EMEND® (aprepitant) Helps Prevent Nausea/Vomiting for Breast Cancer Patients

Main Category: Breast Cancer
Article Date: 19 Apr 2005 - 14:00 PDT

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The results of an investigational study evaluating the effect of an antiemetic regimen including EMEND® in the prevention of nausea and vomiting after chemotherapy in breast cancer patients were published today in the Journal of Clinical Oncology (JCO). Results from this study of patients who received chemotherapy treatments moderately likely to cause nausea and vomiting showed that significantly more breast cancer patients treated with the regimen including EMEND (EMEND in combination with a 5-HT3 receptor antagonist and a corticosteroid) reported a complete response in the five days after initiation of chemotherapy compared to a standard regimen (5-HT3 receptor antagonist and a corticosteroid) (50.8% vs. 42.5%, p=0.015), as measured after the first cycle of chemotherapy. Complete response is defined as no vomiting and no use of other therapies for nausea or vomiting.

Additionally, significantly more patients in the group taking EMEND reported no vomiting over the five days of the study (76% vs. 59%, p <0.001). Use of other therapies for nausea and vomiting was similar between the two treatment groups (59% vs. 56%, p=ns). Also, more patients receiving EMEND reported minimal or no impact of nausea and vomiting on their daily life (63.5% vs. 55.6%, p=0.019).

"Patients often report that the vomiting and nausea associated with chemotherapy is very difficult and distressing for them and their families, and breast cancer patients can be particularly vulnerable to nausea and vomiting," said Kelly B. Pendergrass, M.D., study investigator and clinical oncologist at Kansas City Cancer Center. "In this study of breast cancer patients who received chemotherapy that is moderately likely to cause nausea and vomiting, we found that in the group of patients who received the regimen including EMEND, fewer patients experienced nausea and vomiting after chemotherapy than patients who received other common therapies used alone."

Both regimens were generally well tolerated. The most common adverse events reported with both patient groups were hair loss, fatigue, headache and constipation.

This worldwide, multi-center, randomized, double-blind, parallel-group study evaluated 857 breast cancer patients who had never before undergone chemotherapy. Patients in the study received chemotherapy that is moderately likely to cause nausea and vomiting and is the most frequently used chemotherapy regimen used to treat breast cancer. The following agents were administered either alone or in combination: IV cyclophosphamide 750-1500 mg/m2 (+ 5%); IV cyclophosphamide 500-1500 mg/m2 (+ 5%) and IV doxorubicin <60 mg/m2 (+ 5%); IV cyclophosphamide 500-1500 mg/m2 (+ 5%) and IV epirubicin <100 mg/m2 (+ 5%); other chemotherapeutic agents Hesketh Level 2 or lower were allowed to be added to the above chemotherapeutic regimens. Patients were randomized to receive either the regimen including EMEND (day 1: EMEND 125 mg one hour before chemotherapy, ondansetron 8 mg 30-60 minutes before chemotherapy and dexamethasone 12 mg 30 minutes before chemotherapy followed by ondansetron 8 mg eight hours later; days 2-3: EMEND 80 mg once daily) or a standard regimen (day 1: ondansetron 8 mg 30-60 minutes before chemotherapy, dexamethasone 20 mg 30 minutes before chemotherapy and ondansetron 8 mg eight hours later; days 2-3: ondansetron 8 mg twice daily). Patients reported incidences of nausea, vomiting and use of other medications for nausea and vomiting in a diary for five days.

EMEND, when added with other medicines, is currently approved in the United States to help prevent and control nausea and vomiting caused by initial and repeat courses of chemotherapy treatments that are highly likely to cause nausea and vomiting in adult patients.

Important information about EMEND

EMEND is not used to treat nausea and vomiting that patients already have. Patients should tell their doctor about all the medicines they are taking, if they are pregnant or plan to become pregnant, or if they have liver problems. EMEND may cause serious life-threatening reactions if used with certain medicines. Patients should not take EMEND if they are taking any of the following medicines: ORAP® (pimozide), SELDANE® (terfenadine), HISMANAL® (astemizole) or PROPULSID® (cisapride). Taking EMEND with these medicines could cause serious or life-threatening problems.

EMEND may also affect some medicines, including chemotherapy, causing them to work differently in the body. Women who use birth control medicines during treatment with EMEND and for up to one month after using EMEND should also use a back-up method of contraception to avoid pregnancy.

The most common side effects with EMEND are tiredness, nausea, hiccups, constipation, diarrhea, and loss of appetite. These are not all of the possible side effects of EMEND.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in more than 20 therapeutic categories. The company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.

Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.

EMEND® is a registered trademark of Merck & Co., Inc. All other brands are trademarks of their respective owners and are not trademarks of Merck & Co., Inc.

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