Studies evaluating Positron Emission Tomography scan after 2 cycles of chemotherapy (PET2) in newly diagnosed diffuse large B cell lymphoma (DLBCL) are heterogeneous in patient characteristics, treatments and have conflicting results. Here we report association of PET2 with outcomes in two large independent prospective cohorts of newly diagnosed DLBCL pts treated with two RCHOP-based regimens. The discovery cohort consisted of pts enrolled in single arm phase 2 MC078E study of lenalidomide with RCHOP (R2CHOP). The validation cohort consisted of RCHOP-treated pts from the Molecular Epidemiology Resource (MER) cohort. Pts who received 3-6 cycles of therapy and had PET2 were included in the study. Patients who progressed on PET2 were excluded. Revised response criteria 2007 were used to define PET2 response PET2 positive (PET2 + ) pts had inferior EFS [24-month EFS 45.5% vs 87.9%, HR 4.0, CI95 (2.1–7.9), p < 0.0001) with a trend towards lower OS [24-months OS 77% vs 94.8%, HR 2.0, CI95 (0.9–4.8), P = 0.1] than PET2 negative (PET2−) pts in MC078E cohort. PET2 + pts had an inferior EFS (24 month EFS 48.7% vs 81.6%, HR 2.9, CI95 2.0–4.2, p < 0.0001) and OS (24-month OS 68.6% vs 88.1%, HR 2.3, CI95: 1.5–3.5, p < 0.0001) in the MER cohort. These results were consistent regardless of age, sex and in the subgroup of advanced stage and high-risk international prognostic index (IPI). For MER, PET2 + pts also had higher odds of positive end of treatment PET (OR: 17.3 (CI95 7.9–37.7), p < 0.001). PET2 is an early predictor DLBCL pts at high risk of progression and death in two independent prospective cohorts. PET2-guided risk-adapted strategies may improve outcomes, and should be explored in clinical trials.
评估新诊断弥漫性大B细胞淋巴瘤（DLBCL）患者在完成2个周期化疗后正电子发射断层扫描（PET2）的研究在患者特征、治疗方案方面存在异质性，且结果相互矛盾。本文报告了在两个基于RCHOP方案治疗的大型独立前瞻性新诊断DLBCL患者队列中，PET2与预后的关联性。探索队列纳入单臂二期MC078E研究中接受来那度胺联合RCHOP（R2CHOP）方案治疗的患者。验证队列来自分子流行病学资源（MER）队列中接受RCHOP治疗的患者。研究纳入接受3-6个周期治疗并完成PET2评估的患者，但排除PET2显示疾病进展者。采用2007年修订版疗效标准定义PET2应答：在MC078E队列中，与PET2阴性（PET2−）患者相比，PET2阳性（PET2+）患者无事件生存期显著缩短[24个月EFS 45.5% vs 87.9%，HR 4.0，95%CI (2.1–7.9)，p<0.0001]，总生存期呈降低趋势[24个月OS 77% vs 94.8%，HR 2.0，95%CI (0.9–4.8)，P=0.1]。在MER队列中，PET2+患者的EFS（24个月EFS 48.7% vs 81.6%，HR 2.9，95%CI 2.0–4.2，p<0.0001）和OS（24个月OS 68.6% vs 88.1%，HR 2.3，95%CI: 1.5–3.5，p<0.0001）均显著较差。这些结果在不同年龄、性别及晚期阶段、高危国际预后指数（IPI）亚组中表现一致。在MER队列中，PET2+患者治疗结束时PET阳性的概率也显著更高（OR: 17.3，95%CI 7.9–37.7，p<0.001）。两个独立前瞻性队列数据表明，PET2是早期预测DLBCL患者进展和死亡高风险的有效指标。基于PET2的风险适应调整策略可能改善预后，值得在临床试验中进一步探索。
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