Lasse Hjort Jakobsen, Martin Bøgsted, Paw Jensen, Hans Erik Johnsen, and Tarec Christoffer El-Galaly, Aalborg University Hospital; Lasse Hjort Jakobsen, Martin Bøgsted, Hans Erik Johnsen, and Tarec Christoffer El-Galaly, Aalborg University, Aalborg; Peter de Nully Brown and Bente Arboe, Copenhagen University Hospital, Copenhagen; Judit Jørgensen, Aarhus University Hospital, Aarhus; Thomas Stauffer Larsen and Maja Bech Juul, Odense University Hospital, Odense; Lene Schurmann, Hospitalsenheden Vest, Holstebro; Linda Højberg, Sydvestjysk Sygehus, Esbjerg; Olav Jonas Bergmann, Vejle Sygehus, Vejle; Therese Lassen, Roskilde Sygehus, Roskilde; and Pär Lars Josefsson, Herlev Hospital, Herlev, Denmark.
J Clin Oncol. 2017 Mar;35(7):778-784. doi: 10.1200/JCO.2016.70.0765. Epub 2017 Jan 17.
Purpose The general outlook for patients with diffuse large B-cell lymphoma (DLBCL) in first remission is important information for patients and for planning post-treatment follow-up. The purpose of this study was to evaluate the survival of patients with DLBCL in remission compared with a matched general population. Methods A total of 1,621 patients from the Danish Lymphoma Registry who were newly diagnosed with DLBCL between 2003 and 2011 were included in this study. All patients were ≥ 16 years of age at diagnosis and had achieved complete remission or complete remission unconfirmed after first-line rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or R-CHOP-like therapy. Results The 5-year post-treatment DLBCL survival was inferior to survival in the matched general population (78%; 95% CI, 76 to 80; v 87%; standardized mortality ratio, 1.75; P < .001). Excess mortality was present but reduced for patients achieving post-treatment event-free survival for 24 months (pEFS24; standardized mortality ratio, 1.27; P < .001). In age-stratified analyses, the survival of patients < 50 years of age was normalized to the general population after achieving pEFS24 ( P = .99). During the first 8 years after pEFS24, the average loss of lifetime was 0.31 mo/y (95% CI, 0.11 to 0.50 mo/y). Excess mortality diminished when analyzing death from lymphoma as competing event to death from other causes, suggesting that early and late relapse is responsible for increased mortality in patients with DLBCL. Conclusion Although this population-based study does not support complete normalization of survival for patients with DLBCL achieving pEFS24, the estimated loss of residual lifetime was low for patients in continuous remission 2 years after ending treatment. Therefore, pEFS24 is an appealing and relevant milestone for patient counseling and could be a surrogate end point in clinical trials.
对于初缓解期弥漫性大 B 细胞淋巴瘤(DLBCL)患者,了解其总体预后情况是非常重要的,这不仅与患者相关,也与治疗后随访计划相关。本研究旨在评估缓解期 DLBCL 患者与匹配的一般人群的生存情况。
本研究共纳入了 1621 例 2003 年至 2011 年期间在丹麦淋巴瘤登记处新诊断为 DLBCL 的患者。所有患者在诊断时均≥16 岁,且在接受一线利妥昔单抗联合环磷酰胺、多柔比星、长春新碱和泼尼松(R-CHOP)或 R-CHOP 样治疗后达到完全缓解或不完全完全缓解。
治疗后 5 年的 DLBCL 生存率低于匹配的一般人群(78%;95%CI,76%至 80%;v 87%;标准化死亡率比,1.75;P<.001)。然而,对于达到治疗后无事件生存(EFS)24 个月(pEFS24)的患者,死亡风险有所降低(标准化死亡率比,1.27;P<.001)。在年龄分层分析中,年龄<50 岁的患者在达到 pEFS24 后,其生存率与一般人群相匹配(P=.99)。在达到 pEFS24 后的前 8 年,平均损失的预期寿命为 0.31 个月/年(95%CI,0.11 至 0.50 个月/年)。当将淋巴瘤死亡作为其他原因死亡的竞争事件进行分析时,死亡风险会降低,这表明早期和晚期复发是导致 DLBCL 患者死亡风险增加的原因。
尽管本项基于人群的研究不支持达到 pEFS24 的 DLBCL 患者的生存情况完全正常化,但在治疗结束后 2 年持续缓解的患者中,估计的剩余预期寿命损失较低。因此,pEFS24 是一个有吸引力且相关的里程碑,可用于患者咨询,并可作为临床试验的替代终点。