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
| Autor: | Yong Lee Sung, Joung Soon Jang, Jae Weon Kim, Kil Yeon Lee, Chi Heum Cho, Eun Kim Cho, Myung-Ju Ahn, Kyung Wan Min, Do Jin Kim, Jeong Eun Kim, Hun Jung, Myung Ah Lee, Myong Choel Lim, Sun Jin Sym |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Adult Male medicine.medical_specialty Nausea Vomiting Morpholines Population Placebo Dexamethasone Ondansetron 03 medical and health sciences Young Adult 0302 clinical medicine Double-Blind Method Internal medicine Neoplasms Antineoplastic Combined Chemotherapy Protocols medicine Humans education Cyclophosphamide Aprepitant Aged Aged 80 and over education.field_of_study business.industry Middle Aged Regimen 030104 developmental biology Oncology 030220 oncology & carcinogenesis Anesthesia Antiemetics Female medicine.symptom business medicine.drug Chemotherapy-induced nausea and vomiting |
| Zdroj: | Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 25(3) |
| ISSN: | 1433-7339 |
| Popis: | 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 ) |
| Databáze: | OpenAIRE |
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