PDG Country Clinical OperationsLatin American Capabilities

CANCER RESEARCH CENTER OF GUATEMALALand Of The Eternal SpringOncology Overview31 de Octubre, 2014

Dr. Hugo CastroDr. Cesar Hernandez

Geography and Sociodemographic Indicators Health Care System Overview Cancer Risk Factors in the country Cancer Mortality Profile Mortality rates, by cancer type (if available) Cancer Registry and Screening Cancer Treatment availability Opportunities and Strengths Main Institutions in the Country (public/private) References

Index

Guatemala: Geography

14757000

• Total population: 14757300 • Life expectancy at birth (years):

Total: 71 Male: 68 Female: 75

• Average annual deaths: 80500 • Adult literacy rate: 74.5% • Gross National Income US$ per

capita: $550

Sociodemographic Indicators

Guatemala: Health Care System Overview

Guatemala

Population covered by Public Sector through contributions from employer, employee and taxpayers1

18%

Population covered by direct subsidies from government2

70%

Population covered by Private Sector3 12%

Medications in public sector Restricted to those included in official list

NOTES1. Uneven quality. Covers all diagnostic and therapeutic procedures for high cost diseases2. Low quality or basic care. Covers only a very limited number of high costs diseases3. Quality ranging to poor to that of most developed Western nations.

Prevalence of: Total (%) Male (%) Female (%) Current adult tobacco smokers

10.0 20.0 2.0

Adolescent tobacco smokers 16.6 19.7 13.3

Fruit and vegetable intake in adults

19.0 20.4 18.1

Alcohol consumers, past 12 months

22.8 41.6 5.8

Low physical activity in adults 50.4 56.0 45.0

Obesity among adults (BMI ≥30)

21.3 16.0 25.8

HPV prevalence (women with normal cytology)

... ... 33.2

Cancer Risk Factors in the country

CANCER MORTALITY PROFILE (2009)

MEN: 3220 deaths

CANCER MORTALITY PROFILE (2009)

WOMEN: 3845 deaths

Cervix 20%

Gastric 10%

Page 9

Cancer Screening:

• Cancer Screening:- Cervical Cancer: guidelines recommendations Pap test/25-54 years of

age/every 3 years VIA/25-54 years of age/every 3 years. Cervical cytology generally not available in the public sector but available in the private sector

- Breast Cancer: guidelines available. Clinical Breast examinations available in both public and private sectors. Mammography generally not available in the public sector but available in the private sector.

- Colorectal Cancer: guidelines available. Faecal occult blood test, fecal immunological test or colonoscopy generally not available in the public sector but available in the private sector.

• Day hospital cubicles 20• Outpatient offices 08• Laboratory

– Clinical microbiology– Mollecular biology

• Radiology– NMR– CT– Conventional radiology

• Nuclear Medicine– PET-CT 01– Gamma camera 05

• Radiotherapy– Lineal accelarators 06– Brachytherapy room 08– Intensity modulated 02

Facilities

Guatemala: Opportunities and Strengths

Institutions Key research interest High Incidence

Significant unmet need

IGSS, INCAN, Hospital Roosevelt (Public Institutions). Private centers (Centro Oncológico Sixtino, Grupo Ángeles). Many CROs and SMOs with experience in this country.

Breast, cervix, gastric, lung, ovary and brain cancers.

Breast, cervix, thyroid, gastric, colon, prostate,

lung.

Met Cervix cancer

Landscape: There are a few public/private hospital specialized in cancer & hematology with national coverage, most of them located in the main cities. More than 50% of the population lives in the capital, the other are covered by referral to the same national centers. The strategy is to bring on board oncological private centers and get patients referral from public institutions.

• Strengths: • A unique feature of CRC of Guatemala is the multidisciplinary character of

our medical team, wich includes more than 40 professionals who specialize in the diagnosis and treatment of cancer, who work together to archive the most successful outcomes possible.

• Good fundamental academic research capacity• Positive culture to participate in clinical trials in the general population.• End-to-end startup timelines could be as short as 5 months. • Independent Ethics Committees like ZUGUEME could act as lead sites in

multi-center ethical review. • We are the top recruiters in Latin America in the Katherine and Gatsby

studies.

SCORE: Strengths, Challenges, Opportunities, Risks and Expectations

• Challenges:• In Guatemala, the CRC Network was created in June 2013 .• CRC relies on a network of private and government agencies, pathology

and clinical laboratories -IATA certification-, radiology, surgery, radiotherapy and Palliative care center, universities and industries, all with dedicated expertise and priorities.

• Targeted and coordinated efforts by the various players help to improve research efficiency as well as in the diffusion and use of knowledge.

• This kind of networking is expected to help eliminate obstacles which would otherwise hinder the research activities

SCORE: Strengths, Challenges, Opportunities, Risks and Expectations

14

• opportunities: • improve our research center getting new technology with the support of

industry • CRC staff may continue to acquire research skills for continuous learning• Generate research protocols in the region, cervical uterine cancer• Integrating Central America as a collaborative group

SCORE: Strengths, Challenges, Opportunities, Risks and Expectations

1515

• Risk:• High cost and relatively low availability of new therapy • Fundamental research or technical cooperation is not always

compatible with commercial approach

SCORE: Strengths, Challenges, Opportunities, Risks and Expectations

16

• Expectation: • meet the goals of inclusion of patient • generating studies at regional and international levels

SCORE: Strengths, Challenges, Opportunities, Risks and Expectations

• Our multidisciplinary approach to cancer means that a team of specialists works together to ensure the best treatment possible for each patient.

• Our nursing team specializes in cancer care and our nurse-to-patient ratio is higher than in most hospitals. This ensures that patients receive the best care at every step.

• Audits of FDA and sponsor successful • Guatemala has the technology • Government authorities are committed to access to clinical

trials

Research is one of the mainstays of the CRC of Guatemala

About Cancer Research Center we are located in the area of highest prevalence of cancer (60%) We have two headquarters in Guatemala cityIn 2014 our incidence is: Cervical uterine : 500 new casesBreast 300 Gastric cancer 150 Lung cancer 130 Bladder Cancer

the proportion of patients who have health insurance is 40%.

sponsor Publication Goal/recruitedCapecitabine/Cisplatin Versus 5-Fluorouracil/Cisplatin as First-line Therapy in Patients with Advanced Gastric Cancer: A Randomised Phase III Noninferiority Trial

Roche Ann Oncol. 2009;20(4):666-673

4/6

RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer.

Roche J Clin Oncol. 2011 Apr 1;29(10):1252-60

8/16

CLEOPATRA: Pertuzumab plus Trastuzumab plus Docetaxel for Metastatic Breast Cancer

Roche N Engl J Med 2012;366:109-19

8/8

MARIANNE: A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Patients With Metastatic Breast Cancer

Roche 8/12

APHINITY: A Study of Pertuzumab in Addition to Chemotherapy and Herceptin (Trastuzumab) as Adjuvant Therapy in Patients With HER2-Positive Primary Breast Cancer

Roche 8/16

ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer

Roche 4/4

19

sponsor Publication Goal/recruitedHannaH study. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I—III breast cancer (): a phase 3, open-label, multicentre, randomised trial

Roche The Lancet Oncology, Volume 13, Issue 9, Pages 869 - 878, September 2012

3/3

Kamilla. Trastuzumab Emtansine for HER2-positive Advanced Breast Cancer

Roche N Engl J Med 2012 367:1783-1791

5/8

PREF MAB LINFOMA Roche 6/8OAK CA PULMON Roche 2/3MET GASTRIC CA GASTRICO Roche 3/5

(1) PAHO/WHO. Non communicable Diseases in the Americas: Basic Health Indicators 2011. Washington D.C, USA, 2011. (2) PAHO/WHO. Tobacco Control Report for the Region of the Americas, 2013. Washington D.C, USA, 2013. (3) WHO. Global Information System on Alcohol and Health, retrieved August 28,2013, from http://bit.ly/17zhuqZ. (4) ICO. Information Centre on HPV and Cancer, retrieved August 28, 2013, from http://www.hpvcentre.net/ . (5) PAHO/WHO Mortality Database, 2012. (6) PAHO/WHO Survey on National Capacity for the Prevention and Control of Non-communicable Diseases, 2013. (7) PAHO/WHO Comprehensive Family Immunization Unit. Immunization Country Profiles, retrieved August 28, 2013, from http://bit.ly/1dn4Td3; Immunization Reported Coverage in the Americas, by vaccine, retrieved August 28, 2013 from http://bit.ly/1dn59ZK . (8) PAHO/WHO. Cervical cancer prevention and control programs: A rapid assessment in 12 countries of Latin America. Washington D.C.: PAHO, 2010. (9) WHO/IAEA Directory of Radiotherapy Centers (DIRAC) Database, retrieved August 28, 2013 from http://www-naweb.iaea.org/nahu/dirac/. (10) University of Wisconsin. WHO Collaborating Centre for Pain Policy and Palliative Care, Opioid Consumption Database 2010, retrieved August 28, 2013, from http://www.painpolicy.wisc.edu/countryprofiles/amro.

References