Accuracy of the SEER HPV status site specific factor 10 (SSF-10) variable for head and neck cancer (HNC) cases in Iowa:

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1 Accuracy of the SEER HPV status site specific factor 10 (SSF-10) variable for head and neck cancer (HNC) cases in Iowa: Amanda Kahl, MPH Mary Charlton, PhD, Nitin Pagedar, MD, MPH, Steven Sperry, MD, Bobbi Matt, CTR, Charles Platz, MD, & Charles Lynch, MD, PhD Student Oral Presentation, NAACCR June 20, 2017

2 Background Oropharyngeal squamous cell carcinoma incidence rising 70% of patients test positive for HPV In 2008, NCCN recommended: HPV testing should be done for certain subsites within head and neck cancer (HNC) Tests recommended: PCR, ISH SEER began collecting HPV status (SSF-10) for HNC subsites in cases diagnosed in 2010+

3 SEER Code Values for SSF-10: HPV Status HPV Negative Code HPV Positive Codes 000 HPV negative for all types 010 HPV positive for low-risk types only 020 HPV positive for specified high risk type(s) other than types 16/ HPV positive for high-risk type 16 ONLY 040 HPV positive for high-risk type 18 ONLY 050 HPV positive for high-risk types 16 AND HPV positive for high-risk type(s), NOS 070 HPV positive, NOS 988 Not applicable: Information not collected for this case 997 Test ordered, results not in chart 998 Test not done 999 Unknown

4 p16 HPV can be tested via surrogate marker p16 Established method of assessing HPV status in HNC patients No mention of p16 in coding guidelines Certified tumor registrars abstract cases from pathology reports Many do not have a science background May not know that p16 is a surrogate test for HPV May mistakenly conclude that p16 positive is equivalent to HPV-type 16 positive

5 Purpose Review HPV test status for all HNC cases to determine: 1. Accuracy of SSF Types of HPV testing being performed in Iowa 3. Impact of excluding p16 from the definition of HPV testing 4. Patient, tumor, and facility characteristics associated with HPV testing

6 Inclusion Criteria Iowa resident Diagnosed between Invasive or in situ HNC HPV-relevant ICD-O-3 topography included in CS Schema: Tongue base, palate soft, oropharynx, pharyngeal tonsil, nasopharynx, hypopharynx, pharynx other Squamous cell carcinoma histology N=1,007

7 Methods Cases manually reviewed to determine: HPV status Pathology tests performed Statistical analysis was performed in SAS Chi-square tests Logistic regression

8 Methods: Our Recoding Guidelines 000 HPV negative for all types; p16 negative 010 HPV positive for low-risk types only 020 HPV positive for specified high risk type(s) other than types 16/ HPV positive for high-risk type 16 ONLY 040 HPV positive for high-risk type 18 ONLY 050 HPV positive for high-risk types 16 AND HPV positive for high-risk type(s), NOS; p16 positive 070 HPV positive, NOS; p16 positive *If p16 and HPV-DNA was performed coded according to HPV-DNA results

9 Results: Patient Characteristics N % Age at diagnosis < % % % % Race/Ethnicity White % Black/Other 31 3% Sex Male % Female % Insurance Status Private Insurance % Not Insured 32 3% Medicaid % Medicare % Unknown 24 2% N % Marital Status Married % Divorced/separated % Single/never married % Widowed 81 8% Unknown 23 2% Diagnosis Year % % % % %

10 Results: Tumor Characteristics N % CS schema Hypopharynx % Nasopharynx 37 4% Oropharynx % Palate Soft 38 4% Pharynx Other/Pharyngeal Tonsil 41 4% TongueBase % Grade Well Differentiated 53 5% Moderately Differentiated % Poorly Differentiated % Undifferentiated 26 3% Unknown % Surgery Yes % No % N % Radiation Yes % No % Chemo Yes % No % Stage 1 Localized 80 8% 2 Localized 69 7% 3 - Regional % 4A - Regional % 4B - Regional 71 7% 4C - Distant Metastasis 44 4% 4NOS 58 6% Unknown 93 9%

11 Results: HPV testing Originally 40% (N=400) coded as having HPV testing After Recode Test Results Tested N % Positive % Negative % Discordant* % Yes % % % 28 6% HPV-DNA only % 59 59% 41 69% - - p16 only % % 66 31% - - p16 + HPV-DNA % 68 61% 16 24% 28 25% No % Total 1007

12 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Original Recode HPV Status Before And After Recoding Cases: Testing Status & Results, Iowa, *p16 Recoded As 070: HPV NOS Not tested 997: Test ordered, no results 070: HPV + NOS 060: HPV + HR NOS 050: HPV + 16 & : HPV + 18 only 030: HPV + 16 only 020: HPV + HR not 16/18 010: HPV + low risk only 000: HPV -

13 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Original Recode with p16 coded as unknown HPV Status Before And After Recoding Cases: Testing Status & Results, Iowa, *p16 Recoded As Not Tested Not tested 997: Test ordered, no results 070: HPV + NOS 060: HPV + HR NOS 050: HPV + 16 & : HPV + 18 only 030: HPV + 16 only 020: HPV + HR not 16/18 010: HPV + low risk only 000: HPV -

14 Logistic Regression Model Predicting Odds of Receiving HPV Testing among HNC cases Diagnosis Year OR CI Referent (1.34, 3.69) (2.10, 5.80) (2.89, 7.85) (6.34, 18.43) CS schema Hypopharynx 0.17 (0.09, 0.30) Nasopharynx 0.36 (0.15, 0.85) Oropharynx 1.00 Referent PalateSoft 0.55 (0.23, 1.34) PharynxOther/ PharyngealTonsil 0.23 (0.09, 0.58) TongueBase 0.62 (0.43, 0.89) OR CI Grade Well Differentiated 1.00 Referent Moderately Differentiated 1.26 (0.61, 2.61) Poorly Differentiated 2.65 (1.29, 5.46) Undifferentiated 4.24 (1.25, 14.45) Unknown 0.97 (0.45, 2.08) Surgery Yes 1.77 (1.23, 2.54) No 1.00 Referent Bed size < (0.28, 1.42) (Missing 34) (0.16, 0.55) (0.18, 0.51) Referent

15 100% Distribution of HPV SSF values initially recorded by the SEER-18 Registries compared with the Iowa, % 80% 70% 60% 50% 40% 30% 20% 10% 0% Not tested 997: Test ordered, no results 070: HPV + NOS 060: HPV + HR NOS 050: HPV + 16 & : HPV + 18 only 030: HPV + 16 only 020: HPV + HR not 16/18 010: HPV + low risk only 000: HPV -

16 Conclusions Revealed issues with consistency and accuracy of SSF-10: HPV Status Testing rate Increased from 39% to 49% Large shift in distribution of coding values p16 positivity being equated to HPV-type 16 positivity Over 50% of Iowa cases who were tested received p16 testing

17 Conclusions Nature of oropharyngeal cancer has changed Need for accurate epidemiologic data to inform clinical practice and investigation SSF-10 coding options & guidelines should be updated to improve Accuracy, consistency, and usefulness of this variable Discordant HPV and p16 results May be of interest to researchers and should be captured

18 Limitations If both tests were performed, SSF-10 coded to HPV-DNA results Inconsistencies in structure of, and language used in pathology reports from different institutions Possible classification of test types could be incorrect in some patients

19 Recommendations 1. Create new SSF SSF-11: p16 status Easily capture p16 results and separate from HPV 2. Change SSF-10 HPV or p16 status Add new codes: p16 positive p16 positive and HPV-DNA negative

20 Questions? Thank you

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