Department of Thoracic Surgery, Peking University People's Hospital, Beijing, China.
Guangdong General Hospital & Guangdong Academy of Medical Science, Guangdong Lung Cancer Institute, Guangzhou, China.
Lung Cancer. 2019 Jul;133:75-82. doi: 10.1016/j.lungcan.2019.04.024. Epub 2019 Apr 24.
The use of adjuvant chemotherapy (ACT) in completely resected stage IB non-small cell lung cancer (NSCLC) is still controversial. The divergent outcomes of prospective trials have created uncertainty as to the utility of ACT in stage IB NSCLC. This study assesses the effect of postoperative adjuvant chemotherapy in stage IB patients in clinical practice.
Patients with pT2aN0M0 stage IB NSCLC who underwent complete resection from 2004 to 2015 were identified from prospectively collected databases in two medical centers. The log-rank test was used to compare overall survival (OS) and disease free survival (DFS). Fine and Gray's competing risks regression model was built to identify predictors of cancer-specific survival. One to one propensity-score matching (PSM) was performed to reduce the selection bias and additional analyses were performed on these subgroups.
Of 1005 patients identified for the study, 202 (20.1%) received ACT and 803 (79.9%) underwent surgery alone (observation group). Compared with the observation group, patients who underwent ACT were younger (p < 0.001), had larger tumors (p = 0.004), and had higher rates of squamous cell carcinoma (p < 0.001) and lymphovascular invasion (p = 0.017). After propensity score matching, 196 pairs of patients were 1:1 matched in the two groups and all baseline characteristics were well balanced. ACT was not associated with improved survival (including OS, DFS; all log-rank p > 0.05) in both unmatched and matched (196 pairs) cohorts. In subgroup analysis of the matched population, ACT was not associated with survival benefits for patients regardless of whether their tumors measured <4 cm or ≥4 cm (both log-rank p > 0.05).
In patients with completely resected stage IB (T2aN0M0) NSCLC, ACT is not associated with improved prognosis. Further large multicenter studies are needed to confirm these findings.
在完全切除的ⅠB 期非小细胞肺癌(NSCLC)中使用辅助化疗(ACT)仍然存在争议。前瞻性试验的不同结果使得 ACT 在ⅠB 期 NSCLC 中的应用效果存在不确定性。本研究评估了临床实践中ⅠB 期患者术后辅助化疗的效果。
从两个医学中心前瞻性收集的数据库中确定了 2004 年至 2015 年间接受完全切除术的 pT2aN0M0 ⅠB 期 NSCLC 患者。采用对数秩检验比较总生存期(OS)和无病生存期(DFS)。建立 Fine 和 Gray 竞争风险回归模型来确定癌症特异性生存的预测因素。采用 1:1 倾向评分匹配(PSM)来减少选择偏差,并对这些亚组进行了额外的分析。
在确定的 1005 例患者中,202 例(20.1%)接受了 ACT,803 例(79.9%)仅接受了手术(观察组)。与观察组相比,接受 ACT 的患者年龄更小(p<0.001),肿瘤更大(p=0.004),且鳞状细胞癌(p<0.001)和血管淋巴管侵犯(p=0.017)的发生率更高。经过倾向评分匹配后,两组各有 196 对患者 1:1 匹配,所有基线特征均得到很好的平衡。在未匹配和匹配(196 对)队列中,ACT 均未改善生存(包括 OS、DFS;所有 log-rank p>0.05)。在匹配人群的亚组分析中,无论肿瘤大小<4cm 还是≥4cm,ACT 均与生存获益无关(两者 log-rank p>0.05)。
在完全切除的ⅠB 期(T2aN0M0)NSCLC 患者中,ACT 并不能改善预后。需要进一步进行大型多中心研究来证实这些发现。