Objective:To evaluate the clinical significance of OncoDrug-Seq™ tumor gene detection in patients with head and neck malignancies. Methods: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. Results: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%（P<0.05）, respectively, the 5-year overall survival（OS） was 54.18% and 84.74%（P<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. Conclusion: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.
目的：评估OncoDrug-Seq™肿瘤精准治疗基因检测在头颈部恶性肿瘤患者中应用的临床意义。 方法：回顾性分析2011年4月—2021年2月解放军总医院耳鼻咽喉头颈外科收治的局部中晚期或手术无法切除的头颈部恶性肿瘤患者338例，其中病理诊断为鳞状细胞癌301例，非鳞状细胞癌37例。所有患者均行药敏检测，根据检测结果与诱导化疗后肿瘤治疗反应情况，评估是否更换化疗方案，并计算检测的准确率及患者的生存率。 结果：301例头颈部鳞状细胞癌患者，药敏检测与临床实际反应结合对比后，真阳性率、真阴性率、阳性预测值、阴性预测值、总预测准确率分别为85.37%、65.45%、91.70%、50.00%、81.73%；更换化疗方案（真阴性+假阳性）与未更换化疗方案（真阳性+假阴性）的患者5年无进展生存率（PFS）分别为63.45%和80.58%（P<0.05），5年总生存率（OS）分别为54.18%和84.74%（P<0.05）。37例头颈部非鳞状细胞癌患者的真阳性率、真阴性率、阳性预测值、阴性预测值、总预测准确率分别为88.46%、72.73%、88.46%、72.73%、83.78%；更换化疗方案与未更换化疗方案的患者5年PFS分别为68.57%和56.00%（P>0.05），5年OS分别为69.26%和48.72%（P>0.05）。 结论：肿瘤药敏检测在临床医生制定个性化化疗方案中具有一定的指导意义。及时更换化疗方案，可使患者获得更为理想的疗效。相较于鳞状细胞癌，非鳞状细胞癌患者可从药敏检测中得到更大的生存获益。但由于药敏检测结果的准确性较实际情况仍存在一些偏差，因此应根据药敏检测结果结合临床实际进行决策。.
Keywords: carcinoma, squamous cell; chemosensitivity assay; head and neck neoplasms; precision medicine; survival.
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