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Key Words

Breast cancer, nausea, vomiting, aprepitant (Emend®), quality of life. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary.)

Summary

Women receiving chemotherapy for breast cancer suffered significantly less vomiting and had better quality of life when they took a new drug called aprepitant (Emend®) in addition to standard drugs given to control nausea and vomiting.

Source

Journal of Clinical Oncology, April 20, 2005 (see the journal abstract).

Background

Nausea and vomiting (emesis) are common side effects of chemotherapy. However, chemotherapy drugs vary in the extent to which they cause nausea and vomiting. The drug cisplatin, for example, is considered “highly emetogenic” - that is, it makes most patients severely nauseated. Other drugs - considered “moderately emetogenic” - may cause nausea and vomiting in half of all patients who take them. Some studies suggest that women are more susceptible than men to this side effect.

Drugs used to prevent or treat nausea and vomiting caused by chemotherapy are called antiemetics. Two studies published in 2003 found that cancer patients treated with cisplatin who received a new antiemetic drug called aprepitant suffered less nausea and vomiting than patients who received standard antiemetic drugs (see the related story).

The current study was the first to test the effectiveness of aprepitant at preventing nausea and vomiting in patients who were taking chemotherapy drugs considered moderately likely to cause these side effects. Previous studies have shown that drugs that reduce the occurrence of nausea and vomiting in patients taking cisplatin are also effective against nausea and vomiting caused by other chemotherapy drugs.

The study involved patients in 11 countries, including the United States and Canada. The principal investigator was David G. Warr of Princess Margaret Hospital in Toronto, Canada.

The Study

A total of 866 women with breast cancer received chemotherapy with the drugs cyclophosphamide and either doxorubicin or epirubicin. These drug combinations are considered moderately likely to cause nausea and vomiting.

Patients were randomly assigned to receive one of two drug regimens to prevent this side effect. One group got aprepitant in addition to two standard antiemetic drugs, ondansetron and dexamethasone. The other group got the standard drugs and a placebo (dummy pill) instead of aprepitant. All patients took the antiemetic drugs shortly before receiving chemotherapy and for two days afterward.

The study was double-blinded, meaning neither the patients nor their doctors knew who was getting which drug regimen until the study was over.

Patients were allowed to take other (“rescue”) medications for relief of nausea and vomiting, as needed. On the day they received chemotherapy and for the next five days, they recorded in diaries how many episodes of nausea and vomiting they had and how much rescue medication they took. They also completed questionnaires that asked them to rate the impact of nausea and vomiting on their daily life.

Results

After one cycle of chemotherapy, 51 percent of the patients receiving aprepitant reported having a complete response - that is, they had no vomiting and did not need to take any rescue medication - compared with 42 percent of the patients who received a placebo. More patients taking aprepitant reported that nausea and vomiting had minimal or no impact on their daily life.

Aprepitant’s most pronounced effect was on the prevention of vomiting. Among patients who reported a complete response, 76 percent of those taking aprepitant reported no vomiting, compared with 59 percent of those who got a placebo. Aprepitant had no significant effect on nausea.

Limitations

Because of the way the body breaks down aprepitant, this drug may cause an increase in the side effects of other prescription medications (both cancer drugs and drugs for other conditions) that patients are taking, says Ted Trimble, M.D., of the National Cancer Institute’s Cancer Therapy Evaluation Program.

Doctors should observe patients carefully for possible adverse interactions with other drugs while they are taking aprepitant, Trimble recommends. In the current study, researchers saw no adverse events caused by the interaction of aprepitant with the chemotherapy drugs patients received.

Comment

“In this study, the addition of aprepitant to standard antiemetic therapy significantly improved control of vomiting and quality of life among women receiving moderately emetogenic chemotherapy for breast cancer,” says Trimble, adding that doctors should consider using aprepitant as a standard part of antiemetic therapy for this group of women.

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