The sequence of treatment with rolapitant and ondansetron does not appear to impact the efficacy of these drugs for preventing chemoradiation-induced nausea and vomiting (cRINV) in patients with malignant glioma, a study suggests.
There was no significant difference in cRINV between patients who received ondansetron monotherapy followed by dual therapy with rolapitant and ondansetron (sequence A) and those who received dual therapy with rolapitant and ondansetron followed by ondansetron monotherapy (sequence B).
These results were presented in a poster at the Society for Neuro-Oncology 27th Annual Meeting.
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This phase 2 study included 48 patients with newly diagnosed, histologically-confirmed malignant glioma. The mean age of the patients was 52.67 years, 58.33% were men, 95.83% were White, and 72.92% had glioblastoma. The patients received 6 weeks of daily temozolomide and radiotherapy.
For the prevention of cRINV, the patients were randomly assigned to receive treatment sequence A (n=25) or B (n=23). Sequence A consisted of 3 weeks of ondansetron monotherapy (8 mg daily), followed by rolapitant (180 mg) plus ondansetron (8 mg daily) for 3 weeks. Sequence B consisted of 3 weeks of the same dual therapy, followed by 3 weeks of the same monotherapy.
There was no significant difference in treatment adherence between the arms. Adherence was defined as completing at least 20 days of treatment. The adherence rate for the first 3 weeks was 86.96% for sequence A and 95.00% for sequence B (P =.6105). Adherence rates during the second 3 weeks were 65.22% and 85.00%, respectively (P =.1753).
Complete response (CR) rates did not differ between the arms during the first 2 weeks of treatment. CR was defined as no vomiting or use of rescue antiemetic drugs. Using the Multinational Association of Supportive Care in Cancer Antiemesis Tool (MAT), the CR rate was 57.17% with sequence A and 73.68% with sequence B (P =.2734). Using MAT supplemented with nurse notes, the CR rate was 60.00% and 65.22%, respectively (P=.7091).
The reported rates of nausea and vomiting did not differ significantly between the treatment arms during the first 2 weeks of treatment or during the entire 6-week treatment period. During the entire treatment period, the rate of nausea was 50.00% for sequence A and 55.56% for sequence B (P =.7385). The rate of vomiting was 27.78% and 11.11%, respectively (P =.4018).
When asked which treatment they preferred, 61.75% of patients said they preferred ondansetron monotherapy, 20.59% said they preferred rolapitant and ondansetron dual therapy, and 17.32% said they had no preference.
The researchers also assessed patient satisfaction at week 3 using the Treatment Satisfaction Questionnaire for Medication. Patients reported higher effectiveness scores with dual therapy vs monotherapy (mean, 94.44 vs 83.60; P =.0406). They also reported higher convenience scores with dual therapy vs monotherapy (mean, 94.15 vs 85.71; P =.0541). The difference in overall satisfaction scores with dual therapy and monotherapy was not significant (mean, 90.94 vs 81.88; P =.0781).
Disclosures: The study authors did not provide disclosures.
Reference
Affronti ML, Patel MP, Severance E, et al. 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. Presented at SNO 2022; November 16-20, 2022. Abstract QOL-08.
