Department of Radiation Oncology (MAASTRO clinic), GROW-School for Oncology and Developmental Biology, University Medical Centre Maastricht, Maastricht, The Netherlands.
J Thorac Oncol. 2012 Oct;7(10):1547-55. doi: 10.1097/JTO.0b013e318262caf6.
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.
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.
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-deoxyglucose uptake was significantly correlated with OS or PFS. The treatment was well tolerated.
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.
对于所有宏观肿瘤部位均接受根治性治疗的寡转移（<5 个转移病灶）IV 期非小细胞肺癌（NSCLC）患者，可能会长期生存，但尚无同步寡转移 NSCLC 的前瞻性数据。
进行了一项前瞻性单臂 II 期试验。主要纳入标准为病理证实的 IV 期 NSCLC，初诊时转移灶少于 5 个，可进行根治性局部治疗（手术或放疗）。该研究在 clinicaltrials.gov 上注册，编号为 NCT01282450。
共纳入 40 例患者，其中 39 例可评估（18 例男性，21 例女性）；平均年龄为 62.1±9.2 岁（范围为 44-81 岁）。29 例（74%）为局部 III 期；17 例（44%）脑转移，7 例（18%）骨转移，4 例（10%）肾上腺转移。35 例（87%）患者仅有单一转移病灶。37 例（95%）患者在初治时接受了化疗。中位总生存（OS）为 13.5 个月（95%置信区间为 7.6-19.4）；1、2 和 3 年 OS 分别为 56.4%、23.3%和 17.5%。中位无进展生存（PFS）为 12.1 个月（95%置信区间为 9.6-14.3）；1 年 PFS 为 51.3%，2 年和 3 年 PFS 分别为 13.6%。仅有 2 例（5%）患者出现局部复发。无患者或肿瘤参数（包括体积和 F-脱氧葡萄糖摄取）与 OS 或 PFS 显著相关。治疗耐受性良好。
在这项 II 期研究中，根治性治疗同步寡转移 NSCLC 的亚组患者中发现了长期的 PFS。需要在治疗前确定这一有利的亚组。
