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 .
Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer.
PURPOSE This multicenter , r and omized trial compared capecitabine plus oxaliplatin ( XELOX ) with bolus fluorouracil ( FU ) and folinic acid ( FA ) as adjuvant therapy for patients with stage III colon cancer . PATIENTS AND METHODS Patients who had undergone curative resection were r and omly assigned to XELOX ( oxaliplatin 130 mg/m(2 ) on day 1 plus capecitabine 1,000 mg/m(2 ) twice daily on days 1 to 14 every 3 weeks for 24 weeks ) or a st and ard bolus FU/FA adjuvant regimen ( Mayo Clinic for 24 weeks or Roswell Park for 32 weeks ) . The primary study end point was disease-free survival ( DFS ) . RESULTS The intention-to-treat population comprised 1,886 patients ; 944 patients were r and omly assigned to XELOX and 942 to FU/FA ( Mayo Clinic , n = 664 ; Roswell Park , n = 278 ) . After 57 months of follow-up for the primary analysis , 295 patients ( 31.3 % ) in the XELOX group had relapsed , developed a new primary colon cancer , or died compared with 353 patients ( 37.5 % ) in the FU/FA group ( hazard ratio [ HR ] for DFS , 0.80 ; 95 % CI , 0.69 to 0.93 ; P = .0045 ) . The 3-year DFS rate was 70.9 % with XELOX and 66.5 % with FU/FA . The HR for overall survival ( OS ) for XELOX compared to FU/FA was 0.87 ( 95 % CI , 0.72 to 1.05 ; P = .1486 ) . The 5-year OS for XELOX and FU/FA were 77.6 % and 74.2 % , respectively . Follow-up is ongoing . Preplanned multivariate and subgroup analyses supported the robustness of these findings . CONCLUSION The addition of oxaliplatin to capecitabine improves DFS in patients with stage III colon cancer . XELOX is an additional adjuvant treatment option for these 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 .