Spiegel Marshall L, Goldman Jonathan W, Wolf Brian R, Nameth Danielle J, Grogan Tristan R, Lisberg Aaron E, Wong Deborah J L, Ledezma Blanca A, Mendenhall Melody A, Genshaft Scott J, Gutierrez Antonio J, Abtin Fereidoun, Wallace W Dean, Adame Carlos R, McKenzie Jordan R, Abarca Phillip A, Li Alice J, Strunck Jennifer L, Famenini Sina, Carroll James M, Tucker D Andrew, Sauer Lauren M, Moghadam Nima M, Elashoff David A, Abaya Christina D, Brennan Meghan B, Garon Edward B
Department of Medicine, Division of Hematology/Oncology, Geffen School of Medicine at the University of California-Los Angeles, Los Angeles, California.
Department of Medicine, Statistics Core, Geffen School of Medicine at the University of California-Los Angeles, Los Angeles, California.
Cancer. 2017 Dec 15;123(24):4800-4807. doi: 10.1002/cncr.31056. Epub 2017 Nov 10.
Clinical trials in lung cancer increasingly require patients to provide fresh tumor tissue as a prerequisite to enrollment. The effects of this requirement on enrollment rates, enrollment durations, and patient selection have not been fully elucidated.
The authors retrospectively reviewed data generated by patients who consented to 1 or more interventional lung cancer clinical trials at the University of California-Los Angeles Jonsson Comprehensive Cancer Center between January 2013 and December 2014. Trials were considered to require a biopsy when enrollment was conditional on the procurement of tissue without intervening therapy between procurement and enrollment.
In total, 311 patients underwent 368 screening incidents for 1 or more of 19 trials. Trials that required a new biopsy had a longer median screening duration (34 vs 14 days) than trials that did not require a biopsy (P < .001). Trials that required a biopsy had a greater screen failure rate (49.1% vs 26.5%; P < .001), which was largely driven by patients who did not undergo the required biopsy or lacked the required biomarker. Worsening performance status led to the majority of screen failures (56.5%) among biomarker-eligible patients.
Although the scientific benefits of obtaining a new biopsy and requiring specific results for trial enrollment are clear, these requirements lead to a lengthening of the screening period, which, in some patients, is associated with clinical decline before enrollment. Implications for the interpretation of data from studies of this design should be explored. Cancer 2017;123:4800-7. © 2017 American Cancer Society.
肺癌临床试验越来越要求患者提供新鲜肿瘤组织作为入组的前提条件。这一要求对入组率、入组持续时间和患者选择的影响尚未完全阐明。
作者回顾性分析了2013年1月至2014年12月期间在加利福尼亚大学洛杉矶分校琼森综合癌症中心同意参与1项或多项介入性肺癌临床试验的患者所产生的数据。当入组以获取组织为条件且在获取组织与入组之间无干预性治疗时，这些试验被视为需要活检。
共有311例患者因19项试验中的1项或多项接受了368次筛查事件。需要重新活检的试验的中位筛查持续时间（34天对14天）比不需要活检的试验更长（P < .001）。需要活检的试验的筛查失败率更高（49.1%对26.5%；P < .001），这在很大程度上是由未接受所需活检或缺乏所需生物标志物的患者导致的。在符合生物标志物条件的患者中，大多数筛查失败（56.5%）是由身体状况恶化导致的。
尽管获取新活检并要求特定结果以进行试验入组的科学益处是明确的，但这些要求会导致筛查期延长，在某些患者中，这与入组前的临床衰退有关。应探索对此类设计研究数据解释的影响。《癌症》2017年；123：4800 - 7。© 2017美国癌症协会。
