Liu Kun, Gu Xiang, Chen Nanxiang, You Wei, Wei Jian, Ma Lin, Zhang Xinxin
College of Otolaryngology Head and Neck Surgery，Chinese PLA General Hospital，Chinese PLA Medical School，National Clinical Research Center for Otolaryngologic Diseases，Beijing，100853，China.
Department of Radiotherapy，Chinese PLA General Hospital.
Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2022 Mar;36(3):205-211. doi: 10.13201/j.issn.2096-7993.2022.03.010.
To evaluate the clinical significance of OncoDrug-Seq™ tumor gene detection in patients with head and neck malignancies. A retrospective analysis of 338 patients with locally advanced or unresectable head and neck malignancies admitted to the Department of Otorhinolaryngology Head and Neck Surgery, Chinese PLA General Hospital from April 2011 to February 2021. Among them, 301 patients were pathologically diagnosed as squamous cell carcinoma, 37 cases were non-squamous cell carcinoma. All patients underwent OncoDrug-Seq™ gene detection, combined with the test results and the treatment response after induction chemotherapy to evaluate whether to change the chemotherapy regimen, and to calculate the accuracy of the gene detection and the survival rate of the patient. Among 301 patients with head and neck squamous cell carcinoma, the results of the drug sensitivity test were compared with the actual clinical response, the true positive rate（TP）, true negative rate（TN）, positive predictive value（PPV）, negative predictive value（NPV） and total predictive accuracy rates were 85.37%, 65.45%, 91.70%, 50.00% and 81.73%, respectively. For patients who changed chemotherapy regimen（TN+FP） and did not change（TP+FN）, the 5-year progression-free survival（PFS） was 63.45% and 80.58%（<0.05）, respectively, the 5-year overall survival（OS） was 54.18% and 84.74%（<0.05）. Among 37 patients with non-squamous cell carcinoma, the TP, TN, PPV, NPV and total predictive accuracy rates were 88.46%, 72.73%, 88.46%, 72.73%, and 83.78%, respectively. The 5-year PFS of the patients who changed（TN+FP） and did not change the treatment regimen（TP+FN） were 68.57% and 56.00%, and the 5-year OS was 69.26% and 48.72%, the difference was not statistically significant. OncoDrug-Seq™ testing has certain significance in guiding clinicians to formulate personalized chemotherapy regimens. Timely replacement of the treatment plan can enable the patient to obtain a more ideal curative effect. Compared with patients with squamous cell carcinoma, patients with non-squamous cell carcinoma can obtain greater survival benefit from this testing. However, there are still some deviations in the accuracy of the test results compared with the actual clinical situation. Therefore, the decision should be made based on the test results in combination with the clinical reality.
评估OncoDrug-Seq™肿瘤基因检测在头颈部恶性肿瘤患者中的临床意义。回顾性分析2011年4月至2021年2月解放军总医院耳鼻咽喉头颈外科收治的338例局部晚期或不可切除的头颈部恶性肿瘤患者。其中，301例经病理诊断为鳞状细胞癌，37例为非鳞状细胞癌。所有患者均接受OncoDrug-Seq™基因检测，结合检测结果及诱导化疗后的治疗反应评估是否更改化疗方案，并计算基因检测的准确性及患者生存率。在301例头颈部鳞状细胞癌患者中，将药敏试验结果与实际临床反应进行比较，真阳性率（TP）、真阴性率（TN）、阳性预测值（PPV）、阴性预测值（NPV）及总预测准确率分别为85.37%、65.45%、91.70%、50.00%和81.73%。对于更改化疗方案（TN+FP）和未更改（TP+FN）的患者，5年无进展生存期（PFS）分别为63.45%和80.58%（<0.05），5年总生存期（OS）分别为54.18%和84.74%（<0.05）。在37例非鳞状细胞癌患者中，TP、TN、PPV、NPV及总预测准确率分别为88.46%、72.73%、88.46%、72.73%和83.78%。更改（TN+FP）和未更改治疗方案（TP+FN）的患者5年PFS分别为68.57%和56.00%，5年OS分别为69.26%和48.72%，差异无统计学意义。OncoDrug-Seq™检测在指导临床医生制定个体化化疗方案方面具有一定意义。及时更换治疗方案可使患者获得更理想的疗效。与鳞状细胞癌患者相比，非鳞状细胞癌患者可从该检测中获得更大的生存获益。然而，检测结果的准确性与实际临床情况仍存在一定偏差。因此，应结合临床实际情况根据检测结果做出决策。
