Access to hormone receptor testing and other basic diagnostic pathology services in Colombia

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1 Access to hormone receptor testing and other basic diagnostic pathology services in Colombia Dr Fernando Perry Clínica de seno y tejidos blandos Instituto Nacional de Cancerología de Colombia

2 Breast cancer incidence Women (All ages) - ASR per

3 Cancer incidence and mortality in Colombia Women (All ages) ASR per 100,000 Breast Cervix Thyroid Stomach Colon and rectum Lung Ovary etc. Non-Hodgkin lymphoma Leukemia New cases yearly Breast: 7,007 Incidence Mortality Melanoma Pardo C et al. Cancer incidence and mortality in Colombia INC; 2010

4 New cancer cases at the I.N.C.; 2008 Skin Uterine cervix Breast Stomach In situ breast cancer : 4.7% Anuario Estadístico INC 2008

5 ASCO: A basic pathology report Review of 13 markers and their clinical usefulness The evaluation of estrogen, progesterone, and Her2 receptors is supported by scientific evidence American Society of Clinical Oncology 2007 Update of recommendations for the Use of Tumor Markers in Breast Cancer VOLUME 25 NUMBER 33 NOVEMBER

6 Receptor ASCO St. Gallen NCCN Estrogen receptors Progesterone receptors HER2/neu receptors Yes Yes Yes Yes Yes Yes Yes Yes Yes Hernan Vargas. The Breast Journal, Volume 9, Suppl. 2, 2003 S81 S85

7 A basic pathology report for a primary tumor in Colombia Hematoxilyn and eosin stain Cancer diagnostic: in situ - Invasive Histology of cancer in situ? Tumor grade: cellular - nuclear Lymphovascular invasion Intraductal component Histological type?

8 A basic pathology report for axillary lymph nodes in Colombia Sentinel lymph node Hematoxilyn and eosin: metastases Extent of metastatic disease: micrometastases, partial, total, extracapsular extension Number of lymph nodes Axillary dissection Similar exception made of micrometastases.

9 Hormone receptors: review Receptor Review (1) Double reading (5997 specimens) Positive estrogen receptor (ER+) Positive progesterone receptor (PR+) 75 % 55 % ER + / PR % 55 % ER +/ PR % 20 % ER - / PR % 0 % ER - / PR % 25 % Lancet 2005 ; 365 :

10 Current status of hormone receptors evaluation in Colombia Clínica San Pedro Claver (Bogota) : hormone therapy 40 % in 240 cases. González. Revista Salud Publica 8(2) Hospital San Ignacio (Bogota): 207 patients, estrogen receptors 59.9 %, progesterone receptors 55.2 %, Her2/neu 5.2 %. Angarita. Rev Colom Cir 2010; 25 : INC (Bogota): Positive estrogen receptors 65 %, progesterone 56.5 %, non assesed 10 %. Piñeros M & Perry F. Rev Colom Cancerol 2008;12(4): Clínica del Country (Bogota): Positive hormone receptors 60.4 %, negative receptors 16.5 %, unknown 23.1 %

11 Benefits Hormone receptors: Hormone blocking therapy, adjuvant tamoxifen Decrease in mortality by 31% and relapse decreased by 41%. Aromatase inhibitors: No significant difference in mortality reduction against tamoxifen Her 2 / neu : Adjuvant trastuzumab Relapse decrease by 37% and mortlaity reduction by 34% (3 years).

12 Hormone receptors accessibility in Colombia

13 Amplification of the Oncogen HER2 by Immunohistoquemistry and FISH in Patients with Breast Cancer in Colombia. Analysis of 2879 Consecutive Cases Comparing Results between Peripheral Laboratories and a Single Reference Institution False negative rate 24.4 % False positive rate 14.8 % A high number of inadequate block tissues send for FISH. Andrade RE, Plata A, López R. Departamento de Patología y Laboratorio Clínico. Abstract: 99th annual Meeting United States And Canadian Academy of pathology Maarriot hotal Washintongton. DC Marzo Hospital Universitario Fundación Santa Fe de Bogota. Bogota, Colombia.

14 Breast cancer mortality and breast cancer centers in Colombia Oncology-pathology services Oncology pathologists Breast surgeons

15 Base case input data Cost of Tamoxifen ($US annual) Cost Trastuzumab ($US annual) 54,931.3 Cost of immunohistochemical test hormonal receptor ($US) 24.9 Cost of immunohistochemical test HER2neu ($US) 75.6 Cost Fish test ($US) Cost of relapse treatment in hormone positive receptor patients (1) 15,108.6 Cost of relapse tratment in HER2-Neu positive patients (2) 75,865.9 Relapse risk among patients receiving tamoxifen (%) (3) 33.2 Relapse risk without tamoxifen (%) (3) 45.0 Relapse risk among patients receiving trastuzumab (%) (4) 8.2 Relapse risk without trastuzumab (%) (4) 15.3 Risk of death among patients receiving trastuzumab (%) (4) 6.0 Risk of death withour trastuzumab (%) (4) Instituto Nacional de Cancerología. Estrategia óptima de manejo con hormonoterapia adyuvante en pacientes con cáncer de mama receptor hormonal positivo para Colombia Bogotá: INC, In press 2. Sanchez O. Estudio de costo efectividad del uso de trastuzumab como tratamiento adyuvante del cáncer de mama temprano her2 positivo en el Instituto Nacional de Cancerologia, desde el punto de vista del pagador. Tesis de grado programa Maestría en Epidemiología Clínica Universidad Nacional de Colombia. 3. Clarke M, Collins R, Darby S et al. Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomized trials. Lancet. 2005; 365: Viani GA, Alfonso SL, Stefano EJ, De Fendi LI, Soares FV. Adjuvant trastuzumab in the treatment of her-2-positive early breast cancer: a meta-analysis of published randomized trials. BMC Cancer. 2007;8(7):153

16 Incremental and averted costs for breast cancer treatment in Colombia Tamoxifen Trastuzumab Cost in thousand ($US) Incremental costs Averted costs Cost in thousand ($US) Incremental costs Averted costs

17 Incremental Cost-Effectiveness Ratio Trastuzumab Per capita GDP (2007): US 4,891 Relapse Death ICER (Thousand US$/averted events) Case HER2neu positive Relapse (%) 1 Overall mortality 1 (%) Relapse (No. cases) Deaths (No. events) Trastuzumab 1, No trastuzumab 1, Cases averted

18 Our proposal To standardize sample processing regarding quality of tissue section, paraffin, and buffered formalin. Reading and interpretation by a specialized pathologist. Progesterone receptors? To reduce cost of Her2/neu diagnosis: tariff control,.

19 GRACIAS