美国研究中早期肺癌患者的指南一致性手术和辅助化疗率

3  April 2022

Rates of Guideline-Concordant Surgery and Adjuvant Chemotherapy Among Patients With Early-Stage Lung Cancer in the US ALCHEMIST Study (Alliance A151216)

(IF: JAMA Oncol., 31.777)

• Kehl KL, Zahrieh D, Yang P, Hillman SL, Tan AD, Sands JM, Oxnard GR, Gillaspie EA, Wigle D, Malik S, Stinchcombe TE, Ramalingam SS, Kelly K, Govindan R, Mandrekar SJ, Osarogiagbon RU, Kozono D. Rates of Guideline-Concordant Surgery and Adjuvant Chemotherapy Among Patients With Early-Stage Lung Cancer in the US ALCHEMIST Study (Alliance A151216). JAMA Oncol. 2022 Mar 17:e220039. 

• Corresponding Author: Kenneth L. Kehl, MD, MPH, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02215 (kenneth_kehl@dfci.harvard.edu).

IMPORTANCE 重要性

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.

可切除非小细胞肺癌（NSCLC）的标准治疗，包括对于适合患者的具有足够淋巴结解剖和辅助化疗的解剖学切除。从历史上看，许多早期NSCLC患者尚未接受过此类治疗，这可能会影响对于辅助治疗试验结果的解释。

OBJECTIVE 目的

To ascertain patterns of guideline-concordant treatment among patients enrolled in a US-wide screening protocol for adjuvant treatment trials for resected NSCLC.

为了可切除的NSCLC辅助治疗试验，在美国范围的筛查方案中，确定患者指南一致性治疗的模式。

DESIGN, SETTING, AND PARTICIPANTS 设计、设置与参与者

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.

这项回顾性队列研究纳入了2833名IB至IIIA期NSCLC患者（根据美国癌症联合委员会第七版标准），他们在2014年8月18日至2019年4月1日期间，参加了辅助性肺癌富集标记物鉴定和测序试验（ALCHEMIST）筛查研究（肿瘤学临床试验联盟A151216），且未参加辅助治疗性临床试验；患者至少有4cm的肿瘤和/或淋巴结阳性。统计分析于2020年6月1日到2021年10月1日进行。

EXPOSURES 暴露

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.

护理模式由社会人口学和临床因素确定，包括年龄、性别、种族和民族、教育水平、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。

MAIN OUTCOMES AND MEASURES 主要结果与方法

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.

报告了五种结果：患者（1）是否进行了解剖性手术切除，（2）是否进行了充分的淋巴结清扫（≥1 N1淋巴结位点加≥3 N2淋巴结位点），（3）是否接受了任何辅助化疗，（4）是否接受了任何基于顺铂的辅助化疗以及（5）是否接受了至少4个周期的辅助化疗。

RESULTS 结果

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.

在纳入本分析的2833名患者（1505名女性[53%]；平均[SD]年龄，66.5[9.2]岁）中，2697名（95%）进行了解剖手术切除，1513名（53%）进行了充分的淋巴结清扫，1617名（57%）接受了任何辅助化疗，1237名（44%）接受了至少4个周期的辅助铂类化疗，965名（34%）接受了任何基于顺铂的辅助化疗。不同种族和民族的发病率相似。

CONCLUSIONS AND RELEVANCE 结论与意义

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.

该队列研究发现，在切除的早期NSCLC辅助临床试验筛选方案的参与者中，尽管有此类治疗的指征，但只有53%的人接受了充分的淋巴结清扫术，57%的人接受了辅助化疗。这些结果可能会影响辅助试验的解释。需要努力优化早期NSCLC的经验疗法的使用。

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