Addition of Emend® Proven Superior for Prevention of Chemotherapy-Induced Nausea

Addition of Emend® Proven Superior for Prevention of Chemotherapy-Induced Nausea and Vomiting

According to two articles recently published in the Journal of Clinical Oncology, the addition of Emend® (aprepitant) to standard therapy is superior to standard therapy alone for the prevention and/or reduction of nausea and vomiting during cisplatin-based chemotherapy.

Nausea and vomiting are common side effects of chemotherapy treatment. When severe, nausea and vomiting can cause dehydration, complete loss of appetite, and disturbances in electrolytes and nutritional management. Dosing and/or scheduling of chemotherapy treatments may be affected due to severe nausea and vomiting, ultimately resulting in the delivery of suboptimal regimens. Therefore, the prevention and/or reduction or reducing chemotherapy-induced nausea and vomiting is of important consideration and researchers are continuing to develop and evaluate novel agents to address this issue.

Nausea and vomiting are typically managed with one or several conventional agents called antiemetics. Often, physicians will use combinations of antiemetics with different modes of action for either the prevention and/or treatment of chemotherapy-induced nausea and vomiting. The Food and Drug Administration (FDA) recently approved Emend® (aprepitant), an antiemetic classified as a neurokinin-1 antagonist, to be used in combination with other antiemetics, for the prevention of acute and delayed nausea and vomiting caused by chemotherapy.

The first trial reported in the Journal of Clinical Oncology was a multi-institutional clinical trial that evaluated the addition of Emend® to standard therapy for the prevention or reduction of chemotherapy-induced nausea and vomiting. This trial involved 202 patients who were all being treated with the chemotherapy agent cisplatin (Platinol®), which typically produces high rates of nausea and/or vomiting. All patients also received a standard regimen for prevention/reduction of nausea and vomiting consisting of ondansetron (Zofran®) and dexamethasone. Patients then either received Emend® in addition to ondansetron/dexamethasone, or placebo (inactive substitute) with ondansetron/dexamethasone and were compared in terms of nausea and vomiting. In the first course of chemotherapy, no vomiting (complete response) occurred in 64% of patients treated with Emend®, compared with only 49% of patients who received a placebo. In the sixth course of chemotherapy, complete responses were achieved in 59% of patients treated with Emend®, compared to only 34% of patients who received a placebo.1

The second clinical trial was also a multi-institutional clinical trial conducted to directly compared the addition of Emend® to standard therapy for the prevention/reduction of chemotherapy-induced nausea and vomiting, to standard therapy alone. This trial involved 520 patients who were all receiving cisplatin for treatment of cancer. Patients were divided into two groups: one group received Emend® plus ondansetron and dexamethasone, and the other group received placebo/ondansetron/dexamethasone for the prevention or reduction of nausea and vomiting caused by cisplatin. Between 1 and 5 days following treatment with cisplatin, complete responses (no vomiting) was achieved in 72% of patients who received Emend®, compared with only 52% of patients who received ondansetron/dexamethasone only. In addition, Emend® was generally well tolerated.2

The researchers from both of these trials concluded that the addition of Emend® to standard therapies greatly improve responses, compared to standard therapies alone, in the prevention or reduction of chemotherapy-induced nausea and vomiting. This finding is important as nausea/vomiting not only greatly reduces the quality of life of patients, but also carries medical implications such as dehydration, adverse nutritional maintenance, electrolyte disturbances and suboptimal delivery of treatment regimens. Patients who are to receive chemotherapy that is associated with nausea and vomiting may wish to speak with their physician about the risks and benefits of treatment with Emend®.

References:

1.de Wit R, Herrstedt J, Rapoport B, et al. Addition of the oral NK1 antagonist aprepitant to standard antiemetics provides protection against nausea and vomiting during multiple cycles of cisplatin-based chemotherapy. Journal of Clinical Oncology. Early release. Published online ahead of print October 14, 2003. Available at: http://www.jco.org/cgi/content/abstract/JCO.2003.10.128v1?ck=nck. Accessed October 28, 2003.

2.Hesketh P, Grunberg S, Gralla R, et al. The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatinthe aprepitant protocol 052 study group. Journal of Clinical Oncology. Early release. Published online ahead of print October 14, 2003. Available at: http://www.jco.org/cgi/content/abstract/JCO.2003.01.095v1?ck=nck. Accessed October 28, 2003.

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