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Novel Image Analysis Algorithms for Quantifying Expression of Nuclear Proteins assessed by Immunohistochemistry Elton Rexhepaj , MSc UCD School of Biomolecular and Biomedical Science UCD Conway Institute, University College Dublin, Ireland. [email protected] Biomarker Validation: Application of Tissue Microarrays DISCOVERY VALIDATION BIOMARKER PANEL BIOMARKER DEVELOPMENT Interpretation of IHC Manual • • • • Subjective, time consuming Inherent intra-observer variability Semi-quantitative data Pathologist-based analysis remains the current standard Automated • • • • Objective quantification of IHC staining Reproducible data Continuous output A new tool in the hand of the pathologist Application of Image Analysis Approaches to assess IHC •Altered nuclear-cytoplasmic ratio of survivin is a prognostic indicator in breast cancer Brennan et al resubmitted, Clinical cancer research, 2007 •Automated quantification of ER/PR expression in breast cancer patients Rexhepaj et al, manuscript in preparation Altered Nuclear-Cytoplasmic Ratio of Survivin is a Prognostic Indicator in Breast Cancer • Promising tumour marker • Located in the cytoplasm and the nucleus • Nuclear and cytoplasmic fractions of survivin have different biological roles • Manual interpretation of survivin is challenging • Conflicting data exists on its prognostic impact in breast cancer • Need for new automated scoring models • Can automated scores lead to discovery of new prognostic subgroups Automated image analysis of survivin H&E • • IHC x10 IHC x40 Staining Intensity Low Breast Cancer TMA – 102 patients – 0.6mm cores arrayed in duplicate – Full clinicopathological data – Median follow-up 77 months Image acquistion – Aperio Scanscope CS Autoscanner Medium High Brennan et al submitted 2007 Separating nuclear from cytoplasmic stain Positive pixel count algorithm Cytoplasm HIGH Cytoplasm & nuclear We were able to separate cytoplasm from nuclear staining and independently quantify the IHC staining intensity LOW Random Forest Clustering Survivin cytoplasmic to nuclear ratio RFC dim 2 3 4 1 2 RFC dim 1 • By applying RFC we were able to find 4 cluster of patients • Cytoplasm to nuclear ratio was differently expressed in each cluster Brennan et al submitted 2007 CNR and patient survival High CNR CNR < 5 High CNR CNR < 5 CNR > 5 Low CNR CNR > 5 P = 0.05 Overall Survival BC Specific Survival Low CNR P = 0.005 Time (Months) Time (Months) • Clusters with high CNR showed a increase of both BCS and OS survival Brennan et al submitted 2007 Cox Regression Analysis of OS Univariate Multivariate* HR 95% CI p value HR 95% CI p value CNR (<5 v’s > 5 0.1 0.01 - 0.73 0.023 0.09 0.01 - 0.72 0.024 Nodal status (pos v’s neg) 3.03 1.48 - 6.20 0.002 2.74 1.21 - 6.19 0.015 Grade (1 & 2 v’s 3) 2.52 1.32 - 4.81 0.005 0.63 0.27 - 1.48 0.29 ER status (pos v’s neg) 0.38 0.20 - 0.73 0.004 0.61 0.22 - 1.67 0.334 Her2 (1 & 2+ v’s 3+) 2.19 1.06 - 4.52 0.034 2.0 0.84 - 4.78 0.119 PR status (pos v’s neg) 0.41 0.21 - 0.80 0.009 0.86 0.36 - 2.08 0.737 Tumor size (continuous) 1.04 1.02 - 1.06 0.001 1.05 1.02 - 1.08 0.002 Ki-67 (0 – 10% v’s 11-100%) 2.60 1.01 – 6.67 0.047 0.98 0.31 – 3.10 0.975 Univariate and Multivariate analysis revealed that the CNR was a significant predictor of OS in this cohort along with tumour size and nodal status Brennan et al submitted 2007 Low CNR a new prognostic subgroup Tumor Size Median (Range) 0-20mm >21mm ER status1 ER ER + PR status1 PR PR + NHG NHG I & II NHG III p53 Status2 p53 p53 + Myc Amplification3 Low Intermediate/High Missing Cytoplasmic:Nuclear Ratio <5 (n = 78) Cytoplasmic:Nuclear Ratio >5 (n = 18) 22(10-100) 33 (42) 45 (58) 24 (11-60) 6 (33) 12 (67) 26(33) 52(67) 1 (6) 17 (94) 0.0195 35 (45) 43 (55) 3 (17) 15 (83) 0.0335 37 (47) 41 (53) 18 (100) 0 * 53 (68) 25 (42) 17 (94) 1 (6) 0.0055 43 (55) 16 (21) 22 17(94) 1 (6) 0.0165 P value 0.6014 A low Survivin CNR is associated with a mitotic/proliferative phenotype Survivin - conclusions • Image analysis applied to Survivin IHC • Image analysis of IHC can produce new automated quantitative scoring models • RFC was used to identify new prognostic subgroups • Previously unidentified prognostic subgroups can be uncovered • A low Survivin CNR is associated with a mitotic/proliferative phenotype Brennan et al submitted 2007 What can be improved MACHINE LEARNING •The supervised approach - not reproducible and can’t be extended to other tissue types - requires a domain expert for the selection of validation and test cohort of patients • The manual calibration : - It is time consuming - Need to be repeated for each new slide/cohort/type of tissue MANUAL CALIBRATION PATTERN • Size • Shape • Distance ... Apply the learned or calibrated patterns to the rest of the cohort. Alternative : Application of non-supervised learning algorithms to learn the patterns in a case by case basis Automated image analysis of ER and PR • Members of the nuclear hormone family • Expressed in around 70% of breast cancer cases • Estrogen often induces a multiplication of progesterone receptors • Currently, hormone receptor status is manually assessed by a pathologist • an arbitrary cut off of 10% positive cells is used to decide whether a patient should have adjuvant hormonal therapy Data COHORT I - 564 pre-menopausal women with primary breast cancer - Patients were randomly assigned to either two years of adjuvant tamoxifen COHORT II - 512 consecutive breast cancer cases COHORT III - 179 consecutive cases of invasive breast cancer • more then 1000 patients • full clinico-pathological follow up Application of IHC nuclear algorithm on tissue cores examples Algorithm validation Manual pathologist assessment Automated percentage - Validation set -18 representative tissue cores stained with ER - A trained pathologist was ask to blindly score each tissue core - A very good correlation was observed between manual and automated score Correlation of manual with automated score of ER • A good correlation was seen between manual and automated scores Correlation of manual with automated score of PR • A good correlation was seen between manual and automated scores Selection of the threshold for ER status – cohort I 0.05 • 358 thresholds were generated in the range 0-100% • For each cut-off • BCS and OS of ER negative patients was compared to that of ER positive patients • The best cut-off for ER was 5% and for 7% for PR A novel approach to automatically define the threshold for ER status – cohort I - Random forest clustering was used to automatically cluster patient in ER+/subgroups A novel approach to automatically define the threshold for PR status – cohort I - Random forest clustering was used to automatically cluster patient in PR+/subgroups. ER/PR status as defined by clusters and correlation with manual scores – cohort I • ER status as defined by RFC was correlated with manual scores. • Spearman correlation coefficient was 0.8 for ER and 0.7 for PR Correlation of RFC clusters with tamoxifen response cohort I • There was a significant effect of 2 years tamoxifen treatment on the ER+ and PR+ cohort of patients as determined by RFC • No treatment effect was evident in ER-, PR- patients as determined by RFC Summary - A novel non-supervised image analysis algorithm - Excellent correlation of manual with automated scoring - Univariate analysis of OS showed no significant difference in the HRs between manual and automated scores - A patient clustering approach to investigate patient stratification. - A new automated approach to stratify patients in ER-/+ - The ability to predict tamoxifen response was similar in manual and automated Acknowledgements Supervisor Prof. William Gallagher UCD School of Medicine and Medical Science Dr Amanda McCann Dr Dermot Leahy UCD School of Medicine and Medical Science Dr. Donal Brennan Gallagher Lab Dr. Darran O’Connor Dr. Linda Whelan Dr. Annette Byrne Dr. Mairin Rafferty Dr. Richard Talbot Dr. Shauna Hegarty Dr. Helen Cooney Caroline Currid Sharon McGee Elaine McSherry Liam Faller Ian Miller Denise Ryan Fiona Lanegan Ben Collins Tom Lau Karen Power Stephen Madden Sarah Penny Aisling O Riordan Dr Catherine Kelly Dr Sallyann O’Brien Dept of Pathology Lund University Sweden Prof Goran Landberg Dr Karin Jirstrom Asa Kronblad TARP Laboratory NCI, NIH, Washington Dr Stephen Hewitt Aperio EMBO practical course on TissueMicroarray construction and image analysis http://coursewiki.embo.org/doku.php?id=tissue_microarrays:microarray_course June 2008 – THE RETURN !!!