3692 - Evaluation of the ESMO-Magnitude of Clinical Benefit Scale Version 1.1 for the Definitive Treatment of HPV Positive Oropharynx Cancer with Radiation
Presenter(s)
Y. Nijjar1, E. Sapir2, B. W. Corn3, and M. F. Gensheimer4; 1Department of Oncology, University of Alberta, Edmonton, AB, Canada, 2Radiation Oncology Institute, Samson Assuta Ashdod University Hospital, Ashdod, Israel, 3Department of Oncology, Hebrew University Faculty of Medicine, Jerusalem, Israel, 4Department of Radiation Oncology, Stanford University School of Medicine, Stanford, CA
Purpose/Objective(s): The European Society for Medical Oncology (ESMO)-Magnitude of Clinical Benefit Scale (MCBS) has been widely used to assess the benefit of systemic therapies; however, its applicability in evaluating the benefit of local therapies, such as radiation therapy (RT), remains under investigation. While the tool has been applied to evaluate the clinical benefit of adjuvant breast cancer radiation and RT in oligometastatic cancer, it has not yet been used in the context of definitive RT. In this study, we aimed to assess the applicability of the ESMO-MCBS v1.1 to oropharyngeal (OPX) cancer treatments by evaluating relevant studies for data scorability, the appropriateness of clinical benefit grades, and identifying limitations in its use for RT.
Materials/Methods: We applied the ESMO-MCBS v1.1 to the references in the American Society for Radiation Oncology (ASTRO) evidence-based guidelines on Human Papilloma Virus (HPV) positive OPX cancer. Seventy-three references that addressed key questions in the paper were identified. For each reference, we recorded whether it was scorable per the ESMO-MCBS v1.1, reason for not being scorable (if applicable), and benefit score for the investigated treatment.
Results: Of the 73 studies cited as evidence in addressing key questions for the guidelines, 9 were scorable with the ESMO-MCBS v1.1. Forty out of 73 studies could not be scored because they did not meet the criteria, as the ESMO-MCBS v1.1 is limited to assessing studies with a quality of evidence at or above that of a randomized controlled trial. Of the remaining 33 studies, 24 could not be scored due to the following limitations: (1) No benefit from the intervention in survival or quality of life (n=13). (2) In studies with significant findings, a score cannot be assigned if there is no hazard ratio (HR) defined (n=2). (3) Studies that show local control benefit without survival benefit cannot be scored as there is no grading assigned for this benefit (n=4). (4) Results of subset analyses are unable to be graded with the current ESMO-MCBS despite influencing practice guidelines in head/neck cancer (n=5). For the 9 scorable interventions, there were 3 Grade A, 5 Grade B, and a trial with 3 arms in which one arm achieved Grade A. Limitations in the ESMO-MCBS v1.1 in this setting included inability to value local control, and ambiguity in the appropriate follow-up time to use when grading studies with long-term follow-up results.
Conclusion: This study further explores the utility of the ESMO-MCBS v1.1 tool in assessing clinical benefits of radiotherapy. Several limitations were identified, which should be addressed in order to develop a version of the ESMO-MCBS that can be effectively applied to radiotherapy treatments. Efforts to assess the value of radiotherapy, by both payers and providers, will be a mandatory expectation of contemporary healthcare systems.