Joel Laudenbach, DMD 1

Transcription

1 Oral Cancer / Lesion Detec1on Devices & Biopsy Joel M. Laudenbach, DMD Diplomate, American Board of Oral Medicine Assistant Prof. & A9ending Medical Staff Department of Oral Medicine Carolinas HealthCare System = Atrium Health CharloFe, North Carolina Adjunct Assistant Prof., Western University of Health Sciences Medical Staff, Cedars-Sinai Medical Center Disclosures: No financial investment with Henry Schein, OralCDx BrushTest, Zila, ViziLite Plus, Tblue, Microlux, VELscope, CTP/Dentrix, OralID, CytID, Goccles *Identafi Oral Lesion Screening Device dona1on by DentalEZ was used in California prac1ces & at WesternU *VELscope Oral Lesion Screening Device with ipod Touch afachment dona1on by LED Dental was used at WesternU *DentalEZ, VELscope & Forward Science are suppor1ng the biopsy & adjunc1ve device workshop *CDx Diagnos1cs support for lectures & workshops Past clinical inves1gator: ViziLite/TBlue, Oral cytology for RNA analysis Consul1ng: Disclosures: Medscape.com/WebMD Author ADA Council on Scien1fic Affairs Oral Medicine Clinical Assistance Programs oral mucosi1s educator for OC/OP cancer drug studies Oral Medicine Prac1ce Lesion assessment protocol Clinical history, past medical history Examina1on: Visualiza1on Palpa1on Descrip1on & documenta1on Lesion assessment protocol Differen1al diagnosis Proceed with tes1ng, management and / or referral Goals: Establish the diagnosis & rule out pre-cancer / cancer Oral lesion biopsy techniques Oral cancer & pre-cancer (dysplasia) Adjunc1ve techniques Apply new concepts / techniques Biopsy Screening for oral cancer: a targeted evidence update Outside the USA, screening lowered the stage of cancer at diagnosis & improved 5-year survival Screening tobacco & alcohol subgroups reduced mortality rate US Preven1ve Services Task Force Recommenda1ons 4/2013 Oral cancer screening in cigarefe and/ or betel quid users: > 2 M Taiwanese Demonstrated effeceveness in: Decreasing stage III & IV cancers Reducing cancer mortality Cancer 2017;123: American Cancer Society Joel Laudenbach, DMD 1

2 Sta1s1cs & risk factors Oral cavity & oropharyngeal cancer vs. Oral cavity & pharynx cancer American Cancer Society. Cancer Facts & Figures 2017 & Oral cavity & oropharyngeal cancer [ACS 2018] 51,540 es1mated new cases in US 2018 ~ 10,030 people will die of these cancers *Avg. age of diagnosis: 62 yrs. > 1/4 ( ~ 12,900 ) occur in pa1ents < 55 yrs. male:female ra1o 2:1 Oral & pharyngeal cancer [ACS 2018] Tongue cancer - 5-year rela1ve survival rates: Based on stage of cancer: Localized = 78 % Regional = 63 % Distant = 36 % (NCI SEER Data ) Oral & pharyngeal cancer [ACS 2018] Floor of mouth cancer - 5-year rela1ve survival rates: Based on stage of cancer: Localized = 75 % Regional = 38 % Distant = 20 % (NCI SEER Data ) Oral & pharyngeal cancer [ACS 2018] Oropharynx & tonsil - 5-year rela1ve survival rates = 66% Gums & other parts of mouth - 5-year rela1ve survival rates = 60% (NCI SEER Data ) Oral cavity & oropharyngeal cancer - Most common sites: tongue (25-30%), tonsils (15-20%), and oropharynx - Gingiva, floor of mouth, lips and minor salivary glands (palate) - Squamous cell carcinoma - most common malignancy (oral cavity) Joel Laudenbach, DMD 2

3 North America = USA + Canada Men Lip, other mouth & other pharyngeal Oral tongue cancer Oropharyngeal cancer North America = USA + Canada Women Tongue, Salivary gland & Oropharyngeal cancer Canada* Oral tongue cancer US* No adjuncts replace the diagnos1c Gold Standard. Scalpel 1ssue biopsy & histologic assessment Routine specimens placed in 10% formalin and JADA May 2010 XXXXXXX Direct immunofluorescence in Michel s or Zeus solution Joel Laudenbach, DMD 3

4 No clinically evident lesion or symptom No clinically evident lesion or symptom Globus sensa1on feels like something is lodged in throat Clinically evident, innocuous or non-suspicious lesion Unexplained ear pain otalgia Unexplained oropharyngeal pain Hoarseness / change in voice Clinically evident, suspicious lesion Seemingly malignant lesion Clinicians* should General den1sts Obtain or Update Comprehensive Hx: Along with lesion evalua1on Specialists Hygienists Consider signs & symptoms of disease: Globus sensa1on Unexplained ear pain - otalgia Oropharyngeal pain hoarseness Joel Laudenbach, DMD 4

5 Clinicians* should Poten1ally Malignant Disorders - PMDs General den1sts Specialists Hygienists Perform an intraoral & extraoral conveneonal visual & tacele exam in all adult paeents JADA 2017 Leukoplakia Erythroplakia Erythroleukoplakia Submucous fibrosis Hereditary disorders with increased risk of malignant transforma1on Fanconi anemia Heavy tobacco use Heavy alcohol use Lichen planus* Immediate referral to specialists that have advanced training in:! If suspicious Lesion Oral and Maxillofacial Surgery Oral and Maxillofacial Pathology Oral Medicine Periodontology Otolaryngology-Head and Neck Surgery (ENT) JADA 2017 JADA JADA Panel does not recommend:! If suspicious Lesion Cytologic, autofluorescence, 1ssue reflectance, or vital staining adjuncts for the evalua1on of PMDs in adult pt s with: Clinically evident, seemingly innocuous lesions Suspicious lesions JADA 2017 Joel Laudenbach, DMD 5

6 ! If suspicious lesion OralCDx BrushTest JADA 2017 Finding dysplasia is the key to preven1ng cancer The BrushTest All of these Essue changes or spots are confirmed dyplasias The BrushTest Non-Homogenous surfaced leukoplakia Joel Laudenbach, DMD 6

7 The BrushTest technique The BrushTest technique Hold the slide up to a light ensure the cellular material is visible on the slide Apply Fixa*ve by flooding slide with liquid Joel Laudenbach, DMD 7

8 Brush - interpretaeon of results: insufficient basal cell count (2-7%) negaeve : no cellular abnormali1es posieve : defini1ve cellular evidence of epithelial dysplasia or carcinoma atypical : abnormal cellular changes warran1ng further inves1ga1on Evidence-based recommenda1ons - screening for oral SCCa Insufficient evidence to support recommenda1on for or against use of [transepithelial cytology]* in seemingly innocuous lesions Rethman MP et al. JADA May 2010 Evidence-based recommenda1ons - screening for oral SCCa In suspicious lesions, [transepithelial cytology]* has validity iden1fying disaggregated dysplas1c cells** Poten1al use: mul1ple lesions (& no history of oral cancer), noncompliant pa1ents, complex medical status, severe access-to-care restraints Rethman MP et al. JADA May 2010 Joel Laudenbach, DMD 8

9 ! If suspicious lesion How helpful is cytologic tes1ng in triaging the need for biopsy? How helpful is cytologic tes1ng in triaging the need for biopsy? Innocuous (non-suspicious) oral cavity lesions: True-Posi1ve Rate = 0.96 True-Nega1ve Rate = 0.90 Suspicious (PM/M) oral cavity lesions: True-Posi1ve Rate = 0.92 True-Nega1ve Rate = 0.94 JADA 2017 Lingen et al. JADA 2017:148(11): Lingen et al. JADA 2017:148(11): Cytologic adjunct tests Provider & pa1ent should consider the longterm downstream consequences of: True posi1ve, false posi1ve, true nega1ve, false nega1ve results Discuss with pa1ent in detail in the context of informed consent* Include point that surgical biopsy/histology is the defini1ve procedure that establishes/rules out dysplasia and neoplasia Cytologic adjunct tests Most importantly clinicians need to periodically monitor cytology test nega1ve pa1ents with persistent lesions* Minimize downstream consequences of poten1al false nega1ve result To avoid a delayed defini1ve diagnosis or treatment New Clinical Pathway It s OK to use cytologic test in the limited scenario when a pa1ent declines biopsy or immediate referral to a specialist Does not men1on toluidine blue dye, 1ssue reflectance, autofluorescence or salivary adjuncts to help triage a lesion Ctyology Tests Available Oral CDx TheBrushTest CytID OralCyte Liquid-based cytology Gynemed Brush ClearPrep OC Joel Laudenbach, DMD 9

10 OralCyte - Liquid-based cytology Benefits: LimitaEons: Cytology - informed consent Fully inform pa1ents about test limitaeons Blood, inflamma1on & mucus are reduced Cells are distributed randomly; on clear background Reduce # of unsa1sfactory slides ExfoliaEve cytology* Surgical biopsy with pathologist diagnosis is the only defini1ve way to rule out pre-cancer and cancer Cytologic tes1ng is NOT a biopsy Cytologic tes1ng is NOT a replacement for biopsy Cytologic test consent Is associated with false + and false - results Associated with delays in diagnosis of precancer and cancer Obtain firm, pa1ent commitment to long-term follow-up care Cytologic test consent Well-documented re-evalua1on program & schedule Pa1ent aware they can always proceed with having scalpel biopsy and/or referral to specialist any1me* Introductory Overview Oral Biopsy Biopsy Informed Consent Start with standard oral surgical consent Review benefits, alterna1ves, risks and financial implica1ons Biopsy Informed Consent Add/clarify based on your planned procedure Post-opera1ve pain, numbness, 1ngling, paresthesia: All of these can be short-term and/or long-term/ permanent Nadeau C, Kerr AR. Dent Clin N Am 62 (2018) Add/clarify based on your planned procedure: AFached gingiva biopsy risk for addi1onal gingival recession* Persistent recession may require Periodontal surgery to repair Mucocele removal / labial mucosa procedures: possible post-opera1ve swelling weeks at site of biopsy that requires another surgical removal procedure Joel Laudenbach, DMD 10

11 Biopsy Informed Consent Tongue biopsy: Inform pa1ent about possible post-opera1ve neck pain, dysphagia/odynophagia and/or myalgia/ TMD. Pulling tongue, surgery on the tongue and holding jaw open are risk factors for above post-opera1ve symptoms Dr. Crispian Scully Armamentarium Oral pathology lab Local anesthesia 30 gauge short needle #15 scalpel blade #12 scalpel blade 5 mm punch scalpel Minnesota retractor 2 mouth mirror retractors Hemostat with gauze pad CoFon plier pickup Hemosta1c agents: ViscoStat, silver nitrate 1p Needle driver, scissors 4-0 chromic gut suture 2 x 2 gauze pads Lab supplies 10% formalin, forms, mailing supplies Lab choice: insurances accepted/processed Private (cash) vs. In-network for medical insurance Strengths of each lab Communicate lab fees* $ / sample Proper forms completed: Lab consents, Medicare, copy of pa1ent s current medical insurance. Joel Laudenbach, DMD 11

12 Tissue fluorescence autofluorescence i.e., VELscope, Identafi, OralID, others Diagnosis: moderate epithelial dysplasia / pre-cancer Addi1onal considera1ons: Sampling error possible Delay in diagnosis Bx Tissue reflectance / chemiluminescence enhance iden1fica1on of oral mucosal abnormali1es False nega1ve reports are possible Even scalpel Bx has up to 23% false nega1ve rate* Use aer conven1onal oral examina1on* Persistent lesions should have 1ssue biopsy Tissue reflectance / chemiluminescence ViziLite - How it works 1% ace1c acid rinse Removes debris, dehydrates epithelial cells Blue-white illumina1on glow s1ck Normal 1ssue blue Abnormal 1ssue dis1nctly white / acetowhite Joel Laudenbach, DMD 12

13 ViziLite Plus lesion iden1fica1on *Reported improvements in: Visualiza1on* Brightness* Margin delinea1on / sharpness Surface texture Evidence-based recommenda1ons - screening for oral SCCa Insufficient evidence to show that Essue reflectance improves detec1on beyond the conven1onal exam Use of these devices can be associated with increased false-posieve findings 2017 JADA Panel does not recommend: Cytologic, autofluorescence, 1ssue reflectance, or vital staining adjuncts for the evalua1on of PMDs in adult pt s with: Clinically evident, seemingly innocuous lesions Suspicious lesions Rethman MP et al. JADA May % toluidine blue 1% ace1c acid 1% toluidine blue / tolonium chloride Dye (dark royal blue vs. pale blue) May stain nucleic acids, abnormal 1ssue Demarcate extent of lesion before excision High sensi1vity for detec1ng carcinomas Use for detec1ng recurrences Posi1ve in ~50% of dysplas1c lesions Joel Laudenbach, DMD 13

14 tol. blue used on leukoplakia Diagnosis: chronic hyperplas1c candidiasis Ram S, Siar CH. Int J Oral Maxillofac. Surg. 2005;34: ELP Mild dysplasia Joel Laudenbach, DMD 14

15 Increased Risk for Oral Leukoplakia Progression to Malignancy: +Dysplasia on 1 st biopsy Larger size > 200 mm 2 Homogenous surfaced leukoplakia Subsite tongue or floor of mouth Non-homogenous appearance* Older age Female Absence of known risk factors Toluidine blue stain SCCa; Leston, Dios. Oral Onc 2010 Non-Homogenous surfaced leukoplakia Prevalence of Dysplasia (pre-cancer) in Oral Leukoplakias = 16 39% Dye is unable to penetrate through thick hyperkerato1c leukoplakias False nega1ve result** GOCF 2016 Prevalence of Dysplasia/Cancer of True Leukoplakias = 43% Woo et al. 14 toluidine blue dye Stains: Ac1ve inflammatory, ulcera1ve, regenera1ng lesions Mechanically retained: Dorsum of tongue filiform papillae Dental plaque Crevices of rough & fissured lesions High false posi1ve rate Schedule repeat stain in 2 weeks* Evidence-based recommenda1ons - screening for oral SCCa Insufficient evidence for or against stand-alone use of toluidine blue to enhance iden1fica1on of poten1ally malignant lesions in the general popula1on Rethman MP et al. JADA May 2010 *Evidence-based recommenda1ons - screening for oral SCCa ** Toluidine blue may assist in assessment of poten1ally malignant lesions if: History of oral cancer >50 yrs. who smoke and drink alcohol When used by dental or medical providers with advanced training/experience** *Rethman MP et al. JADA May 2010 **Speight PM et al. OOOO & GOCF 2016 Joel Laudenbach, DMD 15

16 2017 JADA Panel does not recommend: Cytologic, autofluorescence, 1ssue reflectance, or vital staining adjuncts for the evalua1on of PMDs in adult pt s with: Direct 1ssue fluorescence / autofluorescence Clinically evident, seemingly innocuous lesions Suspicious lesions Also seen with prominent surface vascularity (inflammation) & melanin pigmentation invasive carcinoma vs. normal 1ssue Fluorescence at 365 nm 405 nm 450 nm diascopic fluorescence Is applica1on of pressure onto lesion **Dysplas1c changes can be found in lesions that: Do autofluoresce (look green) Do have loss of autofluorescence (look dark) and blanch Clin Cancer Res Poh et al. DYSPLASIA CANCER VELscope 20 tumors Margin iden1fica1on beyond tumor Evidence-based recommenda1ons - screening for OSCCa Insufficient evidence to show that 1ssue autofluorescence improves detec1on beyond the conven1onal exam Use of these devices can be associated with increased false-posi1ve findings Rethman MP et al. JADA May 2010 Joel Laudenbach, DMD 16

17 Evidence-based recommenda1ons - screening for OSCCa Some evidence: 1ssue autofluorescence* may improve determina1on of surgical margins & selec1on of op1mal biopsy site in large or mul1focal lesions or during surgery 2017 JADA Panel does not recommend: Cytologic, autofluorescence, 1ssue reflectance, or vital staining adjuncts for the evalua1on of PMDs in adult pt s with: Clinically evident, seemingly innocuous lesions Suspicious lesions Identafi Clinical Examples What you will normally see Rethman MP et al. JADA May 2010 The Exam (Part 1) Put the glasses on and begin the exam with White Light The Exam (Part 2) Whether suspicious 1ssue or not, switch to violet for a second observa1on The Exam (Part 3) If you see dark spots or suspicious 1ssue with violet, switch to Green-Amber and look for an increase in redness or blood vessels surrounding the area Joel Laudenbach, DMD 17

18 Joel Laudenbach, DMD 18