Automated in vivo analysis of tumor growth rate as a guide for therapeutic decisions to advance personalized cancer treatment

项目摘要 该项目的目标是开发一种新的分析软件模块，用于在 晚期肺癌患者的治疗。肿瘤生长率是一个评价临床疗效的新概念 癌症治疗的益处，建议作为治疗决定的客观指南，但不包括在内 在现行的肿瘤疗效评价标准中。肿瘤生长率的概念尤其重要。 在肿瘤中有特定突变的患者，如表皮生长因子受体(EGFR)突变 在肺癌中，使用针对其突变的个性化治疗。EGFR突变患者 对使用EGFR抑制剂的靶向治疗表现出最初的戏剧性反应；然而，他们的肿瘤重新生长和 最终会取得进展。目前的临床实践缺乏关于EGFR抑制剂治疗何时可以 在肿瘤恢复生长期间安全地继续治疗，而决定留给治疗医生的自由裁量权。 在使用针对各种癌症的其他靶向剂进行治疗期间观察到类似的临床场景， 表明临床需求不断增加，以满足这一未得到满足的治疗决策客观指南的需求。 精准癌症治疗的时代。这个学术-产业合作团队的调查人员已经开发出 一种利用系列临床CT影像数据客观描述肿瘤生长速度随时间变化的方法 在接受癌症治疗的患者中获得。该方法被应用于EGFR突变的肺癌患者 作为一个经过充分研究的范例，并提供了一个表明快速增长与缓慢增长的可重复的参考值。 考虑到作为临床研究的可行性，该团队建议提供这一新的分析 通过开发用于肿瘤生长率评估的自动分析工具来实现临床设置的功能性 和解释，这对于使该方法在临床工作流程中更广泛地适应是必不可少的。 这个学术-产业团队由来自Dana-Farber/Brigham和Women‘s的资深研究人员组成 来自东芝医疗系统公司的癌症中心和工业科学家，拥有肿瘤学方面的专业知识， 放射学、生物统计学和工程学，他们有卓有成效的合作记录。这支队伍有 开始致力于解决以下目标：目标1)开发肿瘤分析软件模块 肺癌治疗期间的生长速度，在现有的工作站上操作；目标2)优化 基于重复性评估和用户反馈的模块，在30个EGFR突变体的试点队列中 目的3)应用肺癌患者肿瘤生长率分析软件模块 前瞻性试验。将新的肿瘤生长率分析模块交付临床环境将提供 为癌症治疗中的治疗决策提供客观指导，并有助于最大限度地发挥 癌症的精准治疗。学术-产业合作伙伴关系的表现出的生产力 双向研究关系进一步保证了项目目标的顺利完成。

Project Summary The goal of this project is to develop a novel analytic software module for tumor growth rate assessment during therapy in advanced lung cancer patients. Tumor growth rate is a novel concept for evaluation of clinical benefit of cancer therapy and is proposed as objective guides for treatment decisions, however is not included in the current standards of tumor response evaluation. The concept of tumor growth rate is especially important in patients with specific mutations in their tumors, such as epidermal growth factor receptor (EGFR) mutations in lung cancer, treated with personalized therapy specifically targeting their mutations. EGFR-mutant patients show initial dramatic response to targeted therapy using EGFR inhibitors; however, their tumors grow back and eventually progress. Current clinical practice lacks objective guidelines about when EGFR inhibitor therapy can be safely continued while tumors are growing back, and the decision is left to treating physicians’ discretions. Similar clinical scenarios are observed during therapy using other targeting agents for various cancers, indicating an increasing clinical demand to fulfil this unmet need for objective guides for treatment decisions in the era of precision cancer therapy. Investigators of this academic-industrial partnership team have developed a method to objectively characterize of tumor growth rate over time using the serial clinical CT imaging data obtained in patients receiving cancer therapy. The method was applied to EGFR-mutant lung cancer patients as a well-studied paradigm, and provided a reproducible reference value that indicates fast versus slow growth. Given the demonstrated feasibility as a clinical investigation, the team proposes to deliver this novel analytic functionality to the clinical setting, by developing an automated analytic tool for tumor growth rate assessment and interpretation, which is essential to make the approach more widely adaptable within the clinical workflow. The academic-industrial team consists of accomplished investigators from Dana-Farber/Brigham and Women’s Cancer Center and industrial scientists from Toshiba Medical Systems Corporation, with expertise in oncology, radiology, biostatistics, and engineering, who have a track record of productive collaboration. The team has started to work together to address the following aims: Aim 1) Develop an analytic software module for tumor growth rate in lung cancer during therapy, which operates on an existing workstation; Aim 2) Optimize the module based on the reproducibility assessment and user feedback in a pilot cohort of 30 EGFR-mutant patients; and Aim 3) Apply the analytic software module for tumor growth rate in lung cancer patients treated in prospective trials. Delivery of the novel analytic module for tumor growth rate to the clinical setting will provide objective guides for treatment decision making during cancer therapy, and help to maximize the benefit of precision therapy for cancer. The demonstrated productivity of academic-industrial partnership with bidirectional research relationship further ensures successful completion of the project goal.