Financial Toxicity and Patient Experience Outcomes on a Multi-Institutional Phase I Single Fraction Stereotactic Partial Breast Irradiation Protocol for Early-Stage Breast Cancer

Abstract

Given the demonstrated financial toxicity (FT) of radiation treatment on breast cancer patients shown in both conventional and our recent 5 fraction stereotactic APBI (S-PBI) study, we assessed the FT, as well as patient-reported utility, quality-of-life and patient experience measures, on patients treated in our phase I single fraction S-PBI trial. A phase I single fraction dose escalation trial of S-PBI for early-stage breast cancer was conducted. Women with in-situ or stage I-II (AJCC 6) invasive breast cancer following breast conserving surgery were treated with S-PBI in 1 fraction to a total dose of 22.5, 26.5 or 30 Gy (Clinical trials.gov ID NCT02685332). At one month follow-up, patients were asked to complete our novel "Patient Perspective Cost and Convenience of Care Questionnaire". Patients also completed the EQ-5D-5L, including the visual analogue scale of overall health (VAS), at enrollment, 6, 12-, 24-, 36-, and 48-month follow-up. Of 29 patients enrolled and treated, questionnaire data was available for all patients. Our trial encompassed a wide range of annual household incomes, education, and employment status. Overall, 44.8% (n = 13/29) of patients reported that radiation treatment presented a financial burden. Interestingly, no demographic information, such as patient race, marital status, education, household income, or employment during treatment predicted perceived FT. Patients reporting FT trended towards younger age (median 64 vs 70.5) and having a cancer related co-pay similar to our 5 fraction S-PBI FT trial; however, due to the small size of this study, this did not reach significance (p = 0.24 and 0.10, respectively). VAS and utility scores were calculated per the EQ-5D-5L and remained unchanged from baseline through 4-year follow-up. Likewise, there was no difference in the utility or VAS between patients who reported FT and those who did not. Interestingly, while patient reported cosmesis was similar for all patients at enrollment, patients who reported FT noted significantly worse cosmesis scores (fair/poor vs good/excellent) at 6 month and 2-year follow-ups (p = 0.01 and 0.04, respectively). Finally, patients were surveyed on treatment related disruption to their daily activities and enjoyment of life. The median values were 0 (scale 0-10, with 0 being no disruption) regardless of perceived FT. Patients were also uniformly satisfied with treatment time with a median score of 10 (scale 0-10, 10 being most satisfied). Here, we show that despite using SPBI in a single fraction, nearly half of the patients treated still reported FT of treatment. Importantly, single fraction S-PBI has no negative impact on patient VAS or utility scores, and all patients were uniformly satisfied with treatment time without significant disruption to their life.