Lastly, the biggest thanks go to my mentor
@majorajay.bsky.social
, whose passion for PROs and quality of life investigation is incredibly inspiring. Thank you as well to everyone involved at The University of Chicago and @accordsresearch.bsky.social ! /end
bit.ly/3P4R0sy
#ASH24 #lymsm

Thank you for tuning in! This is a mid-study analysis, and we aim to enroll 75 patients before final analysis. We welcome any feedback and impressions from this study as enrollment continues! /14
bit.ly/3P4R0sy

This data also helps us counsel our pts before starting OOT. For example, looking back at HRQOL data, you can see that median FACT-LEU scores dipped at 3 months but increased to > baseline scores at 6 months. Pts might expect worse HRQOL initially, but it should get better! /13

Patients are at risk for FT regardless of out-of-pocket cost (no correlation between COST score and $0 copay), and qualitative data suggests that the uncertainty of future financial support for these often lifetime therapies drives FT /12

What does all of this mean and why is it important to clinicians?
- Patients on 1st line oral oncolytics for CLL are at risk for early and progressive FT AND suboptimal med adherence
- Patients in this group that experience FT are also likely to have worse HRQOL
/11

Take-aways from our qualitative analysis:
- Fear of losing financial assistance was very prevalent
- No one reported intentionally missing medications, but a few pts reported rare unintentional missed dose /10

Now let's look at how they all relate:
- FACIT-COST positively correlated with FACT-LEU score @ all time points
- FACIT-COST positively correlated with PROMIS-PMAS @ baseline
- Social wellbeing positively correlated with PMAS and MARS scores /9

The differences between FACT-LEU total median scores over time did not meet the minimally important difference threshold. When we looked at the components of FACT-LEU, emotional well-being and functional well-being had the lowest median scores at all timepoints. /8

PRO data for adherence similarly demonstrated increased suboptimal adherence behaviors over time. Interestingly, the MARS-5 and PROMIS-PMAS instruments tracked in the same direction, but were discrepant in the incidence of suboptimal adherence they caught. /7

In our PRO analysis, there was already a significant incidence of FT at baseline (22%), which increased over time. /6

47 patients completed PRO instruments at baseline. Longitudinal completion rates remained high (85% 3 mo, 83% 6mo).
- Median age 66, 53% male, 89% white
- 47% medicare, 45% private insurance
- 53% concurrent obinutuzumab
- 66% had $0 copay, 57% grant or PAP support
#ASH24
/5

To further validate these PRO instruments for CLL, we also conducted semi-structured interviews and used thematic analysis to assess concordance and discordance with PRO results. /4

The PROs we used to measure these variables were FACIT-COST for FT, FACT-LEU for health-related quality of life (HRQOL), and PROMIS-PMAS and MARS-5 for adherence. We measured at time of trial enrollment, 3 months, and 6 months /3

Why? Oral oncolytic therapy (OOT) is expensive! Out-of-pocket costs for patients with CLL are predicted to increase 520% by 2025. Additionally, financial toxicity (FT) has been associated with poor health-related quality of life and suboptimal adherence in other malignancies /2