F. Hoffmann-La Roche Ltd, Mississauga, Ontario, Canada.
F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Cancer Med. 2022 Sep;11(17):3312-3322. doi: 10.1002/cam4.4692. Epub 2022 Mar 23.
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.
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.
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.
In this large population of patients with DLBCL, pretreatment PROs provided prognostic information for OS and PFS beyond the well-established IPI.
我们研究了在 GOYA Ⅲ期研究中，接受奥滨尤妥珠单抗/利妥昔单抗联合化疗的弥漫性大 B 细胞淋巴瘤（DLBCL）患者的治疗前患者报告结局（PRO）的预后价值。
患者在研究期间完成了欧洲癌症研究与治疗组织生活质量问卷核心 30 项（EORTC QLQ-C30）和慢性疾病治疗功能评估-淋巴瘤（FACT-Lym）淋巴瘤亚量表（LYMS）。通过对总生存（OS）和无进展生存（PFS）的 Cox 回归分析，确定了具有高预后价值的 PRO 量表。这些量表在国际预后指数（IPI）之外的额外预后价值方面进行了评估。进行了初步评估，以评估这些量表是否提供了比 IPI 更好的患者风险分层。
1259 例具有有效治疗前 PRO 量表的患者纳入分析，1414 例患者中有 1239 例（87.6%）有完整的治疗前数据。确定了四个具有高预后价值的 PRO 量表：FACT-Lym LYMS 和 EORTC QLQ-C30 身体功能、整体健康状况/生活质量（QoL）和疲劳。在调整 IPI 后，所有四个量表对 OS 和 PFS 仍具有显著的预后价值（均 p<0.05）。在调整多个临床变量（IPI、细胞起源、BCL2 状态和总代谢肿瘤体积）后，所有四个量表对 OS 仍具有显著的预后价值（均 p<0.05）。只有 EORTC QLQ-C30 身体功能量表在调整多个临床变量后对 PFS 有显著意义（p<0.05）。
在这个大型 DLBCL 患者群体中，治疗前 PRO 提供了比既定 IPI 更广泛的 OS 和 PFS 预后信息。
