Interim PET after 4 cycles predicts outcome in histomolecularly confirmed primary mediastinal B-cell lymphoma.

This post hoc analysis aimed to detail the outcomes of patients with primary mediastinal B-cell lymphoma (PMBL), verified through expert pathological review and the use of gene expression profiling (GEP) and next-generation sequencing.

这项事后分析旨在详细说明经过专家病理审查和基因表达谱（GEP）分析以及下一代测序技术验证的原发性纵隔 B 细胞淋巴瘤（PMBL）患者的治疗结果。

Of 620 centrally reviewed patients, 138 (22.3%) confirmed PMBL cases were analyzed.

在620名经过中心审查的患者中，分析了138例（22.3%）确诊的原发性纵隔大B细胞淋巴瘤（PMBL）病例。

Baseline characteristics included a median age of 33.5 years, 63.8% female, 55.1% stage III to IV, 90.6% elevated lactate dehydrogenase, 87.6% Eastern Cooperative Oncology Group performance status score of 0 to 1, 62.3% extranodal involvement, 52.6% age-adjusted International Prognostic Index (aaIPI) of 2% to 3%, and 53.6% bulk (>10 cm).

基线特征包括中位年龄为33.5岁，女性占63.8%，III至IV期占55.1%，乳酸脱氢酶升高者占90.6%，东部肿瘤协作组（ECOG）表现状态评分为0至1分者占87.6%，有62.3%的患者存在结外受累，52.6%的患者年龄调整的国际预后指数（aaIPI）为2%至3%，以及53.6%的患者肿瘤体积大于10厘米。

Induction regimens were R/G-CHOP14 (56.9%) and R/G-ACVBP (43.1%).

诱导方案为R/G-CHOP14（56.9%）和R/G-ACVBP（43.1%）。

Postinduction treatments, based on interim PET results, included: standard consolidation chemotherapy (59.8%) if change in maximum standardized uptake value (ΔSUVmax) of >66% after cycle 2 and >70% after cycle 4 (PET2-/4-), intensive treatment and autologous transplantation (26.8%) if PET2+/4-, and salvage therapy (13.4%) if PET4+ (ΔSUVmax of ≤70%).

基于中期PET结果的诱导后治疗包括：如果第2周期后最大标准摄取值变化（ΔSUVmax）>66%和第4周期后>70%（PET2-/4-），则进行标准巩固化疗（59.8%）；如果PET2+，则进行强化治疗和自体移植（26.8%）；如果PET4+（ΔSUVmax≤70%），则进行挽救治疗（13.4%）。

Among patients with GEP data (n = 107), 38 (35.5%) were PDL1high/PDL2high.

在具有基因表达谱（GEP）数据的患者中（n = 107），有38名（35.5%）患者为PDL1高表达/PDL2高表达。

Key somatic mutations data (n = 87) included SOCS1 (70.1%), B2M (56.3%), STAT6 (49.4%), TNFAIP3 (47.1%), GNA13 (39.1%), CIITA (37.9%), CD58 (36.8%), and TP53 (29.9%).

关键的体细胞突变数据（n = 87）包括SOCS1（70.1%），B2M（56.3%），STAT6（49.4%），TNFAIP3（47.1%），GNA13（39.1%），CIITA（37.9%），CD58（36.8%）和TP53（29.9%）。

After a median follow-up of 39.5 months, 2-year progression-free survival(PFS) and overall survival(OS) rates were 86.2% and 93.2%, respectively.

中位随访39.5个月后，2年无进展生存（PFS）和总生存（OS）率分别为86.2%和93.2%。

In a multivariate model including bulk, aaIPI, and ΔSUVmax PET2/PET4, only bulk and ΔSUVmax PET4 of ≤70% were associated with shorter PFS (hazard ratio, 4.39 [95% confidence interval(CI), 1.28-15.11] and 4.95 [95% CI, 1.71-14.3], respectively), whereas none were associated with OS.

在包括肿瘤体积、aaIPI和ΔSUVmax PET2/PET4的多变量模型中，只有肿瘤体积和ΔSUVmax PET4≤70%与较短的无进展生存期（PFS）相关（风险比分别为4.39 [95%置信区间（CI），1.28-15.11]和4.95 [95% CI, 1.71-14.3]），而与总生存（OS）无关。

The ΔSUVmax-based interim PET4 response emerged as the strongest predictor of patient outcomes in this selected clinical trial population.

在这项选定的临床试验人群中，基于最大标准摄取值变化量（ΔSUVmax）的中期正电子发射断层扫描（PET4）反应被证明是患者预后最强的预测因子。

This trial was registered at www.ClinicalTrials.gov as #NCT01659099.

这项试验已在www.ClinicalTrials.gov上注册，注册号为#NCT01659099。