QOL-08. PHASE II RANDOMIZED STUDY TO EVALUATE EFFICACY AND SATISFACTION OF ROLAPITANT PLUS ONDANSETRON VS. ONDANSETRON MONOTHERAPY IN PREVENTING NAUSEA/VOMITING FOR GLIOMAS RECEIVING RADIATION/TEMOZOLOMIDE

Abstract BACKGROUND Nausea and vomiting remain the most feared cancer treatment-related side effects. Trials establishing antiemetic guidelines exclude malignant glioma (MG) patients. In MG patients receiving radiation with concurrent temozolomide, chemoradiation-induced nausea (cRINV) rates are 35 26%, respectively, which reduce quality of life, treatment adherence, potentially control.OBJECTIVES: a randomized phase II open label trial, we compared patient satisfaction efficacy ondansetron monotherapy (short-acting 5HT3-RA; 3h half-life) vs. rolapitant (long-acting NK1-RA; 180h plus in preventing cRINV during 6-weeks daily temozolomide (75 mg/m2/dX42d) radiation. METHODS Fifty-three eligible chemoradiation were to Arm-A (ondansetron 8mg Days 1-42, 180mg on Day 21) or Arm-B (rolapitant 1 ondansetron). Primary endpoint included percentage achieving cRINV-complete response (CR; no rescue) first 2-weeks Secondary endpoints cRIN/cRIV rates, preference for ondansetron, toxicity. RESULTS Forty-eight initiated protocol treatment. Mean age=53, 58% male, median KPS 90%, 71% low alcohol N/V risk factor, 73% glioblastoma. During radiation, cRINV-CR was 60% 25 evaluable 65% 23 rolapitant/ondansetron (p< 0.71). Patient-reported 61% 74%, respectively 0.41); cRIN (44% Arm-A; 53% Arm-B) more than cRIV (28% 11% Arm-B). More alone vomited (22%) (0%); p< 0.05. Among 32 who completed study, preferred (63%) over (19%); 0.0039; 19% had preference. Adverse events attributable (fatigue/constipation) all grade 1-2. CONCLUSIONS While prefer monotherapy, there difference between 2-week treatments some less ondansetron. We will present overall results.