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Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer After Moderately Emetogenic Chemotherapy

From the Princess Margaret Hospital, Toronto, Ontario, Canada; St Elizabeth's Medical Center, Brighton, MA; New York Lung Cancer Alliance; Columbia University, New York, NY; University of Vermont, UHC Campus/St Joseph, Burlington, VT; Copenhagen University Hospital Herlev, Herlev, Denmark; California Cancer Care, Greenbrae, CA; Merck & Co Inc, West Point, PA

Address reprint requests to David G. Warr, MD, Princess Margaret Hospital, Medical Oncology, 610 University Avenue, Toronto, Ontario, Canada M5G 2M9; e-mail: david.warr{at}uhn.on.ca

PURPOSE: This is the first study in which the NK₁-receptor antagonist, aprepitant (APR), was evaluated for the prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy.

PATIENTS AND METHODS: Eligible breast cancer patients were naive to emetogenic chemotherapy and treated with cyclophosphamide ± doxorubicin or epirubicin. Patients were randomly assigned to either an aprepitant regimen (day 1, APR 125 mg, ondansetron (OND) 8 mg, and dexamethasone 12 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, APR 80 qd) or a control regimen (day 1, OND 8 mg and dexamethasone 20 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, OND 8 mg bid). Data on nausea, vomiting, and use of rescue medication were collected with a self-report diary. The primary efficacy end point was the proportion of patients with complete response, defined as no vomiting and no use of rescue therapy, during 120 hours after initiation of chemotherapy in cycle 1. The secondary end point was the proportion of patients with an average item score higher than 6 of 7 on the Functional Living Index–Emesis questionnaire.

RESULTS: Of 866 patients randomized, 857 patients (99%) were assessable. Overall complete response was greater with the aprepitant regimen than with the control regimen (50.8% v 42.5%; P = .015). More patients in the aprepitant group reported minimal or no impact of CINV on daily life (63.5% v 55.6%; P = .019). Both treatments were generally well tolerated.

CONCLUSION: The aprepitant regimen was more effective than the control regimen for prevention of CINV in patients receiving both an anthracycline and cyclophosphamide.

Supported by Merck & Co Inc.

Presented in part at the 40th Annual Meeting of the American Society for Clinical Oncology, New Orleans, LA, June 6, 2004 (late-breaking abstract, oral presentation) and at the 16th International Symposium of the Multinational Association of Supportive Care in Cancer/The International Society of Oral Oncology, Miami Beach, FL, June 24, 2004 (poster).

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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