6615 Background: FT is an important adverse event (AE) that should be objectively measured in clinical practice. We previously developed an evidence-based FT grading system based on differences in HRQoL, analogous to the NCI-Common Terminology Criteria for Adverse Events (grade 1, mild AE; grade 2, moderate AE; grade 3, severe AE ,de Souza et al - ASCO 2015). We aimed to validate this grading system using a new sample of cancer patients (pts) and report its association with bankruptcy. Methods: FT was assessed by the COST (COmprehensive Score for financial Toxicity) in 2 sets of cancer pts. In the previously reported Development Set (DS), gradations of FT 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 independent FACT-G differences attributable to FT in pts with Stage IV cancers on chemotherapy. In the Validation Set (VS), differences in HRQoL and the odds ratio for a pt to have declared bankruptcy after the cancer diagnosis were assessed in a larger cohort of cancer pts on chemotherapy. Results: The grading system was developed in 888 cancer pts with cancer (233 pts in the DS and 655 in the VS). In the DS, ROC analyses produced 4 FT grades (G): G0, no FT, COST ≥26 (99 pts, 42%); G1, mild FT: ≥ 14-26 (71 pts, 31%); G2, moderate FT: > 0-14 (58 pts, 25%); and G3, severe FT: COST = 0 (5 pts, 2%). Applying the FT grading to the 655 pts in VS, we had: G0, 146 pts (22%); G1, 281 (43%); G2, 215 (33%); and G3, 13 (2%). The decreases in FACT-G HRQoL measured in e.s. per FT grading in comparison with G0 were small for G1: -0.4 (95%CI: -0.6 – -0.25); large for G2: -0.9 (95%CI: -1.1 – -0.7); and even larger for G3: -1.5 (95%CI: -2.0 – -0.9), all with p < 0.001. In the VS, 23 pts (4%) had declared bankruptcy after their cancer diagnosis. Compared to FT G0, the odds of having declared bankruptcy were 8.6 (95%CI: 1.1 – 67, p = 0.04) times higher for pts with FT G2, and 29 times higher (95% CI: 2.4 – 355, p = 0.008) for those with G3 FT. Conclusions: We developed a FT grading system anchored on independent differences in HRQoL. We applied the system in a different set of cancer pts and it retained its validity. We also found an larger incidence of bankruptcy after the cancer diagnosis in higher grades of FT, adding to the grading’s meaningful use.
e21673 Background: FT has been defined as an adverse event of cancer treatments. Several patient (pt)-level interventions have been developed to mitigate FT. However, due to the lack of longitudinal studies, the impact of these interventions has not been established. Methods: Pts with cancer receiving Co-Pay Assistance (CPA) from the Patient Access Network Foundation were approached at baseline, 1 and 3 months post-CPA. We assessed the use of pt navigators, social workers, financial counselors, support groups, and transportation vouchers by pts. The outcomes were improvements in disease-specific HRQoL measures, global HRQoL measure (FACTG, lower values are worse) and improvement in FT, as measured by the COST (lower values are worse). Multivariable regression was used to identify whether these interventions were associated with the outcomes. Results: 308 pts with cancer were assessed at baseline (prior to CPA) and at 1 and 3 months after. 275 pts (89%) had an improvement in their FT over 3 months. A majority of these pts had multiple myeloma (MM, 86 pts, 28%). Navigators were used by 179 pts (42%), social workers by 106 (34%), financial counselors by 107 (35%), support groups by 94 (31%), and transportation vouchers by 50 (16%). None of these interventions increased the odds of FT or HRQoL improvement at the 0.05 significance level. Conclusions: The selected population of cancer pts who received CPA for their treatments had a significant improvement in FT over time. Yet, this improvement was not associated with additional interventions, suggesting CPA as the main intervention. The FT improvement was not clearly translated into significant HRQoL improvements, likely due to the multidimensional HRQoL construct (which includes other symptoms) versus the unidimensional aspect of a financial event. [Table: see text]
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