Jorge Gomez, M.D., Ph.D. Director, Office of Latin American Cancer Program Development, Office of the Director, National Cancer Institute Advancing International Collaborations and Partnerships in Scientific and and Clinical Cancer Research, Training, and Infrastructure Development in Latin America April 30, 2010 Tucson, Arizona

Cancer as a National Priority “It will launch a new effort to conquer a disease that has touched the life of nearly every American by seeking a cure for cancer in our time.” Remarks of President Barack Obama (in reference to Recovery Plan) Address to Joint Session of Congress February 24, 2009

Global Health as an NIH Priority “Global health research ‘should be a conversation with other countries,’ but not one in which the great ‘United States tells the world what the answers are without listening to their experiences’." Remarks of NIH Director Francis Collins FIC’s Global Health Matters Newsletter NIH “Town Meeting” August 17, 2009

NCI’s Global Mandate The National Cancer Act of 1971 directs that NCI “support research in the cancer field outside the United States by highly qualified foreign nationals which can be expected to benefit the American people; collaborative research involving American and foreign participants; and training of American scientists abroad and foreign scientists in the United States.”

Understanding the U.S. Hispanic Population: Current Growth Trends As of July 1, 2006:  44.3 million Hispanics, 14.8% of total population of 299 million Between 2000 and 2006:  Hispanics accounted for one-half of the nation’s growth  Hispanic growth rate (24.3%) was more than three times the growth rate of the total population (6.1%) Source: U.S. Census Bureau, Population Estimates July 1, 2006

Hispanic Population Growth: 2000 to 2006 Population in millions Source: U.S. Census Bureau, Population Estimates July 1, 2006

Top 5 Cancers in U.S. Hispanic Men as Compared to Argentina, Brazil, Chile, Mexico and Uruguay US Hispanic Non- Hispanic WhiteArgentinaBrazilChileMexicoUruguay Lung and bronchus Prostate Colon and rectum Liver and intrahepatic bile duct Pancreas *Annual Report to the Nation on the Status of Cancer , Featuring Cancer Among U.S. Hispanic/Latino Populations. Cancer. October 15, Vol. 107, Issue 7. ^Data derived from Globocan 2002 AGE-ADJUSTED MORTALITY RATES ( *)

Top 5 Cancers in U.S. Hispanic Women as Compared to Argentina, Brazil, Chile, Mexico and Uruguay US Hispanic Non- Hispanic WhiteArgentinaBrazilChileMexicoUruguay Breast Lung and bronchus Colon and rectum Pancreas Ovary *Annual Report to the Nation on the Status of Cancer , Featuring Cancer Among U.S. Hispanic/Latino Populations. Cancer. October 15, Vol. 107, Issue 7. ^Data derived from Globocan 2002 AGE-ADJUSTED MORTALITY RATES ( *)

In the US: All Cancers in Latinos All cancers combined, :  Highest Prostate/Breast/Colorectal/Lung; but, –Incidence & mortality lower than in NHW  Although lower but much higher than NHW –Stomach/Liver/Cervix/ALL/Gallbladder 2 nd leading cause of death in the US after cardiovascular diseases Not different than in LA countries

Understanding Cancer in the U.S. and Latin America - The Research Need is Great Hispanics will become the largest minority group in the United States Cancer rates increase for first-generation Hispanics in the United States compared to cancer rates in their country of origin (Pinheiro et al, Cancer Epi Biomarkers Prev 2009;18(8). August 2009) Limited data and understanding of cancer burden by Hispanic subgroups in the United States (Howe et al, Cancer Causes Control. DOI /s July Howe et al, Annual Report to the Nation, DOI /cncr Sep 2006) Reducing the cancer burden in the United States will depend on our ability to understand and control cancer at the cultural, behavioral, and molecular level

Common Believes and Observations Hispanics in the US: lower incidence and death rates Diagnosed with advanced stage Lower survival rates for most cancers (acct age/stage) Less access to health care Less use of screening Larger size tumors More likely to die from cancer when diagnosed Less adherence to treatment >45% have less than HS education (15% in NHW) >20% live below the poverty line (8% in NHW) ~25% do not speak English fluently Temporary workers (% unknown), but how it affects health care coverage? >30% do not have health insurance Other risk factors: overweight

Specific Observations Breast Cancer:  Incidence is 40% lower than NHW  Lower age at first birth (?)  Larger number of children (?)  Less use of screening  When diagnosed, larger tumors  More likely to die of cancer than NHW  Leading cause of death among Hispanic women in the US and LA  When diagnosed, more aggressive, less responsive to treatment, high percentage are premenopausal women (?)

Additional Issues that need to be considered Factors of acculturation should be carefully studied Genetic ancestry as a method of studying risk Other susceptibility genes should also be studied Environmental factors should be systematically measured Place/Region of Origin presents challenges:  Mexico  Central America  South America  Caribean  Recognizable sub-categories among all four regions Only a 2% of all participants in NCI clinical trials are Latinos  Social Responsibility and Scientific Interest/Curiosity  Who is responsible for initiating and sustaining this debate? Who is Latino/Hispanic? A very contentious issue…  Anthropologists should be part of the discussion… Dr. Olopade: “stressful to admit that there are biological differences”…concerns about practicing “race medicine”

Office of Latin American Cancer Program Development Addressing the cancer burden in Latin America as a means of understanding cancer in the US Latino population Closing the research gap in Latin America Fulfilling NCI’s role as a global cancer research leader through knowledge sharing

OLACPD Vision and Mission Vision To advance local and global initiatives to prevent, diagnose, and treat cancer by facilitating the development of a comprehensive cancer research infrastructure in Latin America Mission To advance the mission of NCI by collaborating with government agencies, researchers, and organizations to further cancer research in Latin American countries

Guiding Principles Advancing Science Initiating research projects based on common interests and high bioethical standards will elevate the quality and credibility of cancer research conducted in Latin America. Capacity Building Building research capacity in Latin America will lead to independent, sustainable infrastructure to support first-rate clinical research around the globe.  US investigators will have more capable partners

NCI/FIC Resources Grants Contracts Knowledge Transfer Training NCI/FIC Resources Grants Contracts Knowledge Transfer Training Model for Partnerships and Collaborations Public-Private Partnerships Industry Professional Societies Advocacy Organizations Public-Private Partnerships Industry Professional Societies Advocacy Organizations Latin American Partners Goverments Academia Latin American Partners Goverments Academia Contributions (US/Foreign) Philanthropic and In-kind services Foundations Contributions (US/Foreign) Philanthropic and In-kind services Foundations NCI FIC OLACPD

United States Mexico Brazil Uruguay Chile Argentina United States-Latin America Cancer Research Network (US-LA CRN): A New Model for International Cancer Research Connecting at the government-to-government and investigator levels

Country Partnership Criteria Established healthcare system Ongoing scientific research and supporting technological infrastructure Existing in-country cancer research network Central government agency responsible for:  Healthcare provider  Healthcare policy making  Nation-wide scientific research

US-LA CRN At a Glance Launched in March 2009 Unprecedented Bilateral Partnership Connecting:  Governments  Institutions & Researchers  Non-Governmental Organizations Multi-Phased Strategic Approach Governed by a Steering Committee with input from an External Research Focus Group Co-Developing Pilot Projects  Selecting research areas based on disease burden  Breast Cancer: first pilot project

Research Focus Group [Scientific Input] Steering Committee [Conceptual Input] U.S. – LA CRN [Implementation] Basic and Applied Technologies Clinical Oncology Pathology Epidemiology Bioethics & Intellectual Property Information & Data Management Communications US-LACRN Governance

US – LA CRN US-LA CRN Annual Meetings Shared Bioinformatics Platform Professional Networking Site Communications Working Group Training and Education Workshops Steering Committee Teleconferences Sub-committee Meetings Research Focus Group Teleconferences Infrastructure for Working Together

Enabling Cross-Country Networking Password Protected Website for Collaboration

Harnessing the NCI caBIG® for International Breast Cancer Pilot CLINICAL TRIAL MANAGEMENT SYSTEM CLINICAL DATA MANAGEMENT SYSTEM Adverse Events Reporting (caAERS) Cancer Clinical Patient Registry (C3PR) caXchange Patient Study Calendar TISSUE BANKING AND PATHOLOGY TOOLS caTissue Suite

First Pilot Project: Breast Cancer Study Addressing the high breast cancer incidence in Latin America Providing data to advance cancer management for United States Hispanic population Focusing on 21 st century biomedical concepts  Molecular Profiling of Breast Cancer  Understanding/Improving Early Detection  Clinical Trials Improving biobanking process in Latin America Establishing sustainable infrastructures and cancer research networks

Impact of the Breast Cancer Pilot Study Improve breast cancer diagnosis and effective treatment by elucidating the molecular profile of breast cancer in Latin American women Investigate the association between the molecular profiles and tumor characteristics including histological type, size, lymph node involvement and surrogate markers Identify the correlation between the molecular profiles with long term survival and response to therapy Identify subpopulations of cancer patients with indolent disease which may permit more “personalized” management and reduce unnecessary exposure to CT

Impact of the Breast Cancer Pilot Study (continued) Bring state-of-the-art cancer research to Latin America:  Tissue annotation, storage, management  Use of informatics and data management  Adherence to high ethical standards Create better partners in Latin America for international cancer research Increase the pool of Latin American investigators and provide greater visibility at international cancer meetings

Courtesy Chuck Perou N= 311 p < ER + subtypes ER-neg subtypes Breast Cancer Molecular Profiling

Bilateral Agreements between five Latin American Countries and the U.S. National Cancer Institute 2009 US - LA CRN Launched Breast Cancer Workshop on Pilot Design US - LA CRN Launched Breast Cancer Workshop on Pilot Design Committees: Pathology Epidemiology Clinical Oncology Bioinformatics and Data Mgt. Basic Research Applied Technology Bioethics Communications Establish Committees ~ Conduct Webinars and Workshops ~ Adapt Clinical Protocol and SOPs Establish Committees ~ Conduct Webinars and Workshops ~ Adapt Clinical Protocol and SOPs Latin American Breast Cancer Pilot Study Timeline Argentina Brazil Chile Mexico Uruguay

2010 Latin American Breast Cancer Pilot Study Timeline (continued) 95% Completion of clinical protocol and SOPs Clinical protocol to be submitted to local IRB or ethics committee Activation of clinical protocol begins Estimated patient accrual in all five countries = 2,500 in three years Project will continue in the third/fourth year to complete gene expression studies and correlation analysis MarchMayFebruary

Thank you! ¡Muchas Gracias! Obrigado!