Local Consolidative Therapy Vs. Maintenance Therapy or Observation for Patients With Oligometastatic Non-Small-Cell Lung Cancer: Long-Term Results of a Multi-Institutional, Phase II, Randomized Study
Local Consolidative Therapy Vs. Maintenance Therapy or Observation for Patients With Oligometastatic Non-Small-Cell Lung Cancer: Long-Term Results of a Multi-Institutional, Phase II, Randomized Study
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DOI：
10.1200/jco.19.00201
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发表时间：
2019-06-20
影响因子：
45.3
通讯作者：
Heymach, John, V
中科院分区：
文献类型：
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作者：
Gomez, Daniel R.;Tang, Chad;Heymach, John, V
我们之前发表的研究结果报道，局部巩固治疗（LCT）联合放疗或手术改善了在一线全身治疗后没有进展的少转移性非小细胞肺癌（NSCLC）患者的无进展生存期（PFS）并延迟了新发疾病。在此，我们提出了长期总生存期（OS）结果，并附有额外的次要终点。患者和方法：这项多中心、随机、II期试验招募了IV期NSCLC患者，这些患者有3个或更少的转移，在接受一线全身治疗后3个月或更长时间无进展。患者被随机分配（1:1）到所有活动性疾病部位进行维持治疗或观察（MT/O）或LCT。主要终点为PFS；次要终点是生存期、毒性和新病变的出现。所有分析均为双侧分析，P值小于。其中10项被认为意义重大。数据安全和监测委员会建议在随机分配49例患者后早期结束试验，因为LCT组的PFS显著改善。更新的中位随访时间为38.8个月（范围，28.3至61.4个月），PFS的获益是持久的（LCT的中位为14.2个月[95% CI， 7.4至23.1个月]vs MT/O的中位为4.4个月[95% CI， 2.2至8.3个月]；P = 0.022）。我们还发现LCT组的OS获益（LCT组中位数为41.2个月[95% CI， 18.9个月至未达到]vs MT/O组中位数为17.0个月[95% CI， 10.1至39.8个月]；P = 0.017）。没有观察到额外的3级或更大的毒性。LCT组进展后生存期更长（LCT组37.6个月vs MT/O组9.4个月；P = 0.034）。在MT/O组出现进展的20例患者中，9例在进展后接受了所有病变的LCT治疗，中位OS为17个月（95% CI， 7.8个月至未达到）。结论：在一线全身治疗后未进展的少转移性NSCLC患者中，LCT相对于MT/O延长了PFS和OS。(C) 2019由美国临床肿瘤学会批准
PURPOSE Our previously published findings reported that local consolidative therapy (LCT) with radiotherapy or surgery improved progression-free survival (PFS) and delayed new disease in patients with oligometastatic non-small-cell lung cancer (NSCLC) that did not progress after front-line systemic therapy. Herein, we present the longer-term overall survival (OS) results accompanied by additional secondary end points.PATIENTS AND METHODS This multicenter, randomized, phase II trial enrolled patients with stage IV NSCLC, three or fewer metastases, and no progression at 3 or more months after front-line systemic therapy. Patients were randomly assigned (1:1) to maintenance therapy or observation (MT/O) or to LCT to all active disease sites. The primary end point was PFS; secondary end points were OS, toxicity, and the appearance of new lesions. All analyses were two sided, and P values less than .10 were deemed significant.RESULTS The Data Safety and Monitoring Board recommended early trial closure after 49 patients were randomly assigned because of a significant PFS benefit in the LCT arm. With an updated median follow-up time of 38.8 months (range, 28.3 to 61.4 months), the PFS benefit was durable (median, 14.2 months [95% CI, 7.4 to 23.1 months] with LCT v 4.4 months [95% CI, 2.2 to 8.3 months] with MT/O; P = .022). We also found an OS benefit in the LCT arm (median, 41.2 months [95% CI, 18.9 months to not reached] with LCT v 17.0 months [95% CI, 10.1 to 39.8 months] with MT/O; P = .017). No additional grade 3 or greater toxicities were observed. Survival after progression was longer in the LCT group (37.6 months with LCT v 9.4 months with MT/O; P = .034). Of the 20 patients who experienced progression in the MT/O arm, nine received LCT to all lesions after progression, and the median OS was 17 months (95% CI, 7.8 months to not reached).CONCLUSION In patients with oligometastatic NSCLC that did not progress after front-line systemic therapy, LCT prolonged PFS and OS relative to MT/O. (C) 2019 by American Society of Clinical Oncology