P01.111 Using the ASCO and ESMO frameworks to assess the clinical value of tumor treating fields for newly diagnosed Glioblastoma multiforme

Abstract Background The effectiveness and safety of TTFields in newly diagnosed GBM was recently demonstrated by the final analysis of the large, randomised controlled EF-14 Trial. To account for the need of physicians and policymakers to objectively and comparably capture the clinical value of new cancer treatments, the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) have both developed assessment frameworks. We quantified the clinical value of the TTFields treatment in GBM by applying ASCO and ESMO frameworks to the EF-14 trial data. Material and Methods The EF-14 Trial (n=695) proved the effect of adding TTFields to maintenance Temozolomide (TMZ) for newly diagnosed glioblastoma patients. The ESMO Magnitude of Clinical Benefit Scale (MCBS) and the ASCO Net Health Benefit (NHB frameworks provide separate calculations for a) adjuvant therapies and b) treatments for advanced diseases. We applied both classifications to the EF-14 trial data, using either the interim trial results or final 5-year trial results with mature follow up as required by the framework rules. Quality of life data from the EF-14 Trial was also included. Additionally, we performed a literature search to identify reference points for understanding the NHB score and MCBS results for TTFields in GBM. Results Applying the ASCO framework to the EF-14 data resulted in a NHB score of 56/72 (adjuvant/advanced). The ASCO NHB scores of 56/72 were among the highest reported scores identified in the literature search. Additionally, the ASCO framework valued the reduction in cancer-related symptoms (e.g., pain, weakness of legs) with TTFields. Applying the ESMO framework resulted in MCBS scores of A/5 (adjuvant/advanced). The MCBS scores of A/5 are the highest scores achievable in the ESMO framework. The ESMO framework valued the Health Related Quality of Life (HRQoL) gain during deterioration-free survival time with TTFields. Conclusion Despite differences in their respective concepts, both the ASCO and ESMO frameworks suggest that adding TTFields to maintenance TMZ for newly diagnosed glioblastoma patients provides patients with significant clinical benefits. The high scores underline the fact, that treatment with TTFields extended progression free and overall survival without additional systemic toxicities.