Efficacy and safety of aprepitant for the prevention of chemotherapy-induced nausea and vomiting during the first cycle of moderately emetogenic chemotherapy in Korean patients with a broad range of tumor types.
This study evaluated the efficacy and safety of a 3-day aprepitant regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) during the first cycle of non-anthracycline plus cyclophosphamide (AC)-based moderately emetogenic chemotherapy (MEC) based on government guidelines in Korean patients.



This multicenter, randomized, double-blind, phase IV trial (NCT01636947) enrolled adult South Korean patients with a broad range of tumor types who were scheduled to receive a single dose of ≥1 MEC agent. Patients were randomized to a 3-day regimen of aprepitant (aprepitant regimen) or placebo (control regimen) on top of ondansetron plus dexamethasone. The primary and key secondary efficacy endpoints were the proportions of subjects who achieved no vomiting and complete response (CR) during the overall phase.



Of the 494 randomized subjects, 480 were included in the modified intent-to-treat population. Response rates for no vomiting and CR in the overall phase were numerically higher for the aprepitant regimen compared with the control regimen groups, but failed to reach statistical significance (no vomiting 77.2 vs 72.0%; p = 0.191; CR 73.4 vs 70.4%; p = 0.458). Both the aprepitant and control regimens were generally well tolerated.



A 3-day aprepitant regimen was numerically better but not statistically superior to a control regimen with respect to the achievement of no vomiting or CR during the overall phase in a non-AC MEC Korean population based on government reimbursement guidelines.



ClinicalTrials.gov NCT01636947 ( https://clinicaltrials.Gov/ct2/show/NCT01636947 ).
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic ro 43 gil, Sonpa-gu, Seoul, South Korea.
Jeong Eun
JE
Kim
Department of Internal Medicine, Chung-Ang University College of Medicine, 101 Heukseok-ro, Dongjak-gu, Seoul, South Korea. alsaba@hanmail.net.
Joung-Soon
JS
Jang
Department of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-ro Jongno-gu, Seoul, South Korea.
Jae-Weon
JW
Kim
Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Korea University College of Medicine, 73 Inchon-ro, Seongbuk-gu, Seoul, South Korea.
Yong Lee
YL
Sung
Department of Obstetrics and Gynecology, School of Medicine, Keimyung University, 56 Dalseungro Jungku, Daegu, South Korea.
Chi-Heum
CH
Cho
Department of Medical Oncology, Seoul St. Mary's Hospital, The Catholic University of Korea, 90 1 Hyehwa-dong, Jongno-gu, Seoul, South Korea.
Myung-Ah
MA
Lee
Division of Allergy and Respiratory Medicine, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, 170 Jomaru-ro, Wonmi-gu, Bucheon, South Korea.
Do-Jin
DJ
Kim
Division of Hematology-Oncology, Department of Medicine, The Samsung Medical Center, Sungkyunkwan University School of Medicine, 135-710 Irwon-dong, Gangnam-gu, Seoul, South Korea.
Myung-Ju
MJ
Ahn
Department of Surgery, Kyung Hee University School of Medicine, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, South Korea.
Kil Yeon
KY
Lee
Division of Hematology and Medical Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon Regional Cancer Center, Gachon University School of Medicine, 1198 Guwol-dong, Namdong-Gu, Incheon, South Korea.
Sun Jin
SJ
Sym
Gynecologic Cancer Branch, Research Institute and Hospital, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea.
Myong Choel
MC
Lim
Merck Sharp & Dohme, 942-10 Daechi-dong, Gangnam-gu, Seoul, South Korea.
Hun
H
Jung
Merck Sharp & Dohme, 942-10 Daechi-dong, Gangnam-gu, Seoul, South Korea.
Eun Kim
EK
Cho
Merck Sharp & Dohme, 942-10 Daechi-dong, Gangnam-gu, Seoul, South Korea.
Kyung Wan
KW
Min
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D000077608:Aprepitant; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000009:adverse effects / Q000627:therapeutic use*; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D009369:Neoplasms / Q000188:drug therapy; D017294:Ondansetron / Q000627:therapeutic use; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*; D055815:Young Adult
D000932:Antiemetics; D009025:Morpholines; D000077608:Aprepitant; D017294:Ondansetron; D003907:Dexamethasone; D003520:Cyclophosphamide
Aprepitant; Chemotherapy-induced nausea and vomiting; Moderately emetogenic chemotherapy,; Neurokinin-1 receptor antagonists