Association of Survival With Adjuvant Chemotherapy Among Patients With Early-Stage Non-Small Cell Lung Cancer With vs Without High-Risk Clinicopathologic Features
Association of Survival With Adjuvant Chemotherapy Among Patients With Early-Stage Non-Small Cell Lung Cancer With vs Without High-Risk Clinicopathologic Features
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DOI：
10.1001/jamaoncol.2020.4232
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发表时间：
2020-09-17
期刊：
影响因子：
28.4
通讯作者：
Boffa, Daniel J.
中科院分区：
文献类型：
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作者：
Pathak, Ranjan;Goldberg, Sarah B.;Boffa, Daniel J.
重要性肿瘤大小大于4 cmis被认为是淋巴结阴性非小细胞肺癌（NSCLC）患者辅助化疗的指征。治疗指南建议，高风险特征也与早期非小细胞肺癌患者的辅助化疗疗效相关，但这种相关性尚未充分研究。目的评估淋巴结阴性早期非小细胞肺癌患者在存在和不存在高风险病理特征的情况下，辅助化疗与生存率之间的相关性。这项回顾性队列研究使用来自国家癌症数据库的数据，包括2010年1月1日至2015年12月31日期间诊断为完全切除的淋巴结阴性NSCLC的50814例初治患者。该研究仅限于术后生存至少6周的患者（即，估计的术后开始辅助化疗的中位时间），以减轻永生时间偏倚。从2018年12月1日至2020年2月29日进行统计分析。EXPOSURES辅助化疗与观察，根据是否存在高危病理特征分层（内脏胸膜浸润、淋巴管浸润和高级别组织学发现），肺叶下手术，主要结果和测量使用考克斯比例风险回归模型评估辅助化疗后与观察相比高危病理特征与生存率的关系。确定了50814例符合条件的NSCLC患者（27365例女性[53.9%];平均[SD]年龄为67.4 [9.5]岁]），包括4220例（8.3%）接受辅助化疗的患者和46594例（91.7%）未接受辅助化疗的患者。在肿瘤小于或等于3 cm的患者中，化疗与生存率改善无关（风险比[HR]，1.10; 95%CI，0.96-1.26; P= 0.17）。对于肿瘤大于3 cm至4 cm的患者，辅助化疗与接受肺叶下手术的患者的生存获益相关（HR，0.72; 95% CI，0.56-0.93; P= 0.004）。对于大于4 cm至5 cm的肿瘤，仅在至少有1个高危病理特征的患者中，辅助化疗才能带来生存获益（HR，0.67; 95% CI，0.56-0.80; P= 0.02）。对于大于5 cm的肿瘤，辅助化疗与生存获益相关，无论是否存在高危病理特征（HR，0.75; 95%CI，0.61-0.91; P=.004）。结论和相关性在这项队列研究中，肿瘤大小本身与早期（淋巴结阴性）NSCLC患者辅助化疗疗效改善无关。在评估早期NSCLC患者是否接受辅助化疗时，应同时考虑高危临床病理特征和肿瘤大小。
IMPORTANCE Tumor size larger than 4 cmis accepted as an indication for adjuvant chemotherapy in patients with node-negative non-small cell lung cancer (NSCLC). Treatment guidelines suggest that high-risk features are also associated with the efficacy of adjuvant chemotherapy among patients with early-stage NSCLC, yet this association is understudied.OBJECTIVE To assess the association between adjuvant chemotherapy and survival in the presence and absence of high-risk pathologic features in patients with node-negative early-stage NSCLC.DESIGN, SETTING, AND PARTICIPANTS This retrospective cohort study using data from the National Cancer Database included 50 814 treatment-naive patients with a completely resected node-negative NSCLC diagnosed between January 1, 2010, and December 31, 2015. The study was limited to patients who survived at least 6 weeks after surgery (ie, estimated median time to initiate adjuvant chemotherapy after surgery) to mitigate immortal time bias. Statistical analysis was performed from December 1, 2018, to February 29, 2020.EXPOSURES Adjuvant chemotherapy use vs observation, stratified according to the presence or absence of high-risk pathologic features (visceral pleural invasion, lymphovascular invasion, and high-grade histologic findings), sublobar surgery, and tumor size.MAIN OUTCOMES AND MEASURES The association of high-risk pathologic features with survival after adjuvant chemotherapy vs observation was evaluated using Cox proportional hazards regression models.RESULTS Overall, 50 814 eligible patients with NSCLC (27 365 women [53.9%]; mean [SD] age, 67.4 [9.5] years]) were identified, including 4220 (8.3%) who received adjuvant chemotherapy and 46 594 (91.7%) who did not receive adjuvant chemotherapy. Among patients with tumors 3 cm or smaller, chemotherapy was not associated with improved survival (hazard ratio [HR], 1.10; 95% CI, 0.96-1.26; P=.17). For patients with tumors larger than 3 cmto 4 cm, adjuvant chemotherapy was associated with a survival benefit among patients who underwent sublobar surgery (HR, 0.72; 95% CI, 0.56-0.93; P=.004). For tumors larger than 4 cmto 5 cm, a survival benefit was associated with adjuvant chemotherapy only in patients with at least 1 high-risk pathologic feature (HR, 0.67; 95% CI, 0.56-0.80; P=.02). For tumors larger than 5 cm, adjuvant chemotherapy was associated with a survival benefit irrespective of the presence of high-risk pathologic features (HR, 0.75; 95% CI, 0.61-0.91; P=.004).CONCLUSIONS AND RELEVANCE In this cohort study, tumor size alone was not associated with improved efficacy of adjuvant chemotherapy in patients with early-stage (node-negative) NSCLC. High-risk clinicopathologic features and tumor size should be considered simultaneously when evaluating patients with early-stage NSCLC for adjuvant chemotherapy.