SCI
19May
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
Gomez DR, Tang C, Zhang J, et al. 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. Journal of Clinical Oncology;0:JCO.19.00201.
CORRESPONDING AUTHOR：Daniel R. Gomez, MD, Department of Radiation Oncology, Unit 1422, The University of Texas MD Anderson Cancer Center, 1400 Pressler St, Houston, TX 77030-4008; e-mail: gomezd@.
PURPOSE 目的
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.
我们之前发表的研究结果表明，放疗或手术的局部强化治疗(LCT) 对于一线系统治疗后没有进展的寡转移性的NSCLC可提高无进展生存期(PFS)，并可延迟新疾病发生。在此，我们展示了较长期的总体生存(OS)和其他的次要终点结果。
PATIENTS AND METHODS 患者及方法
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 0.10 were deemed significant.
该多中心、随机、II期临床试验纳入了4期NSCLC，不多于3处转移，在一线系统治疗3个月或更长时间后无进展的患者。患者被随机分配(1:1)到维持治疗或观察(MT/O)组和对所有活动性疾病部位进行LCT组。主要终点为PFS;次要终点为OS、毒性反应和新病灶的出现。所有分析均为双边分析，P值小于0.10有意义。
RESULTS 结果
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).
数据安全与监测委员会在49例患者随机分配后建议尽早结束试验，因为LCT组的PFS获益显著。最新的中位随访时间为38.8个月(范围为28.3 - 61.4个月)，PFS的获益是持久的(中位PFS，LCT组为14.2个月[95% CI, 7.4 - 23.1个月]，MT/O组为4.4个月[95% CI, 2.2 - 8.3个月]，;P = 0.022)。
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).
我们还发现， LCT组的OS获益中值为41.2个月(95% CI, 18.9个月至未及)，MT/O组为17.0个月(95% CI, 10.1至39.8个月，P = 0.017)。没有观察到其他的3级或更大的毒性反应。LCT组进展后生存期也较长(LCT组37.6个月，MT/O组9.4个月;P =0 .034)。
CONCLUSION 结论
In patients with oligometastatic NSCLC that did not progress after front-line systemic therapy, LCT prolonged PFS and OS relative to MT/O.
在一线系统疗法后无进展的寡转移性NSCLC患者中，LCT相对于MT/O延长了PFS和OS。
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