Hesketh, P.J., Grunberg, S.M., Herrstedt, J., de Wit, R., Gralla, R.J., Carides, A.D., ... Horgan, K.J. (2006). Combined data from two phase III trials of the NK1 antagonist aprepitant plus a 5HT 3 antagonist and a corticosteroid for prevention of chemotherapy-induced nausea and vomiting: Effect of gender on treatment response. Supportive Care in Cancer, 14, 354-360.

To assess the effect of gender on treatment response for aprepitant plus a 5-HT₃ antagonist and corticosteroid for the prevention of chemotherapy-induced nausea and vomiting (CINV) 

The data from two phase III studies of aprepitant plus a 5-HT₃ antagonist and corticosteroid for the prevention of CINV were pooled. The two trials were of patients receiving more than 70 mg/m² of cisplatin randomly assigned to control regimen or aprepitant regimen. Patients were randomized to one of the treatment groups and stratified by gender. Patients used a diary to document emetic episodes, severity ratings of nausea (on a 100-mm horizontal visual analogue scale), and any use of rescue medications.

The study reported on 1,044 patients older than 18 years with a Karnofsky score greater than 60 and who were scheduled for first their cycle of chemotherapy, including cisplatin.

The studies were conducted in the United States and the Netherlands, predominately in university cancer centers.

Two identically designed, randomized, double-blind parallel group, placebo-controlled trials were reviewed.

Visual analogue scales (VASs) and patient diaries were used.

• In the control group, 41% of women had an overall complete response (CR) compared with 53% of men.
• In the aprepitant group, 66% of women had an overall CR compared with 69% of men.
• The enhanced efficacy of aprepitant regimen in women occurred during acute and delayed phases and resulted in similar rates of antiemetic control for men and women.
• The aprepitant regimen partly maintained improvement over multiple cycles for men and women.

The addition of aprepitant may reverse the risk of gender for CINV in women receiving highly emetogenic chemotherapy.

Details of design, primary efficacy, and tolerability are not included, but the results of the studies are published elsewhere.