Université Paris Cité, Sorbonne Université, Inserm, Centre de Recherche des Cordeliers, Paris, France.
Département de Médecine Génomique des Tumeurs et Cancers, Service de Biochimie, AP-HP, Hôpital Européen Georges Pompidou, Paris, France.
PLoS One. 2023 Sep 14;18(9):e0291495. doi: 10.1371/journal.pone.0291495. eCollection 2023.
Considering the growing interest in matched cancer treatment, our aim was to evaluate the ability of a comprehensive genomic profiling (CGP) assay to propose at least one targeted therapy given an identified genomic alteration or signature (actionability), and to collect the treatment modifications based on the CGP test results in clinical practise for solid tumors.
This retrospective, multicentre French study was conducted among 25 centres that participated in a free of charge program between 2017 and 2019 for a tissue CGP test. Data were collected on the patient, disease, tumor genomic profile, treatment suggested in the report (related to the genomic profile results) and subsequent therapeutic decisions according to the physician's declaration.
Among the 416 patients, most had lung cancer (35.6%), followed by biliary tract cancer (11.5%) or rare cancers (11.1%); 75% had a metastatic disease. The actionability was 75.0% (95% CI [70.6%-78.9%]) for all patients, 85.1% and 78.4%, respectively in lung cancer and metastatic patients. After exclusion of clinical trial suggestions, the actionability decreased to 62.3% (95% CI [57.5%-66.8%]). Treatment modification based on the test results was observed in 17.3% of the patients and was more frequent in metastatic disease (OR = 2.73, 95% CI [1.31-5.71], p = 0.007). The main reasons for no treatment modification were poor general condition (33.2%) and stable disease or remission (30.2%). The genomic-directed treatment changes were performed mostly during the first six months after the CGP test, and interestingly a substantial part was observed from six to 24 months after the genomic profiling.
This French study provides information on the real-life actionability of a CGP test based on tissue samples, and trends to confirm its utility in clinical practice across the course of the disease, in particularly for patients with lung cancer and/or advanced disease.
考虑到对匹配癌症治疗的兴趣日益浓厚，我们的目的是评估综合基因组分析（CGP）检测在确定基因组改变或特征（可操作性）的情况下提出至少一种靶向治疗的能力，并根据 CGP 测试结果在实体瘤的临床实践中收集治疗修改。
这是一项回顾性、多中心的法国研究，在 2017 年至 2019 年期间，25 个参与免费计划的中心参与了一项组织 CGP 检测。数据收集了患者、疾病、肿瘤基因组谱、报告中建议的治疗（与基因组谱结果相关）以及根据医生声明的后续治疗决策。
在 416 名患者中，大多数为肺癌（35.6%），其次为胆管癌（11.5%）或罕见癌症（11.1%）；75%有转移性疾病。所有患者的可操作性为 75.0%（95%置信区间[70.6%-78.9%]），肺癌和转移性患者分别为 85.1%和 78.4%。排除临床试验建议后，可操作性降至 62.3%（95%置信区间[57.5%-66.8%]）。根据测试结果进行的治疗修改在 17.3%的患者中观察到，在转移性疾病中更为频繁（OR=2.73，95%置信区间[1.31-5.71]，p=0.007）。未进行治疗修改的主要原因是一般状况较差（33.2%）和疾病稳定或缓解（30.2%）。基于基因组的治疗变化主要在 CGP 测试后 6 个月内进行，有趣的是，在基因组分析后 6 至 24 个月内观察到了大量变化。
这项法国研究提供了基于组织样本的 CGP 检测实际可操作性的信息，并倾向于证实其在疾病过程中的临床实践中的效用，特别是对于肺癌和/或晚期疾病患者。
