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672 Longitudinal Differences By Treatment Arm in Health-Related Quality of Life Among High Risk Pediatric Hodgkin’s Lymphoma Patients Treated on the Children’s Oncology Group Ahod 1331 Study

Program: Oral and Poster Abstracts
Type: Oral
Session: 905. Outcomes Research – Lymphoid Malignancies: Patient Reported Outcomes in Hematological Malignancies
Hematology Disease Topics & Pathways:
Research, clinical trials, Hodgkin lymphoma, Lymphomas, Clinical Research, health outcomes research, patient-reported outcomes, Diseases, Lymphoid Malignancies
Sunday, December 10, 2023: 5:45 PM

Annalynn M Williams, PhD, MS1, Angie Mae Rodday, PhD, MS2, Qinglin Pei, PhD3*, Tara O. Henderson, MD4, Frank Keller, MD5*, Angela Punnett, MD6*, Kara M. Kelly, MD7, Sharon M. Castellino, MD, MSc8 and Susan K Parsons, MD, MRCP9

1James P. Wilmot Cancer Institute, University of Rochester, Rochester, NY
2Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA
3University of Florida, Gainesville, FL
4University of Chicago Medical Center, Chicago, IL
5Aflac Cancer Ctr. & Blood Disorders Svc., Atlanta, GA
6The hospital for sick children, Toronto, ON, Canada
7Roswell Park Comprehensive Cancer Center, Buffalo, NY
8Department of Pediatrics, Emory University School of Medicine, Atlanta, GA
9The Center for Health Solutions, Tufts Medical Center, Boston, MA

Introduction: Brentuximab vendotin (BV) with AVE-PC demonstrated superior efficacy to ABVE-PC for pediatric patients with high-risk HL in the AHOD 1331 trial. However, there are no data regarding the impact on health-related quality of life (HRQoL) with the addition of BV into the treatment of pediatric HL.

Methods: Eligibility for AHOD 1331 (NCT 02166463) included previously untreated HL with high risk disease, defined as stage IIB +bulk, IIIB, IVA, or IVB classic HL. Participants were randomized to either BV-AVE-PC (“BV” arm) or ABVE-PC (standard arm). Among the first 309 participants enrolled in a prespecified longitudinal patient-reported outcomes sub study, 280 were age 11+ years and eligible to self-report HRQoL using the seven-item Child Health Ratings Inventories (CHRIs)–Global scale. HRQoL was assessed prior to treatment (T1), at cycle 2 (T2), at cycle 5 (T3), and at the end of treatment (T4). A clinically meaningful increase in HRQoL was considered a change of 7 points in the CHRIs-Global score (CHRIs), translating to a 1/3 standard deviation. Multivariable linear regression estimated the association between demographic/clinical variables and HRQoL at T1. Linear mixed models estimated the change in HRQoL relative to T1 with a time*treatment arm interaction to estimate differences in the change in HRQoL across treatment arm. This model was adjusted for age, sex, race/ethnicity, stage, large mediastinal adenopathy (LMA), B-symptoms at diagnosis, and a time-varying covariate for involved site radiation prior to T4.

Results: Participant and disease characteristics were balanced by treatment arm; mean age at enrollment was 15.6 years (SD= 1.9), 52% were female, 60.4% had LMA, and 58% were stage IV. 93% of participants completed the CHRIs at T1, 92% at T2, 89% at T3, and 74% at T4. At T1, female sex (mean (SD) 64.1 (20.2) vs 71.3 (23.3) p=0.004) and fever (60.8 (23.0) vs. 71.9 (20.4) p=0.024) were associated with worse HRQoL. At each time point after pre-treatment (T1), HRQoL was higher, on average, in the BV arm compared to the standard arm (Figure 1). By T2, participants in the BV arm experienced a statistically and clinically significant increase in HRQoL compared to pre-treatment (T1) (Table 1; β=7.3 95%CI 3.2, 11.4; p≤0.001), which was greater than the change experienced in the standard arm (difference in change β=5.1 95%CI -0.2, 10.3; p=0.057). At T3 and T4 the BV arm continued to experience statistically significant improvements in HRQoL relative to T1 (T3 β=5.3 95%CI 0.8, 9.9; p=0.022; T4 β=14.6 95%CI 10.3, 18.9; p≤0.001). The standard arm did not experience a statistically or clinically significant increase in HRQoL from T1 until T4 (β=9.3 95%CI 4.7, 11.5; p<0.001).

Conclusion: Patients with high-risk pediatric HL treated with BV-AVE-PC experienced more rapid and sustained improvement in HRQoL compared to patients treated with ABVE-PC. These data also demonstrate the feasibility and importance of incorporating HRQoL assessments into pediatric clinical trials.

Disclosures: Keller: Merck: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Scientific advisory council. Kelly: Seagen: Other: Scientific Steering Committee; Merck: Other: Scientific Steering Committee. Castellino: Bristol Meyers Squibb: Honoraria, Other: Scientific Advisory Committee; SeaGen Inc.: Other: Scientific Advisory Committee - No honoraria, Research Funding. Parsons: Seagen: Consultancy.

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