随机临床试验入组的弥漫性大 B 细胞淋巴瘤（DLBCL）患者的 24 个月无进展生存（PFS24）和后续结果。
Progression-free survival at 24 months (PFS24) and subsequent outcome for patients with diffuse large B-cell lymphoma (DLBCL) enrolled on randomized clinical trials.
机构信息
Department of Health Sciences Research, Mayo Clinic, Rochester, USA.
Division of Hematology, Mayo Clinic, Rochester, USA.
出版信息
Ann Oncol. 2018 Aug 1;29(8):1822-1827. doi: 10.1093/annonc/mdy203.
BACKGROUND
Patients with diffuse large B-cell lymphoma treated with first-line anthracycline-based immunochemotherapy and remaining in remission at 2 years have excellent outcomes. This study assessed overall survival (OS) stratified by progression-free survival (PFS) at 24 months (PFS24) using individual patient data from patients with DLBCL enrolled in multi-center, international randomized clinical trials as part of the Surrogate Endpoint for Aggressive Lymphoma (SEAL) Collaboration.
PATIENTS AND METHODS
PFS24 was defined as being alive and PFS24 after study entry. OS from PFS24 was defined as time from identified PFS24 status until death due to any cause. OS was compared with each patient's age-, sex-, and country-matched general population using expected survival and standardized mortality ratios (SMRs).
RESULTS
A total of 5853 patients enrolled in trials in the SEAL database received rituximab as part of induction therapy and were included in this analysis. The median age was 62 years (range 18-92), and 56% were greater than 60 years of age. At a median follow-up of 4.4 years, 1337 patients (23%) had disease progression, 1489 (25%) had died, and 5101 had sufficient follow-up to evaluate PFS24. A total of 1423 assessable patients failed to achieve PFS24 with a median OS of 7.2 months (95% CI 6.8-8.1) after progression; 5-year OS after progression was 19% and SMR was 32.1 (95% CI 30.0-34.4). A total of 3678 patients achieved PFS24; SMR after achieving PFS24 was 1.22 (95% CI 1.09-1.37). The observed OS versus expected OS at 3, 5, and 7 years after achieving PFS24 was 93.1% versus 94.4%, 87.6% versus 89.5%, and 80.0% versus 83.7%, respectively.
CONCLUSION
Patients treated with rituximab containing anthracycline-based immunochemotherapy on clinical trials who are alive without progression at 24 months from the onset of initial therapy have excellent outcomes with survival that is marginally lower but clinically indistinguishable from the age-, sex-, and country-matched background population for 7 years after achieving PFS24.
背景
接受一线蒽环类药物为基础的免疫化疗且在第 2 年仍处于缓解状态的弥漫性大 B 细胞淋巴瘤患者具有极佳的预后。本研究使用来自弥漫性大 B 细胞淋巴瘤患者的个体患者数据，对来自多中心、国际随机临床试验的患者进行了分析，这些患者是作为侵袭性淋巴瘤替代终点（SEAL）合作的一部分入组。这些数据按照 24 个月时无进展生存期（PFS24）进行分层，评估了总生存期（OS）。
方法
PFS24 定义为患者在入组研究后仍然存活且没有疾病进展。从 PFS24 开始的 OS 定义为从确定的 PFS24 状态到任何原因导致死亡的时间。使用预期生存和标准化死亡率比（SMR）将 OS 与每位患者的年龄、性别和国家匹配的一般人群进行比较。
结果
SEAL 数据库中的试验共纳入了 5853 例患者，这些患者在诱导治疗中接受了利妥昔单抗治疗，这些患者被纳入本分析。患者的中位年龄为 62 岁（范围 18-92 岁），56%的患者年龄大于 60 岁。中位随访时间为 4.4 年，1337 例患者（23%）疾病进展，1489 例患者（25%）死亡，5101 例患者有足够的随访时间来评估 PFS24。1423 例可评估患者未能达到 PFS24，进展后中位 OS 为 7.2 个月（95%CI 6.8-8.1）；进展后 5 年 OS 为 19%，SMR 为 32.1（95%CI 30.0-34.4）。3678 例患者达到了 PFS24；达到 PFS24 后的 SMR 为 1.22（95%CI 1.09-1.37）。达到 PFS24 后 3、5 和 7 年时，观察到的 OS 与预期 OS 分别为 93.1%与 94.4%、87.6%与 89.5%、80.0%与 83.7%。
结论
在临床试验中接受利妥昔单抗联合蒽环类药物为基础的免疫化疗的患者，如果在初始治疗后 24 个月时无疾病进展且仍然存活，那么他们的预后极好，在达到 PFS24 后 7 年内，其生存情况略低于但与年龄、性别和国家匹配的背景人群无显著差异。
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