the reality of cancer clinical trials in latin america · the reality of cancer clinical trials in...
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The reality of cancer clinical trials in Latin America
Gustavo Werutsky
Latin American Cooperative Oncology Group (LACOG)
18 April 2018, Mexico City, Mexico
Conflicts of Interest
• None
Cancer in Latin America
http://canceratlas.cancer.org
Cancer incidence and outcomes vary
significantly across the region
Slide 15
Globalization of Clinical Trials
Nature Reviews Drug Discovery 2008; 7: 13-14
Top 30 Countries Ranked By Average Relative Annual Growth Rates
Phase I-III Cancer Clinical Trials Worldwide April, 2018
N=7706
Source:http://ClinicalTrials.gov
4.3 % Latin America
54% US
Number of Research Sites
Region Number of Trial Sites
(per 1M Population)
US 82
Western Europe 11
Central / Eastern Europe 8
Latin America 2
Asia Pacific < 1
Source: Raps Focus, 2009, Latin American CTAs
77% foreign patients and 54% foreign sites
Recruitment profile of LA sites
FDA INSPECTIONS IN LATIN AMERICA
IMS expects drug spending in emerging markets to grow by 10-13% a year until 2017.
Pharmaceutical Markets
Abstracts presented at ASCO by Nationality 2001-08
Majority of abstracts are from US and Europe
Saad ED. Ann Oncol. 2010, (3):627-32
41%
Mauro Zukin et al. JCO 2013;31:2849-2853
Overall survival 9.3 months CP vs 5.3 P (hazard ratio [HR] = 0.62, P = .001)
Progression-free survival 5.8 months CP vs 2.8 months P (HR = 0.46, P < .001)
Cooperative Groups Worldwide
17
All Stage Stage 0-II Stage III-IV
N=3142 Sites=28
Oscar Arrieta, et. al. J Thorac Oncol. 2011;6: 1955–1959
LACOG Structure and Facilities
LACOG Coordinating Office – Porto Alegre, Brazil
CRF and Data base
Statistics
Regulatory process
Monitoring audits
Communication
Study design
5
250 members 150 sites
16 countries
LACOG Membership Status
8
Potential of Accrual
LACOG Members Institutions Number of new cases per month = 32624
4514
2623
1633
1739 1009 445
848
1026
408
496
200 342
364
500
1981
440
821
951 610 254 229 251
Breast Cancer
Prostate Cancer
Lung Cancer
Colorectal Cancer
Gastric Cancer
Esophageal Cancer
Uterine Cancer
Cervical Cancer
Kidney Cancer
Sarcoma
Hepatocellular Carcinoma
Pancreatic Cancer
CNS Cancer
Melanoma
Nonmelanoma Skin Cancer
Laryngeal Cancer
Thyroid Cancer
Other types of Head and Neck Cancer
Non-Hodgkin Lymphoma
Hodgkin Lymphoma
Acute Leukemia
Multiple Myeloma
9
LACOG (Brazil/LA) – GECOPERU (Peru) – GAICO (Argentina)
Gomez H et. al. Clin Breast Cancer. 2016 Feb;16(1):38-44
A STUDY TO OBSERVE PATIENTS CHARACTERISTICS, TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH NEWLY DIAGNOSED
BREAST CANCER IN LATIN AMERICA - LATINABREAST (MO39485 - LACOG 0615)
Primary Objectives: describe patients characteristics, breast cancer subtypes at diagnosis, outcomes and build a electronic plataform/database Countries: Argentina, Brazil, Chile, Colombia, Costa Rica, Cuba, Guatemala, Mexico, Peru, Venezuela (Uruguay).
Prinicipal Investigators: G. Werutsky
N=4500 ELIGIBILITY • Newly diagnosed stage I to IV breast
cancer (recurrent or de novo) no more than 3 months prior to data extraction, although they can have received anti-cancer treatment during that time
• Male or Female • >= 18 years
BASELINE • Patient demographics • Medical History • BC diagnosis and
treatment • Disease status and
outcome
FOLLOW-UP (5 years) • Changes / Sequence of BC
treatment Disease status and outcome
• Medical History • Safety
LACOG BREAST CANCER GROUP STUDIES
Epidemiológico - Fertilidade
Ensaio Clínico - PALLAS (fase 3) - LORELEI (fase 2) - IMPASSION (fase 3)
Epidemiológico - AMAZONA III - Cancer de mama em homem - LATINA BREAST
Epidemiológico - Metastático sequência tto
Phase II randomized study of Abiraterone acetate plus ADT versus
APALUTAMIDE versus Abiraterone and APALUTAMIDE in patients
with advanced prostate cancer with non-castrate testosterone
levels (LACOG 0415)
Primary Objectives: proportion of patients who achieves an undetectable PSA level, defined as ≤ 0.2 ng/mL at week 25 week in each of three arms Countries: Brazil
N = 126 • Prostate adenocarcinoma • Biochemical relapse M0 or M1 and
“de novo” • PSA >= 2 ng/dL • Indication to ADT (testosterone
level >= 230 ng/dL0
R
Abiraterone + ADT
Abiraterone + Apalutamide
Apalutamide
CHALLENGES FOR CANCER CLINICAL RESEARCH IN LATIN AMERICA
BRAZIL
ARGENTINA
CHILE
PERU
COLOMBIA
MÉXICO
CANADA REINO UNIDO
FRANÇA
SUÉCIA
AUSTRÁLIA
9 months
4–5 months
3–4 months
4–4,5 months
3-4 months
3 months
5 months 3 months
4 months
3 months UNITES
STATES
5-12 months
10-14 months
12 months
4-5 month
s
4 months
Adapted from: Hurley D. GCP Journal March 2006. 41st Annual Drug Information Association Meeting, 2005.
Regulatory Timeline Around the World
Bureaucracy behind the scene
In March, the federal government announced that it was slashing the proposed 2017 science budget by 44%, bringing it to the lowest level in 12 years — 2.8 billion reais (US$888 million). Although cuts were made across
almost all federal ministries, the reduction in science spending hit particularly hard because the budget had already been chopped every year
since 2013.
Contribution of Latin American Countries to
Cancer Research and Patent Generation: Recent Patents.
• 12,989 items published and 244 patent applications
• Brazil, Mexico, Argentina, Chile and Peru were highest contributors in cancer research.
• Brazil, Mexico, Cuba and Argentina were highest contributors in cancer patent applications.
To Date No Device or Drug Developed in LA was Implemented in Clinical Practice
Perez-Santos M . Recent Pat Anticancer Drug Discov. 2017;12(1):81-93.
Information about clinical trials for patients
source: http://www.cancer.gov; http://www.clinicaltrials.gov
Initiative for funding academic cancer research
How and Where I can learn about clinical trials
• Clinical Research Center
• your institution
• Clinical Research Fellowships
• Institutions and Organisations in Europe and US
• Clinical Trials Workshops
• ICTW ASCO / Methods EORTC
