Prognostic and Predictive Factors

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1 Diagnosis and Treatment of Patients with Primary and Metastatic Breast Cancer Prognostic and Predictive Factors

2 Prognostic and Predictive Factors Version 2002: Thomssen / Harbeck Version : Costa / Friedrichs / Gerber / Göhring / Harbeck / Schaller / Schmutzler / Simon / Solomayer / Thomssen Version 2010: Schneeweiss

3 Definition A Prognostic Factor* is any parameter available at the time of interest e.g. primary diagnosis that correlates with disease-free or overall survival, in the absence of any therapy and, as a result, is able to correlate with the natural history of the disease. A Predictive Factor is any parameter associated with response to a given therapy. *as mentioned in this context represent markers of BC recurrence

4 Quality Criteria Biological hypothesis Simple and reliable determination method, quality assurance (QA) of the test Prospectively planned statistical evaluation (primary objective) Validation of the clinical significance according to Oxford Level of Evidence (LoE) criteria and Grades of Recommendation Clinical relevance for treatment decisions

5 Prognostic Factors I Early Breast Cancer Factor Tumor size 1a A ++ Nodal status 1a A ++ Metastases 1a B ++ Histological tumor type (colloid, mucinous, tubular etc.) 2b B ++ Grade 2a B ++ (Elston-Ellis) Age 2a B ++ Peritumoral lymphatic vessel and vascular invasion (L1 V1) 2b B +

6 Prognostic Factors II - Early Breast Cancer Factor ER / PgR 2a B ++ upa / PAI-1 (ELISA) 1a A + Triple-negative / basal cell-like tumor 2b B + HER2 (IHC, FISH) 2b B +/- Tumor cell detection in bone marrow 1a B +/- Proliferation markers 2b B +/- Thymidine-labeling index 1b B +/- S-phase fraction 2b B +/- Ploidy 2b B +/- Ki-67 2b B +/- Currently available gene, methylation or protein profiles 2b(-) D -* # Computer guided decision tools ( 2b(-) D + Life style (eg. reg. alcohol consumption 6 g/d) 2ba B + BMI >25 kg/m² 2ba B + *Study participation recommended # Aside from indications specifically adressed in these guidelines

7 Prognostic Factors in Node-Negative Early Breast Cancer Factor Grade 2b B ++ Tumor size 2b B + Age 2b B + upa / PAI-1 (ELISA) 1a A + Proliferation 2b C +/- (SPF, TLI, Ki-67) Oncotype DX TM 2b B +/-* Mammaprint TM 2b B +/-* *Study participation recommended

8 Predictive Factors Adjuvant Therapy Treatment Factor Endocrine therapy ER/PgR Status 1a A ++ HER2 2b D - Oncotype DX TM 2b B +/-* Tamoxifen therapy Cyp2D6 polymorphism 2b B +/-* Ovarian ablation menopausal status 1c A ++ Aromatase inhib. menopausal status 1c A ++ Chemotherapy grading 2b B +/- HER2 2b B +/-* ER/PgR status 2a B +/- upa/pai-1 2a C +/- Oncotype DX TM 2b B +/-* Mammaprint 2b B +/-* HER2 directed therapies HER2 2b D ++ Anthracyclines Topoisomerase IIα 2b a B - *Study participation recommended

9 Neoadjuvant Systemic Chemotherapy Response Prediction Factors predicting a high chance for a pathological complete response: Age < 35 yrs 1a a A ++ ct1 / ct2 tumors 1a a A ++ Negative nodal status 1a a A ++ Grade 3 tumor 1a a A ++ Negative ER and PgR status 1a a A ++ Triple negative breast cancer (TNBC) 1a a B ++ Positive HER2-status 1a a A ++ Non-lobular tumor type 1a a A +/- Prediction algorithm/score 2b B +/- Gene expression profiles 2b C +/-

10 Predictive Factors Metastatic Breast Cancer Therapy Factor Endocrine therapy ER/PgR Status 1a A ++ HER2 3a C +/- 2 nd line endocrine th. response 1 st line 2b B + GnRHa menop. status 1c A ++ Aromatase inhibitors menop. status 1c A ++ Taxanes HER2 2b C - Anthracyclines HER2 3b C +/- Chemotherapy circ. tumor cells* 1b B +/- HER2 directed therapies HER2 1b A ++ HER2 shed antigen 2b C +/- *FDA approved tests only

11 Therapy Monitoring Metastatic Breast Cancer Imaging (lead lesion) + Tumor markers (any if elevated at time of metastasis) CA15-3 or CEA or CA AGO HER2 shed antigen (ECD) + Circulating tumor cells* +/- PET - *FDA approved tests only

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