Abstract 1471P
Background
Deciding between active surveillance and treatment for patients with small renal masses remains a challenge. Kidney injury molecule-1 (KIM-1) is a candidate circulating biomarker for renal cell carcinoma detection and risk stratification. We sought to determine whether plasma KIM-1 can assist in the risk stratification of patients with suspicious kidney masses.
Methods
The WHO/IARC K2 study prospectively enrolled adults undergoing nephrectomy for kidney masses between 2007-2012 in Eastern Europe. We performed a nested case-control study using pre-nephrectomy banked plasma. We identified 162 patients who were subsequently found to have ccRCC (cases) and 162 patients who were subsequently found to have benign renal masses (controls). Plasma KIM-1 was measured in banked pre-nephrectomy plasma. Patients had prospective follow-up to determine clinical outcomes. Area under the receiver operating curve (AUC-ROC) was used to assess the relationship between pre-nephrectomy plasma KIM-1 and the likelihood of detecting ccRCC at time of surgery. Multivariable Cox models were used to assess the relationship between pre-nephrectomy plasma KIM-1 and subsequent metastasis-free survival and overall survival.
Results
Among 324 patients, plasma KIM-1 distinguished ccRCC versus benign masses with AUC-ROC 0.81 (95% CI: 0.76-0.86). Among patients with ccRCC, higher pre-nephrectomy KIM-1 was associated with shorter metastasis free survival (multivariable MFS HR 1.29 per unit increase in log KIM-1, 95% CI 1.10-1.53) and shorter overall survival (multivariable OS HR 1.31 per unit increase in log KIM-1, 95% CI 1.10-1.54). Table: 1471P
Performance of plasma KIM-1 for distinguishing benign versus malignant renal tumors, by size
| Tumor size | N | AUR-ROC (95% CI) |
| 0-4cm | 127 | 0.73 (0.64-0.82) |
| 4-7cm | 89 | 0.72 (0.61-0.83) |
| 7-10cm | 49 | 0.88 (0.73-1.00) |
| >10cm | 51 | 0.89 (0.76-1.00) |
| All tumors | 324 | 0.81 (0.76-0.86) |
Conclusions
In patients with renal masses, pre-nephrectomy plasma KIM-1 helped distinguish between clear cell renal cell carcinoma versus benign tumors. Among patients with ccRCC, higher pre-nephrectomy KIM-1 was associated with worse MFS and OS. Plasma KIM-1 may be a useful risk stratification tool for patients with suspicious kidney masses.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
National Institutes of Health.
Disclosure
M. Freedman: Financial Interests, Personal, Funding: Precede Bio. D.F. McDermott: Financial Interests, Personal and Institutional, Advisory Role: Bristol Myers Squibb, Merck, Novartis, Genentech, Alkermes; Financial Interests, Personal, Advisory Role: Pfizer, Eisai, Exelixis, Array BioPharm, Array BioPharma, Peloton Therapeutics, EMD Serono, Lilly, Calithera Biosciences, Iovance Biotherapeutics, Werewolf Therapeutics, Synthekine, AVEO; Financial Interests, Institutional, Research Grant: Prometheus Laboratories; Financial Interests, Personal, Sponsor/Funding: Jounce Therapeutics. T.K. Choueiri: Financial Interests, Personal, Advisory Board, Advice on GU/RCC drugs: BMS, Pfizer, Merck, Exelixis, AstraZeneca; Financial Interests, Personal, Advisory Board, Advice on Onc drugs: Lilly, EMD Serono, Infinity; Financial Interests, Personal, Advisory Board, Advice on RCC drug: Calithera; Financial Interests, Personal, Invited Speaker, RCC drug: Ipsen; Financial Interests, Personal, Advisory Board, Advice on GU Onc drugs: Surface Oncology; Financial Interests, Personal, Other, Consultant on onc drugs: Analysis Group; Financial Interests, Personal, Invited Speaker, CME, ww2.peerview.com: Peerview; Financial Interests, Personal, Invited Speaker, CME, gotoper.com: PER; Financial Interests, Personal, Invited Speaker, CME, researchtopractice.com: ResearchToPractice; Financial Interests, Personal, Invited Speaker, National Association of Managed Care: NAMC; Financial Interests, Personal, Invited Speaker, ASCO-related event: ASCO-SITC; Financial Interests, Personal, Other, Grant review to Orien Network ($400): ORIEN; Financial Interests, Personal, Advisory Board, Advising oncology strategy: Aptitude Health; Financial Interests, Personal, Invited Speaker, Best of ASCO19 talk: Advent health; Financial Interests, Personal, Invited Speaker, Best of ESMO20 talk ($1000): UAE Society of Onc; Financial Interests, Personal, Invited Speaker, CME, mjhlifesciences.com (OncLive): MJH life sciences; Financial Interests, Personal, Invited Speaker, Grand Rounds: MDACC; Financial Interests, Personal, Invited Speaker, RCC webinar: Cancernet; Financial Interests, Personal, Invited Speaker, CME, Kidney Cancer Association ($1300): France Foundation; Financial Interests, Personal, Invited Speaker, CME, RCC: Springer, WebMed; Financial Interests, Personal, Invited Speaker, CME, ImmunoOncology in RCC: ASiM, CE; Financial Interests, Personal, Invited Speaker, CME, PodCast in RCC ($500.00): Caribou Publishing; Financial Interests, Personal, Invited Speaker, Reimbursement ($432.00): Kidney Cancer Association; Financial Interests, Personal, Other, member of the DSMB for clinical trial: Aravive; Financial Interests, Personal, Invited Speaker, unpaidhttps://www.accru.org/main/public/index.xhtml: ACCRU; Financial Interests, Personal, Invited Speaker, Unpaidhttps://kidneycan.org: KidneyCan; Financial Interests, Personal, Other, External Advisory Board Member: Gustave Roussy; Financial Interests, Personal, Stocks/Shares: Pionyr (not publicly traded), Tempest (publicly traded), Osel (not publicly traded), Nuscan ((not publicly traded)); Financial Interests, Personal, Royalties, For writing and updating chapters in GU Oncology: Up-To-Date online textbook; Financial Interests, Institutional, Funding, National Chair: BMS, Merck, Exelixis, AstraZeneca, Takeda, Tracon, Peloton; Financial Interests, Institutional, Invited Speaker: Roche, Surface Oncology, GSK; Financial Interests, Institutional, Funding, National co-chair: Pfizer, EMD-Serono; Financial Interests, Institutional, Funding, Chair of trial: Lilly; Financial Interests, Institutional, Funding, SC member: Eisai; Financial Interests, Institutional, Funding, National co-chair on 3 ongoing trials: ALLIANCE Cooperative Group; Financial Interests, Institutional, Research Grant, for GU oncology translational research through IION program: BMS; Financial Interests, Institutional, Research Grant, for GU oncology translational research: Exelixis; Financial Interests, Institutional, Research Grant, For Health outcomes research: Roche; Financial Interests, Institutional, Invited Speaker, leads trials as PI: Nikang; Non-Financial Interests, Leadership Role, Co-Chair of the meeting, 2019-: Kidney Cancer Research Summit of KidneyCAN; Non-Financial Interests, Principal Investigator, Trial Global and National PI with GU Cancers, mostly Kidney Cancer: Multiple Academic and Industry entities; Non-Financial Interests, Personal, Other, Track Leader/Session chair/Speaker/Discussant: ASCO; Non-Financial Interests, Personal, Other, Speaker/Discussant/Track Leader: ESMO; Non-Financial Interests, Institutional, Other, Access to genomic database: Foundation Med, Guardant, Invitae; Non-Financial Interests, Personal, Other, Grants reviewers: AACR; Non-Financial Interests, Personal, Other, Reviewer of papers: Various journals (e.g. NEJM, Lancet, JCO); Non-Financial Interests, Personal, Other, Medical writing and editorial assistance support (e.g. ClinicalThinking, Envision Pharma Group, Fishawack Group of Companies, Health Interactions, Parexel, Oxford PharmaGenesis, pharmagenesis, and others). However, first draft frequently initiated by myself when I am 1st author: Medical Communication; Non-Financial Interests, Member: ASCO, AACR; Non-Financial Interests, Other, Political vote usually as “independent”, not a member of any political party. I am an issue voter: General US Politics; Other, Employee at DFCI. Please see https://www.dana-farber.org/ for mission statement (non-profit hospital). I am also the past President of Medical Staff at DFCI 2015-2018: Dana-Farber Cancer Institute (DFCI); Other, Professor at HMS, Please see https://hms.harvard.edu/ for mission statement (non-profit school): Harvard Medical School (HMS); Other, No financial interest. Institutional. Filed patents related to biomarkers of immune checkpoint blockers, and circulating free methylated DNA. No money made and some patents were abandoned: Filed patents. R. Bhatt: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. All other authors have declared no conflicts of interest.