Delayed Release Chemo Anti-Nausea Drug Performs Well in Trials

According to an abstract presented at the 2015 American Society of Clinical Oncology (ASCO) Breast Cancer Symposium in San Francisco, a delayed release formulation of an anti-nausea drug could be of benefit to patients who are receiving so-called highly emetogenic chemotherapy (HEC), meaning chemo regimens with a high likelihood of nausea and/or vomiting.

The formulation in question is APF530, which is a delayed release formulation of granisetron. It should be noted that granisetron itself is not currently approved by the US FDA.

The presentation discussed the MAGIC trial, a phase III, prospective, randomized, placebo-controlled, double-dummy, double-blind trial that included 942 patients who were receiving an HEC regimen, with the most common being either doxorubicin/cyclophosphamide-based or cisplatin-based regimens.

In one arm, patients received ondansetron and a placebo injection. In the other, they received an ondansetron placebo and an injection of the investigative drug, APF530.

Both arms received fosaprepitant and dexamethasone.

In short, those in the APF530 arm experienced a higher rate of delayed-phase complete response, a higher complete control rate, and a higher rate of no emetic episodes. However, the numbers were pretty close in all categories.

Perhaps the most troubling aspect of this story comes from cancernetwork.com, which reports that during this symposium presentation, Clifford A. Hudis, MD, of Memorial Sloan Kettering Cancer Center in New York noted that "many oncologists may not even be aware of what anti-emetic drugs are used with which chemotherapy regimens, as they are automated and built into drug ordering systems." (Those are the words of cancernetwork.com, not a direct quote from Dr. Hudis).

Source: cancernetwork.com

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