In a new journal article published online ahead of print in Supportive Care in Cancer, Hoosier Cancer Research Network investigators reported on results of QL12-153, a phase II study of fosaprepitant + 5HT3 receptor agonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy. The multi-center study was led by sponsor investigator Lawrence H. Einhorn (pictured), of the Indiana University School of Medicine.

The study authors hypothesized that the substitution of multi-day oral aprepitant with intravenous fosaprepitant, in combination with a 5-HT3 receptor antagonist and dexamethasone, would provide comparable protection from 5-day cisplatin chemotherapy induced nausea and vomiting, compared to the results of a prior study of fosaprepitant in single-day cisplatin chemotherapy.

Sixty-five subjects were enrolled in the study, of whom 54 were eligible for analysis. Fifty-one subjects received bleomycin, etoposide, and cisplatin (BEP) chemotherapy. The primary objective was to determine the rate of complete response (CR), defined as no emetic episodes or use of rescue medications. The authors reported a CR rate of 24.1 percent, slightly lower than their expected CR rate of at least 27 percent.

The authors concluded, “the data in this phase II study, in contrast to our prior phase III study, appears to indicate a lower CR rate with the substitution of fosaprepitant for aprepitant. It is unknown whether the substitution of fosaprepitant for aprepitant provides the same benefit in multi-day cisplatin that was achieved with single-day cisplatin.”

Learn more about the QL12-153 study.

About Hoosier Cancer Research Network:

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in collaboration with academic and community physicians and scientists across the United States. The organization provides comprehensive clinical trial management and support, from conception through publication. Created in 1984 as a program of the Walther Cancer Institute, Hoosier Cancer Research Network became an independent nonprofit clinical research organization in 2007. Since its founding, Hoosier Cancer Research Network has initiated more than 150 trials in a variety of cancer types and supportive care, resulting in more than 300 publications. More than 4,600 subjects have participated in Hoosier Cancer Research Network clinical trials.