Department of Radiology and Medical Imaging, University of Virginia, Charlottesville, VA.
Department of Translational and Precision Medicine, Sapienza University, Rome, Italy.
Blood Adv. 2021 Mar 9;5(5):1283-1290. doi: 10.1182/bloodadvances.2020002690.
GOYA was a randomized phase 3 study comparing obinutuzumab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) vs standard-of-care rituximab plus CHOP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). This retrospective analysis of GOYA aimed to assess the association between progression-free survival (PFS) and overall survival (OS) with positron emission tomography (PET)-based complete response (CR) status. Overall, 1418 patients were randomly assigned to receive 8 21-day cycles of obinutuzumab (n = 706) or rituximab (n = 712) plus 6 or 8 cycles of CHOP. Patients received a mandatory fluoro-2-deoxy-d-glucose-PET/computed tomography scan at baseline and end of treatment. After a median follow-up of 29 months, the numbers of independent review committee-assessed PFS and OS events in the entire cohort were 416 (29.3%) and 252 (17.8%), respectively. End-of-treatment PET CR was highly prognostic for PFS and OS according to Lugano 2014 criteria (PFS: hazard ratio [HR], 0.26; 95% confidence interval [CI], 0.19-0.38; P < .0001; OS: HR, 0.12; 95% CI, 0.08-0.17; P < .0001), irrespective of international prognostic index score and cell of origin. In conclusion, the results from this prospectively acquired large cohort corroborated previously published data from smaller sample sizes showing that end-of-treatment PET CR is an independent predictor of PFS and OS and a promising prognostic marker in DLBCL. Long-term survival analysis confirmed the robustness of these data over time. Additional meta-analyses including other prospective studies are necessary to support the substitution of PET CR for PFS as an effective and practical surrogate end point. This trial was registered at www.clinicaltrials.gov as #NCT01287741.
GOYA 是一项随机 3 期研究，比较了奥滨尤妥珠单抗联合环磷酰胺、多柔比星、长春新碱和泼尼松（CHOP）与标准护理利妥昔单抗联合 CHOP 治疗未经治疗的弥漫性大 B 细胞淋巴瘤（DLBCL）患者。本项针对 GOYA 的回顾性分析旨在评估无进展生存期（PFS）和总生存期（OS）与基于正电子发射断层扫描（PET）的完全缓解（CR）状态之间的相关性。总体而言，1418 例患者被随机分配接受 8 个 21 天周期的奥滨尤妥珠单抗（n = 706）或利妥昔单抗（n = 712）联合 6 或 8 个周期的 CHOP。患者在基线和治疗结束时接受强制性氟-2-脱氧-d-葡萄糖-PET/计算机断层扫描扫描。在中位随访 29 个月后，整个队列中独立审查委员会评估的 PFS 和 OS 事件数量分别为 416（29.3%）和 252（17.8%）。根据卢加诺 2014 标准，治疗结束时的 PET-CR 对 PFS 和 OS 具有高度预后价值（PFS：风险比 [HR]，0.26；95%置信区间 [CI]，0.19-0.38；P<0.0001；OS：HR，0.12；95%CI，0.08-0.17；P<0.0001），而与国际预后指数评分和细胞起源无关。总之，这项前瞻性大样本队列研究的结果与之前发表的较小样本量数据一致，表明治疗结束时的 PET-CR 是 PFS 和 OS 的独立预测因子，也是 DLBCL 有前途的预后标志物。长期生存分析证实了这些数据随时间推移的稳健性。需要额外的荟萃分析包括其他前瞻性研究，以支持将 PET-CR 替代 PFS 作为有效的和实用的替代终点。该试验在 www.clinicaltrials.gov 上注册为 #NCT01287741。
