Abstract：
OBJECTIVE: Clinical and imaging examinations frequently have indeterminate results during cancer surveillance, which can lead to overtreatment and cause psychological and financial harm to the patient. This study addresses the critical need to enhance diagnostic precision and decision-making in the management of HPV-associated oropharyngeal cancer. This study evaluated the utility of tumor tissue-modified viral (TTMV)-HPV DNA to resolve indeterminate disease status following definitive treatment for HPV-associated oropharyngeal cancer.
METHODS: In this retrospective cohort, patients treated for HPV-associated oropharyngeal cancer at eight U.S. institutions and who received one or more TTMV-HPV DNA tests during post-treatment surveillance between February 2020 and January 2022 were included.
RESULTS: Among 543 patients, 210 patients (38.7%; 210/543) experienced one or more clinically indeterminate findings (CIFs) during surveillance, with 503 CIFs recorded. Of those patients with an \"indeterminate\" disease status at a point during surveillance, 79 were associated with contemporaneous TTMV-HPV DNA testing. TTMV-HPV DNA testing demonstrated high accuracy (97.5%; 77/79) in correctly determining recurrence status. Patients whose disease status was \"indeterminate\" at the time of a positive TTMV-HPV DNA test were clinically confirmed to recur faster than those whose disease status was \"no evidence of disease.\" Only 3% of patients (17/543) experienced indeterminate TTMV-HPV DNA tests during surveillance. Discordance between TTMV-HPV DNA tests and clinical results was minimal, with only 0.6% (3/543) of patients showing positive tests without recurrence.
CONCLUSIONS: Our findings support the utility of circulating TTMV-HPV DNA in resolving indeterminate disease status and informing the subsequent clinical course.
METHODS: In this retrospective cohort, patients treated for HPV-associated oropharyngeal cancer at eight U.S. institutions and who received one or more TTMV-HPV DNA tests during post-treatment surveillance between February 2020 and January 2022 were included.
RESULTS: Among 543 patients, 210 patients (38.7%; 210/543) experienced one or more clinically indeterminate findings (CIFs) during surveillance, with 503 CIFs recorded. Of those patients with an \"indeterminate\" disease status at a point during surveillance, 79 were associated with contemporaneous TTMV-HPV DNA testing. TTMV-HPV DNA testing demonstrated high accuracy (97.5%; 77/79) in correctly determining recurrence status. Patients whose disease status was \"indeterminate\" at the time of a positive TTMV-HPV DNA test were clinically confirmed to recur faster than those whose disease status was \"no evidence of disease.\" Only 3% of patients (17/543) experienced indeterminate TTMV-HPV DNA tests during surveillance. Discordance between TTMV-HPV DNA tests and clinical results was minimal, with only 0.6% (3/543) of patients showing positive tests without recurrence.
CONCLUSIONS: Our findings support the utility of circulating TTMV-HPV DNA in resolving indeterminate disease status and informing the subsequent clinical course.
摘要：
目的：在癌症监测期间，临床和影像学检查经常有不确定的结果，这可能导致过度治疗并对患者造成心理和经济伤害。这项研究解决了在HPV相关口咽癌症的管理中提高诊断精度和决策的迫切需要。这项研究评估了肿瘤组织修饰病毒（TTMV）-HPVDNA在确定HPV相关口咽癌治疗后解决不确定疾病状态的实用性。
方法：在本回顾性队列中，纳入了在美国8家机构接受HPV相关口咽癌治疗的患者,以及在2020年2月至2022年1月期间的治疗后监测期间接受一次或多次TTMV-HPVDNA检测的患者.
结果：在543名患者中，210名患者（38.7%；210/543）在监测期间经历了一个或多个临床上不确定的发现（CIF），记录了503CIFs。在监测期间某个时间点疾病状态“不确定”的患者中，79例患者与同期TTMV-HPVDNA检测相关。TTMV-HPVDNA检测在正确确定复发状态方面具有很高的准确性（97.5％；77/79）。在TTMV-HPVDNA检测阳性时，疾病状态为“不确定”的患者在临床上被证实比疾病状态为“无疾病证据”的患者复发更快。“只有3％的患者（17/543）在监测期间经历了不确定的TTMV-HPVDNA检测。TTMV-HPVDNA检测和临床结果之间的不一致是最小的，只有0.6％（3/543）的患者显示阳性测试而无复发。
结论：我们的研究结果支持循环TTMV-HPVDNA在解决不确定的疾病状态和随后的临床过程中的效用。
方法：在本回顾性队列中，纳入了在美国8家机构接受HPV相关口咽癌治疗的患者,以及在2020年2月至2022年1月期间的治疗后监测期间接受一次或多次TTMV-HPVDNA检测的患者.
结果：在543名患者中，210名患者（38.7%；210/543）在监测期间经历了一个或多个临床上不确定的发现（CIF），记录了503CIFs。在监测期间某个时间点疾病状态“不确定”的患者中，79例患者与同期TTMV-HPVDNA检测相关。TTMV-HPVDNA检测在正确确定复发状态方面具有很高的准确性（97.5％；77/79）。在TTMV-HPVDNA检测阳性时，疾病状态为“不确定”的患者在临床上被证实比疾病状态为“无疾病证据”的患者复发更快。“只有3％的患者（17/543）在监测期间经历了不确定的TTMV-HPVDNA检测。TTMV-HPVDNA检测和临床结果之间的不一致是最小的，只有0.6％（3/543）的患者显示阳性测试而无复发。
结论：我们的研究结果支持循环TTMV-HPVDNA在解决不确定的疾病状态和随后的临床过程中的效用。
