Chest Disease Department, Jean Minjoz University Hospital, Besancon, France.
J Thorac Oncol. 2012 May;7(5):841-9. doi: 10.1097/JTO.0b013e31824c7d92.
Our study aimed to evaluate whether pathologic complete response (pCR) in early-stage non-small-cell lung cancer (NSCLC) after neoadjuvant chemotherapy resulted in improved outcome, and to determine predictive factors for pCR.
Eligible patients with stage-IB or -II NSCLC were included in two consecutive Intergroupe Francophone de Cancérologie Thoracique phase-III trials evaluating platinum-based neoadjuvant chemotherapy, with pCR defined by the absence of viable cancer cells in the resected surgical specimen.
Among the 492 patients analyzed, 41 (8.3%) achieved pCR. In the pCR group, 5-year overall survival was 80.0% compared with 55.8% in the non-pCR group (p = 0.0007). In multivariate analyses, pCR was a favorable prognostic factor of overall survival (relative risk = 0.34; 95% confidence interval = 0.18-0.64) in addition to squamous-cell carcinoma, weight loss less than or equal to 5%, and stage-IB disease. Five-year disease-free survival was 80.1% in the pCR group compared to 44.8% in the non-pCR group (p < 0.0001). Two patients (4.9%) in the pCR group experienced disease recurrence compared to 193 patients (42.8%) in the non-pCR group. SCC subtype was the only independent predictor of pCR (odds ratio [OR] = 4.30; 95% confidence interval = 1.90-9.72).
Our results showed that pCR after preoperative chemotherapy was a favorable prognostic factor in stage-IB-II NSCLC. Our study is the largest published series evaluating pCRs after preoperative chemotherapy. The only factor predictive of pCR was squamous-cell carcinoma. Identifying molecular predictive markers for pCR may help in distinguishing patients likely to benefit from neoadjuvant chemotherapy and in choosing the most adequate preoperative chemotherapy regimen.
本研究旨在评估早期非小细胞肺癌(NSCLC)患者接受新辅助化疗后病理完全缓解(pCR)是否能改善预后,并确定 pCR 的预测因素。
本研究纳入了两项连续的法国胸外科肿瘤学组(IFCT)III 期临床试验中符合条件的 I 期 B 或 II 期 NSCLC 患者,评估了以铂类为基础的新辅助化疗,pCR 定义为切除的手术标本中无存活癌细胞。
在分析的 492 例患者中,有 41 例(8.3%)达到 pCR。在 pCR 组中,5 年总生存率为 80.0%,而非 pCR 组为 55.8%(p=0.0007)。在多变量分析中,pCR 是总生存的有利预后因素(相对风险=0.34;95%置信区间=0.18-0.64),此外还有鳞癌、体重减轻等于或小于 5%和 I 期 B 疾病。在 pCR 组中,5 年无病生存率为 80.1%,而非 pCR 组为 44.8%(p<0.0001)。在 pCR 组中有 2 例(4.9%)患者出现疾病复发,而非 pCR 组中有 193 例(42.8%)患者出现疾病复发。SCC 亚型是 pCR 的唯一独立预测因素(优势比[OR]=4.30;95%置信区间=1.90-9.72)。
我们的结果表明,术前化疗后 pCR 是 I 期 B-II 期 NSCLC 的一个有利预后因素。我们的研究是发表的最大系列评估术前化疗后 pCRs 的研究。唯一预测 pCR 的因素是鳞癌。确定 pCR 的分子预测标志物可能有助于区分可能从新辅助化疗中获益的患者,并选择最合适的术前化疗方案。