We aimed to determine whether pretherapeutic assessment of HPV circulating tumoral DNA (HPV ctDNA) by droplet‐based digital PCR (ddPCR) could constitute a predictive and prognostic biomarker for HPV‐associated oropharyngeal squamous cell carcinoma (OPSCC). A mono‐institutional prospective biomarker study on 66 patients with p16+/HPV16‐positive oropharyngeal squamous cell carcinoma (OPSCC) was conducted in European Georges Pompidou Hospital, Paris, France. Blood samples were collected at the time of diagnosis before any treatment. Optimized digital PCR assays were used to quantify HPV16 ctDNA. Forty‐seven (71%) patients showed a positive pretherapeutic HPV ctDNA at time of diagnosis. Interestingly, the quantity of HPV16 ctDNA at baseline, as assessed by ddPCR, was significantly correlated with the T/N/M status or OPSCC stages according to the 2018 new staging criteria for high‐risk human papillomavirus (HR HPV) related OPSCC from American Joint Committee on Cancer (AJCC). Moreover, all recurrences and the majority (83%) of death reported events occurred in patients with positive HPV16 ctDNA at baseline. Finally, when posttreatment blood samples were available (n = 6), the kinetic of pretreatment/posttreatment HPV16 ctDNA was clearly associated with treatment success or failure. HPV ctDNA monitoring by ddPCR could constitute a useful and noninvasive dynamic biomarker to select HR HPV‐related OPSCC patients eligible for potential treatment de‐escalation and to monitor treatment response.

中文翻译：

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通过基于液滴的数字PCR进行的HPV循环肿瘤DNA定量：HPV相关口咽癌的一种有前途的预测和预后生物标志物。

我们旨在确定通过基于液滴的数字PCR（ddPCR）对HPV循环肿瘤DNA（HPV ctDNA）进行治疗前评估是否可以构成与HPV相关的口咽鳞状细胞癌（OPSCC）的预测和预后生物标志物。在法国巴黎的蓬皮杜欧洲医院对66例p16 + / HPV16阳性口咽鳞状细胞癌（OPSCC）患者进行了单机构前瞻性生物标记研究。在进行任何治疗之前，应在诊断时采集血样。使用优化的数字PCR测定法定量HPV16 ctDNA。47例（71％）患者在诊断时显示出治疗前HPV ctDNA阳性。有趣的是，通过ddPCR评估，基线时HPV16 ctDNA的数量，根据美国癌症联合委员会（AJCC）2018年针对高危人乳头瘤病毒（HR HPV）相关OPSCC的新分期标准，与T / N / M状态或OPSCC阶段显着相关。而且，所有复发和报告的大多数死亡事件（83％）发生于基线时HPV16 ctDNA阳性的患者。最后，当有后处理血样时（n = 6），HPV16 ctDNA预处理/后处理的动力学与治疗成功或失败明显相关。通过ddPCR监测HPV ctDNA可能是有用且无创的动态生物标志物，用于选择符合潜在治疗降级条件的HR HPV相关OPSCC患​​者并监测治疗反应。