Progression-Free Survival and Overall Survival Beyond 5 Years of NSCLC Patients With Synchronous Oligometastases Treated in a Prospective Phase II Trial (NCT 01282450)
Progression-Free Survival and Overall Survival Beyond 5 Years of NSCLC Patients With Synchronous Oligometastases Treated in a Prospective Phase II Trial (NCT 01282450)
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DOI：
10.1016/j.jtho.2018.07.098
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发表时间：
2018-12-01
影响因子：
20.4
通讯作者：
Dingemans, Anne-Marie C.
中科院分区：
文献类型：
--
作者：
De Ruysscher, Dirk;Wanders, Rinus;Dingemans, Anne-Marie C.
简介：两项随机研究显示，在缓解的寡转移性NSCLC患者中，通过在全身治疗基础上增加根治性局部治疗，可增加无进展生存期（PFS），但缺乏长期数据。我们更新了我们以前的第二阶段试验的结果，最低限度的后续超过7 years.Methods：这是一个前瞻性的单臂第二阶段试验。主要入选标准为经病理证实的IV期NSCLC，初步诊断时转移灶少于5个，可接受根治性局部治疗（手术或放疗）。没有以前的反应，全身treatment是need.Results：40例患者参加，其中39人可评价（18名男性，21名女性），平均年龄为62.1 +/- 9.2岁（范围，44至81岁）。29例（74%）患有N2或N3疾病; 17例（44%）脑转移，7例（18%）骨转移和4例（10%）肾上腺转移。35例（87%）有单个转移性病灶。37例（95%）患者接受化疗作为其主要治疗的一部分。中位总生存期（OS）为13.5个月（95%置信区间：7.6-19.4个月）; 1、2、3、5和6年OS分别为56.4%、23.3%、12.8%、10.3%、7.7%和5.1%。中位PFS为12.1个月（95%置信区间：9.6-14.3个月）; 1年、2年、3年、5年和6年OS分别为51.3%、13.6%、%、12.8%、7.7%、7.7%和2.5%。只有3例患者（7.7%）有局部复发。结论：在没有根据系统治疗反应选择的患者中，5年的PFS为8%。将患者纳入局部治疗与新型全身性药物（例如，免疫疗法（immunotherapy）仍然是强制性的。(C)2018年国际肺癌研究协会。爱思唯尔公司出版All rights reserved.
Introduction: Two randomized studies have shown an increased progression-free survival (PFS) by adding a radical local treatment to systemic therapy in responding patients with oligometastatic NSCLC, but long-term data are lacking. We updated the results of our previous phase II trial with a minimal follow-up exceeding 7 years.Methods: This is a prospective single-arm phase II trial. The main inclusion criteria were pathologically proven NSCLC stage IV with less than five metastases at primary diagnosis, amendable for radical local treatment (surgery or radiotherapy). No previous response to systemic treatment was needed.Results: Forty patients were enrolled, 39 of whom were evaluable (18 men, 21 women); mean age was 62.1 +/- 9.2 years (range, 44 to 81 years). Twenty-nine (74%) had N2 or N3 disease; 17 (44%) brain, 7 (18%) bone, and 4 (10%) adrenal gland metastases. Thirty-five (87%) had a single metastatic lesion. Thirty-seven (95%) of the patients received chemotherapy as part of their primary treatment. Median overall survival (OS) was 13.5 months (95% confidence interval: 7.6-19.4 months); 1-, 2-, 3-, 5-, and 6- year OS was 56.4%, 23.3%, 12.8%, 10.3%, 7.7%, and 5.1%, respectively. Median PFS was 12.1 months (95% confidence interval: 9.6-14.3 months); 1-, 2-, 3-, 5-, and 6- year OS was 51.3%, 13.6%, %, 12.8%, 7.7%, 7.7%, and 2.5%, respectively. Only three patients (7.7%) had a local recurrence.Conclusions: In patients who were not selected according to response to systemic treatment, the PFS at 5 years was 8%. Entering patients in trials combining local therapy with novel systemic agents (e.g., immunotherapy) remains mandatory. (C) 2018 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.