Dana-Farber/Partners CancerCare, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts.
Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, Minnesota.
JAMA Oncol. 2022 May 1;8(5):717-728. doi: 10.1001/jamaoncol.2022.0039.
Standard treatment for resectable non-small cell lung cancer (NSCLC) includes anatomic resection with adequate lymph node dissection and adjuvant chemotherapy for appropriate patients. Historically, many patients with early-stage NSCLC have not received such treatment, which may affect the interpretation of the results of adjuvant therapy trials.
To ascertain patterns of guideline-concordant treatment among patients enrolled in a US-wide screening protocol for adjuvant treatment trials for resected NSCLC.
DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included 2833 patients with stage IB to IIIA NSCLC (per American Joint Committee on Cancer 7th edition criteria) who enrolled in the Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) screening study (Alliance for Clinical Trials in Oncology A151216) from August 18, 2014, to April 1, 2019, and who did not enroll in a therapeutic adjuvant clinical trial; patients had tumors of at least 4 cm and/or with positive lymph nodes. Statistical analysis was conducted from June 1, 2020, through October 1, 2021.
Care patterns were ascertained overall and by sociodemographic and clinical factors, including age, sex, race and ethnicity, educational level, marital status, geography, histologic characteristics, stage, genomic variant status, smoking history, and comorbidities.
Five outcomes are reported: whether patients (1) had anatomic surgical resection, (2) had adequate lymph node dissection (≥1 N1 nodal station plus ≥3 N2 nodal stations), (3) received any adjuvant chemotherapy, (4) received any cisplatin-based adjuvant chemotherapy, and (5) received at least 4 cycles of adjuvant chemotherapy.
Of the 2833 patients (1505 women [53%]; mean [SD] age, 66.5 [9.2] years) included in this analysis, 2697 (95%) had anatomic surgical resection, 1513 (53%) had adequate lymph node dissection, 1617 (57%) received any adjuvant chemotherapy, 1237 (44%) received at least 4 cycles of adjuvant platinum-based chemotherapy, and 965 (34%) received any cisplatin-based adjuvant chemotherapy. Rates were similar across race and ethnicity.
This cohort study found that among participants in a screening protocol for adjuvant clinical trials for resected early-stage NSCLC, just 53% underwent adequate lymph node dissection, and 57% received adjuvant chemotherapy, despite indications for such treatment. These results may affect the interpretation of adjuvant trials. Efforts are needed to optimize the use of proven therapies for early-stage NSCLC.
ClinicalTrials.gov Identifier: NCT02194738.
可切除非小细胞肺癌（NSCLC）的标准治疗包括解剖性切除术和足够的淋巴结清扫，以及为合适的患者提供辅助化疗。历史上，许多早期 NSCLC 患者未接受此类治疗，这可能会影响辅助治疗试验结果的解读。
确定纳入美国广泛辅助治疗试验筛选方案的患者中符合指南的治疗模式。
设计、设置和参与者：这是一项回顾性队列研究，纳入了 2833 名患有 I 期到 IIIA 期 NSCLC（按美国癌症联合委员会第 7 版标准）的患者，他们于 2014 年 8 月 18 日至 2019 年 4 月 1 日参加了辅助肺癌富集标志物鉴定和测序试验（ALCHEMIST）筛选研究（肿瘤临床研究协作组 A151216），并且没有参加治疗性辅助临床试验；患者的肿瘤至少有 4cm 且/或有阳性淋巴结。统计分析于 2020 年 6 月 1 日至 2021 年 10 月 1 日进行。
总体上以及通过社会人口统计学和临床因素（包括年龄、性别、种族和民族、教育程度、婚姻状况、地理位置、组织学特征、分期、基因组变异状态、吸烟史和合并症）来确定治疗模式。
报告了五个结果：患者是否（1）进行了解剖性手术切除，（2）进行了足够的淋巴结清扫（≥1 个 N1 淋巴结站加≥3 个 N2 淋巴结站），（3）接受了任何辅助化疗，（4）接受了任何顺铂类辅助化疗，以及（5）接受了至少 4 个周期的辅助化疗。
在这项分析中，纳入了 2833 名患者（1505 名女性[53%]；平均[标准差]年龄为 66.5[9.2]岁），其中 2697 名（95%）进行了解剖性手术切除，1513 名（53%）进行了足够的淋巴结清扫，1617 名（57%）接受了任何辅助化疗，1237 名（44%）接受了至少 4 个周期的顺铂类辅助化疗，965 名（34%）接受了任何顺铂类辅助化疗。不同种族和民族的比例相似。
这项队列研究发现，在早期 NSCLC 辅助临床试验筛选方案的参与者中，只有 53%的患者接受了足够的淋巴结清扫，57%的患者接受了辅助化疗，尽管有这种治疗的指征。这些结果可能会影响辅助试验的解读。需要努力优化早期 NSCLC 经证实疗法的应用。
ClinicalTrials.gov 标识符：NCT02194738。
