EMEND indication helps women prevent CINV

May 26 2010

EMEND(R) indication updated by Health Canada includes broader group of women patients

More women fighting cancers such as breast, lung, colorectal and ovarian can now help prevent the nausea and vomiting associated with their treatment of moderately emetogenic (vomit-inducing) cancer chemotherapy (MEC). Although new treatment entities have been developed in the past 10 years for control of chemically-induced nausea and vomiting (CINV), CINV remains a significant problem in the context of current practice.

Today Merck announced that Health Canada has updated the indication for EMEND(R) (aprepitant) in combination with a 5-HT3 antagonist class of antiemetics and dexamethasone for the prevention of nausea and vomiting in women due to treatment with moderately emetogenic cancer chemotherapy (MEC). This new indication replaces the former indication "for the prevention of nausea and vomiting in women due to moderately emetogenic cancer chemotherapy consisting of cyclophosphamide and anthracycline". The indication in prevention of acute and delayed nausea and vomiting due to highly emetogenic cancer chemotherapy remains unchanged.

Consequences of chemotherapy-induced nausea and vomiting

Up to 75 per cent of cancer patients can experience CINV. Patients who are beginning cancer treatment consistently list CINV as one of their greatest fears. Uncontrolled nausea and vomiting might even influence patients to discontinue their treatment early.

The burden that CINV places on patients with cancer and the healthcare system can be considerable. In observational studies:

- 90 per cent of patients affected with CINV reported an impact on their quality of life - Over one in eight patients had a follow-up hospital visit associated with CINV defined as outpatient hospital visit, emergency room visit or hospitalization. Hospitalization was the most common type of visit for uncontrolled CINV.

More patients reported no vomiting

A randomized, double-blind, gender-stratified, parallel-group study involved 848 patients with a variety of tumour types - breast, lung, colorectal and ovarian. Patients scheduled to receive a single dose of one or more of a broad range of moderately emetogenic chemotherapy agents (any IV dose of carboplatin, oxaliplatin, epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, doxorubicin; cyclophosphamide IV (less than) 1500 mg/m2 ; or cytarabine IV (greater than) 1 g/m2) were randomized into the:

- Aprepitant group who received an antiemetic regimen consisting of 125 mg aprepitant, ondansetron 8 mg twice daily and dexamethasone 12 mg on Day 1, and aprepitant 80 mg once daily on Days 2 and 3>

The study's primary efficacy endpoint was met as significantly more patients taking aprepitant in combination with standard therapy reported no vomiting during the 120 hours following initiation of the first cycle of chemotherapy compared to the control group (76.2 per cent vs. 62.1 per cent, p(less than)0.0001).

In addition, the study's key secondary efficacy endpoint was met as significantly more patients achieved a complete response (defined as no vomiting and no use of rescue medications) up to 120 hours post-chemotherapy compared to the control group (68.7 per cent vs. 56.3 per cent,>

Aprepitant generally well tolerated

In this study, the overall incidence and types of adverse events were generally similar between the two treatment groups. The percentage of patients with drug-related adverse events, serious adverse events (including deaths), and adverse events resulting in discontinuation were comparable in the two treatment groups. The most frequently reported drug-related clinical adverse events in both treatment groups were constipation, fatigue, headache and diarrhea.