[1]Jilin Province Cancer Hospital, Changchun, China.
Background: Clinical studies have shown that Aprepitant (APR), a Neurokinin-1 receptor antagonist, is efficacious in preventing chemotherapy induced nausea and vomiting (CINV) and well tolerated. The efficacy, safety, and tolerability of APR in Chinese patients have not been studied. In this phase III, multicenter, double-blind, placebo-controlled, randomized study, we assessed the efficacy, safety, and tolerability of a 3-day oral APR regimen compared with that provided by a standard therapy regimen (ST) in Chinese patients. Methods: Four hundred twenty-one patients receiving chemotherapy including cisplatin (≥70 mg/m(2)) were randomly assigned (1:1) to receive the APR regimen (APR 125 mg po d1 and 80 mg d2-3, granisetron 3 mg iv d1, DEX 6 mg po d1, and 3.75 mg d2-4) (n=209) or the ST (placebo d1-3, granisetron 3 mg iv d1, and DEX 10.5 mg d1 and 7.5 mg d2-4) (n=212). The primary endpoint was the percentage of patients with complete response (CR; no emesis and no use of rescue therapy) in the overall phase (0 - 120 hours after chemotherapy); secondary endpoints were no vomiting (NV), time to first vomiting episode, and patient-reported impact of CINV on daily life. Results: Overall baseline characteristics were balanced between two arms. All patients received at least one dose of treatment drug and had at least one post-treatment assessment. The proportions of patients with CR in the overall phase were 69.6% in the APR regimen and 57.0% in the ST regimen (p=0.007). The proportions of patients with NV were 70.6% and 57.0%, respectively (p=0.003). Results from the Quality of Life questionnaire showed significant differences between the APR and ST in two of the vomiting domains: 'ability to enjoy a meal' (76.0% vs. 66.3%; p<0.05) and 'hardship on others' (78.0% vs. 67.3%; p<0.05). The incidence of adverse events was generally similar in both treatment groups. In addition, the distribution of toxicity grades was also generally similar between groups. Conclusions: In our study, the addition of APR to the standard antiemetic treatment regimen was superior in preventing CINV and was well tolerated compared with the ST alone in Chinese patients undergoing cisplatin therapy.
(8.0+极速模式)