High rates of financial toxicity and time toxicity in patients receiving chimeric antigen receptor therapy and bispecific antibodies for lymphoma and multiple myeloma: A prospective mixed methods study. Free

Background Financial toxicity (FT) is defined as the negative financial consequences that pts and their families experience as a result of medical treatments. Time toxicity (TT) describes the significant time pts spend attending appointments, undergoing treatment, and managing side effects. Immunotherapies, such as bispecific antibodies (BsAbs) and chimeric antigen receptor T (CAR T) cell therapy, have transformed the treatment landscape of multiple myeloma (MM) and lymphoma but have been associated with significant costs. However, there is limited data on their FT and TT. This pilot study aims to capture the financial and toxicity of these novel immunotherapies in lymphoma and MM pts.

Methods We used a mixed methods design for this study with a qualitative component, where we enrolled pts with MM or lymphoma who completed CAR T or BsAbs, and a quantitative component, where we enrolled pts who are initiating standard of care BsAbs or CAR T therapy into a longitudinal prospective cohort study.

Patient surveys were administered at baseline, 1 wk, 1 mo, and 3 mos after treatment initiation. We used the validated Comprehensive Score for Financial Toxicity (COST) to assess for FT, using a validated cutoff for FT as a COST less than the 25^th percentile COST score. TT was measured using physical days with healthcare system contact. Quality of Life (QoL) was measured using the FACT-Lym and FACT-MM instruments, with the NCCN Distress Thermometer measuring psychological distress.

Key informant interviews were conducted using semi-structured guides and thematically analyzed. For the quantitative data, categorical data is presented as frequencies and percentages. Continuous data is presented as a mean with standard deviation or a median with interquartile range (IQR).

Results We included 66 pts in the prospective cohort study (40 lymphoma, 26 MM), 48 of whom received CAR T (20 MM, 29 lymphoma) and 18 received BsAbs (8 MM, 10 lymphoma). The median age was 65 (I 35-91), 62% were male, and 83% lymphoma pts had DLBCL. Regarding demographics, financial status, and employment, 47% were non-Hispanic white, 25% Hispanic, and 17% Asian; 56% of pts had a household income below the US median; 25% were currently employed, 21% were disabled, and 43% were retired. Median prior lines was 2 and 3.5 in the CAR T and BsAb cohorts respectively.

Regarding FT, 21% reported it at baseline, 25% at 1 week, 26% at 1 month, and 25% at 3 months. Regarding time toxicity, pts reported a mean of 3.28±2.10 days of health system contact at baseline, 5.32±2.29 at 1 week, and 1.87±1.68 at 3 months. FT and TT were both strongly correlated with QoL (correlation coefficient(r)=0.82 and -0.79) and psychological distress (0.86 and -0.81).

When we compared CAR T and BsAbs, CAR T pts had a higher baseline FT (29% vs 6%, p=0.03), but there was a trend towards higher FT in BsAbs pts at 1 month (39% vs 20%, p=0.11) without a statistical difference at 3 months (33% vs 22% respectively, p=0.36). TT was higher in CAR T pts at baseline (mean 3.83 days vs. 1.76 days, p<0.001) and at 1 month (5.93 days vs. 3.5 days, p<0.001) but not different at 3 months (1.66 days vs. 2.2 days, p=0.34).

12 pts completed one-on-one open-ended interviews. Key themes that were identified included “a recognition of caregivers' time given during commuting and attending appointments”, “relying on partner or children to manage finances”, “waiting on paperwork and approval to apply insurance”, and “making financial adjustments in response to treatment-related costs.”

Conclusions Our preliminary results demonstrate high rates of FT (25% at 3 mos) following BsAbs or CAR T therapy. There were also substantial rates of TT, with higher rates experienced by CAR T pts both at baseline and in the first month after treatment. Despite CAR T pts having higher rates of FT at baseline, BsAbs had a significant increase in FT in the first month of treatment, with a trend towards higher rates than CAR T. Both FT and TT were associated with lower QoL and higher rates of psychological distress. Our interviews identified that patients receiving BsAbs and CAR T expressed unique concerns about the adjustments that they and their caregivers had to make to the financial and time burden of therapy. These data highlight the importance of screening for financial distress before starting these therapies and the need for close monitoring with focused interventions to address the FT and TT concerns of patients and their caregivers.