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  • Patient‐reported outcomes p...
    Huang, Huang; Datye, Asim; Fan, Ming; Knapp, Andrea; Nielsen, Tina; Bottos, Alessia; Paulson, Joseph N.; Trask, Peter C.; Efficace, Fabio

    Cancer medicine (Malden, MA), September 2022, Letnik: 11, Številka: 17
    Journal Article

    Purpose We investigated the prognostic value of pretreatment patient‐reported outcomes (PROs) in patients with diffuse large B‐cell lymphoma (DLBCL) receiving obinutuzumab/rituximab plus chemotherapy in the GOYA phase III study. Methods Patients completed the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ‐C30) and the Functional assessment of chronic illness therapy‐Lymphoma (FACT–Lym) lymphoma subscale (LYMS) during the study. PRO scales with high prognostic value were identified through Cox regression analyses of overall survival (OS) and progression‐free survival (PFS). These scales were evaluated in terms of their additional prognostic value beyond the International Prognostic Index (IPI). A preliminary assessment was performed to evaluate whether the scales provided improved patient‐risk stratification beyond IPI. Results One thousand two hundred and fifty‐nine patients with valid pretreatment PRO scales were included in the analyses, and complete pretreatment data were available for 1239/1414 patients (87.6%). Four PRO scales with high prognostic value were identified: FACT–Lym LYMS and EORTC QLQ‐C30 physical functioning, global health status/quality of life (QoL), and fatigue. All four scales retained significant prognostic value for OS and PFS after IPI adjustment (all p < 0.05). After adjusting for multiple clinical variables (IPI, cell of origin, BCL2 status, and total metabolic tumor volume), all four scales retained significant prognostic value (all p < 0.05) for OS. Only the EORTC QLQ‐C30 physical functioning scale was significant (p < 0.05) for PFS after adjustment for multiple clinical variables. Conclusions In this large population of patients with DLBCL, pretreatment PROs provided prognostic information for OS and PFS beyond the well‐established IPI. Patient reported outcomes were exhaustively reviewed for prognostic signal in GOYA ‐ the largest trial to date for DLBCL ‐ and multiple scales at baseline were prognostic even after multiple testing correction. The prognostic value was often orthogonal and additionally prognostic on top of the International Prognostic Index (IPI) clinical score used in DLBCL.