Ferry-Galow Katherine V, Datta Vivekananda, Makhlouf Hala R, Wright John, Wood Bradford J, Levy Elliot, Pisano Etta D, Tam Alda L, Lee Susanna I, Mahmood Umar, Rubinstein Lawrence V, Doroshow James H, Chen Alice P
Frederick National Laboratory for Cancer Research, Frederick; National Cancer Institute, Bethesda MD; Beth Israel Deaconess Medical Center; Harvard Medical School; Massachusetts General Hospital, Boston, MA; American College of Radiology, Reston, VA; and University of Texas MD Anderson Cancer Center, Houston, TX.
J Oncol Pract. 2018 Oct 4;14(11):JOP1800092. doi: 10.1200/JOP.18.00092.
: Research biopsy specimens collected in clinical trials often present requirements beyond those of tumor biopsy specimens collected for diagnostic purposes. Research biopsies underpin hypothesis-driven drug development, pharmacodynamic assessment of molecularly targeted anticancer agents, and, increasingly, genomic assessment for precision medicine; insufficient biopsy specimen quality or quantity therefore compromises the scientific value of a study and the resources devoted to it, as well as each patient's contribution to and potential benefit from a clinical trial.
: To improve research biopsy specimen quality, we consulted with other translational oncology teams and reviewed current best practices.
: Among the recommendations were improving communication between oncologists and interventional radiologists, providing feedback on specimen sufficiency, increasing academic recognition and financial support for the time investment required by radiologists to collect and preserve research biopsy specimens, and improving real-time assessment of tissue quality.
: Implementing these recommendations at the National Cancer Institute's Developmental Therapeutics Clinic has demonstrably improved the quality of biopsy specimens collected; more widespread dissemination of these recommendations beyond large clinical cancer centers is possible and will be of value to the community in improving clinical research and, ultimately, patient care.
临床试验中收集的研究活检标本通常有超出诊断用肿瘤活检标本的要求。研究活检是假设驱动的药物研发、分子靶向抗癌药物的药效学评估以及越来越多的精准医学基因组评估的基础；因此，活检标本质量或数量不足会损害研究的科学价值、投入的资源以及每位患者对临床试验的贡献和可能从中获得的益处。
为提高研究活检标本质量，我们与其他转化肿瘤学团队进行了磋商，并回顾了当前的最佳实践。
建议包括改善肿瘤学家与介入放射科医生之间的沟通、提供标本充足性的反馈、增加对放射科医生收集和保存研究活检标本所需时间投入的学术认可和资金支持，以及改善组织质量的实时评估。
在美国国立癌症研究所的发育治疗诊所实施这些建议已显著提高了所收集活检标本的质量；这些建议在大型临床癌症中心之外更广泛地传播是可行的，并且将对改善临床研究以及最终改善患者护理对业界有价值。
