Grading financial toxicity based upon its impact on health-related quality of life (HRQol).

16 Background: Financial toxicity (FTox) is an important symptom. We hypothesized that FTox can be graded based on statistically significant and clinically meaningful changes in HRQoL. Methods: FTox was assessed by the COST (COmprehensive Score for financial Toxicity) in 2 sets of cancer patients (pts). Set 1(S1): pts with Stage IV cancers on chemotherapy. Gradations of FTox were determined by ROC analyses based on conventions for clinically meaningful small (0.2), medium (0.5) and large (0.8) effect sizes (e.s.) for the FACT-G HRQoL instrument. Demographics, income, mood disorders (POMS), and symptoms (EORTC QLQ-C30) were collected. We computed η 2 (Eta squared) to estimate the magnitude of the variability in HRQoL explained by specific symptoms. Set 2 (S2): pts and survivors with thyroid cancer within 3 years of diagnosis. In S2, HRQoL was assessed by the thyroid-specific City of Hope HRQoL measure. Results: A total of 600 cancer pts were assessed (233 in the S1 and 367 in the S2). S1: the median COST value was 23 (range 0-44). ROC curve analyses produced 4 COST grades (G): G0 ≥ 26 (99 pts, 42%); G1: ≥ 14-26 (71 pts, 31%); G2: > 0-14 (58 pts, 25%); and G3: = 0 (5 pts, 2%). Pts with G0 had no impact of FTox on their HRQoL. Absolute e.s. decreases in FACT-G by grade compared to G0 were: G1, 0.59 (95% CI: 0.27 – 0.90); G2, 0.92 (CI: 0.59 – 1.26); G3, 1.77 (CI: 0.83 – 2.70). In multivariate analyses, mood explained 22% (CI 13-31%) of the variability in FACT-G; FTox, 7.6% (CI 2.2-15%); fatigue, 5.6% (CI 1.1-12%); pain, 3.6% (CI 0.3-9.6%); and loss of appetite, 3.4%(CI 0.3-9.3%). VS: applying the COST thresholds to S2, we had: G0: 154 pts (42%); G1: 126 (34%); G2: 84 (23%); and G3: 3(1%). The decreases in HRQoL measured in e.s. were: G1: 0.84 (CI: 0.68 – 1.00); G2: 1.88 (CI: 1.67 – 2.09); G3: 2.99 (CI: 2.29 – 3.68). The association between HRQoL and FTox was significant in multivariate models in both sets (p < 0.001). Conclusions: We developed and validated a FTox grading system in 2 different set of patients. This grading was anchored on independent and clinically meaningful changes in HRQoL attributable to FTox. FTox is a meaningful event that can be objectively measured, and should be included in the assessment of patient-centered outcomes.