Is there evidence of disparate effects on gender?
• I do not agree with the conclusion that there is a low level of evidence that gender is a relevant factor in defining antiemetic outcomes. Early on, there was widespread recognition that female gender was an important predictive factor for antiemetic outcome, with women consistently having more nausea and vomiting than men with the same emetic stimulus. See references 6-9 from the Hesketh 2008 NEJM review. An analysis of the combined database from the two pivotal phase III trials of aprepitant with highly emetogenic chemotherapy by Hesketh et al43 again demonstrated significantly worse outcome in the control arms in women compared to men. Of note, for the first time the significant difference by gender was negated with the addition of aprepitant in the investigational arms, suggesting an even greater benefit with the addition of aprepitant in women compared to men. In my opinion the reports conclusions on p 32 that “further studies are highly likely to change these findings” are misl
