Addition of the Neurokinin-1-Receptor Antagonist (RA) Aprepitant to a XXXX -RA and @entity619 in the Prophylaxis of @entity390 and Vomiting Due to Radiation Therapy With Concomitant @entity900 .

@entity1 @entity9766 @entity390 @entity391 @entity900 @entity619 @entity750
PURPOSE: To  assess, in a prospective, observational study, the safety and efficacy of the addition of the neurokinin-1-receptor antagonist ( @entity9766 -RA) aprepitant to concomitant radiochemotherapy, for the prophylaxis of radiation therapy-induced @entity390 and @entity391 . @entity1 AND METHODS: This prospective observational study compared the antiemetic efficacy of an @entity9766 -RA (aprepitant), a @entity750 -RA, and @entity619 (aprepitant regimen) versus a @entity750 -RA and @entity619 (control regimen) in @entity1 receiving concomitant radiochemotherapy with @entity900 at the Department of Radiation Oncology, University Hospital Halle (Saale), Germany. The primary endpoint was complete response in the overall phase, defined as no @entity391 and no use of rescue therapy in this period. RESULTS: Fifty-nine @entity1 treated with concomitant radiochemotherapy with @entity900 were included in this study. Thirty-one @entity1 received the aprepitant regimen and 29 the control regimen. The overall complete response rates for cycles 1 and 2 were 75.9% and 64.5% for the aprepitant group and 60.7% and 54.2% for the control group, respectively. Although a 15.2% absolute difference was reached in cycle 1, a statistical significance was not detected (P=.22). Furthermore maximum @entity390 was 1.58      1.91 in the control group and 0.73      1.79 in the aprepitant group (P=.084); for the head-and-neck subset, 2.23      2.13 in the control group and 0.64      1.77 in the aprepitant group, respectively (P=.03). CONCLUSION: This is the first study of an @entity9766 -RA-containing antiemetic prophylaxis regimen in @entity1 receiving concomitant radiochemotherapy. Although the primary endpoint was not obtained, the absolute difference of 10% in efficacy was reached, which is defined as clinically meaningful for @entity1 by international guidelines groups. Randomized phase 3 studies are necessary to further define the potential role of an @entity9766 -RA in this setting.
