Phase II randomized glioma study to evaluate efficacy and satisfaction of rolapitant plus ondansetron in preventing chemoradiation-induced nausea and vomiting.
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2025-08
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Abstract
Background
Nausea and vomiting remain feared cancer treatment-related side effects. Antiemetic guideline trials exclude malignant glioma patients. In patients receiving radiation with concurrent temozolomide, chemoradiation-induced nausea; vomiting (cRINV) rates are 35% and 26%, respectively, which reduce quality of life, treatment adherence, and cancer control.Methods
This randomized phase-II open-label trial, evaluated efficacy, patient preference, and satisfaction of ondansetron (short-acting 5HT3-RA; 3 h-half-life) monotherapy versus rolapitant (long-acting NK1-RA; 180 h-half-life) plus ondansetron in preventing cRINV during 6 weeks of temozolomide (75 mg/m2/day × 42 day) with radiation. Fifty-three eligible patients were randomized to Sequence-A (ondansetron-8 mg days: 1-42, day 22 rolapitant-180 mg) or Sequence-B (rolapitant day 1 plus daily ondansetron). Primary endpoint was percentage achieving cRINV-complete response (no vomiting/antiemetic rescue) during the first 2 weeks of radiation. Secondary endpoints: cRIN/cRIV rates, preference/satisfaction for rolapitant/ondansetron, toxicity, and adherence.Results
Forty-eight (Sequence-A: 25; Sequnce-B: 23) initiated chemoradiation. Mean age = 53, 58% male, 73% Karnofsky performance status (KPS) > 90%, and 73% glioblastoma. During first 2 weeks of radiation, cRINV-CR was 57% with ondansetron and 74% receiving rolapitant/ondansetron (P = .27). Patient-reported 6-week cRINV-CR was 55% for both arms. First 2-week cRIN rates (38% Sequence-A; 32% Sequence-B) were more than cRIV rates (19% Sequence-A; 0% Sequence-B). Patients receiving ondansetron alone vomited more during the first 2 weeks and overall (26%) than with rolapitant/ondansetron (11%). Among 35 completers, 20% preferred rolapitant/ondansetron, 60% preferred ondansetron, and 20% had no preference (P = .0004). Adverse-events attributable to antiemetics were grade 1-2.Conclusions
No difference was found in cRINV-CRs between the first 2-week treatments or overall satisfaction. Although not a positive study, less vomiting occurred with rolapitant/ondansetron. While patients prefer ondansetron monotherapy, most perceived better effectiveness with rolapitant/ondansetron.Type
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Affronti, Mary Lou, Mallika P Patel, Erin K Severance, Charles Loughlin, Claire Bradbury, James E Herndon, Kendra Boyd, Eric S Lipp, et al. (2025). Phase II randomized glioma study to evaluate efficacy and satisfaction of rolapitant plus ondansetron in preventing chemoradiation-induced nausea and vomiting. Neuro-oncology practice, 12(4). pp. 618–630. 10.1093/nop/npaf014 Retrieved from https://hdl.handle.net/10161/34361.
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Mary Louise Affronti
Dr. Mary Lou Affronti DNP, RN, MHSc, ANP, FAAN is a Clinical Professor, Assistant Dean of the Doctor of Nursing Practice Program and Director of the Oncology Specialty who joined the Duke University School of Nursing faculty in February 2014. She is the Adult Gerontology Nurse Practitioner and Oncology Specialty Lead Faculty. She earned both her DNP and her MSN at DUSON and additionally earned a Master of Health Science degree in Clinical Research from the Duke University School of Medicine. She held a Clinical Associate faculty appointment in the Duke University Medical Center Department of Surgery /Neurosurgery. She is also Primary Investigator and Adult Nurse Practitioner at the Preston Robert Tisch Brain Tumor Center in the Duke Cancer Institute.
Dr. Affronti has been a part of Duke’s oncology clinical and research community for over four decades and has been associated with DUSON since 1989 in a variety of roles, including clinical associate, guest lecturer, preceptor, and clinical instructor. She was instrumental in developing the oncology curriculum for DUSON nurse practitioner students. In 2005, she was honored by the Friends of Nursing at Duke with the Evelyn Morgan Award for Excellence in Oncology Nursing. Dr. Affronti’s DNP Project on adherence to antiemetic guidelines in patients with malignant glioma, received the Outstanding Capstone Doctoral Project Award in 2013, was published in Supportive Care in Cancer, and was cited in 2016 New England Journal of Medicine Antiemetic Review Article. Dr. Affronti was the Recipient of the Southern Nursing Research Society Clinical Research Award in 2018. In recognition of her many scholarly, teaching, service, and practice contributions, she was inducted as a Fellow in the American Academy of Nursing (FAAN) and was a Great 100 Nurses in North Carolina award recipient in 2020.
Dr. Affronti has been developing and leading therapeutic and supportive care research while seeing patients in the consult setting as a nurse practitioner and is continuing both her clinical and research activities at the Brain Tumor Center. She has a strong interest in the development and testing of therapies and supportive care for primary brain tumors as a co-principal or principal investigator on many Phase II clinical trials at the Duke Brain Tumor Center. She was chairman of the Multinational Association of Supportive Care in Cancer (MASCC) guideline committee on Patient Antiemetic Guidelines and a member on the 2023 global antiemetic guideline committee. She is co-chair of the MASCC Antiemetic Study Group and a Society for Neuro-Oncology Board Member representative for the neuro-oncology advanced practice providers and allied health.
Annick Desjardins
Margaret Johnson
I am a neuro-oncologist, neurologist, and palliative care physician at the Preston Robert Tisch Brain Tumor Center. I also provide neuro-oncology expertise for the National Tele-Oncology Program and National Precision Oncology Program at the Veteran's Health Administration. My clinical and research interests encompass supportive care and palliative care with a special interest in older adults with brain tumors. The incidence of malignant brain tumors like glioblastoma and non-malignant tumors like meningioma affect aging populations and it is crucial to be able to provide better care for these patients.
Katherine Barnett Peters
Katy Peters, MD, PhD, FAAN is a professor of neurology and neurosurgery at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke. Her academic medical career started at Stanford University School of Medicine, receiving an MD and Ph.D. in Cancer Biology. After completing a neurology residency at Johns Hopkins University and a fellowship in cognitive neurosciences, Katy joined the PRTBTC as a neuro-oncology fellow. In 2009, she became a faculty member at PRTBTC. With a fantastic team of nursing and advanced practice providers, she actively sees and cares for patients with primary brain tumors. Her research interests include supportive care for brain cancer patients, cognitive dysfunction in cancer patients, and physical function and activity of brain cancer patients. While she runs clinical trials to treat primary brain tumors, her key interest is on clinical trials that focus on improving brain tumor patients' quality of life and cognition. In 2019, the PRTBTC designated her as the Director of Supportive Care, thus furthering the PRTBTC and her committee to better the quality of life for brain tumor patients. She is active in teaching medical school students, residents, fellows, and advanced practice providers and is the Program Director of the PRTBRC neuro-oncology fellowship. She is board certified by the American Board of Psychiatry and Neurology and the United Council of Neurologic Subspecialties for neuro-oncology.
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