Department of Medicine, Oregon Health and Science University, Portland.
Knight Cancer Institute, Division of Hematology Oncology, Oregon Health & Science University, Portland.
JAMA Netw Open. 2020 Apr 1;3(4):e202488. doi: 10.1001/jamanetworkopen.2020.2488.
Drugs are used in the adjuvant, metastatic, or both settings in cancer, but the rate, direction, and speed with which drugs are tested and indicated in each setting are unknown.
To identify the number of unique agents that are currently category 1 or 2A per National Comprehensive Cancer Network (NCCN) guidelines in metastatic and adjuvant settings of non-small cell lung cancer (NSCLC), breast cancer, and colon cancer, as well as the mean delay between use in these 2 settings and the quality of supporting evidence.
DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used NCCN treatment guidelines current as of May 15, 2019, and the clinical trials cited either by these guidelines or within corresponding drug labels. Trials published between 1970 and 2019 were evaluated. The analysis included published clinical trials of systemic therapy options deemed by the NCCN as category 1 or 2A. Participants included patients with early or metastatic NSCLC, breast cancer, or colon cancer who were included in clinical trials evaluating current NCCN-recommended systemic therapy options. Data analysis was performed from March 2019 to May 2019.
Systemic therapy regimens used as either adjuvant treatment or as therapy for metastatic disease in the 3 cancer types.
Number of agents recommended for use in adjuvant and metastatic settings of NSCLC, colon cancer, and breast cancer, the mean delay between use in these 2 settings, and the percentage of agents supported by trials with substantial improvement in either progression-free survival (disease-free survival for adjuvant agents) or overall survival.
This study identified 69 agents recommended for use in metastatic disease compared with 25 agents recommended for adjuvant use. For agents used in both settings, the mean (SD) delay between use in metastatic disease and as adjuvant therapy was 10.0 (7.5) years. On the basis of trials with positive outcomes, 39 of 69 agents (56.5%) were approved or recommended in the metastatic setting, compared with 23 of 25 agents (92.0%) approved for use as adjuvant therapy.
There is a substantial difference in the number of agents available for use, as well as the timing of supporting evidence, in the metastatic and adjuvant settings for NSCLC, breast cancer, and colon cancer. Given the potential benefit of adjuvant therapy in these cancer types, further investigation into additional adjuvant systemic therapy options is warranted.
在癌症的辅助治疗、转移性或两者中都使用药物，但在每种情况下测试和指示药物的速度、方向和速度尚不清楚。
确定根据国家综合癌症网络 (NCCN) 指南，在非小细胞肺癌 (NSCLC)、乳腺癌和结肠癌的转移性和辅助性环境中，目前每个类别 1 或 2A 的独特药物数量，以及在这些 2 种环境中使用之间的平均延迟以及支持证据的质量。
设计、环境和参与者：这项横断面研究使用了截至 2019 年 5 月 15 日的 NCCN 治疗指南，以及这些指南或相应药物标签中引用的临床试验。评估了 1970 年至 2019 年期间发表的试验。分析包括 NCCN 认为是类别 1 或 2A 的系统治疗选择的已发表临床试验。参与者包括接受当前 NCCN 推荐的系统治疗选择评估的早期或转移性 NSCLC、乳腺癌或结肠癌患者。数据分析于 2019 年 3 月至 2019 年 5 月进行。
在这 3 种癌症类型中，作为辅助治疗或转移性疾病治疗使用的系统治疗方案。
推荐用于 NSCLC、结肠癌和乳腺癌辅助治疗和转移性治疗的药物数量、在这 2 种治疗方案之间使用的平均延迟时间，以及在无进展生存期（辅助药物的无病生存期）或总生存期方面具有实质性改善的试验支持的药物百分比。
本研究确定了 69 种推荐用于转移性疾病的药物，而 25 种推荐用于辅助治疗。对于在这两种情况下使用的药物，转移性疾病和辅助治疗之间使用的平均（SD）延迟为 10.0（7.5）年。根据阳性结果试验，69 种药物中有 39 种（56.5%）在转移性环境中获得批准或推荐，而 25 种药物中有 23 种（92.0%）获得批准作为辅助治疗。
在 NSCLC、乳腺癌和结肠癌的转移性和辅助性环境中，可用药物的数量以及支持证据的时间存在很大差异。鉴于这些癌症类型辅助治疗的潜在益处，进一步研究其他辅助性系统治疗选择是合理的。
