presentación de los centros de investigación en Guatemala

1. PDG Country Clinical Operations
Latin American Capabilities
CANCER RESEARCH CENTER OF GUATEMALA
Land Of The Eternal Spring
Oncology Overview
31 de Octubre, 2014
Dr. Hugo CastroDr. Cesar Hernandez

2.  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

3. Guatemala: Geography
14757000

4. • 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

5. 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
NOTES
1. Uneven quality. Covers all diagnostic and therapeutic procedures for high cost diseases
2. Low quality or basic care. Covers only a very limited number of high costs diseases
3. Quality ranging to poor to that of most developed Western nations.

6. 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 RiskFactors in thecountry

7. CANCER MORTALITY PROFILE (2009)
MEN: 3220 deaths

8. CANCER MORTALITY PROFILE (2009)
WOMEN: 3845 deaths
Cervix 20%
Gastric 10%

9. 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.

10. • 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

11. 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.

12. • 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

13. • 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. 1
4
• 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

15. 1
5
1
5
• 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. 1
6
• Expectation:
• meet the goals of inclusion of patient
• generating studies at regional and international levels
SCORE: Strengths, Challenges,
Opportunities, Risks and Expectations

17. • 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

18. About Cancer Research Center
we are located in the area
of ​​highest prevalence of cancer
(60%)
We have two headquarters in
Guatemala city
In 2014 our incidence is:
Cervical uterine : 500 new cases
Breast 300
Gastric cancer 150
Lung cancer 130
Bladder Cancer
the proportion of patients who
have health insurance is 40%.

19. sponsor Publication Goal/recruited
Capecitabine/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
1
9

20. sponsor Publication Goal/recruited
HannaH 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 6/8
OAK CA PULMON Roche 2/3
MET GASTRIC CA GASTRICO Roche 3/5

21. (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