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There was a trend toward greater survival in patients randomized to PS (hazard ratio,3.25;95%CI,0.63 to 16.8;P=0.13),but most study deaths were not directly related to TW.In contrast,patients randomized to PC appeared more likely to achieve complete clinical(odds ratio,0.67;CI,0.2 to 1.97;P> 0.2)and radiologic responses(odds ratio,0.28;CI,0.08 to 0.96;P=0.02). Multivariate analysis revealed drug effects to be largely independent of other variables.Similar efficacy of the treatments was also suggested by a hazard analysis of resolution of abnormal mental status,fever,and headache.Skin rash was the most common adverse event in both treatment arms.Because of toxicity,six patients randomized to PC and 11 patients randomized to PS had to switch to the alternate treatment,but only three were unable to complete therapy after crossover.The results of several end points of efficacy,taken together,suggest that the relative efficacy of PC approximately equals that of PS.PC appears to be an acceptable alternative in patients unable to tolerate PS. |
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