Aloxi™ plus Emend® Highly Effective in Preventing Chemotherapy-Induced Nausea and Vomiting

According to results presented at the 40th annual meeting of the American Society of Clinical Oncology (ASCO), the combination of the anti-emetics Aloxi™ (palonosetron) plus Emend® (aprepitant) is highly effective in the prevention of acute and delayed chemotherapy-induced nausea and vomiting.

Nausea and vomiting caused by chemotherapy remains one of the most distressing side effects for patients undergoing treatment for cancer. Depending upon the chemotherapy agents or regimens given, up to 90% of patients may suffer from some form of chemotherapy-induced nausea and vomiting (CINV). Besides significantly reducing a patient’s quality of life, symptoms from CINV can be severely debilitating and often result in patients refusing further courses of chemotherapy, which minimizes chances for an optimal outcome. Furthermore, CINV is burdensome on the medical system, as nurses must spend follow-up time with phone calls or patient visits in addressing this issue. The time spent in dealing with CINV creates a financial impact, and steals time from the healthcare staff who could otherwise attend to other patients or medical issues.

CINV is divided into two main categories: acute CINV and delayed CINV. Acute CINV occurs within the first 24 hours of treatment, and delayed CINV occurs from 24 hours to 120 hours following treatment. Delayed CINV remains a highly under treated side effect in patients undergoing chemotherapy, as healthcare providers tend to underestimate the number of patients who suffer from delayed CINV. Furthermore, delayed CINV greatly impairs a patient’s ability to provide care to themselves or others once they have been discharged and are at home.

The anti-emetics referred to as the 5-HT3 inhibitors are the most effective anti-emetics and constitute the single greatest advance in the management of nausea and vomiting in patients with cancer. These drugs are designed to block one or more of the signals that cause nausea and vomiting. The most sensitive signal during the first 24 hours after chemotherapy appears to be 5-HT3. Blocking the 5-HT3 signal is one approach to preventing acute emesis (vomiting), or emesis that is severe, but relatively short-lived. All approved 5-HT3 inhibitors, except Aloxi™, are approved to prevent acute CINV. Aloxi™, the newest 5-HT3 inhibitor, has a distinct advantage over the other 5-HT3 inhibitors because it is approved for the prevention of delayed CINV in addition to acute CINV. Emend®, classified as a neurokinin1-receptor antagonist, is the first agent in its class to be approved for the prevention of CINV. It is approved, in combination with a 5-HT3 inhibitor and dexamethasone, for the prevention of delayed CINV in highly emetogenic chemotherapy (chemotherapy that is associated with high rates of emesis).

A multi-institutional clinical trial was recently conducted to evaluate the combination of Aloxi™ and Emend® in the prevention of CINV following several different chemotherapy regimens that were moderately or highly emetogenic. This trial, which was the first trial to evaluate this anti-emetic combination, included 39 patients, the majority of whom had breast cancer. The most commonly used chemotherapy combinations in this trial included doxorubicin plus cyclphosphamide, and paclitaxel plus carboplatin. Aloxi™ was administered only once, immediately prior to the administration of chemotherapy, and Emend® was administered on the first 3 days. Complete responses (no emesis and no additional medication for nausea and vomiting) was achieved in 90% of patients during the acute phase, and 80% of patients in the delayed phase. During both the acute phase (first 24 hours) and the delayed phase (24-120 hours), 97% of patients experienced no emesis. The most common side effects associated with the anti-emetic regimen were diarrhea, fatigue and constipation.

The researchers concluded that the combination of Aloxi™ and Emend® is highly effective in preventing both acute and delayed CINV following a variety of moderately to highly emetogenic chemotherapy regimens. The prevention of CINV not only allows for a significantly greater quality of life for patients during and following treatment, but for a higher compliance rate with subsequent treatment for their disease, resulting in optimal chances for a cure and/or improved long-term outcomes. Patients undergoing chemotherapy associated with nausea and vomiting may wish to speak with their physician about Aloxi™ or an Aloxi™-containing anti-emetic regimen.

Reference: Grote T, Hajdenberg J, Cartmell A, et al. Palonosetron (PALO) plus aprepitant (APREP) and dexamethasone (DEX) for the prevention of chemotherapy-induced nausea and vomiting (CINV) after emetogenic chemotherapy (CT). Proceedings from the 40th annual meeting of the American Society of Clinical Oncology. New Orleans, LA. 2004. Abstract #8262.

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