Crump Michael, Neelapu Sattva S, Farooq Umar, Van Den Neste Eric, Kuruvilla John, Westin Jason, Link Brian K, Hay Annette, Cerhan James R, Zhu Liting, Boussetta Sami, Feng Lei, Maurer Matthew J, Navale Lynn, Wiezorek Jeff, Go William Y, Gisselbrecht Christian
Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
Division of Cancer Medicine, Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.
Blood. 2017 Oct 19;130(16):1800-1808. doi: 10.1182/blood-2017-03-769620. Epub 2017 Aug 3.
Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma. Although 5-year survival rates in the first-line setting range from 60% to 70%, up to 50% of patients become refractory to or relapse after treatment. Published analyses of large-scale outcome data from patients with refractory DLBCL are limited. SCHOLAR-1, an international, multicohort retrospective non-Hodgkin lymphoma research study, retrospectively evaluated outcomes in patients with refractory DLBCL which, for this study, was defined as progressive disease or stable disease as best response at any point during chemotherapy (>4 cycles of first-line or 2 cycles of later-line therapy) or relapsed at ≤12 months from autologous stem cell transplantation. SCHOLAR-1 pooled data from 2 phase 3 clinical trials (Lymphoma Academic Research Organization-CORAL and Canadian Cancer Trials Group LY.12) and 2 observational cohorts (MD Anderson Cancer Center and University of Iowa/Mayo Clinic Lymphoma Specialized Program of Research Excellence). Response rates and overall survival were estimated from the time of initiation of salvage therapy for refractory disease. Among 861 patients, 636 were included on the basis of refractory disease inclusion criteria. For patients with refractory DLBCL, the objective response rate was 26% (complete response rate, 7%) to the next line of therapy, and the median overall survival was 6.3 months. Twenty percent of patients were alive at 2 years. Outcomes were consistently poor across patient subgroups and study cohorts. SCHOLAR-1 is the largest patient-level pooled retrospective analysis to characterize response rates and survival for a population of patients with refractory DLBCL.
弥漫性大B细胞淋巴瘤(DLBCL)是非霍奇金淋巴瘤最常见的亚型。尽管一线治疗的5年生存率在60%至70%之间,但仍有高达50%的患者在治疗后出现难治性或复发。已发表的关于难治性DLBCL患者大规模结局数据的分析有限。SCHOLAR-1是一项国际多队列回顾性非霍奇金淋巴瘤研究,回顾性评估了难治性DLBCL患者的结局,在本研究中,难治性DLBCL定义为化疗期间任何时间(一线治疗>4个周期或后续治疗2个周期)的最佳反应为疾病进展或稳定疾病,或自体干细胞移植后≤12个月复发。SCHOLAR-1汇总了2项3期临床试验(淋巴瘤学术研究组织-CORAL和加拿大癌症试验组LY.12)和2个观察队列(MD安德森癌症中心以及爱荷华大学/梅奥诊所淋巴瘤卓越研究专项计划)的数据。从难治性疾病挽救治疗开始时间估计缓解率和总生存期。在861例患者中,636例符合难治性疾病纳入标准。对于难治性DLBCL患者,下一线治疗的客观缓解率为26%(完全缓解率为7%),中位总生存期为6.3个月。20%的患者在2年时仍存活。各患者亚组和研究队列的结局均持续较差。SCHOLAR-1是最大规模的患者水平汇总回顾性分析,用于描述难治性DLBCL患者群体的缓解率和生存率。