racial/ethnic groups ( hazard ratios for African-Americans versus Caucasians : disease recurrence = 1.1 , 95 % CI = 0.9 to 1.3 ; death = 1.1 , 95 % CI = 0.9 to 1.3 ) . Treatment-related toxicity differed between the African-American and Caucasian patients , with African-Americans experiencing statistically significantly lower rates of diarrhea ( P<.001 ) , nausea ( P<.001 ) , vomiting ( P = .01 ) , stomatitis ( P<.001 ) , and overall toxicity ( P = .005 ) . CONCLUSIONS In this study of patients with similar access to health care re sources and treatment with adjuvant chemotherapy , we found similar 5-year DFS and OS in African-Americans and Caucasians with stage II and III colon cancer . The two groups derived similar benefits from adjuvant chemotherapy . Moreover , African-Americans appeared to experience less treatment-related toxicity
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 .