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The Impact of Adding Aprepitant for the Patients Receiving Moderate Risk of Emetogenic Chemotherapy, a Prospective, Randomized, Cross-Over Trial

Authors :
Fukutaro Shimamoto
Ken Asaishi
Kazuhide Higuchi
Motoki Yoshida
Hitoshi Nishitani
Masahiro Gotoh
Takahiro Miyamoto
Tetsuji Terazawa
Shin Kuwakado
Takayuki Kii
Source :
Annals of Oncology. 25:iv521
Publication Year :
2014
Publisher :
Elsevier BV, 2014.

Abstract

Aim: Aprepitant, a neurokinin 1 antagonist, showed efficacy for chemotherapy-induced nausea and vomit(CINV). Antiemetic guidelines recommend aprepitant for high emetogenic chemotherapy(HEC). This prospective, randomized, cross-over trial aimed to evaluate the efficacy of aprepitant for patients(pts) receiving moderate emetogenic chemotherapy(MEC). Methods: Gastrointestinal cancer pts receiving MEC were randomly assinged to GroupA and B. We administered as follows; in GroupA; on first course, pts received palonosetron (0.75mg iv on day 1) and dexamethasone (9.9mg on day 1, and 8mg p.o. on days 2-3) (control premedication) and on second course, pts received oral aprepitant (125mg on day 1 and 80mg on days 2-3) with control premedication (dexamethasone; 4.95mg iv and 4mg p.o.). In GroupB, pts received aprepitant with control premedication on the first course and they received control premedication on second course. The primary endpoint was rate of CR (complete response; neither emesis nor rescue therapy) and degree of nausea. Results: From January 2011 to March 2013, 100 pts were enrolled, and 83 pts were analyzed(female/male, 35/48; median age, 65 years; colorectal/gastric, 64/19; irinotecan/oxaliplatin 53/30). The CR rates of aprepitant/control were 73.5%/60.2%(p = 0.064). The degree of nausea was(more than intermediate) was 4.9%/19.0%(p = 0.02). Conclusions: Adding aprepitant significantly reduced moderate and severe emesis compared with standard premedication. Although the rate of CR was not statistically significant, aprepitant reduced the degree of nausea. Adding aprepitant is promising for gastrointestinal cancer pts receivig MEC. Disclosure: All authors have declared no conflicts of interest.

Details

ISSN :
09237534
Volume :
25
Database :
OpenAIRE
Journal :
Annals of Oncology
Accession number :
edsair.doi...........f020f5e174652325246ac12b9c4993e9
Full Text :
https://doi.org/10.1093/annonc/mdu356.13