Affronti and Colleagues Publish Article in Supportive Care in Cancer

Mary Lou Affronti, associate professor, published an article entitled "Randomized open-label phase II trial of 5-day aprepitant plus ondansetron compared to ondansetron alone in the prevention of chemotherapy-induced nausea-vomiting (CINV) in glioma patients receiving adjuvant temozolomide" in Supportive Care in Cancer. Co-authors include Malika Patel, Sarah Woodring, Dina Randazzo, Henry Friedman, Annick Desjardins, Patric Healy, James Herndon II, Frances McSherry, Eric Lipp, Elizabeth Miller, and Katherine Peters. These co-authors represented multiple areas of Duke including Department of Pharmacy, Department of Neurosurgery, Department of Neurology, Duke Cancer Center Biostatistics, and Department of Biostatistics and Bioinformatics.

Abstract

PurposeCINV remains a distressing side effect experienced by glioma patients receiving multi-day temozolomide therapy, inspite of guideline-based antiemetic therapy with selective serotonin-receptor-antagonists. Antiemetic research with aprepitant hasroutinely excluded glioma patients. In this randomized open-label phase II study, use of a nonstandard 5-day regimen ofaprepitant for glioma patients was investigated.MethodsOne hundred thirty-six glioma patients receiving their first cycle of adjuvant temozolomide (150–200 mg/m2/day ×5 days every 28 days) were randomized to Arm-A (ondansetron 8 mg days 1–5 with aprepitant day 1: 125 mg, days 2–5: 80 mg)or Arm-B (ondansetron). Randomization was stratified by tumor grade and number of prior chemotherapy regimens. The primaryendpoint was the percentage of patients achieving complete control (CC), defined as no emetic episode or antiemetic rescuemedication over the 7-day study period. Secondary endpoints included CINV efficacy in the acute phase (≤24 h) and delayedphase (days 2–7), as well as safety and quality of life (QoL).ResultsPatients were 61% male, 97% white, 48% with KPS > 90%, 60% non-smokers, mean age 54, 92% with low alcohol use,and 46% with a CINV history. The CC was 58.6% (Arm-A) and 54.5% (Arm-B). Acute-complete response (CR) rates, defined asCC on day 1 in Arm-A and -B, were 97.1% and 87.9%, respectively (p= 0.056). Treatment-related toxicities were mild ormoderate in severity.ConclusionsAprepitant plus ondansetron may increase acute-CR, may have benefit regarding CINV’s effect on QoL, and is safefor 5-day temozolomide compared to ondansetron. This study provides no evidence that aprepitant increases CC rate overondansetron alone.