7th Annual Symposium on Gastrointestinal Cancers " St. Louis, Mo, 9/20/08
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1 Molecular markers to aid in early diagnosis of pancreatic cancer Michael Goggins, MD Professor of Pathology, Medicine and Oncology Johns Hopkins Medical Institutions, Baltimore, MD 7th Annual Symposium on Gastrointestinal Cancers " St. Louis, Mo, 9/20/08
2 Disclosure Dr. Goggins has licensing agreements with Oncomethylome sciences for several DNA methylation markers
3 Early diagnosis of symptomatic disease Early detection of asymptomatic disease
4 Survival for Ductal Pancreas Adenocarcinoma iving Proportion Surv Tumor Diameter p< < 3 cm 3 cm iving Proportion Survi Lymph Node Status p< no positive nodes positive nodes months months viving Proportion Surv Margin Status p< negative margin positive margin viving Proportion Surv Histologic Grade p< well or moderate poor or undifferentiated months months
5 Early detection of small asymptomatic neoplasms may result in cure Best outcome: 79 patients wth small, asymptomatic, < 1 cm cancers 5- year survival 100% after surgery if PC limited to duct epithelium (CIS?) Ariyama 1997
6 What is the natural history of patients who present with symptoms and are ultimately diagnosed with pancreatic cancer? We do not have much quantitative information on the obstacles to diagnosis for patients with pancreatic cancer
7 When there are delays in diagnosis, what are their causes?
8 Pancreatic CT abnormalities up to 18 months prior to a diagnosis of pancreatic cancer Chari et al, AJR 2004;182:897
9 How many patients would have a significantly improved outcome if they were optimally diagnosed as soon as symptoms presented?
10 Markers of Pancreatic Neoplasia What performance characteristics are needed for a(serum) molecular marker for the Diagnosis of pancreatic cancer
11 The performance characteristics of a marker often vary by population (disease stage, heterogeneity): Ca panc ca amp cbd ca pancreatitis/panc cyst islet cell neoplasm healthy Sensitivity for resectable PC =65% (Sensitivity for unresectable PC=80%) PC AmpCA CP islet ca controls JHU unpublished
12 Disease prevalence 50% (e.g. pancreatic mass) Disease No Disease Positive 900 (TP) 200 (FP) 1, (FN) 800 (TN) Negative 900 1,000 1,000 PPV: 900/1100=81% NPV: 800/900=91% 91% Test Sensitivity: 90% Specificity: 80% (for cancer)
13 Disease prevalence ~10%, e.g. mid-back pain, wt loss Disease No Disease Positive 182 (TP) 360 (FP) (FN) 1540 (TN) Negative ,800 PPV: 182/542=34% NPV: 1540/1558=98% Sensitivity: 90% Specificity: 80% (for resectable cancer)
14 What performance characteristics are needed for a molecular marker for Screening for pancreatic cancer?
15 General Population: Age 65: 5 year Risk PPV NPV Surveillance Epidemiology and End Result
16 Disease prevalence, 1% Disease No Disease Positive 18 (TP) 396 (FP) (FN) 1584 (TN) Negative ,980 PPV: 18/414=4.3% 4 NPV: 1584/81856=99.8% 8% Sensitivity:90% Specificity: 80%
17 New Onset Diabetics: 3 yr PC risk PPV NPV Chari et al. Gasto 2005
18 Family Hx PC 3 1 st -degree relatives: 3-yr PC risk PPV NPV Klein et al. Cancer Research 2004
19 Family Hx PC 2 1 st -degree relatives: 3-yr PC risk PPV NPV Klein et al. Cancer Research 2004
20 Is this the right question to ask of our markers? What performance characteristics are needed for a molecular marker to Screen for pancreatic cancer?
21 What about the performance characteristics for a molecular marker of neoplastic precursors?
22 Strong Family Hx of PC, prevalence: 10% (IPMN) Test: Sensitivity: 95% Specificity: =90% (EUS or MRI) Disease No Disease Positive Negative PPV: 95/105=91% NPV: 90/95=95%
23 Cancer of the Pancreas Screening (CAPS) clinical trials Who are we screening? Asymptomatic High risk individuals with a strong family history of pancreatic cancer and certain germline mutation carriers CAPS1:1999 CAPS2: 2001 CAPS3: 2006 CAPS4: 2008
24 Familial PC Screening Programs Canto, CGH 2004,n=36 Popn Screening Diagnostic Tests Yield (IPMN/PC) FPC (> 3) PJS EUS 5.8% Canto, CGH FPC (> 3) EUS + CT 10.2% 2006,n=78 PJS Kurtz, DDW FPC CT/MRI 76% 7.6% 2007,n=66 +/- EUS Poley, DDW FPC, PJS, EUS 23.9% 2007,n=46 FAMM, BRCA1/2 Other studies ongoing, eg. Brentnall et al (Seattle), Europac, U Pitt, Zubarik et al, (Vt)
25 Cancer of the Pancreas Screening Study (CAPS) 3 CAPS 3 1 st national American multicenter screening study EUS/CT/MRI + biomarkers (juice) Hopkins, Mayo, MDACC, Dana Farber, UCLA caps3@jhmi.edu lizst.onc.jhmi.edu/caps3
26 CAPS 4 Single center, long-term screening and surveillance (V foundation) Evaluate expanded eligibility 1 FDR, 1 SDR (eg. parent and grandparent) BRCA2 mutation carriers Biomarker discovery
27 baseline 3 months 10 mm 12 months 18 mm
28 Lobular CP like changes on EUS
29 Extensive PanIN Lobulocentric atrophy Brune et al, AJSP, 2006
30 Is the identification of IPMNs and PanINs in asymptomatic individuals justified when we have not proven that surveillance of these lesions leads to improved outcome?
31 What molecular markers are on the horizon and can they help identify cancer or advanced neoplasia?
32 Molecular alterations in pancreatic cancer DNA: Somatic mutations RNAs: Aberrant DNA methylation ti Chromosomal losses/gains RNAs and micrornas Proteins Other Peptides, glycopeptides eg. Autoantibodies Infiltrating pancreatic ca
33 Normal Duct PanIN 1A PanIN 1B PanIN 2 PanIN 3 Invasive AdenoCa Intraductal Papillary Mucinous Neoplasm (IPMN) Cystic Adenoma Carcinoma in Invasive Lesion situ AdenoCa Mucinous Cystic Neoplasm (MCN)
34 Pancreatic cancer research: Era of systematic discovery 100% Research Activity Systematic Discovery ( Omics ) Translational Evaluation of markers 0% Candidate Markers Time
35 The Pancreatic Cancer Genome
36 Number of somatic mutations in pancreatic cancer Data figure on the pc genome
37 Pancreatic cancer chromosomal gains + losses Gains Losses Walter et al, Cancer Biol Ther, 2008
38 Quantifying mutant KRAS in Pancreatic juice: LigAMP PC CP Shi et al, Cancer Biol Ther, 2008
39 Discovering i the cancer methylome Methylome = genome wide DNA methylation patterns
40 Chr1 Log ratio Chr7 Chr2 Chr8 Chr3 Chr9 Chr4 Chr10 Chr5 Chr11 Chr6 Chr12
41 100Aberrant DNA methylation in IPMNs % TSLC1 RELN TFPI2 RELN SARP2 SPARC UCHL IPMN with low gradedysplasia IPMN with moderate dysplasia IPMN with high-grade dysplasia Hong et al, Modern Path in press
42 Quantitative Methylation analysis of ERCP Brushings of common bile duct strictures
43
44 QMSP of biliary and Pancreatic duct Brushings performed to diagnose strictures QMSP 1 gene + 3 gene panel, >3% conc. n Sens (CI) Spec (CI) Accuracy (CI) Pancreatic adenocarcinoma (58-84) a 86.4 (7-24) 81 (73-88) i Biliary tract cancer (49-94) b 86.4 (7-24) 86 (76-92) Cytology Pancreatic adenocarcinoma (14-34) c 100 (95-100) 69 (60-77) Biliary tract cancer (11-60) d 100 (95-100) 92 (84-96) Cytology + QMSP Pancreatic adenocarcinoma (61-76) e 86.4 (7-24) 82 (74-88) h Biliary tract cancer (60-96) f 86.4 (7-24) 88 (79-94) Parsi et al, Clin Gastro Hep, 2008
45 Pancreas juice sampling for markers
46 Quantifying pancreatic juice DNA methylation alterations 5 gene panel, quantified by QMSP, CAPS2 study population Cancer Res 2006:66:1208
47 Discovering Pancreatic cancer expression patterns B. Marker Hs76T PC16 PC17 PC15 PC12a PC1 PM1 Normal 1 Normal 2 Normal 3 MiaPaca2 Panc1 PL45 PL12 PL1 BxPC3 CAPAN1 CFPAC1 CAPAN2 PL8 PL1 Su86.86 AsPC1 PL3
48 e rie s1 Candidate pancreatic cancer markers: Serum Macrophage inhibitory cytokine-1 (MIC-1) MIC S ELISA 0 0 PC CP Nl PC=pancreatic cancer CP=chronic pancreatitis Nl=normal Clin Cancer Res 2006;12:442
49
50 MicroRNA alterations in pancreatic cancer Hahn et al, Oncogene 2007;264442
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