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J. De La Garza
Moderator of
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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: 6
- 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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SC23.02 - Co-Operative Groups in Europe: Lessons Learned and Perspectives (ID 6695)
16:15 - 16:30 | Author(s): S. Peters
- Abstract
- Presentation
Abstract not provided
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SC23.03 - How Could High-Volume Centers in Developing Countries Access Cooperative Group Trials? (ID 6696)
16:30 - 16:45 | Author(s): U. Yılmaz
- Abstract
- Presentation
Abstract:
Lung cancer has the second highest absolute incidence globally as well as in developing countries and ranks fourth in developed countries. It is the most common cause of cancer death by absolute cases globally as well as in developing and developed regions. The economic burden of lung cancer care is highest relative to other cancers in the European Union. Research is at the core of achieving improved outcomes from cancer, be it in defining country-specific epidemiology of the disease, understanding the pathogenesis of disease, identifying new targets for therapeutic agents, or directing policy to achieve affordable and equitable outcomes. Cancer researchs are one of the most globally active domains of science, with more than $14 billion per annum. A critical part of the health research portfolio is the testing of interventions through randomized controlled trials. Trials can range from highly controlled explanatory trials through to pragmatic trials of new health technologies and models of service delivery. Recruitment problems also have practical and financial impacts, as they can delay completion of research or reduce its timely impact on patient health and wellbeing. Achieving appropriate levels of patient and professional participation has been a significant obstacle to evidence-based practice. Published data show that the minority of trials recruit successfully, either in terms of reaching their planned sample size, or delivering the planned sample in the expected recruitment window Despite all the diffuculties, clinical trials have become increasingly globalized due to the inclusion of more non-traditional locations, especially those in central and eastern Europe, Latin America, and Asia. The increased globalization of clinical research has arisen for several reasons, but primarily due to the need for faster and more economically efficient studies. Moves towards standardizing and harmonizing clinical research practices have facilitated the rise of globalized clinical research. However, the expansion of multinational clinical research peaked in 2009, which could reflect that the large-scale expansion of multinational clinical research effort has reached its global capacity. When the distribution of multinational clinical trials is examined after being stratified according to the condition or disease, lung cancer is not among the five most frequently studied conditions apart from Asia. The results of a bibliometric analysis of global research on lung cancer between 2004-2013 in the 24 leading countries in cancer research showed that despite a doubling of the volume of lung cancer research worldwide between 2004 and 2013, it still only accounts for a small proportion of the overall oncology research publication output (5.6%). In fact, the relative commitment (RC) to lung cancer research compared with that to total oncology research output has fallen in most countries during this period, including in the 23 countries with exception of the China. Turkey, Poland, Canada, Greece, and the United States, despite having the highest country-specific burden of lung cancer, have all seen a decrease in their RC to lung cancer research. Research from Norway, Austria, Switzerland, Belgium, and Sweden had the highest proportion of international contributors . By comparison, relative to their research output, the East Asian countries (Taiwan, India, the Republic of Korea, and Japan) and Turkey had the least amount of international collaboration. With regard to multinational studies, only 1.2% of articles had collaborators from five or more countries and 0.3% from 10 or more countries. The aim of co-operative groups in oncology is to perform multi-center clinical trials for cancer research. Research results are often conveyed to the worldwide medical community through scientific publications. In order to complete the trials within the period specified, it is obvious the need of the qualified and high-volume cancer centers. The barriers to participation of high-volume hospitals in the cooperative group trials should be determined and eliminated. Since the 1970s, centers for thoracic diseases that emerged from former tuberculosis hospitals, particularly in Europe, have focused on the diagnosis and treatment of patients with lung cancer. Traditionally, these centers were staffed by pulmonologists and thoracic surgeons, but now include an extended range of health care workers including the disciplines of radiation oncology, medical oncology, palliative care and rehabilitation medicine. These high-volume centers treat all aspects of problems affecting patients with lung cancer. In 2010, the hospitals with a median 400 new patients per year were in Albania, Belarus, Bulgaria, the Czech Republic, Poland, Romania and Slovenia. The hospitals with more than 1000 new patients with lung cancer per year were in Poland, Bulgaria, Croatia, Turkey. We have to foster the cooperative study groups in lung cancer to provide collaboration between study group and these hospitals. High-volume hospitals should be identified and hospital-based representatives should be determined. Supreme organisations as European Thoracic Oncology Platform providing collaboration among study groups and hospitals, should be able to invite the high-volume hospitals with site evaluation. These high-volume centers have to review whether adequately equipped and set up or not for participation in research projects and clinical trials. References 1- Gaga M. An Official American Thoracic Society/European Respiratory Society Statement: The role of the pulmonologist in the diagnosis and management of lung cancer. Am J Respir Crit Care Med 2013; 188(4): 503-7. 2- Blum T. G. The European initiative for quality management in lung cancer care. Eur Respir J. 2014; 43: 1254-77 3- Loddenkemper R, 100 years DGP-100 years of pneumology in Germany. Pneumologie 2010; 64:7-17. 4- Richter TA. Clinical research: A globalized network. PLoS ONE 2014; 9(12): 1-12 5- Aggarwal A. The state of lung cancer research: A global analysis. J Thorac Oncol 2016; 11(7): 1040-50
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SC23.04 - Cooperative Groups in China: The CSCO Experience (ID 6697)
16:45 - 17:00 | Author(s): Q. Zhou
- Abstract
- Presentation
Abstract:
In order to keep up with the rapid development of world cancer treatment exploring, Chinese clinical oncology professionals, relevant enterprises and public institutions voluntarily constituted a non-profit professional academic group which is known as The Chinese Society of Clinical Oncology (CSCO) in April 1997. The CSCO organization not only pay attention to international collaboration such as establishing reciprocal memberships with American Society of Clinical Oncology (ASCO) , European Society for Medical Oncology (ESMO), Clinical Oncological Society of Australia (COSA) and participating rotation of presidency organization of Asia Clinical Oncology Society (ACOS), but also committed to Chinese Oncology development. The CSCO annual meeting delivered the latest advancements and research fruit from home and abroad which offered a great academic exchange platform for vast amount of Chinese oncologists. CSCO also organize experts to make tumor diagnosis and treatment standardized guideline. Up to date, CSCO has launched dozens of guidelines regarding many major cancers in china, including non-small cell lung cancer, colorectal cancer and hepatocellular carcinoma. The newly made guideline about non-small cell lung cancer has fully considered Chinese special situation, not only disease characteristics, but also social economic factors, which made a good example of better suiting Chinese oncologists and patients. Other than this, CSCO developed multi-center clinical researches which offered solid evidence for Chinese cancer patients and made contribution to world cancer diagnosis and treatment. Most of clinical researches were carried out by Study Group majored in different cancers, such as Chinese Thoracic Oncology Group (CTONG), Chinese Breast Cancer Study Group (CBCSG) and Chinese Gastrointestinal Oncology Group (CGOG). The CSCO also keeps an open mind and follows the trend of hot spot, such as building expert committee on cancer biomarkers and precise medicine, even making consensus on standard of driver gene mutation test, standard of operation procedure and so on. Of all the Study Groups in CSCO, CTONG is the most active and fruitful committee. CTONG is also the most active organization in lung cancer field in China. Through the great effort of four top experts majored in lung cancer (Yi-Long Wu, Li Zhang, Shun Lu and Cai-Cun Zhou), CTONG was successfully established in 2007. With the goal of designing and developing multi-center clinical trials in the field of chest tumor, especially for lung cancer, providing high level of evidence for clinical practice of thoracic tumor, promoting standardization, modernization and internationalization of clinical and research work in thoracic tumor area and finally improving the level of diagnosis and treatment of chest tumor in China, as well as international status, CTONG has actually made massive efforts and achieved great success. Up to date, CTONG has 31 members from 15 provinces and municipality cities and has successfully performed 47 clinical trials in China. Half of these clinical trials established China lung cancer treatment modalities. Take CTONG 0802 study (OPTIMAL) for example, the multicenter open-label randomized phase II study compared erlotinib with combination of gemcitabine and cisplatin in first-line treatment of patients with EGFR mutation-positive NSCLC[1], Median progression-free survival was significantly longer in erlotinib-treated patients than in those on chemotherapy (13.1 [95% CI 10.58-16.53] vs 4.6 [4.21-5.42] months; hazard ratio 0.16, 95% CI 0.10-0.26; p<0.0001). Chemotherapy was associated with more grade 3 or 4 toxic effects than was erlotinib (including neutropenia in 30 [42%] of 72 patients and thrombocytopenia in 29 [40%] patients on chemotherapy vs no patients with either event on erlotinib), which suggested that erlotinib is important for first-line treatment of patients with advanced EGFR mutation-positive NSCLC. The results of CTONG0802 was orally presented on ESMO2010, WCLC 2011, discussed on ASCO 2011 and published on Lancet Oncology. CTONG 0901 study compared erlotinib with gefitinib in patients with EGFR mutation positive stage IIIb/IV NSCLC and found no PFS or OS difference between these two regimens which offered solid evidence for clinical choice[2]. CTONG also paid attention to first-line maintenance therapy, second-line treatment, Another well-known study of CTONG is FASTACT-II (CTONG0902) proved that erlotinib maintenance therapy after first-line gemcitabine combined with cisplatin improves overall survival of stage IIIB/IV NSCLC patients[3]. CTONG 0806 study suggested improvement in PFS and an improved OS trend with pemetrexed compared with gefitinib as second-line setting treatment of EGFR wild-type advanced non-squamous NSCLC[4]. There were also many studies focused on palliative treatment, brain metastasis and peri-operative treatments and achieved meaningful results in these fields. Additionally, CTONG has initiated the very first real-world study in China targeting 1st line treatment pattern of advanced non-squamous NSCLC patients, the study concern difference between scientific achievements and clinical practice in China and set a great beginning of caring for patients’ actual profits. The currently ongoing reform for new drug approval of CFDA provides great chances for the development of clinical trials in China and domestic drug innovation such as icotinib and apatinib. CTONG and other study groups also face more opportunities. CTONG, as the successful example of CSCO study groups, is expected to make more contributions to china lung cancer treatment. Hopefully, CSCO achievements will finally benefit more Chinese cancer patients and make more contribution to world cancer control. Reference: 1. Zhou C, Wu YL, Chen G, et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2011;12(8):735-742. 2. Yang JJ, Zhou Q, Yan HH, et al. A Randomized Controlled Trial of Erlotinib versus Gefitinib in Advanced Non-Small-Cell Lung Cancer Harboring EGFR Mutations (CTONG0901). J Thorac Oncol 2015;10(2), S321(ABSTRACT MINI 16.03) 3. Wu YL, Lee JS, Thongprasert S, et al. Intercalated combination of chemotherapy and erlotinib for patients with advanced stage non-small-cell lung cancer (FASTACT-2): a randomised, double-blind trial. Lancet Oncol. 2013 Jul;14(8):777-86. 4. Zhou Q, Cheng Y, Yang JJ, et al. Pemetrexed versus gefitinib as a second-line treatment in advanced nonsquamous nonsmall-cell lung cancer patients harboring wild-type EGFR (CTONG0806): a multicenter randomized trial. Ann Oncol. 2014 ;25(12):2385-2391.
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SC23.05 - Co-Operative Groups in North America (ID 6698)
17:00 - 17:15 | Author(s): S. Malik
- Abstract
- Presentation
Abstract not provided
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SC23.06 - Challenges and Costs of Cooperative Group Trials (ID 6699)
17:15 - 17:30 | Author(s): T. Brodowicz
- Abstract
- Presentation
Abstract not provided
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ED12 - Regional Tobacco Control Policies: Advances & Challenges (ID 281)
- Event: WCLC 2016
- Type: Education Session
- Track: Epidemiology/Tobacco Control and Cessation/Prevention
- Presentations: 1
- Moderators:Z. Zain, F. Mihaltan
- Coordinates: 12/07/2016, 11:00 - 12:30, Hall C7
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ED12.06 - Tobacco Control Policies in Latin America (ID 6494)
12:15 - 12:30 | Author(s): J. De La Garza
- Abstract
- Presentation
Abstract:
Introduction Smoking is the single most important cancer risk factor and accounts for 26% of all cancer deaths and 84% of lung cancer deaths in Latin America[1]. Lung cancer is one of the most preventable cancer types; and doctors of all expertise are essential to impart to patients and their families the idea of smoking prevention, thereby contributing to the reduction of mortality from lung cancer. There are around 145 million smokers age 15 years or older in Latin American. Adult smoking prevalence varies from 35% in Chile and 30% in Bolivia to 11% in Panama and 11∙7% in El Salvador[2, 3]. The continuing popularity of smoking among adolescents is particularly worrisome as smoking rates among teens and young adults predict future lung cancer rates. Smoking rates among young people aged 13–15 years are now higher than in adults in many Latin American countries. Prevalence among female adolescents has surpassed their male counterparts in Argentina, Brazil, Chile, Mexico, and Uruguay. Unless these high rates of smoking are curtailed, cancer mortality rates will continue to rise[3]. We have assessed the impact on smoking rates of anti-tobacco policies adopted by five Latin American countries, in compliance to the WHO’s Framework Convention on Tobacco Control (FCTC). Argentina, Brazil, Mexico, Peru, and Uruguay were used as case studies to illustrate the challenges and ways in which governments and civil society organizations can effectively work together to reduce lung cancer deaths and other tobacco-related diseases. Since the endeavor for approving anti-tobacco policies was met with a strong lobby against it in these countries, different degrees of compliance with the FCTC terms were reached. We analyzed reports issued by local governments and epidemiologic surveys found in the literature. Tobacco farming in Latin-America has increased in recent years, representing almost 16% of the global production. Argentina and Brazil are among the ten largest world producers and the cultivated area in Latin America reaches 13.55% of the global land dedicated to tobacco farming worldwide. The prices paid by the tobacco industry to farmers are also increasing since 2007, and the sector employs 650,000 people. Tobacco farming is also present in Colombia, Dominican Republic, Honduras, Ecuador, Guatemala, Mexico, Nicaragua and Paraguay[4]. Therefore, tobacco control policies must necessarily include solutions to help tobacco growers to escape from the influence of the tobacco industry without loss of income and jobs. Results We have found a differential decrease (and increase) in smoking among the population of the studied countries in the last decades: Argentina: (from 29% in 2007 to 22.1% in 2014); Brazil (from 34.8% in 1989 to 14.7% in 2013); Mexico (21.7% in 2008-2011 to 23.6% in 2014); Peru (from 44.5% in 1998 to 21.1% in 2010 and 13.3% in 2013); Uruguay (from 34% in 1998 to 23.5% in 2011)[5 – 11]. Discussion According to the 2014 FCTC Progress Report[12], the implementation degree of the articles among the countries varied from <20% to more than >75% in most cases. One-third of all FCTC signing countries have not enacted anti-tobacco legislation or reached the full implementation of at least two important time-bound articles: tobacco advertising ban and health warnings on cigarette packages and at the selling points. Our data also showed uneven degrees of implementation among the studied countries. One of the underlying causes for slow implementation in some countries, like Mexico and Argentina, is the strong political lobby by the tobacco industry. In our study, Argentina has come in third in smoking prevalence, with a 22.1% smoking rate among adults, due to the strong pressure upon legislators by the tobacco industry that so far has prevented the FCTC ratification by the Congress. Nevertheless, the Argentinean political environment was more sensitive than the Mexican, to the persistent anti-smoking advocacy by the medical associations and organizations of the civil society. Therefore, some of the FCTC tobacco control policies were enacted by legislators in 2011 and implemented in 2013. Mexico, however, was the one with the poorest implementation of tobacco control policies and the highest in smoking prevalence among adults (23,60%), seconded by Uruguay (23.5%), where the past administration has neither enforced the already existing tobacco-control policies, nor promoted new ones, such as heavy taxes upon tobacco products. One of the important measures recommended by the FCTC - which has proved to be effective in smoking prevention among children and teenagers - is high taxation (over 75%) of tobacco products[12]. Conclusion The degree of compliance with the terms of the Convention seems to have a direct impact on the reduction of smoking rates in the countries studied. Other solutions should contemplate tobacco farmers, whose fear of shifting to new unfamiliar cultures is exploited by the tobacco industry to prevent FCTC ratification in many countries. But farmers should not stop growing tobacco plants, but just shift to transgenic tobacco farming[13]. Transgenic tobacco is being successfully tested for expression of for more than fifteen human therapeutic proteins, including antibodies, antigens for vaccines, and autoimmune inhibitor factors. [(14-17)]. Pharmaceutical companies could benefit from the existing agricultural tradition of tobacco farming in Brazil, Argentina, and elsewhere by fostering the commercial production of those molecules. Transgenic tobacco is improper for smoking and could also have the nicotine gene knocked out to discourage misuse. Therefore, the pharma industry could open new roads to smoking eradication while preserving the economic activity and profitability of traditional tobacco farmers. Effective tobacco control requires a close cooperation between health institutions, medical societies, NGOs, and the press - and the regular funding of surveillance programs and educational campaigns. Smoking prevention programs must be part of the educational curricula from the pre-school onwards.
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P2.03b - Poster Session with Presenters Present (ID 465)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03b-003 - Mutation Profile & Histology According to ERS/ATC/IASCL Associated with IPFS to WBI in BM Patients with Recent Adenocarcinoma Lung Cancer (ID 5817)
14:30 - 14:30 | Author(s): J. De La Garza
- Abstract
Background:
Brain-metastases (BM) are a common metastatic site in non-small-cell lung cancer (NSCLC). We studied the impact of genetic alterations (EGFR, ALK and KRAS) in relation to objective response rate (ORR), intracranial-progression-free survival (IPFS) and overall-survival (OS) after whole-brain irradiation (WBI) in patients at recently diagnosis with NSCLC and BM.
Methods:
From 2009-2015, 231 NSCLC patients with BM were reviewed for eligibility. Among them, 121 patients with recently diagnosis of NSCLC, were treated with WBI and have available genotyping status.
Results:
EGFR, KRAS, ALK and WT patients were found in 38.0%, 6.6%, 5.8% and 49.6%, respectively. Overall, ORR and disease control rate (DCR) were 62.0% and 76.8%, respectively. ORR for EGFR, KRAS, ALK and WT patients were 82.6%, 25.0%, 71.4% and 50.0%, respectively (p=0.001). Female gender (OR 2.22 [95% CI: 1.01 – 4.89] P=0.047) and EGFR were associated to better response to WBI (OR 5.67 [95% CI 2.0-15.8], P = 0.001). A high architectural histological grade was independently associated with resistance to WBI. Median IPFS was 9.06 months [95% CI 6.5 -11.4]. IPFS for EGFR, K-RAS,ALK and WT patients were 11.9, 4.6,12.5 and 6.6 months, respectively (P <0.0001). EGFR mutation status (HR 0.54 [95%CI 0.3-0.9], P = 0.030) was the only factor associated with higher IPFS in the multivariate Cox-regression analysis. Median OS was 16.6 months [95% CI 11.6-22.6]. OS for EGFR, ALK, KRAS and WT patients were 26.8, 13.5, 4.9 and 13.6 months, respectively (P < 0.001). Intracranial OR was associated with a higher OS (HR 0.28 [95%CI 0.2-0.5], P < 0.001), while KRAS mutation positive status (HR 3.45 [95%CI 1.4-8.4], P = 0.006) was independently associated with worse OS. Figure 1
Conclusion:
EGFR mutation is an independent predictive factor for OR to WBI for BM in patients with NSCLC. KRAS mutation is an independent predictive factor for worse OS after BM.
