Biological biomarkers of oral cancer

Periodontology 2000, Год журнала: 2023, Номер 96(1), С. 250 - 280

Опубликована: Дек. 10, 2023

The oral squamous cell carcinoma (OSCC) 5 year survival rate of 41% has marginally improved in the last few years, with less than a 1% improvement per from 2005 to 2017, higher rates when detected at early stages. Based on histopathological grading dysplasia, it is estimated that severe dysplasia malignant transformation 7%-50%. Despite these numbers, does not reliably predict its clinical behavior. Thus, more accurate markers predicting progression cancer would enable better targeting lesions for closer follow-up, especially stages disease. In this context, molecular biomarkers derived genetics, proteins, and metabolites play key roles oncology. These signatures can help likelihood OSCC development and/or have potential detect disease an stage and, support treatment decision-making responsiveness. Also, identifying reliable detection be obtained non-invasively enhance management OSCC. This review will discuss emerged different biological areas, including genomics, transcriptomics, proteomics, metabolomics, immunomics, microbiomics.

Язык: Английский

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Analytical Validation of NavDx, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Cancers

Diagnostics, Год журнала: 2023, Номер 13(4), С. 725 - 725

Опубликована: Фев. 14, 2023

The NavDx® blood test analyzes tumor tissue modified viral (TTMV)-HPV DNA to provide a reliable means of detecting and monitoring HPV-driven cancers. has been clinically validated in large number independent studies integrated into clinical practice by over 1000 healthcare providers at 400 medical sites the US. This Clinical Laboratory Improvement Amendments (CLIA), high complexity laboratory developed test, also accredited College American Pathologists (CAP) New York State Department Health. Here, we report detailed analytical validation NavDx assay, including sample stability, specificity as measured limits blank (LOBs), sensitivity illustrated via detection quantitation (LODs LOQs). LOBs were 0-0.32 copies/μL, LODs 0-1.10 LOQs <1.20-4.11 demonstrating data provided NavDx. In-depth evaluations accuracy intra- inter-assay precision shown be well within acceptable ranges. Regression analysis revealed degree correlation between expected effective concentrations, excellent linearity (R2 = 1) across broad range analyte concentrations. These results demonstrate that accurately reproducibly detects circulating TTMV-HPV DNA, which aid diagnosis surveillance

Язык: Английский

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Negative Predictive Value of Circulating Tumor Tissue Modified Viral (TTMV)-HPV DNA for HPV-driven Oropharyngeal Cancer Surveillance

Clinical Cancer Research, Год журнала: 2023, Номер 29(20), С. 4306 - 4313

Опубликована: Авг. 11, 2023

Abstract Purpose: Human papillomavirus (HPV) is causally linked to oropharyngeal squamous cell carcinoma (OPSCC). Consensus guidelines recommend clinical exams and imaging in decreasing frequency as part of posttreatment surveillance for recurrence. Plasma tumor tissue modified viral (TTMV)-HPV DNA testing has emerged a biomarker which can inform disease status during surveillance. Experimental Design: This retrospective observational cohort study involved 543 patients who completed curative-intent therapy HPV-associated OPSCC between February 2020 January 2022 at eight U.S. cancer care institutions. We determined the negative predictive value (NPV) TTMV-HPV recurrence when matched physician-reported outcome data (median follow-up time: 27.9 months; range: 4.5–154). Results: The included mostly men with median age 61 had locoregionally advanced disease. HPV was by p16 positivity 87% patients, positive PCR/ISH among 55%; while pretreatment unknown most (79%) patients. Patients mean 2.6 tests almost half three or more results per-test per-patient sensitivity assay 92.5% [95% confidence interval (CI): 87.5–97.5] 87.3% (95% CI: 79.1–95.5), respectively. NPV 99.4% 98.9–99.8) 98.4% 97.3–99.5), Conclusions: yields few false missed recurrences. These could decisions on pursue reimaging following first restaging future practice. Additional how impacts needed.

Язык: Английский

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Personalized ctDNA for Monitoring Disease Status in Head and Neck Squamous Cell Carcinoma

Clinical Cancer Research, Год журнала: 2024, Номер 30(15), С. 3329 - 3336

Опубликована: Июнь 2, 2024

Many patients with locoregionally advanced human papillomavirus-negative head and neck squamous cell carcinoma (HNSCC) relapse. ctDNA has the potential to identify minimal residual disease, but its clinical utility for virus-negative HNSCC is not well understood.

Язык: Английский

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Post-treatment monitoring of surgically treated oropharyngeal squamous cell carcinoma patients using human papillomavirus cell-free DNA

Oral Oncology, Год журнала: 2025, Номер 163, С. 107225 - 107225

Опубликована: Март 5, 2025

The incidence rate of human papillomavirus (HPV)-driven oropharyngeal squamous cell carcinoma (OPSCC) is increasing. Despite good prognosis, recurrence can decrease health-related quality life and increase mortality, so post-treatment monitoring important for patient outcomes. One potential biomarker HPV cell-free DNA (cfDNA) from blood plasma. Plasma samples at start treatment during follow-up 27 OPSCC patients were analyzed cfDNA six high-risk types using a multiplex digital PCR assay. Presence was compared to tumor status determined by p16INK4a immunohistochemistry, DNA, RNA HPV16 E6 serology. At treatment, sensitivity detection in HPV-driven cases 89 % (17/19), while specificity 100 among 39 plasma 8 HPV-negative cases. A median 4 per over mean time 11 months available. Positive negative predictive values assessed on per-test-basis. testing after completion therapy had positive value HPV-OPSCC within one year, 98 %. In recurrent OPSCC, detectable between 3 6.8 before routine examination methods. Post-treatment early could be aided patients.

Язык: Английский

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Personalizing Surveillance in Head and Neck Cancer

American Society of Clinical Oncology Educational Book, Год журнала: 2023, Номер 43

Опубликована: Янв. 1, 2023

Head and neck squamous cell carcinoma (HNSCC) encompasses a spectrum of heterogeneous diseases originating in the oral cavity, pharynx, larynx. Within United States, head cancer (HNC) accounts for 66,470 new cases, or 3% all malignancies, annually. 1 The incidence HNC is rising, largely driven by increases oropharyngeal cancer. 2 - 4 Recent molecular clinical advancements, particularly with regard to tumor biology, reflect heterogeneity subsites contained within neck. Despite this, existing guidelines post-treatment surveillance remain broad without much consideration given different anatomic etiologic factors (such as human papillomavirus [HPV] status tobacco exposure). 5 Surveillance incorporating physical examination, imaging, emerging biomarkers an essential part care patients treated allows detection locoregional recurrence, distant metastases, second primary malignancies aiming better functional survival outcomes. Additionally, it evaluation management complications.

Язык: Английский

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Circulating Tumor HPV DNA for Surveillance of HPV-Positive Oropharyngeal Squamous Cell Carcinoma

JAMA Oncology, Год журнала: 2023, Номер 9(12), С. 1716 - 1716

Опубликована: Окт. 12, 2023

Human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma has an overall favorable prognosis, yet a subset of patients will experience devastating disease recurrence. Current surveillance standards for detection recurrent are imperfect. There is growing interest in improving through the use plasma-based assays able to detect circulating tumor HPV DNA.Although most DNA remain research domain, tissue-modified viral assay became commercially available United States early 2020 and been increasingly used clinical setting. With rapidly increasing incidence HPV-positive concomitant expansion biomarker capabilities this disease, it critical reexamine current posttreatment practices determine whether emerging technologies may be improve outcomes survivor population. However, caution advised; not known biomarker-based truly beneficial, as true with any intervention, capacity cause harm.Using Margaret Pepe's classic 5 phases development cancer framework, article reviews state knowledge, highlights existing knowledge gaps, suggests that should prioritized understand association between patient outcomes. Specific attention paid assay, given its use. This review serve road map future guide clinicians considering adoption practice. Enrollment into trials incorporating prioritized.

Язык: Английский

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Comparing the Diagnostic Performance of Quantitative PCR, Digital Droplet PCR, and Next-Generation Sequencing Liquid Biopsies for Human Papillomavirus–Associated Cancers

Journal of Molecular Diagnostics, Год журнала: 2023, Номер 26(3), С. 179 - 190

Опубликована: Дек. 15, 2023

Human papillomavirus (HPV)-associated cancers, including oropharyngeal squamous cell carcinoma (HPV + OPSCC), cervical cancer, and of the anus SCCA), release circulating tumor HPV DNA (ctHPVDNA) into blood. The diagnostic performance ctHPVDNA detection depends on approaches used individual assay metrics. A comparison these has not been systematically performed to inform expected performance, which in turn affects clinical interpretation. meta-analysis was using Ovid MEDLINE, Embase, Web Science Core Collection databases assess accuracy across cancer anatomic sites, platforms, blood components. population included patients with OPSCC, HPV-associated SCCA pretreatment samples analyzed by quantitative PCR (qPCR), digital droplet (ddPCR), or next-generation sequencing (NGS). Thirty-six studies involving 2986 met inclusion criteria. sensitivity, specificity, quality each study were assessed pooled for analysis. sensitivity greatest NGS, followed ddPCR then qPCR when pooling all studies, whereas specificity similar (sensitivity: > qPCR, P < 0.001; NGS ddPCR, = 0.014). from OPSCC more easily detected compared SCCA, overall (P 0.044). In conclusion, platform, site component must be considered interpreting results. Plasma NGS-based testing may most sensitive approach overall. papillomaviruses (HPVs) are a family oncoviruses that cause benign malignant lesions genital mucosa, upper respiratory tract, skin. More than 200 distinct types have identified, at least 14 them classified as high risk, capable tumorigenesis, specific sites.1Saraiya M. Unger E.R. Thompson T.D. Lynch C.F. Hernandez B.Y. Lyu C.W. Steinau Watson Wilkinson E.J. Hopenhayn C. Copeland G. Cozen W. Peters E.S. Huang Y. Saber M.S. Altekruse S. Goodman M.T. 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Gilson Gender-neutral UK, rising male rates, lack awareness.Lancet Infect Dis. 2019; 19: 131-132Abstract (34) 13Centers Disease Control Prevention: Associated Papillomavirus, States—2015–2019. USCS Data Brief, no. 31. Centers Prevention, US Department Health Services, Atlanta, GA:2022https://www.cdc.gov/cancer/uscs/about/data-briefs/no31-hpv-assoc-cancers-UnitedStates-2015-2019.htm#Date accessed: December 29, 2023Google 14Tota J.E. Best A.F. Zumsteg Z.S. Gillison M.L. Rosenberg P.S. Chaturvedi A.K. Evolution epidemic States: moderation increasing younger individuals shift older individuals.J Clin 37: 1538-1546Crossref (107) 15Zhang Fakhry D'Souza Projected association US, 2020-2045.JAMA 2021; 7e212907Crossref (49) 16Chaturvedi Engels E.A. Pfeiffer R.M. Xiao Kim Jiang Sibug-Saber Wentzensen Jordan R.C. Anderson W.F. States.J 29: 4294-4301Crossref (2815) Existing diagnose monitor invasive, costly, variable accuracy, indicating need improve standard care. 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Anker Stroun Origins, structures, functions oncology.Cancer Metastasis 2016; 35: 347-376Crossref (550) Results detecting ctDNA shown broad applicability, molecular profiling, adaptive treatment during therapy, minimal residual disease, recurrence detection.23Dawson S.-J. Tsui D.W.Y. Murtaza Biggs H. Rueda O.M. Chin S.-F. Dunning M.J. Gale Forshew Mahler-Araujo Rajan Humphray Becq Halsall Wallis Bentley Analysis metastatic breast cancer.N Engl 368: 1199-1209Crossref (1751) 24Chen Zhao Shi Yang Wang L.T. Kang Nie Perioperative dynamic changes lung (DYNAMIC).Clin Res. 25: 7058-7067Crossref (129) 25Bettegowda Sausen Leary R.J. Kinde Agrawal et al.Detection early- late-stage malignancies.Sci Transl 2014; 6: 224ra224Crossref (3381) 26Stejskal Goodarzi Srovnal Hajdúch van't Veer L.J. Magbanua M.J.M. nucleic acids: biology, mechanisms, relevance.Mol 2023; 22: 15Crossref (28) 27Bernard D.U. San Lucas F.A. Castillo Allenson Mulu F.C. Stephens B.M. Semaan Guerrero P.A. Kamyabi Hurd M.W. Koay Taniguchi C.M. Herman Javle Wolff Katz Varadhachary Maitra Alvarez H.A. acids associated outcomes pancreatic cancer.Gastroenterology. 156: 108-118.e104Abstract (251) 28Li R.-Y. Liang Z.-Y. real-time disease evolution response.Chin Med (Engl). 133: 2476-2485Crossref (13) 29Magbanua Swigart L.B. Wu H.-T. Hirst G.L. Yau Wolf D.M. Tin Salari Shchegrova Pawar Delson A.L. DeMichele M.C. Chien A.J. Tripathy Asare C.-H.J. Billings Aleshin Sethi Louie Zimmermann Esserman neoadjuvant-treated reflects response survival.Ann 32: 229-239Abstract (167) 30Schwarzenbach Alix-Panabières Müller Letang Vendrell J.-P. Rebillard Cell-free plasma marker prostate cancer.Clin 15: 1032-1038Crossref (211) 31Tie Tomasetti Li Springer Silliman Tacey Wong H.-L. Christie Kosmider Skinner Steel Tran Desai Haydon Hayes Price T.J. Strausberg R.L. Diaz Jr., L.A. Papadopoulos Kinzler K.W. Vogelstein Gibbs analysis detects predicts stage II colon cancer.Sci 8346ra392Crossref (963) 32Tie Cohen Simons Lee Ananda McKendrick Cho J.H. Faragher I.T. Ptak Schaeffer Dobbyn analyses markers risk benefit adjuvant therapy III cancer.JAMA 5: 1710-1717Crossref (345) 33Reinert Henriksen T.V. Christensen Sharma al.Analysis cell-free ultradeep stages I colorectal 1124-1131Crossref (470) (ctHPVDNA), advantages over somatic due smaller size viral genome its cells, making an optimal target application biopsies.34Faden D.L. diagnosis head neck cancer.Cancer Cytopathol. 130: 12-15Crossref (3) Numerous detectable serum time diagnosis. It can biomarker detect earlier care imaging.35Cao Banh Kwok Krakow Khong Bavan Bala Pinsky B.A. Colevas Pourmand Koong A.C. Kong C.S. Le Q.-T. Quantitation patients.Int Radiat Oncol Biol Phys. 82: e351-e358Abstract (97) 36Ahn J.Y.K. Zhang Z. Khan Bishop J.A. Westra Koch W.M. Califano Saliva polymerase chain reaction-based surveillance papillomavirus-related Otolaryngol Head Neck Surg. 140: 846-854Crossref 37Chera B.S. Kumar Beaty B.T. Marron Jefferys Green Goldman Amdur Sheets Dagan D.N. Weiss Grilley-Olson Zanation Hackman Blumberg Patel Weissler Tan X.M. Parker Mendenhall Gupta G.P. Rapid clearance profile 16 chemoradiotherapy correlates control 4682-4690Crossref (178) 38Chera Shen Thorp Yarbrough cancer.J 38: 1050-1058Crossref 39Hanna G.J. Lau Mahmood U. Supplee J.G. Mogili Haddad R.I. Janne Paweletz C.P. Salivary informs locoregional status advanced cancer.Oral 95: 120-126Crossref (31) 40Damerla R.R. N.Y. You Soni Shah Reyngold Katabi McBride Tsai Riaz Powell S.N. Babady N.E. Viale Higginson D.S. Detection papillomavirus-associated biopsy.JCO Precis 3PO.18.00276PubMed 41Naegele Efthymiou Das Sadow P.M. Richmon Iafrate Faden sinonasal nasopharyngeal cancers.JAMA 149: 179-181Crossref (5) 42Jeannot Becette Campitelli Calméjane M.-A. Lappartient Ruff Saada Holmes Bellet Sastre-Garau diagnosed invasive carcinoma.J Pathol 201-209Crossref (122) 43Jeannot Latouche Bonneau Beaufort Ruigrok-Ritstier Bataillon Larbi Chérif Dupain Lecerf Popovic la Rochefordière Lecuru Fourchotte Jordanova von der Leyen Tran-Perennou Legrier M.-E. Dureau Raizonville Bello Roufai Tourneau Bièche Rouzier Berns E.M.J.J. Kamal Scholl relapse 27: 5869-5877Crossref (35) 44Bernard-Tessier Jeannot Guenat Debernardi Michel Proudhon Vincent-Salomon Pierga J.-Y. Buecher Meurisse François Jary Vendrely Samalin Hajbi Baba-Hamed Borg Clinical validity ancillary epitopes-HPV02 trial.Clin 2109-2115Crossref (59) 45Naegele Hirayama Double trouble: synchronous metachronous primaries confound monitoring.Head Neck. 45: E25-E30Crossref (1) ctHPVDNA-based diagnostics improved reduced cost, shorter existing tissue-based diagnostics.46Siravegna O'Boyle Varmeh Queenan Stein Thierauf Faquin W.C. Perry S.K. Bard A.Z. Deschler D.G. Emerick K.S. Varvares M.A. Park J.C. Clark J.R. Andreu Arasa V.C. Sakai Lennerz Corcoran R.B. Wirth provides accurate rapid 28: 719-727Crossref (36) past, conventional (qPCR) common method ctDNA, but newer (and costly) techniques, droplet-digital (ddPCR) (NGS), emerged.47Postel Roosen Laurent-Puig Taly Wang-Renault Droplet-based next generation DNA: perspective.Expert Mol Diagn. 2018; 18: 7-17Crossref literature influences We tested hypothesis superior cancers. medical librarian (D.G.) following guidelines Preferred Reporting Items Systematic Reviews Meta-Analyses.48Moher Liberati Tetzlaff Altman PRISMA GroupPreferred reporting items reviews meta-analyses: statement.Ann 151 (W64): 264-269Crossref (19877) search published MEDLINE (Wolters-Kluwer, 1946–February 2022), Embase (Elsevier, 1947–February Collections (Clarivate, 1900–February 2022) designed conducted reference February 18 23, 2022. (Registration required access databases.) Search customized database. Each combination controlled vocabulary key word terms relating (head neck, cervical, penile) testing. constructed exclude non-human studies. No filters language, design, date publication, origin search, produced 251 articles (Figure 1). All references exported EndNote X7.8 Philadelphia, PA). Duplicates removed first automated process manually librarian; this left 153 articles, Covidence (Melbourne, VIC, Australia) screening, selection, data extraction. Nine subsequent found through searching thus yielding total 162 screening. Studies examined any eligible inclusion. Extracted comprised following: subsite; status; method; number assay; true-positive, false-positive, false-negative, true-negative findings; source (plasma serum); probe gene (if used); amplicon hybrid capture used). Only written English included. Titles abstracts screened independently two authors (S.N. D.A.R.-T.) full-text review. same Any disagreements settled discussion consensus between authors. duplicate comparing authors, timeframe collection, outcomes. After full text 36 remained synthesis. R 4.1.2 (R Foundation Statistical Computing, Vienna, Austria; https://cran.r-project.org) conduct statistical packages "meta" "metafor" meta-analysis. missing one values [true positive, false negative (TP, FN) true negative, positive (TN, FP)] excluded. Using random effects model, 95% confidence intervals (CIs), computed TP FN, CI TN FP. Subgroups defined differently means calculated respectively. Subsequently, separate meta-regressions test characteristic sensitivities specificities. Interstudy variability between-study variance Cochran's Q statistic. percentage variation explained heterogeneity opposed sampling error I2 two-sided 0.05 significant. Potential publication bias evaluated Quality Assessment Diagnostic Accuracy Studies-2 tool (https://www.bristol.ac.uk/population-health-sciences/projects/quadas/quadas-2). judged low answers signaling questions four domains yes no, If information sufficient, unclear used. Most flow timing index 2). Notably, standard, three patient bias. Regarding 33 test, five selection. containing (Table 135Cao Scholar,40Damerla Scholar,42Jeannot 46Siravegna Scholar,49Cabel Bernard-Tessier Héquet Féron J.-G. Brun J.-F. Benoît Rodrigues Scher

Язык: Английский

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Liquid Biopsies with Circulating Plasma HPV–DNA Measurements—A Clinically Applicable Surveillance Tool for Patients with HPV-Positive Oropharyngeal Cancer

Clinical Cancer Research, Год журнала: 2023, Номер 29(19), С. 3914 - 3923

Опубликована: Июль 21, 2023

To evaluate the accuracy of cell-free human papillomavirus-DNA (cfHPV-DNA) measurements in liquid biopsies predicting disease patients with HPV-positive/p16-positive (HPV+/p16+) oropharyngeal squamous cell carcinoma (OPSCC).This was a prospective cohort study. Plasma samples were collected before treatment, serially after curative intended therapy at follow-up visits 2 weeks, and 6, 9, 12, 18, 24, 30 months treatment. A droplet digital PCR assay comprising eight HPV genotypes used. found plasma tumor tissue compared. We correlated biopsy- or imaging-verified progression to cfHPV-DNA samples.We enrolled 72 HPV+/p16+ OPSCC. Baseline sensitivity for detection 97.2% (95% confidence interval, 90.3%-99.6%). CfHPV-DNA copy number/milliliter stage. 100% concordance between genotype plasma. Fifty-four followed serial blood median 19.7 (interquartile range, 13.5-25.5 months). Forty-one had undetectable all samples, none developed recurrences. Thirteen classified as cfHPV-DNA-positive sample. Of these, five recurrence, three residual cancer. It possible detect 97 166 days prior proven recurrence.To our knowledge, date, study, largest study OPSCC, using an ultrasensitive multiplex gene panel, revealed high biopsies. recommend clinical monitoring

Язык: Английский

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Preoperative Circulating Tumor HPV DNA and Oropharyngeal Squamous Cell Disease

JAMA Otolaryngology–Head & Neck Surgery, Год журнала: 2024, Номер 150(5), С. 444 - 444

Опубликована: Апрель 4, 2024

Importance The utility of preoperative circulating tumor tissue-modified viral human papillomavirus DNA (TTMV-HPV DNA) levels in predicting (HPV)–associated oropharyngeal squamous cell carcinoma (HPV+ OPSCC) disease burden is unknown. Objective To determine if HPV (ctHPVDNA) associated with patients HPV+ OPSCC who have undergone transoral robotic surgery (TORS). Design, Setting, and Participants This cross-sectional study comprised underwent primary TORS between September 2021 April 2023 at one tertiary academic institution. Patients treatment-naive (p16-positive) ctHPVDNA were included, those neck mass excision before collection excluded. Main Outcomes Measures main outcome was the association increasing size lymph node involvement surgical pathology. secondary adverse pathology, which included lymphovascular invasion, perineural or extranodal extension. Results A total 70 (65 men [93%]; mean [SD] age, 61 [8] years). Baseline ranged from 0 fragments/milliliter plasma (frag/mL) to 49 452 frag/mL (median [IQR], 272 [30-811] frag/mL). Overall, 58 (83%) had positive results for ctHPVDNA, 1 (1.4%) indeterminate results, 11 (15.6%) negative results. sensitivity detectable identifying pathology-confirmed 84%. Twenty-seven (39%) pathologic (pT) staging pT0 pT1, 34 (49%) pT2 staging, 9 (13%) pT3 pT4 staging. No clinically meaningful difference undetectable cohorts found Although median appeared be higher through stages pN1 pN2 stages, effect sizes small (pT stage: η2, 0.002 [95% CI, −1.188 0.827]; pN 0.043 −0.188 2.600]). Median log(TTMV-HPV active smokers (8.79 3.55-5.76]), compared never (5.92 −0.97 1.81]) former (4.99 0.92-6.23]). Regression analysis did not show an dimension metastatic deposit DNA). After univariate analysis, no Conclusions Relevance In this study, TORS.

Язык: Английский

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