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 .
Chemoradiation comparing cisplatin versus carboplatin in locally advanced nasopharyngeal cancer: randomised, non-inferiority, open trial.
PURPOSE This single centre , open labelled , r and omised non-inferiority trial compared concurrent chemoradiotherapy with carboplatin versus st and ard concurrent chemoradiotherapy with cisplatin in patients with locoregionally advanced nasopharyngeal cancer ( NPC ) . PATIENTS AND METHODS From August 1999 to December 2004 , 206 patients with locally advanced NPC were r and omised with 101 to cisplatin arm and 105 to carboplatin arm . Planned radiotherapy was the same in both groups . All the patients were evaluated for toxicity and survival according to the as-treated principle . RESULTS With a median follow-up of 26.3 months ( range 3 - 74.6 months ) , 59 % of patients in the cisplatin arm completed the planned concurrent chemoradiation treatment , compared to 73 % in the carboplatin arm . Forty-two percent of cisplatin patients completed the 3 cycles of adjuvant therapy compared to 70 % in the carboplatin group . There were more renal toxicity , leucopenia , and anaemia in the cisplatin group , and more thrombocytopenia in the carboplatin arm . The 3 year disease free survival rates were 63.4 % for the cisplatin group and 60.9 % for the carboplatin group ( p=0.9613 ) ( HR 0.70 , 95 % confidence interval ( CI ) : 0.50 - 0.98 ) . The 3 year overall survival rates were 77.7 % and 79.2 % for cisplatin and carboplatin groups , respectively ( p=0.9884 ) ( HR 0.83 , 95 % CI : 0.63 - 1.010 ) . CONCLUSION We concluded that the tolerability of carboplatin based regimen is better than that of the cisplatin regimen . Moreover , the treatment efficacy of carboplatin arm is not different from the st and ard regimen in the treatment of locoregional advanced stage NPC
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 .