Radical Treatment of Non-Small-Cell Lung Cancer Patients with Synchronous Oligometastases Long-Term Results of a Prospective Phase II Trial (Nct01282450)
Radical Treatment of Non-Small-Cell Lung Cancer Patients with Synchronous Oligometastases Long-Term Results of a Prospective Phase II Trial (Nct01282450)
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DOI：
10.1097/jto.0b013e318262caf6
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发表时间：
2012-10-01
影响因子：
20.4
通讯作者：
Lambin, Philippe
中科院分区：
文献类型：
--
作者：
De Ruysscher, Dirk;Wanders, Rinus;Lambin, Philippe
背景资料：IV期非小细胞肺癌（NSCLC）患者的寡转移（< 5个转移灶）可能会经历长期生存时，所有宏观肿瘤部位进行根治性治疗，但没有前瞻性的数据与同步寡转移NSCLC是available.Methods：前瞻性单臂II期试验进行。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）。该研究已列入临床试验。结果：40例患者入组，其中39例可评价（18例男性，21例女性）;平均年龄为62.1 ± 9.2岁（范围：44-81岁）。29例（74%）为局部III期; 17例（44%）为脑转移，7例（18%）为骨转移，4例（10%）为肾上腺转移。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）; 1年、2年和3年OS分别为56.4%、23.3%和17.5%。中位无进展生存期（PFS）为12.1个月（95%置信区间9.6-14.3）; 1年PFS为51.3%，2年和3年PFS均为13.6%。仅2例患者（5%）局部复发。没有患者或肿瘤参数，包括体积和F-18-脱氧葡萄糖摄取与OS或PFS显著相关。结论：在这项II期研究中，长期PFS被发现在一个亚组的NSCLC患者同步寡转移时，根治性治疗。需要在治疗前识别该有利亚组。
Background: Stage IV non-small-cell lung cancer (NSCLC) patients with oligometastases ( < 5 metastatic lesions) may experience long-term survival when all macroscopic tumor sites are treated radically, but no prospective data on NSCLCs with synchronous oligometastases are available.Methods: A prospective single-arm phase II trial was conducted. 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). The study is listed in clinicaltrials. gov, number NCT01282450.Results: Forty patients were enrolled, 39 of whom were evaluable (18 men, 21 women); mean age was 62.1 +/- 9.2 years (range, 44-81). Twenty-nine (74%) had local stage III; 17 (44%) brain, seven (18%) bone, and four (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); 1-, 2-, and 3-year OS was 56.4%, 23.3%, and 17.5%, respectively. Median progression-free survival (PFS) was 12.1 months (95% confidence interval 9.6-14.3); 1-year PFS was 51.3%, and both 2-and 3-year PFS was 13.6%. Only two patients (5%) had a local recurrence. No patient or tumor parameter, including volume and F-18-deoxyglucose uptake was significantly correlated with OS or PFS. The treatment was well tolerated.Conclusion: In this phase II study, long-term PFS was found in a subgroup of NSCLC patients with synchronous oligometastases when treated radically. Identification of this favorable subgroup before therapy is needed.