Presentation is loading. Please wait.

Presentation is loading. Please wait.

The Oncotype DX ® Assay in the Contemporary Management of Invasive Early-stage Breast Cancer.

Similar presentations


Presentation on theme: "The Oncotype DX ® Assay in the Contemporary Management of Invasive Early-stage Breast Cancer."— Presentation transcript:

1 The Oncotype DX ® Assay in the Contemporary Management of Invasive Early-stage Breast Cancer

2 Cancer – The Biology Century Understanding and treating the underlying tumor biology –Cancer genetic studies demonstrate the transition of basic research to clinical application (i.e. BRCA testing) –Targeted cancer therapies developed based on the unique tumor genetic characteristics (i.e. tamoxifen and trastuzumab) –Sequencing of the human genome –Gene expression profiling shown to predict clinical outcome 2 Scientific breakthroughs making personalized medicine in cancer a reality

3 Evaluating Biomarkers for Clinical Use Key Principles Does the test deliver what patients, physicians, regulators, and payers need? –Most importantly, tests must be “Fit for Purpose” with evidence relevant to that specific purpose –Consistent results across multiple well-designed studies are required to provide evidence for analytic performance, clinical validity, and clinical utility (see Roadmap to Establish Clinical Utility) –Test must be shown to have value beyond traditional measures Has the test been brought to a standardized implementation? And has the evidence which supports its use been obtained in that standardized implementation? Hayes DF. Am Soc Clin Oncol Ed Book. 2008: Simon R. J Clin Oncol. 2005;23:

4 Key Questions When Evaluating Genomic Classifiers 4 Hayes DF. Am Soc Clin Oncol Ed Book. 2008: Simon R. J Clin Oncol. 2005;23:

5 The Oncotype DX ® Gene Panel Was Developed from Clinical Trial Evidence 250 cancer-related genes were selected based on extensive literature review (candidate-gene approach) Genes were analyzed for expression and relapse-free interval correlations across 3 independent studies of 447 breast cancer patients Study siteN Node status ER status Treatment NSABP B-20, Pittsburgh, PA 233N–ER+Tamoxifen (100%) Rush University, Chicago, IL 78 ≥ 10 positive nodes ER+/– Tamoxifen (54%) Chemotherapy (80%) Providence St. Joseph’s Hospital, Burbank, CA 136N+/–ER+/– Tamoxifen (41%) Chemotherapy (39%) Paik S, et al. SABCS Abstract 16. Cobleigh MA, et al. Clin Cancer Res. 2005;11: Esteban J, et al. Proc Am Soc Clin Oncol. 2003;22: abstract From these studies, 21 genes were selected 5

6 The Recurrence Score ® Result Uses Key Genes Linked to Critical Molecular Pathways 16 B REAST C ANCER RELATED GENES Paik S, et al. N Engl J Med. 2004;351: ER PR Bcl2 SCUBE2 ER PR Bcl2 SCUBE2 GRB7 HER2 GRB7 HER2 Ki-67 STK15 Survivin Cyclin B1 MYBL2 Ki-67 STK15 Survivin Cyclin B1 MYBL2 Stromelysin 3 Cathepsin L2 Stromelysin 3 Cathepsin L2 GSTM1 CD68 BAG1 Beta-actin GAPDH RPLPO GUS TFRC 5 R EFERENCE GENES EstrogenProliferationHER2InvasionOthers 6

7 The Recurrence Score ® Result Assesses Individual Tumor Biology for ER+ Breast Cancer Paik S, et al. N Engl J Med. 2004;351:2817; Paik S, et al. J Clin Oncol. 2006;24:3726; Habel LA, et al. Breast Cancer Res. 2006;8:R25-R39. Distant recurrence at 10 years Recurrence Score value C ONTINUOUS B IOLOGY 40% 35% 30% 25% 20% 15% 10% 5% 0% LOW RECURRENCE SCORE DISEASE Indolent Hormone therapy-sensitive Minimal, if any, chemotherapy benefit LOW RECURRENCE SCORE DISEASE Indolent Hormone therapy-sensitive Minimal, if any, chemotherapy benefit HIGH RECURRENCE SCORE DISEASE Aggressive Less sensitive to hormone therapy Large chemotherapy benefit HIGH RECURRENCE SCORE DISEASE Aggressive Less sensitive to hormone therapy Large chemotherapy benefit 7

8 Continuous Biology: ER and HER2 Expression as Measured by RT-PCR HER2+ Triple-negative* ER+ HER2– HER2 Expression (relative to ref genes; log 2 ) ER Expression (relative to ref genes; log 2 ) *> 94% of these cases are PR–; rarely strongly PR+ N = 10,618 Shak S, et al. Breast Cancer Res Treat. 2006;100(suppl 1): abstract

9 Clinical Validation of the Oncotype DX ® Breast Cancer Assay in Node-Negative Disease

10 Oncotype DX ® Clinical Validation: NSABP B-14 Objective: Prospectively validate the Recurrence Score ® result as a predictor of distant recurrence in node- negative, ER+ patients Multicenter study with prespecified 21-gene assay, algorithm, endpoints, analysis plan Randomized Registered Placebo—not eligible Tamoxifen—eligible Paik S, et al. N Engl J Med. 2004;351:

11 Oncotype DX ® Clinical Validation: NSABP B-14, Distant Recurrence Distant recurrence over time 10-Year rate of recurrence = 6.8%* 95% CI: 4.0%, 9.6% Years Paik S, et al. N Engl J Med. 2004;351: % 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Proportion without distant recurrence RS < 18, n = 338 RS 18-30, n = 149 RS ≥ 31, n = 181 All Patients, n = 668 P < Year rate of recurrence = 14.3% 95% CI: 8.3%, 20.3% 10-Year rate of recurrence = 30.5%* 95% CI: 23.6%, 37.4% *10-Year distant recurrence comparison between low- and high-risk groups: P < RS, Recurrence Score ® result 11

12 All Patients Low Risk (RS <18) Int Risk (RS 18-30) High Risk (RS ≥31) Paik S, et al. N Engl J Med. 2004;351: Oncotype DX ® Clinical Validation: NSABP B-14, Subgroup Analysis by Tumor Grade All patients N=668 Well Moderate Poor % Distant Recurrence-free at 10 Years RS, Recurrence Score 12

13 Oncotype DX ® Clinical Validation: NSABP B-14, Subgroup Analysis by Tumor Size Size ≤1 cm Size 1-2 cm Size 2-4 cm Size >4 cm % Distant Recurrence-free at 10 Years All patients (N=668) All Patients Low Risk (RS <18) Int Risk (RS 18-30) High Risk (RS ≥31) RS, Recurrence Score Paik S, et al. N Engl J Med. 2004;351:

14 Oncotype DX ® Clinical Validation: NSABP B-14, Subgroup Analysis by Age Age >60 Age Age Age <40 All patients (N=668) % Distant Recurrence-free at 10 Years All Patients Low Risk (RS <18) Int Risk (RS 18-30) High Risk (RS ≥31) RS, Recurrence Score Paik S, et al. N Engl J Med. 2004;351:

15 Objective: Prospectively determine the relationship between Recurrence Score ® result and chemotherapy benefit in node-negative, ER+ patients Multicenter study with prespecified 21-gene assay, algorithm, endpoints, analysis plan Tam Oncotype DX ® Clinical Validation: NSABP B-20 Randomized Tam + MF Tam + CMF Paik S, et al. J Clin Oncol. 2006;24:

16 High Recurrence Score ® Result Correlates with Greater Benefit from Chemotherapy (NSABP B-20) RS, Recurrence Score result Proportion without distant recurrence Years % absolute benefit from tamoxifen + chemotherapy NEvents All patients Tamoxifen + chemotherapy Tamoxifen P = 0.02 RS Tamoxifen + chemotherapy Tamoxifen P = 0.39 RS < 18 Tamoxifen + chemotherapy Tamoxifen P = 0.61 NEvents RS ≥ 31 Tamoxifen + chemotherapy Tamoxifen P < PATIENTS WITH HIGH RS 28% absolute benefit from tamoxifen + chemotherapy PATIENTS WITH HIGH RS 28% absolute benefit from tamoxifen + chemotherapy Paik S, et al. J Clin Oncol. 2006;24:

17 High Recurrence Score ® Disease Is Chemo-sensitive Whereas Low Recurrence Score Disease is Not (NSABP B-20) Recurrence Score vs Distant Recurrence at 10 Years Tam vs Tam + CMF/MF 50% 45% 40% 30% 25% 20% 35% 10% 5% 0% 15% Breast Cancer Recurrence Score Rate: Tam 95% Cl: Tam Rate: Tam + CMF/MF 95% Cl: Tam + CMF/MF Tam Tam + CMF/MF Average Rate of Distant Recurrence at 10 Years Absolute Benefit of Chemotherapy (CMF/MF) at 10 Years by Recurrence Score Group % Decrease in Distant Recurrence at 10 Years (mean ± SE) 50% 40% 30% 20% 10% 0% -10% Recurrence Score < 18 (n = 353) Recurrence Score (n = 134) Recurrence Score ≥ 31 (n = 164) Node Negative, ER-Positive Breast Cancer Chemotherapy Benefit 17

18 NSABP B-20: Many Small Tumors Have Intermediate to High Recurrence Score ® Disease Paik S, et al. J Clin Oncol. 2006;24: % 20% 19% 23%21% 46% N = 110 N = 318 N = 196 N = 24 Recurrence Score ≤1 cm cm cm>4 cm Clinical tumor size P= % 56% 46% 16% 25% 30% 18

19 NSABP B-20: Many Younger Patients Have Low Recurrence Score ® Disease P= % 24% 28% 19% 14% 21% 22% 21% 44% 55% 50% 60% N = 63 N = 226 N = 166 N = 196 Recurrence Score Paik S, et al. J Clin Oncol. 2006;24:

20 NSABP B-20: Significant Proportion of High-Grade Tumors Have Low Recurrence Score ® Disease 12% 22% 42% 16% 22% 22% 73% 56% 36% N = 77 N = 339 N = 163 P < % 12% 61% 12% 24% 19% 83% 64% 19% N = 119 N = 340 N = 190 Recurrence Score Paik S, et al. J Clin Oncol. 2006;24:

21 NSABP B-20: The Recurrence Score ® Result Is the Strongest Predictor of Chemotherapy Benefit Assessable B20 Patients (n = 651) VariableHRLower 95%Upper 95%P Recurrence Score Age ≥50 yrs Tumor size >2 cm Quantitative ER ≥ Quantitative PR ≥ Grade site Poor Moderate Grade, pathologist A Poor Moderate Grade, pathologist B Poor Moderate Paik S, et al. J Clin Oncol. 2006;24:

22 Oncotype DX ® Node-Negative Clinical Experience

23 Clinical Experience Supports Findings from NSABP B-14 and NSABP B-20 RS Groups by Patient Age RS Groups by Tumor Size RS Groups by Tumor Grade Liebermann N, et al. ASCO Abstract 632 (poster presentation). <50 yrs (n=367) ≥50 yrs (n=1497) ≤2 cm (n=1447) >2 cm (n=402) Small tumors have proportionately fewer high RS values. However, there is a range of RS values across both categories of tumor size. Not all grade 1 tumors have low RS values. Only 31% of grade 3 tumors have high RS values. Grade 1 (n=277) Grade 2 (n=964) Grade 3 (n=289) 23

24 Does the Recurrence Score ® Impact Treatment Decisions? Is the Oncotype DX ® Assay Cost-Savings and Cost- Effective?

25 Meta-Analysis: The Recurrence Score ® Result Changes Decisions Across 7 Independent Decision Impact Studies Before RS CT + HTHT Total After RS CT + HTHTCT + HTHT Asad et al Henry et al Klang et al Liang et al Lo et al Oratz et al Thanasoulis et al Consistent, large impact of RS on treatment decisions in both directions : Half of patients initially recommended CT+HT are changed to HT only Some patients initially recommended HT alone have CT added upon being informed of “High RS Disease” Asad J, et al. Am J Surg. 2008;196: ; Henry LR, et al. J Surg Oncol. 2009;99: ; Klang SH, et al. Value Health. 2010;13: ; Liang H, et al. SABCS 2007: Abstract 2061; Lo SS, et al. J Clin Oncol. 2010;28: ; Oratz R, et al. J Oncol Pract. 2007;3: ; Thanasoulis T, et al. Am Soc Br Surg Annual Meeting Hornberger J, et al. SABCS Poster P RS, Recurrence Score ® result; CT, chemotherapy; HT, hormone therapy N = 912 patients 25

26 Meta-Analysis: Overall Impact of Recurrence Score ® on Treatment Decisions Treatment plan prior to Oncotype DX ® Treatment plan after RS CT + HT HT Overall, the RS led to a 37% change in treatment decisions 33% from CT + HT  HT 4% from HT  CT + HT Overall, the RS led to a 37% change in treatment decisions 33% from CT + HT  HT 4% from HT  CT + HT 4% change 33% change Hornberger J, et al. SABCS Poster P RS, Recurrence Score result 26

27 Most Patients Were Positively Influenced by the Recurrence Score ® Result * Those not satisfied noted a negative impact on QOL, treatment side effects including aches, hot flashes, pain, mood alteration, and negative impact on self image. * Lo SS, et al. SABCS Abstract [poster presentation] 27 N= 89 patients In addition, the Recurrence Score result helped reduce patients’ anxiety and decisional conflict

28 The Oncotype DX ® Assay Reduces Unnecessary Treatment and is Cost Saving Studies show net savings up to $2,000 per patient tested with Oncotype DX 1,2 Saves patients the negative health and QOL impact of unnecessary chemotherapy 3 A reduction in chemotherapy use of approximately 30%, as observed in the Hornberger meta-analysis 4, results in $195,000 savings per 100 patients tested annually 5 1. Hornberger J, et al. Am J Manag Care. 2005;11: Horberger J, et al. J Oncol Pract 2011; 7: e38S-e45S. 3. Lo SS, et al. J Clin Oncol. 2010;28: Hornberger J, et al. SABCS Poster P Data on file. 28

29 Oncotype DX ® Testing in Node-Positive Disease

30 Validity of the Oncotype DX ® Assay Consistently Demonstrated in Node-Positive Patients 1. Dowsett M, et al. J Clin Oncol. 2010;28(11): Albain KS, et al. Lancet Oncol. 2010;11(1): Goldstein LJ, et al. J Clin Oncol. 2008;26: StudyTypeNodal statusNo. of patients TransATAC 1 Prospective Tam vs anastrozole Node positive Node negative 1231 SWOG Prospective Tam vs CAF → Tam Node positive367 ECOG Prospective AC vs AT Node positive Node negative Total N+ patients in all three studies =905

31 Trans ATAC Study Overview Secondary analyses: –Determine whether the relationship between continuous Recurrence Score ® result and time to distant recurrence differs by nodal status or treatment arm –Determine the relationship of predefined Recurrence Score groups with time to distant recurrence by nodal status and treatment arm –Evaluate whether Recurrence Score result adds to the Adjuvant! Online estimate of risk Dowsett M, et al. J Clin Oncol. 2010;28(11): Tamoxifen Anastrozole Tamoxifen + Anastrozole ATAC study population (N = 9366) (combination arm not examined) Primary Analysis: To determine whether Oncotype DX ® assay significantly adds to a proportional hazards model for time to distant recurrence (age, tumor size, grade, treatment) in node-negative, HR+, patients with no adjuvant chemotherapy 31

32 Trans ATAC: The Recurrence Score ® Value Is a Significant Predictors of Distant Recurrence (node-negative patients, both treatment arms) VariableHR (95% CI)*P value Recurrence Score / 50*5.25 (2.84, 9.73)< Tumor Size: > 2 vs ≤ 2 cm2.78 (1.70, 4.57)< Central grade Moderate vs Well Poor vs Well 1.70 (0.75, 3.86) 2.06 (0.82, 5.17) Dowsett M, et al. J Clin Oncol. 2010;28(11): Multivariate analysis adjusted for treatment arm and patient age *Hazard Ratio for a 50-point increment in Recurrence Score value Multivariate analysis confirms that the Oncotype DX ® Recurrence Score result as a continuous variable is a highly significant predictor of time to distant recurrence 32

33 Trans ATAC: Recurrence Score ® Value Is Prognostic in Node-Positive Patients Dowsett M, et al. J Clin Oncol. 2010;28(11): Recurrence Score group Hazard ratio* (95% CI) High vs Low2.7 ( ) Int vs Low1.8 ( ) Node+ (n = 306; both treatment arms) 83% 72% 51% Years Proportion distant recurrence-free N (%) Events Low 160 (52%) 25 Int 94 (31%) 25 High 52 (17%) 24 Log-rank P <

34 Trans ATAC: Rate of Distant Recurrence Increases with Number of Positive Nodes for All Recurrence Score ® Values Year risk of distant recurrence (%) Recurrence Score Node negative n = Positive nodes n = 243 ≥ 4 Positive nodes n = % CI Mean Low Recurrence Score suggests a low risk of recurrence for patients with 1-3 positive nodes. Dowsett M, et al. J Clin Oncol. 2010;28(11):

35 Superior disease-free survival and overall survival over 10 years Tamoxifen × 5 yrs n = 361 Tamoxifen × 5 yrs n = 361 CAF × 6  tamoxifen n = 566 CAF × 6  tamoxifen n = 566 CAF × 6 + tamoxifen n = 550 CAF × 6 + tamoxifen n = 550 SWOG 8814 Postmenopausal, node-positive, ER-positive breast cancer N = 1477 Patients with samples (n = 666) RT-PCR obtained (n = 601) Tamoxifen alone (n = 148) CAF + T (n = 243) CAF  T (n = 219) Sample for primary analysis = 367 (40% of parent trial) Patients with samples (n = 666) RT-PCR obtained (n = 601) Tamoxifen alone (n = 148) CAF + T (n = 243) CAF  T (n = 219) Sample for primary analysis = 367 (40% of parent trial) SUB ANALYSIS SWOG 8814:Oncotype DX ® Clinical Validation in Node-Positive Patients Albain KS, et al. Lancet Oncol. 2010;11(1):

36 SWOG 8814: Recurrence Score ® Result Is Prognostic for Node-Positive Patients (Tamoxifen Arm) RS < 18 (n = 55) RS (n = 46) RS ≥ 31 (n = 47) Stratified log-rank P = at 10 years RS < 18 (n = 55) RS (n = 46) RS ≥ 31 (n = 47) Stratified log-rank P = at 10 years DFS by risk group (tamoxifen-alone arm) OS by risk group (tamoxifen-alone arm) Years since registration 10-Year DFS: 60%, 49%, 43% 10-Year OS: 77%, 68%, 51% RS, Recurrence Score result Albain KS, et al. Lancet Oncol. 2010;11(1):

37 SWOG 8814: Breast Cancer-Specific Survival of Node-Positive Patients by Treatment and Recurrence Score ® Group B REAST CANCER - SPECIFIC SURVIVAL BY TREATMENT 10-yr BCSS T: 92% vs CAF  T: 87% RS < Years since registration CAF  T (n = 91, 10 events) Tamoxifen (n = 55, 4 events) Stratified log-rank P = 0.56 at 10 years 10-yr BCSS T: 70% vs CAF  T: 81% RS Years since registration CAF  T (n = 46, 10 events) Tamoxifen (n = 57, 11 events) Stratified log-rank P = 0.89 at 10 years 10-yr BCSS T: 54% vs CAF  T: 73% RS ≥ Years since registration CAF  T (n = 47, 18 events) Tamoxifen (n = 71, 20 events) Stratified log-rank P = at 10 years No benefit to CAF over time for low Recurrence Score Strong benefit to CAF over time for high Recurrence Score Interaction P = Albain KS, et al. Lancet Oncol. 2010;11(1): RS, Recurrence Score result 37

38 Is the Oncotype DX ® Assay Included in Treatment Guidelines?

39 Oncotype DX ® Is the Only Multigene Expression Assay Incorporated into NCCN ®, ASCO ®, and St. Gallen’s Guidelines Newly diagnosed patients with node-negative, ER+ breast cancer who will receive tamoxifen ASCO Guidelines NCCN Guidelines TM St. Gallen Consensus Consider use in > 0.5 cm, HR+, HER2– disease pT1, pT2, or pT3; pN0 and pN1mi (≤ 2 mm axillary node metastasis) Consider use in > 0.5 cm, HR+, HER2– disease pT1, pT2, or pT3; pN0 and pN1mi (≤ 2 mm axillary node metastasis) Oncotype DX has been shown to predict chemotherapy benefit among patients with HR+ disease Harris L, et al. J Clin Oncol. 2007;33(25): Adapted from NCCN Practice Guidelines in Oncology – v Goldhirsch A, et al. Ann Oncol. 2011;22: ASCO is a trademark of the American Society of Clinical Oncology. NCCN and NCCN Guidelines are trademarks of the National Comprehensive Cancer Network. ASCO and NCCN do not endorse any therapy or product. 39

40 The Oncotype DX ® Assay Provides Consistent Results in Over 4,000 Breast Cancer Patients Studied StudyDesignNNodal statusPrognosticPredictive NSABP B-14 1 Prospective; tam only 668NegYES- Kaiser Permanente 2 Prospective; case-control 790 cases/controls NegYES- NSABP B-14 3 Prospective; placebo vs tam 645NegYES Quantitative ER predicts tamoxifen benefit NSABP B-20 4 Prospective; tam ± chemo 651Neg- YES RS predicts chemotherapy benefit ECOG Prospective; AC vs AT 465Neg/PosYES- SWOG Prospective; tam ± chemo 367PosYES RS predicts chemotherapy benefit TransATAC 7 Prospective; tam vs AI 1231Neg/PosYES- 1. Paik S, et al. N Engl J Med. 2004;351: Habel LA, et al. Breast Cancer Res. 2006;6:R25-R39.5. Goldstein LJ, et al. J Clin Oncol. 2008;26: Paik S, et al. J Clin Oncol. 2005;23(16S): abstract Albain KS, et al. Lancet Oncol. 2010;11: Paik S, et al. J Clin Oncol. 2006;24: Dowsett M, et al. J Clin Oncol. 2010;28:

41 The Oncotype DX ® Assay Fulfills Criteria for Level I Evidence Level of evidence CategoryStudy designValidation studies available I ABAB Prospective Prospective using archived samples None required One or more with consistent results II BCBC Prospective using archived samples Prospective / observational None, or inconsistent results Two or more with consistent results IIICProspective / observational None, or one with consistent results, or inconsistent results IV-VDRetrospective / observational Not applicable* Simon RM, et al. J Natl Cancer Inst. 2009;101: *Level of evidence IV and V studies will never be satisfactory for determination of medical utility Proper study design determines strength of results and level of evidence 41

42 Patient Cases

43 PATIENT A 68-year-old patient with 1.1-cm tumor Menopausal Status: Postmenopausal Tumor Type: Infiltrating Ductal Carcinoma (IDC) Tumor Size: 1.1 cm ER Status (IHC): Positive PR Status (IHC): Positive HER2/neu Status: Negative Histologic Grade: 2 Lymph Node Status: Negative General Health: Fair ______________________________________ CASE SUBMITTED BY: Victor G. Vogel, MD PATIENT B 69-year-old patient with 1.3-cm tumor Menopausal Status: Postmenopausal Tumor Type: Infiltrating Ductal Carcinoma (IDC) Tumor Size: 1.3 cm ER Status (IHC): Positive (2) PR Status (IHC): Positive (2) HER2/neu Status: Negative (IHC) Histologic Grade: 3 Lymph Node Status: Negative General Health: PS 0 ______________________________________ CASE SUBMITTED BY: Ella Tepper, MD Can You Guess the Recurrence Score ® ? 68 & 69 year-old patients, small node-negative tumors, grade 2 & 3 43

44 PATIENT B RESULTS Clinical Experience Patients with a Recurrence Score of 11 in the clinical validation study had an Average Rate of Distant Recurrence at 10 years of 7% (95% CI: 5%-10%). PATIENT A RESULTS Clinical Experience Patients with a Recurrence Score of 34 in the clinical validation study had an Average Rate of Distant Recurrence at 10 years of 23% (95% CI: 18%-28%). Can You Guess the Recurrence Score ® ? 68 & 69 year-old patients, small node-negative tumors, grade 2 & 3 44

45 PATIENT A 45-year-old patient with 0.9-cm tumor Menopausal Status: Premenopausal Tumor Type: Infiltrating Ductal Carcinoma (IDC) Tumor Size: 0.9 cm ER Status (IHC): Positive (99%) PR Status (IHC): Positive (13%) HER2/neu Status: Negative (1.7 by FISH) Ki-67: 38% Histologic Grade: 2 Lymph Node Status: Negative (0/2 SLNs) ______________________________________ CASE SUBMITTED BY: Barbara Schwartzberg, MD PATIENT B 46-year-old patient with 0.7-cm tumor Menopausal Status: Premenopausal Tumor Type: Infiltrating Ductal Carcinoma (IDC) Tumor Size: 0.7 cm ER Status (IHC): Positive (91%) PR Status (IHC): Positive (99%) HER2/neu Status: Negative (0.7 by FISH) Ki-67: 35% Histologic Grade: 3 Lymph Node Status: Negative ______________________________________ CASE SUBMITTED BY: Barbara Schwartzberg, MD Can You Guess the Recurrence Score ® ? 45 & 46 year-old patients, small node-negative tumors, grade 2 & 3 45

46 PATIENT A RESULTS Clinical Experience Patients with a Recurrence Score of 15 in the clinical validation study had an Average Rate of Distant Recurrence at 10 years of 10% (95% CI: 7%-12%). PATIENT B RESULTS Clinical Experience Patients with a Recurrence Score of 35 in the clinical validation study had an Average Rate of Distant Recurrence at 10 years of 24% (95% CI: 18%-30%). Can You Guess the Recurrence Score ® ? 45 & 46 year-old patients, small node-negative tumors, grade 2 & 3 46

47 Conclusions

48 The Oncotype DX ® Report Provides Valuable Information Along a Continuum of ER+ Breast Cancer The Oncotype DX report provides valuable information on: –Node-negative prognosis –Node-negative predicted chemotherapy benefit –Quantitative data on ER/PR/HER2 Node-positive report contains an additional page with prognosis and predicted chemo benefit information specific to node-positive patients 48

49 The Oncotype DX ® Breast Cancer Assay Quantitatively predicts the likelihood of breast cancer recurrence and assesses the benefit from both hormonal therapy and chemotherapy (Level I Evidence) High and low Recurrence Score ® results reflect different intrinsic tumor biology You cannot predict the risk of distant recurrence or chemotherapy benefit by relying on clinical and pathological variables Changes treatment decisions based on traditional measures 37% of time, sparing patients the negative health and QOL impact of unnecessary chemotherapy and resulting in cost savings Only assay incorporated into ASCO ®, NCCN ® and St Gallen’s clinical practice guidelines Longest history of commercial genomic assays with over 200,000 patients tested worldwide ASCO is a trademark of the American Society of Clinical Oncology and NCCN is a trademark of the National Comprehensive Cancer Network. ASCO and NCCN do not endorse any therapy or product. 49


Download ppt "The Oncotype DX ® Assay in the Contemporary Management of Invasive Early-stage Breast Cancer."

Similar presentations


Ads by Google