Session: 624. Hodgkin Lymphomas: Clinical and Epidemiological: Poster III
Hematology Disease Topics & Pathways:
Research
Methods: The study randomized 1,500 pts (1:1) to receive BrECADD or eBEACOPP in 4-6, 21-day, treatment cycles. TRMB included any Common Terminology Criteria for Adverse Events (CTCAE) acute hematological (grade 4 anemia, thrombocytopenia, infections) and nonhematological (grade ≥3 cardiac, gastrointestinal, hepatobiliary, nervous system, renal/urinary, and respiratory, thoracic and mediastinal disorders) toxicity collected during the treatment period. The patient-reported European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire – Core 30 items (QLQ-C30) was administered at baseline, during the treatment period and posttreatment follow-up (FU) period up to 60 months (mth)s. Physical functioning (PF), fatigue (FA), and global health/quality of life (GH/QL) were identified as key concepts that could be negatively impacted by TRMB. PRO description according to TRMB and multivariate analysis of PROs according to TRMB, adjusted for age, sex and baseline PROs, were carried out at each available visit.
Results: The PRO analysis set (PAS – all pts with a baseline PRO and at least one postbaseline PRO from the intent-to-treat (ITT) population) included 732 pts (54% male, mean age of 34 years, and 68% with ECOG of 0 at baseline). Pts who had TRMB tended to report poorer overall health, PF, and more fatigue, with overall mean PRO scores lower (GH/QL and PF) or higher (FA) in pts with TRMB than in pts without TRMB. Mean GH/QL in pts with TRMB vs. those without TRMB was 51.2 vs. 57.8 at restaging after chemotherapy (RaC), 65.5 vs. 68.7 at 3-mth, and 68.2 vs. 75.3 at 24-mth FU, respectively. Mean PF in pts with TRMB vs. those without TRMB was 70.6 vs. 76.0 at RaC, 84.0 vs. 86.5 at 3-mth, and 89.2 vs. 93.2 at 24-mth FU, respectively. Mean FA in pts with TRMB vs. those without TRMB was 55.7 vs. 49.0 at RaC, 36.0 vs. 32.8 at 3-mth, and 31.8 vs. 22.9 at 24-mth, respectively. Similar results were seen at other visits. The GH/QL and PF score distributions showed lower first quartile in pts with TRMB vs. those without TRMB, suggesting that more pts with TRMB generally reported poorer PROs (except at 36-mth for GH/QL, 6-mth and 12-mth FU for PF). A similar pattern was observed for FA, except at later FU. Multivariate analysis showed consistent results, with mean estimates generally lower (GH/QL and PF) or higher (FA) in the TRMB group than in pts without TRMB, and significant results for GH/QL at most timepoints.
Conclusion: These findings suggest the detrimental effect of TRMB on pts’ HRQoL from the patient’s perspective especially during the treatment period and early FU. Treatments with fewer TRMB events are not only relevant clinically but can also improve pts’ experience in advanced stage cHL. These data validate TRMB during the treatment period as a clinically meaningful and patient-relevant endpoint.
Disclosures: Kristo: Takeda Development Center Americas, Inc. (TDCA): Current Employment, Current equity holder in publicly-traded company. Regnault: Modus Outcomes: Current Employment. Ferdinandus: Takeda Oncology: Honoraria; Roche Pharma: Honoraria. Borchmann: Takeda Oncology, BMS, Roche, Amgen, Miltenyi Biotech, Gilead, MSD: Consultancy; Takeda Oncology, BMS, Roche, MSD, Celgene, Miltenyi Biotech, Gilead, Abbvie: Honoraria; Takeda Oncology, MSD, Incyte: Research Funding. Ashaye: Takeda Development Center Americas, Inc.: Current Employment, Current equity holder in publicly-traded company.
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