Disclosures. Skin Cancer in Transplant Recipients 9/26/2018

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1 Investigator Menlo Therapeutics Leo Pharma SunPharma Castle Biosciences Pfizer Eli Lilly Kiniksa Regeneron Sanofi/Genzyme Consultant Genentech Biossance/Amyris Zebra MedTech Castle Creek Pharmaceuticals Pennside Partners Gerson Lehrman Group Disclosures Skin Cancer in Transplant Recipients SCC risk in Medicare patients among patients with dermatology visits, adjusted for age, sex, UV, nondermatology and dermatology visit frequency Non Hodgkin Lymphoma Solid Organ Transplant Bone Marrow Transplant Graft vs. Host Disease HIV Yanik et al., Cancer Epidemiol Biomarkers Prev

2 SCC after Organ Transplantation Skin Cancer Mortality in US OTR (N=496,951) US Mortality Rate OPTN Data Overall* ,308 Cancer, All Sites Breast Colon/Rectum Melanoma Merkel Cell 4.59 cscc 4.96 *per 100,000 person/years Garrett et al., J Am Acad Dermatol Apr Should We Screen OTR for Skin Cancer? 2016 USPSTF statement: insufficient data to support skin cancer screening based on a goal of reducing mortality Potential Benefits Possible reduction of morbidity/mortality Opportunity to educate patients about modifiable sun exposure/lifestyle factors Opportunity to identify specific medication associated risks Opportunity to intervene on other transplant associated dermatologic conditions Potential Harms Cost to the health care system Potential to increase invasive procedures and complications Potential anxiety arising from biopsy Obstacles to Screening Patient health status, travel time Referring physician awareness Access to dermatologic care (ex. rural areas) Should We Screen OTR for Skin Cancer? Our goal: Risk prediction algorithm and formal consensus on skin cancer screening based on US incidence and risk factors Gap in the data: population based incidence in OTR 2

3 Transplant Skin Cancer Network A research network focused on multicenter studies of skin cancer in organ transplant recipients, Seed funded by the AAD and Galderma Membership largely drawn from researchers in the ITSCC and SCOPE networks Goal: to determine the populationbased incidence and predictors of post transplant skin cancer. Retrospective review of all OTR at 26 centers transplanted in 2003, ,649 OTR contributed 59,923 years of follow up Barnes Jewish Hospital Baylor All Saints Medical Center Baylor University Medical Center Beth Israel Medical Center Brigham and Women's Hospital Cleveland Clinic Foundation Mayo Clinic Hospital, Arizona Mayo Clinic Hospital, Florida Mayo Clinic Hospital, Rochester Methodist Mayo Clinic Hospital, St. Mary Medical College of Wisconsin NY Presbyterian/Columbia Medical Center NY University Langone Medical Center Oregon Health and Science University Parkland Memorial Hospital Parkland Southwestern Hospital Scripps Green Hospital UCLA Medical Center UCSD Medical Center UCSF Medical Center University of Alabama Hospital University of Arizona Medical Center University of Minnesota Medical Center University of Pennsylvania University of Pittsburgh Medical Center Yale New Haven Hospital Study cohort All OTR Total, N % Total, N (%) 10,649 44,469 Total Age at Transplant mean 51 (s.d. 12) 50 (s.d. 13) median 53 (IQR 44-60) 52 (IQR 42-60) % 3,347 7% ,175 11% 5,319 12% ,242 21% 9,523 21% ,504 33% 14,301 32% ,532 24% 10,061 23% % 1,918 4% 50 6,526 61% 26,280 59% <50 4,123 39% 18,189 41% Gender Male 6,776 64% 28,116 63% Female 3,873 36% 16,353 37% Race White 7,184 67% 27,762 63% Black 1,503 14% 8,555 19% Hispanic 1,239 11% 5,512 12% Asian 561 5% 1,914 4% Other * 163 2% 725 2% White 7,184 67% 27,762 62% Non-white 3,465 33% 16,706 38% Organ Lung** 981 9% 2,415 5% Heart 1,017 10% 3,456 7% Kidney 5,158 48% 26,679 61% Pancreas*** 386 4% 1,905 5% Liver 3,107 29% 10,014 21% Thoracic 1,998 19% 5,871 13% Abdominal 8,651 81% 38,598 86% Transplant Year ,004 47% 21,512 47% ,645 53% 24,471 53% Latitude mean 39 N s.d. 7 n/a median 40 N IQR n/a p Garrett et al., JAMA Dermatol Post Transplant Skin Cancer Incidence Total N Incidence Rate 95% CI All Skin Cancers SCC MM MCC Skin Cancer (N) Incidence Rate 95% CI Total Sex Male Female Race White Non-white Organ Thoracic Abdominal Age < Tx Year Garrett et al., JAMA Dermatol Incidence Rate in the US population (SEER Registry Data) All Sites Breast Prostate Lung/Bronchus 57.3 Incidence Rate in nontransplant Est. IRR SCC 38.0* 35.7 Melanoma Merkel Cell 0.24** ~ *Tejera Vaquerizo et al. Actas Dermosifiliogr **Agelli et al. J Am Acad Dermatol Nov;49(5): Delphi Consensus Panel: Skin Cancer Screening after Transplantation Specialty N Dermatology 47 Medical Dermatology dermatologists and transplant Mohs Micrographic Surgery 21 Transplant 37 physicians Cardiology 6 Pulmonology 15 Nephrology US institutions Hepatology 2 Surgery 2 Three rounds of anonymous Total 84 Years Treating SOTR surveys and aggregate results to Total Among Panelists 1105 achieve 80% consensus on 3 Practice Type Academic 81 topics: Private 3 Risk assessment vs. cancer screening by full body examination Which OTR should be screened When OTR should be risk assessed and screened Recommendations are endorsed by the ITSCC and ISHLT for use in the US Mean (Range) 13.2 (1-42) 3

4 Panel Recommendations Panel Recommendations Preferred threshold: Screen 50 patients to detect one cancer (2% incidence) Crow et al., under review Crow et al., under review Skin Cancer Risk Evaluation after transplant (SCREEN): 5 minute, evidence based tool to predict post transplant skin cancer SCREEN Decision Tree Variable SHR [95% CI] Beta [95% CI] Points White race Pretransplant skin cancer Age > Male Heart or Lung Tp SCREEN Risk Category (points) 1: Low Risk (0 6) 2: Medium risk (7 13) 3: High Risk (14 17) 4: Immediate Risk (18 22) Low Risk screen within 10 yrs Medium Risk screen within 2 yrs High Risk screen within 1 yr Immediate Risk screen within 6 mos Jambusaria et al, under review Jambusaria et al, under review 4

5 Important Considerations for Use Screening applies only to asymptomatic patients, with no active lesions. Subjects with pretransplant skin cancer should have an FBSC within the recommended time period at a minimum; or sooner as directed by their dermatologist. A patient with a concerning lesion should be referred immediately for evaluation. Other patient specific pretransplant risk factors should be considered at the time of patient visit. Pretransplant sun damage/ UV exposure, pretransplant immunosuppression This tool does not incorporate risk for KS or genital dysplasia, both of which may be higher in OTR of color or HIV positive OTR. For Your Patients: skincancer.ucsf.edu Arron Lab Christine Kembikian Lauren Crow Brian Lu Rebecca Bremer Stefan Lowenstein Ernesto Llamado UCSF High Risk Skin Cancer Program Amanda Twigg Sue Yom Jon George Ivan El-Sayed P. Daniel Knott Rahul Seth Alain Algazi UCSF Dermatologic Surgery Roy Grekin Isaac Neuhaus Siegrid Yu Collaborators: Biology Peter Howley & Elizabeth White Charlotte Proby & Catherine Harwood & Karin Purdie James Cleaver Andrew South Raymond Cho Thea Mauro Collaborators: Epidemiology Eric Engels & Elizabeth Yanik Maryam Asgari Anokhi Jambusaria-Pahlajani Christina Chung Transplant Skin Cancer Network UCSF Transplant Program Jeffrey Golden Jonathan Singer Steven Hays Peter Chin-Hong Ryutaro Hirose 5