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C. Mathias
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P2.02 - Poster Session with Presenters Present (ID 462)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.02-030 - Consolidation Chemotherapy Following Concurrent Chemoradiation for Stage III Non-Small Cell Lung Cancer: A Brazilian Multicentric Cohort (ID 4670)
14:30 - 14:30 | Author(s): C. Mathias
- Abstract
Background:
Locally advanced stage III grossly accounts for 25% newly diagnosed non-small cell lng cancer (NSCLC) cases. Albeit some patients (pts) are amenable to surgical resection, most will be treated with concurrent chemoradiation (CRT), whilst the addition of consolidation chemotherapy (CC) is still a debatable topic. We decided to look into the impact of CC in stage III NSCLC Brazilian pts treated in the daily clinical practice.
Methods:
We retrospectively collected data of stage III NSCLC pts treated in five different Brazilian cancer institutions from Jan/2007 to Dec/2011, whom have received CRT followed or not by CC. Eligible pts were ≥18yo and must have been treated with cisplatin or carboplatin plus etoposide, paclitaxel or vinorelbine, concurrently with thoracic irradiation (RT). Patients treated with surgery or neoadjuvant chemotherapy were excluded. Primary endpoint was overall survival (OS) from the date of diagnosis. Association between CC and clinical variables and demographics were evaluated by Pearson´s Chi-square test (Χ²). Survival curves were calculated by Kaplan-Meier method and compared by log-rank test. Univariate and multivariate analysis were made using Cox proportional model (CPM). P-values<0.05 were deemed statistically significant.
Results:
We collected data from 165 pts. Median age was 60yo (range: 27-79) and most pts were male (69.1%), Caucasian (77.9%), current or former smoker (93.3%), and staged as IIIB (52.7%). Adenocarcinoma was the most common histologic type (47.9%). Weight loss>5% and ECOG-PS 2 were observed in 39.1% (n=61) and 14.6% (n=24), respectively. Median follow-up was 25 mo. CC was administered to 27 pts. The only variable associated with CC was T stage (Χ²(4) = 11.410, p=0.022), with more T3 tumors receiving CC than expected. We observed no statistically significant difference in OS between patients treated or not with CC (p=0.211), although 3-year OS rate was numerically higher in CC pts (40% vs. 31%). Median OS in was 24 and 25 months in CC and no CC groups, respectively (HR 1.408, 95%CI 0.814-2.434). A total delivered RT dose ≥ 61Gy was the only variable independently associated with improved survival (HR 0.617, 95%CI 0.419-0.909, p=0.012).
Conclusion:
CC did not improve OS in stage III NSCLC patients after concurrent CRT. RT dose < 61 Gy negatively impacted OS.
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SC23 - The Importance of Co-Operative Groups (ID 347)
- Event: WCLC 2016
- Type: Science Session
- Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
- Presentations: 1
- Moderators:J. De La Garza, J.S. Lee
- Coordinates: 12/06/2016, 16:00 - 17:30, Strauss 3
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SC23.01 - Cooperative Groups in Latin America (ID 6694)
16:00 - 16:15 | Author(s): C. Mathias
- Abstract
- Presentation
Abstract:
More than 100 million people in Latin America will be > 60 years of age by 2020. Age, smoke exposure and infectious causes of cancer (HPV, Hepatitis B, and H. pylori) will continue to drive the burden of cancer in the region. Cancer mortality rates in Latin America are approximately twice those of the United States (1). Until not so long ago, drug development and cancer clinical research were conducted almost exclusively in wealthy developed regions of the world. However, over the last 2 or 3 decades, clinical trials have been progressively incorporated in a challenging globalization process. As such, the conduct of trials in a global scale represents a major aspect to be taken into account when analyzing the future development of the area. The globalization of clinical trials, as well as multinational and multi-institutional research collaboration, represents a scenario that requires permanent and concentrated efforts by all involved if we are to achieve the fundamental objective of generating the appropriate answers to the health problems we face around the world (2). Up to the 1980s, North American and European cooperative groups mostly sponsored by the National Cancer Institute (NCI) conducted most of the pivotal practice changing trials. At that time, a progressive shift in the funding of research toward pharmaceutical companies was seen. In parallel, an increasing participation of research sites from countries outside North America and Western Europe was identifıed and has since transformed the development of new medications to what is now an increasingly globalized process (2). The number of registered clinical trials has increased in all geographic regions during this time period, with the average annual growth greatest in the Asian (30%) and Latin American/ Caribbean (12%) regions (3). Early trials seem to be conducted more frequently in North America (62%), whereas confırmatory trials are more frequent in Eastern Europe, Latin America, and Asia (4). Data from ClinicalTrials.gov shows that over 70% of the registered cancer phase I trials are conducted in the United States, whereas less than 1% are conducted in Latin America. In larger registered phase III studies, 40% are conducted in the United States, 43% in Western Europe, and 17% in Latin America (5). Involvement of investigators from developing countries in the planning phases of the trial is essential as they may provide valuable contribution while being exposed to an experience that will have long lasting effects in the future development of regional studies. Other than addressing a question that interests a pharmaceutical company, developing a reliable research infrastructure and local expertise allow researchers to expect the development of locally coordinated research addressing pertinent regional health questions benefıting the local community. As quality is a fundamental principle in the conduct of clinical research, we need to address monitoring, auditing, and inspections as a basic element in the process of globalization. In recent years, a number of independent research groups have been created in Latin America: The Chilean Cooperative Group for Oncological Research (Grupo Oncológico Cooperative Chileno de Investigación, or GOCCHI) is a nonprofit corporation registered in Chile since 1998. GOCCHI is conducting academic clinical trials in oncology based on the highest scientific, methodologic, and ethical standards (http://www.gocchi.org). The Peruvian Oncology Clinical Studies Group (Grupo de Estudios Clínicos Oncológicos Peruano, or GECOPERU) was founded in March 2005 as a nonprofit academic and research organization. It has a central operating office and partnerships with several international groups (CIBOMA, IBCSG, BIG, and others) (http://www.gecoperu.pe). Founded in 2007, the Argentine Group for Clinical Research in Oncology (Grupo Argentino de Investigación Clínica en Oncología, or GAICO [is composed of 15 cooperating groups and includes various health professionals from public and private institutions (www.gaico.org.ar). The Latin American Cooperative Oncology Group (LACOG) was founded in 2008 by medical oncologists from several Latin American countries that has developed a network of investigators in oncology for epidemiologic and clinical studies in cancer. LACOG has 47 members in 39 sites from 10 countries in the region. Currently, the group has several ongoing studies. The Brazilian Group of Thoracic Oncology (GBOT) is currently hosted at LACOG and is involved in some research initiatives (www.lacog.org.br) (www.gbot.med.br). CLICaP (Latin American Consortium for Lung Cancer Research) This consortium was created in 2010 to develop collaborative studies on the biology, diagnosis and treatment of lung cancer. CLICaP has published over 20 studies involving participants from Mexico, Costa Rica, Panama, Venezuela, Colombia, Ecuador, Peru, Chile, Argentina and Uruguay. Some of this work has established genomic differences between populations for mutations in EGFR, KRAS and ALK ROS1 following analysis of over 8500 samples (7). There are several challenges of research in South America including costs (6), regulatory issues and difficulty in recruitment but there also several advantages of performing trials in developing countries such as availability of patients, lower costs and faster accrual. As an added and very important characteristic, patients enrolled in developing countries are more frequently treatment-naive and have less, or many times, no competing trials as alternative (8) As more trials are conducted in resource-limited settings, good clinical practices and ethical assurances must be secured. Human participation in clinical research is essential to advance medicine and public health, and expanding clinical trials mandates constant oversight to ensure research quality and protection of study subjects. Some decades ago, the development of global clinical research could have been considered a dream; it is now a pressing need that should be considered unavoidable in the future (2). References: 1 Goss, P; Lee, BL; Badovinac-Crnjevic, T et al. Planning Cancer Control in Latin America and the Caribbean. Lancet Oncol 2013; 14: 391–436 2 Barrios, C; Werutsky, G and Martinez-Mesa, J. The Global Conduct of Cancer Clinical Trials: Challenges and Opportunities. ASCO Educational Book, e132- e139, 2015 3 Drain PK, Robine M, Holmes KK, et al. Trail watch: global migration of clinical trials. Nat Rev Drug Discov. 2014;13:166-167 4 Thiers FA, Sinskey AJ, Ernst R. Trends in the globalization of clinical trials. Nature Reviews Drug Discovery. 2008;7:13-14. 5 www.clinicaltrials.gov 6 Kaitin KI. The Landscape for pharmaceutical innovation: drivers of cost- effective clinical research. Pharm Outsourcing. 2010;2010: 3605. 7 Rolfo C, Caglevic C, Bretel B et al. Cancer clinical research in Latin America: current situation and opportunities. Expert opinion from the first ESMO workshop on clinical trials, Lima, 2015. ESMO Open 2016;1 8 Smith WT. FDA requires foreign clinical studies be in accordance with good clinical practices to better protect human subjects. ABA Health eSource. 2008; 5:1-3.
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