Wessels Sabine, Muley Thomas, Christopoulos Petros, Meister Michael, Heinzmann-Groth Ingrid, Warth Arne, Herpel Esther, Hummler Simone, Klingmüller Ursula, Kuon Jonas, Heussel Claus-Peter, Eberhardt Ralf, Herth Felix J F, Winter Hauke, Bischoff Helge, Stenzinger Albrecht, Reck Martin, Huber Rudolf Maria, Thomas Michael, Schneider Marc A
Department of Thoracic Oncology, Thoraxklinik at University Hospital Heidelberg, D-69126 Heidelberg, Germany.
Translational Lung Research Center Heidelberg (TLRC), German Center for Lung Research (DZL), Heidelberg, Germany.
Transl Lung Cancer Res. 2020 Aug;9(4):1000-1014. doi: 10.21037/tlcr-20-137.
Availability of tumor material at baseline and disease progression is increasingly important for patient management in non-small-cell lung cancer (NSCLC), especially for the application of targeted therapies like tyrosine kinase inhibitors and for immune checkpoint inhibitor treatment. Here we report the experience of prospective biomaterial acquisition in advanced NSCLC from a pilot project.
Main objective was the longitudinal collection of high-quality, cryoconserved biopsies in addition to formalin-fixed paraffin-embedded (FFPE) biopsies required for routine diagnostics, along with blood samples and detailed clinical annotation using standardized questionnaires.
Over five years, 205 patients were enrolled for the project, yielding 387 cryoconserved biopsies and 1,098 serum, plasma and buffy-coat samples. The feasibility of obtaining the cryoconserved biopsies in addition to the FFPE biopsies was 89% for newly diagnosed cases, but dropped down to 56% and 47% at first and second disease progression, respectively. While forceps biopsy was the preferred procedure for tissue acquisition, the highest tissue amounts were received using the cryobiopsy method. Biopsies had a median tumor cellularity of 34% and yielded in median 13.6 µg DNA and 12 µg RNA (median RIN =8). During the five-year project, a maximum of 38 follow-up blood samples per patient were assembled in up to four therapy lines.
Despite the poor condition and limited prognosis of most NSCLC patients, this serial biomaterial acquisition including routine collection of cryoconserved biopsies is feasible to support individualized management. The standardized collection of high-quality material has enabled and enriched several translational research studies that can advance therapeutic options.
在非小细胞肺癌（NSCLC）患者管理中，基线和疾病进展时获取肿瘤材料对于患者管理愈发重要，特别是对于酪氨酸激酶抑制剂等靶向治疗以及免疫检查点抑制剂治疗的应用。在此，我们报告一项关于晚期NSCLC前瞻性生物材料采集的试点项目经验。
主要目标是除常规诊断所需的福尔马林固定石蜡包埋（FFPE）活检外，纵向收集高质量的冷冻保存活检样本，同时采集血样并使用标准化问卷进行详细的临床注释。
在五年时间里，205例患者参与了该项目，共获得387份冷冻保存活检样本以及1098份血清、血浆和血沉棕黄层样本。对于新诊断病例，除FFPE活检外获取冷冻保存活检样本的可行性为89%，但在首次和第二次疾病进展时分别降至56%和47%。虽然钳取活检是获取组织的首选方法，但采用冷冻活检方法获得的组织量最多。活检样本的肿瘤细胞中位数为34%，中位数产生13.6μg DNA和12μg RNA（中位数RIN =8）。在为期五年的项目中，每位患者最多在四条治疗线中收集了38份随访血样。
尽管大多数NSCLC患者病情不佳且预后有限，但包括常规收集冷冻保存活检样本在内的这种系列生物材料采集对于支持个体化管理是可行的。高质量材料的标准化采集已经促成并丰富了多项转化研究，这些研究可以推进治疗选择。
