PowerPoint Presentation Attitudes of Patients with Cutaneous Melanoma Towards Prognostic Testing Using Gene Expression Profiling Background ›The 31-gene expression profile (31-GEP) test for cutaneous melanoma (CM) assesses gene expression measurements from formalin-fixed paraffin-embedded primary tumor tissue to predict risk of tumor recurrence or metastasis. ›The 31-GEP stratifies risk into one of three risk categories: low risk (Class 1A), intermediate risk (Class 1B/2A), and high risk (Class 2B) and has been validated in multiple prospective and retrospective studies1-7. Presented at 2022 Winter Clinical Dermatology Conference; January 14-19, 2022. Lorrie-Beth Miley1, Kelli Ahmed PhD2, Jennifer J. Siegel PhD2, Sonia K. Morgan-Linnell PhD2, Kyleigh LiPira1 1.Melanoma Research Foundation; Washington, DC, USA; 2. Castle Biosciences, Inc. Friendswood, Texas Objective ›Understand patients’ perspectives on prognostic and 31-GEP testing and whether patients experience decision regret after having 31-GEP testing performed. Table 1. Participant Demographics Methods ›A 43-question online survey was distributed by the Melanoma Research Foundation from June 14, 2021, through August 2, 2021. ›Patients were asked a series of five validated questions that gauge patients’ level of regret regarding the decision to undergo 31-GEP testing and the extent to which they experienced decision regret8-9, which was scored on a scale of 1–5, 1 being no regret, 5 being high regret, and 3 neutral. Responses were limited to those self-reporting a melanoma diagnosis in or after 2014 (n=120), at which time 31-GEP prognostic testing became available. Demographics (n=120) Total, n (%) Tested, n Not Tested, n Unknown, n Gender Male 19 (24.2%) 6 23 -- Female 90 (75%) 22 68 -- Prefer not to share 1 (0.8%) 0 1 -- Did you have DecisionDx testing? Yes 28 (23.3%) No 75 (62.5%) Unsure 17 (14.2%) Insurance coverage Commercial 84 (73.7%) 22 55 7 Commercial with MedAdvantage 6 (5.3%) 2 4 0 Medicare 21 (18.4%) 3 12 6 None 1 (0.9%) 0 1 0 I don’t know 2 (1.8%) 0 1 1 Results Figure 1. Did you want prognostic testing at the time of your diagnosis? Respondents were asked if they wanted prognostic information about their tumor at the time of diagnosis. Most respondents, whether they received 31- GEP or not, desired prognostic testing about their tumor. Acknowledgments & Disclosures References › This study was sponsored by Castle Biosciences, Inc. › KA, JJS, and SKM are employees and shareholders of Castle Biosciences, Inc. LM and KL have no conflicts of interest. 1. Lawson DH CR. Continued evaluation of a 31-gene expression profile test (GEP) for prediction of distant metastasis (DM) in cutaneous melanoma (CM). J Clin Oncol. 2015;33(15_suppl):9066. 2. Ferris LK, Farberg AS, Middlebrook B, Johnson CE, Lassen N, Oelschlager KM, et al. Identification of high-risk cutaneous melanoma tumors is improved when combining the online American Joint Committee on Cancer Individualized Melanoma Patient Outcome Prediction Tool with a 31-gene expression profile-based classification. J Am Acad Dermatol. 2017 May;76(5):818-825.e3. 3. Dillon LD, Gadzia JE, Davidson RS, McPhee M, Covington KR, Cook RW, et al. Prospective, Multicenter Clinical Impact Evaluation of a 31-Gene Expression Profile Test for Management of Melanoma Patients. SKIN J Cutan Med. 2018 Mar;2(2):111–21. 4. Greenhaw BN. Estimation of Prognosis in Invasive Melanoma Using a Gene Expression Profile Test. In 2016. 5. Keller J, Schwartz TL, Lizalek JM, Chang E, Patel AD, Hurley MY, et al. Prospective validation of the prognostic 31‐gene expression profiling test in primary cutaneous melanoma. Cancer Med. 2019 May;8(5):2205–12. 6. Podlipnik S, Carrera C, Boada A, Richarz NA, López-Estebaranz JL, Pinedo-Moraleda F, et al. Early outcome of a 31-gene expression profile test in 86 AJCC stage IB-II melanoma patients. A prospective multicentre cohort study. J Eur Acad Dermatol Venereol JEADV. 2019 May;33(5):857–62. 7. Hsueh EC, DeBloom JR, Lee JH, Sussman JJ, Covington KR, Caruso HG, et al. Long-Term Outcomes in a Multicenter, Prospective Cohort Evaluating the Prognostic 31-Gene Expression Profile for Cutaneous Melanoma. JCO Precis Oncol [Internet]. 2021 Apr 6 [cited 2021 Apr 6]; Available from: https://ascopubs.org/doi/pdf/10.1200/PO.20.00119 8. Brehaut JC, O’Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, et al. Validation of a Decision Regret Scale. Med Decis Making. 2003 Jul;23(4):281–92. 9. AM O. User Manual - Decision Regret Scale [Internet]. 1996 [cited 2020 Sep 29]. Available from: https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Regret_Scale.pdf. ›90% of patients wanted prognostic information about their tumors at the time of diagnosis. ›Patients wanted 31-GEP testing to increase their knowledge about their disease (76.9%) and inform treatment decisions (46.2%). ›Patients (>90%) felt 31-GEP testing was useful and felt they gained understanding (60.7%) and relief from uncertainty (39.3%). ›Patients receiving 31-GEP results did not experience decision regret, even among patients who had Class 2, high-risk tumors Conclusions Figure 5. Decision Regret Scores Respondents were asked a validated series questions regarding the level of regret they experienced with their decision to undergo 31-GEP testing. Blue (Class 1) and orange (Class 2) circles represent the mean decision regret score for each respondent. The dashed line indicates decision regret (3.05). Median decision regret scores for all Class 1 or Class 2 respondents (red circles) were not significantly different (p=0.058). Both Class 1 (p<0.001) and Class 2 (p=0.036) median decision regret scores were significantly below the decision regret line, indicating no or little regret regardless of high or low risk results. *, statistically significant; n.s., not significant *p < 0 .0 0 1 *p = 0 .0 3 6 n.s., p=0.058 Results Figure 2. Factors that influenced patients’ decisions to get 31-GEP testing Figure 4. Benefits of 31-GEP testing for patients Respondents who received 31-GEP testing were asked what factors impacted their decision to get 31-GEP testing. Respondents were allowed to select all choices that applied. The percent of respondents who selected a particular reason are shown. Internally driven choices are indicated in blue; externally driven choices are indicated in orange. Respondents who received 31-GEP testing (n=24 responses) answered whether they felt that the results were useful. The graph indicates the number of respondents who chose a particular choice and their reported 31-GEP class call. Most patients thought the 31-GEP was at least somewhat useful. Respondents who received 31-GEP testing were asked how they benefitted from their 31-GEP test results. Respondents were first asked to select all the benefits they felt they gained (select as many responses as applied), and the percent of respondents that selected a given choice are shown. ›Participants who received 31-GEP testing felt that the results were useful to them. Testing game them increased knowledge, relief from uncertainty, personalized treatment options, and information for life planning. 0 20 40 60 80 100 Increased knowledge and understanding Relief from uncertainty about future More personalized treatment options Information relevant to life planning Other Not useful Percent of Respondents Figure 3. Utility of 31-GEP test information 0 20 40 60 80 100 My health care provider recommended it A friend or family member recommended it I wanted to get all information I could about my melanoma I wanted to better understand my future I thought it would better inform my treatment options Percent of Respondents