Jeong Eun Kim1, Joung-Soon Jang2, Jae-Weon Kim3, Yong Lee Sung4, Chi-Heum Cho5, Myung-Ah Lee6, Do-Jin Kim7, Myung-Ju Ahn8, Kil Yeon Lee9, Sun Jin Sym10, Myong Choel Lim11, Hun Jung12, Eun Kim Cho12, Kyung Wan Min12. 1. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic ro 43 gil, Sonpa-gu, Seoul, South Korea. 2. Department of Internal Medicine, Chung-Ang University College of Medicine, 101 Heukseok-ro, Dongjak-gu, Seoul, South Korea. alsaba@hanmail.net. 3. Department of Obstetrics and Gynecology, Seoul National University College of Medicine, 101 Daehak-ro Jongno-gu, Seoul, South Korea. 4. Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Korea University College of Medicine, 73 Inchon-ro, Seongbuk-gu, Seoul, South Korea. 5. Department of Obstetrics and Gynecology, School of Medicine, Keimyung University, 56 Dalseungro Jungku, Daegu, South Korea. 6. Department of Medical Oncology, Seoul St. Mary's Hospital, The Catholic University of Korea, 90 1 Hyehwa-dong, Jongno-gu, Seoul, South Korea. 7. 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. 8. 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. 9. Department of Surgery, Kyung Hee University School of Medicine, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, South Korea. 10. 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. 11. Gynecologic Cancer Branch, Research Institute and Hospital, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea. 12. Merck Sharp & Dohme, 942-10 Daechi-dong, Gangnam-gu, Seoul, South Korea.
Abstract
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT01636947 ( https://clinicaltrials.Gov/ct2/show/NCT01636947 ).
RCT Entities:
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT01636947 ( https://clinicaltrials.Gov/ct2/show/NCT01636947 ).
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