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