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J. Schiller
Moderator of
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ED 03 - Global Lung Cancer Coalition – Data-Driven Lung Cancer Advocacy (ID 3)
- Event: WCLC 2015
- Type: Education Session
- Track: Advocacy
- Presentations: 4
- Moderators:M. Rigney, J. Schiller
- Coordinates: 9/07/2015, 14:15 - 15:45, 703
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ED03.01 - Global Lung Cancer E-Atlas - How Can This Be Used as a Tool to Advocate for Change? (ID 1778)
14:20 - 14:40 | Author(s): S. Winstone
- Abstract
- Presentation
Abstract:
Background: The Global Lung Cancer Coalition (GLCC) is a unique partnership dedicated to improving disease outcomes for all lung cancer patients worldwide. The GLCC has a clear objective to place lung cancer on the global agenda. There are known to be significant variations both between and within countries in terms of: lung cancer incidence, mortality and survival; access to the latest treatments and to high quality specialist healthcare professionals; and investment in research and clinical trials. Evidence of variations can be a powerful tool for advocates – both clinicians and patient advocacy groups – to use to engage with policymakers about the ways in which legislative or regulatory policies can be shaped to optimise treatment and care for people living with lung cancer. However, there was no single statistical resource for the global lung cancer community to use in comparing countries, benchmarking progress, and campaigning. In 2014, therefore, the GLCC created the Global Lung Cancer E-Atlas, making accessible in one place the latest published information about lung cancer's global impact and outcomes, in an interactive format. Creating the E-Atlas: Potential data sources were mapped to identify the most current and comparable available. Incidence and mortality data were drawn from GLOBOCAN 2012[i], which provides contemporary estimates of the incidence, mortality and prevalence from major types of cancer, at national level, for 184 countries. The estimates are based on the most recent data available at the International Agency for Research on Cancer (IARC) though more recent figures may be available directly from local sources. Survival data were drawn from a variety of sources, where available. These included: CONCORD-2[ii], which includes data provided by 279 cancer registries in 67 countries; the EUROCARE-5 study[iii], which provides the most up-to-date survival analysis for patients diagnosed with cancer across 29 European countries; and the International Cancer Benchmarking Partnership (ICBP)[iv], which includes data from population-based cancer registries in 6 countries – Australia, Canada, Denmark, Norway, Sweden and the United Kingdom. The E-Atlas also details whether each country operates a cancer plan or has implemented the World Health Organization Framework Convention on Tobacco Control with data drawn from responses to the World Health Organization Noncommunicable Diseases Country profiles[v], covering 184 countries. GLCC members were invited to validate data for their country and identify any more recent national data. If more recent data were found then these were added. Using the E-Atlas: The E-Atlas allows anyone to compare statistics for lung cancer across the world. It is publically accessible on the GLCC’s website: http://www.lungcancercoalition.org/atlas/ (Figure 1): Figure 1 Figure 1: GLCC Global Lung Cancer E-Atlas home page By clicking on individual countries, or using the search function, users can 'zoom in' on different areas to see the figures for that nation. The E-Atlas also has a comparison tool, enabling the user to select up to four countries and directly compare the figures for them (Figure 2). Figure 2 Figure 2: the comparator tool GLCC campaigners have been using the E-Atlas to support engagement with national policy-makers and influencers. To support this, the project team produced a campaigning toolkit, giving headline figures, tips for engagement and template materials (press releases, briefing documents and a presentation for adaptation). Conclusions: Feedback from GLCC members confirms that the E-Atlas is a helpful resource in their campaigning and advocacy. The GLCC is continuing to develop the E-Atlas, and it will be updated with breakdowns by age and gender. The GLCC is also keen for the E-Atlas to be shared and to receive feedback (via http://www.lungcancercoalition.org/atlas/contact.php) on additional national data for inclusion or suggestions for further development. References: [i] GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 11, Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F. Lyon, 2013, France: International Agency for Research on Cancer. Available at: http://globocan.iarc.fr/Default.aspx [ii] Global surveillance of cancer survival 1995–2009: analysis of individual data for 25 676 887 patients from 279 population-based registries in 67 countries (CONCORD-2), C Allemani, H Weir, H Carreira, R Harewood, D Spika, X Wang, et al. The Lancet, Volume 385, No. 9972, p977–1010, 14 March 2015. [iii] EUROCARE-5-a population-based study of cancer survival in Europe 1999-2007 by country and age. Available at: https://w3.iss.it/site/EU5Results/ [iv] Cancer survival in Australia, Canada, Denmark, Norway, Sweden and the UK, 1995-2007 (the International Cancer Benchmarking Partnership): an analysis of population-based cancer registry data, MP Coleman, D Forman, H Bryan, J Butler, B Rachet, C Maringe, et al. The Lancet Volume 377, No. 9760, p127–138, 8 January 2011. [v] Noncommunicable Diseases Country Profiles 2011, World Health Organization (WHO), 2011. Available at: http://whqlibdoc.who.int/publications/2011/9789241502283_eng.pdf
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ED03.02 - Bibliometric Research on Published Lung Cancer Research - What Are the Implications for Policy Work? (ID 1779)
14:40 - 15:00 | Author(s): R. Sullivan
- Abstract
Abstract not provided
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ED03.03 - The Value of National Lung Cancer Audit Data - The UK Experience (ID 1780)
15:00 - 15:20 | Author(s): J. Fox
- Abstract
- Presentation
Abstract:
Background Despite recent advances, lung cancer remains a disease characterised by negativity, late diagnosis and poor outcomes. The need for advocacy in lung cancer is obvious. Recent years have seen an increase in the number of organisations and individuals advocating for improvements in this disease. All organisations engaging in lung cancer advocacy are different and respond to the particular cultures and needs of their regions or countries. However, there are a number of common campaign themes: Integrated Tobacco Control programs. Increased funding for lung cancer research Increase in the number of patients enrolled in Clinical Trials Earlier diagnosis Equitable access to best practice treatment and care The Need for High Quality Data Underpinning advocacy in all of the above, is the need for advocates to access high quality, timely data on survival, quality of life and patient experience. Such data, not only provides a benchmark for the quality and outcomes of lung cancer services, but also provides advocates with a tool to campaign for improvement and showcase good practice. A good example is the work of the International Cancer Benchmarking Partnership [1], which has shown huge variation in one year and five year survival in lung cancer across the study countries, prompting health policy makers to investigate differences. The publication of the recent CONCORD- 2 data [2] has had a similar effect, with advocates highlighting 5 years survival inequalities. In November 2014, the Global Lung Cancer Coalition launched it’s online e-atlas [3 ], bringing together international lung cancer data sets and information, where available, in every WHO country. An important national initiative is the UK’s National Lung Cancer Audit [4], which is examined in further detail The UK’s National Lung Cancer Audit (NLCA) – Example of a tool for advocates The NLCA has taken around 20 years from conception to its establishment as a gold standard national clinical audit. The first discussions around the need to audit services and patient outcomes took place among a small group of UK lung cancer clinicians, in 1994. Since then, the NLCA has developed into a national audit which captures information on almost every case of lung cancer and mesothelioma that reaches hospital in the UK. It captures data on a range of demographics, clinical features and key process measures in treatment and care, spanning the patient journey. The NLCA is used by a wide variety of stakeholders within the lung cancer community to understand how care is being delivered across the country and to drive improvements to services. It includes data which are as close to real-time as possible. As contained in the Roy Castle Lung Cancer Foundation’s 2014 report on the NLCA [5], this audit has been vital to lung cancer advocates in driving improvements in lung cancer service provision. Findings of this Report highlight the NLCA’s vital contribution to: Improving clinical practice – average rates of active treatment, surgery, histological diagnosis and access to lung cancer nurse specialists have all improved during the lifetime of the audit Creating further advocacy tools - this audit data has been extensively used by UK advocacy groups, as in the web based ‘Smart Map’ [6], displaying the data in a patient friendly, easily accessible format. Supporting clinical research –The 2014 RCLCF Report [5] notes that there were at least 13 clinical research projects ongoing across the UK which were making use of NLCA data. Also, 175 key clinical journal articles published between 2006 and 2013 referenced the NLCA. Informing cancer policy and guidelines – the NLCA has been cited in much policy documentation.. The 2014 RCLCF Report [5] notes that the National Institute for Health and Care Excellence (NICE) references the NLCA at least 36 times in documents ranging from guidance, implementation guides, and audit tools to briefings. Also. the National Cancer Intelligence Network (NCIN) references the NLCA 32 times in the documents currently available on its website and uses most of the NLCA’s ‘headline indicators’ in its on-line lung cancer service profiles Raising awareness of lung cancer issues - the annual NLCA report helps to raise awareness of lung cancer issues among national and local decision-makers and the general public. It has been used almost exclusively to positively evaluate the major clinical impact of the 2011 and 2012 national public awareness campaigns (the Be Clear on Cancer campaign for lung cancer [7]), relating to persistent cough as an early warning symptom of lung cancer. Roy Castle Lung Cancer Foundation has used data from the NLCA to raise awareness of lung cancer, and variations in lung cancer care and outcomes across England and Scotland, through the publication of two reports[i] on variations in lung cancer care across the country [8,9]. Learnings for all lung cancer advocates There is a need for high quality, timely, lung cancer data on incidence, mortality, survival. Also, a need for high quality, timely data to assess health services – on diagnositics, treatment availability and support/care provision. If the above is not available – advocates need to ask why not and campaign for data collection Quality data provides lung cancer advocates with a key tool to highlight good practice, variation and inadequacies. Thus, advocating for change and improvement. References 1. Coleman MP et al, ‘Cancer survival in Australia, Canada, Denmark, Norway, Sweden, and the UK 1995-2007 (the international Cancer Benchmarking Partnership): an analysis of population-based cancer registry data’, The Lancet, Vol. 377, January 2011 2. Allemani C, Weir HK, Carreira H, et al., and the CONCORD Working Group. Global surveillance of cancer survival 1995-2009: analysis of individual data for 25,676,887 patients from 279 population-based registries in 67 countries (CONCORD-2). Lancet 2015; 385: 977–1010 3. GLCC website – Global Lung Cancer e-Atlas. http://www.lungcancercoalition.org 4. Health and Social Care Information Centre, National Lung Cancer Audit annual reports, via: http://www.hscic.gov.uk/lung 5. Roy Castle Lung Cancer Foundation, Leading the information revolution in lung cancer intelligence: why the National Lung Cancer Audit is the key to transforming lung cancer outcomes, January 2014. 6. Roy Castle Lung Cancer Foundation’s Smart Map. http://roycastle.org/news-and-campaigning/campaigns/interactive-map 7. Be Clear on Cancer – Lung Cancer campaign, via http://www.campaigns.dh.gov.uk/category/beclearoncancer/ 8. Roy Castle Lung Cancer Foundation, Explaining variations in lung cancer in England, July 2011 9.Roy Castle Lung Cancer Foundation, Explaining variations in lung cancer in Scotland, 2011
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ED03.04 - Advocating for Tobacco Control - the Australia Experience (ID 1781)
15:20 - 15:40 | Author(s): M. Peters
- Abstract
- Presentation
Abstract:
Lung cancer was a rarity a century ago. A dramatic increase in the use of tobacco, in the form of cigarettes, and the science-based reformulation of tobacco that renders the modern cigarette so addictive, the world would not be in the grip of the current lung cancer epidemic. Several other critical factors contributed. These include ready access for sale and purchase, few limitations on time and place of tobacco use and highly skilled promotion and marketing. This combination of corporate success and health tragedy was supported by carefully orchestrated public disinformation and the achievement and maintenance of political influence. It follows from these observations that reversing the course of this epidemic requires that each of these be addressed. Now that legislation for the introduction of mandatory plain packaging of tobacco products has been passed in Ireland and the United Kingdom, Australia is not unique in any single tobacco control action. However, it has been innovative and the extent and breadth of activity is world-leading. A non-exhautive list of innovations includes Pack warnings and regulation Simple text messages(1972) Rotating text messages Graphic health warnings(2004) Mandatory plain packaging(2012) Product and sale restrictions Public information on tar content Restrictions on sales to minors Prohibition of "kiddy-packs" with <20 cigarettes Smoke-free indoors policy - non smoking in Workplaces (Federal Government initially in 1985) Domestic aircraft(1987) Public transport vehicles (bus/train/tram) Large shopping centres Motor vehicles carrying cars Indoor restaurants/bars Hospitals and health centres Smoke-free outdoors policy Al fresco dining Sports stadiums Children’s play areas Beaches and parks Railway stations and bus/tram stops Counter-advertising First TV campaign in late 1970's. Several innovative TV and radio campaigns since including "Every cigarette is doing you damage". Aims were to broaden knowledge of harms and bring risk into the present Tobacco Advertising and Promotion Restriction Voluntary banning of tobacco advertsing by the Medical Journal of Australia Banning TV and radio and later print advertising Elimination of sports and arts sponsorships Price and taxation Introduction of hypothecated tax to replace tobacco sponsorship income Removal of tobacco from consumer price (inflation) index calculation Aggressive tax increases (current Marlbro 20's > $US25) From time to time, opportunistic targetting a single state or local government entity, aimed at a specific innovation, has established a policy precedent. This has been achieved with a relatively small group of tobacco control advocates and effective health NGOs. Effective use of media has been critical in the process. The tobacco industry, in tactics used to oppose effective interventions, is quite predictable. Separate from simplistic themes of civil liberties, crystallised in the absurdist “nanny-state” concept. Common themes used to oppose evidence-based actions, include the threat of large legal penalties, spectre of illicit tobacco sales and the harm potentially caused to Australia more generally as a place to do business. Effective lobbying campaigns can be transplanted. For example, promoting the right of workers to work long hours in safe workplaces can aid arguments in favour of smoke-free dining and other public places. All of the policy victories achieved are within the scope of aims of the Framework Convention on Tobacco Control. This remains the international template and its objects are proven able to be implemented. These policy innovations have been achieved despite tobacco industry interference via the political process and well-documented donations to major political parties. Although major parties have eschewed tobacco company donations by law or choice in recent years, influence is still peddled. To counter interference, the case for tobacco control was made politically impelling. That is, the community was perceived by political decision takers to have a desire to be rid of the harms of smoking that exceeds any concerns about restrictions that need to be imposed to achieve this. A lesson from Australia is that health professionals interested in tobacco control must educate communities at the same time as they seek to alter public policy.
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Author of
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MINI 07 - ChemoRT and Translational Science (ID 110)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:D. Raben, B. Kavanagh
- Coordinates: 9/07/2015, 16:45 - 18:15, 201+203
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MINI07.05 - Discussant for MINI07.01, MINI07.02, MINI07.03, MINI07.04 (ID 3311)
17:05 - 17:15 | Author(s): J. Schiller
- Abstract
- Presentation
Abstract not provided
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MINI 09 - Drug Resistance (ID 107)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
- Moderators:L. Villaruz, J. Minna
- Coordinates: 9/07/2015, 16:45 - 18:15, 205+207
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MINI09.06 - Oncogenic Drivers including RET and ROS1 plus PTEN Loss and MET by IHC in Patients with Lung Adenocarcinomas: Lung Cancer Mutation Consortium 2.0 (ID 2114)
17:15 - 17:20 | Author(s): J. Schiller
- Abstract
- Presentation
Background:
The Lung Cancer Mutation Consortium (LCMC) 1.0 demonstrated multiplexed genomic platforms can assay 10 oncogenic drivers in tumor specimens from patients with lung adenocarcinomas. 28% of the patients with oncogenic drivers could be effectively targeted. The survival of these 275 patients treated with targeted agents was longer than the patients who were not treated with a targeted agent (Kris and Johnson JAMA 2014). The efficiency of Next-Generation Sequencing enables more comprehensive testing of additional aberrations with less tumor tissue. LCMC 2.0 was initiated to test tumor specimens for 12 oncogenic drivers and to provide the results to clinicians for treatment decisions and research purposes.
Methods:
The 16 site LCMC 2.0 is testing tumors from 1000 patients with lung adenocarcinomas in CLIA laboratories for mutations in KRAS, EGFR, HER2, BRAF, PIK3CA, AKT1, and NRAS, MET DNA amplification, and rearrangements in ALK as done in LCMC 1.0. The new genes that were added because of emerging information about potential therapeutic targets include MAP2K1 mutations, RET and ROS1 rearrangements, PTEN (MAb 138G4) loss and MET (MAb SP44) overexpression by immunohistochemistry (IHC). All patients were diagnosed with stage IIIB/IV lung adenocarcinoma after May 2012, had a performance status 0-2, and available tumor tissue.
Results:
Of 1073 patients registered, data is now reported for 759. The median age of the patients is 65 (23-90). The population includes 369 (55%) women; 164 (24%) never smokers, 399 (59%) former smokers, and 73 (11%) current smokers; 26 (4%) Asians, 58 (9%) African American, 548 (81%) Caucasian, and 43 (6%) of other races. As of April 2015 information on genomic and immunohistochemical changes for 675 eligible patients were recorded in our database. Alterations in oncogenic drivers were found in 45% of samples as follows: 159 KRAS (24%), 88 EGFR (13%), 25 ALK (4%), 19 BRAF (3%), 17 PIK3CA (3%), 9 HER2 (1%), 4 NRAS (1%) 0 AKT1, 28 had ≥ 2 findings (4%) and 25 MET DNA amplification (4%). The new genes studied in LCMC 2.0 revealed 1 MAP2K1 mutation (<1%), 19 RET (3%) and 9 ROS (1%) rearrangements, 94 had PTEN loss (14%), and 362 with MET overexpression (54%). As expected, PIK3CA mutations and PTEN loss by IHC were mutually exclusive in 109 of 111 (98%) patients’ tumors. Seventeen of the 23 (74%) with MET DNA amplification studied thus far with IHC had MET overexpression. Next-Generation platforms were used at 13 of 16 LCMC 2.0 sites.
Conclusion:
Next-Generation Sequencing is rapidly becoming routine practice at LCMC 2.0 centers with use going from 0 to 81% of sites since 2012. LCMC 2.0 identified additional targets (RET and ROS1 rearrangements and PTEN loss). PIK3CA and PTEN were largely mutually exclusive and an actionable oncogenic driver has been identified in the 45% of initial lung adenocarcinoma specimens. Supported by Free to Breathe
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ORAL 12 - Quality of Life and Trials (ID 96)
- Event: WCLC 2015
- Type: Oral Session
- Track: Advocacy
- Presentations: 2
- Moderators:E. Bachrach Makovsky, C. Malnati
- Coordinates: 9/07/2015, 10:45 - 12:15, 708+710+712
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ORAL12.03 - The Predictors and Effects of Explicit and Implicit Attitudes Against Lung Cancer (LC) (ID 1459)
11:07 - 11:18 | Author(s): J. Schiller
- Abstract
- Presentation
Background:
LC may be associated with negative societal perceptions compared to other cancers. This study measured the explicit, conscious attitudes (EAs), implicit, unconscious attitudes (IAs) and implicit stereotypes of LC relative to breast cancer (BC), explored the demographic factors associated with the explicit and implicit biases in LC, and whether these biases affect the LC drug treatment rates.
Methods:
EAs were derived from participants (Ps) [cancer patients (n = 493), caregivers (n = 1332), healthcare providers (HCPs, n = 623), and the general public (n = 1356)] ratings about how patients with LC and BC “do feel” (descriptive attitudes) or “ought to feel” (normative attitudes) about their disease. IAs and implicit stereotypes were measured with the Implicit Association Test (IAT). Analysis of covariance (ANCOVA) was used to assess the demographic factors associated with bias toward LC. Linear regressions were performed to analyze the association between the biases against LC and LC treatment rates across different states in the United States.
Results:
Females (p < 0.001), higher income (p = 0.015), and people reporting themselves with more knowledge about cancer disease (p < 0.001), caregivers (p = 0.008), and whites (p < 0.001) expressed stronger negative descriptive attitudes toward LC. Males (p = 0.007), and higher income (p = 0.010) expressed less-positive normative attitudes toward LC. Females (p < 0.001), higher education (p = 0.003), non-cancer patient participants (p = 0.019), and whites (p = 0.031) had stronger negative IAs about LC. State-level analysis showed that the lower drug treatment rates for LC patients are significantly associated with older patients population (p = 0.011) and higher percentage of government as payer (p = 0.023). State-level analysis shows no significant association between IAT scores and LC treatment rates.
Conclusion:
Explicit and implicit bias against LC compared to BC was associated with gender, education, income levels and cancer knowledge, but not treatment rates.
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ORAL12.05 - Impact of Time to Drug Approval on Potential Years of Life Lost: The Compelling Need for Improved Trial and Regulatory Efficiency (ID 1547)
11:28 - 11:39 | Author(s): J. Schiller
- Abstract
- Presentation
Background:
Survival of incurable cancer patients is improving gradually. Several hundred new therapies are under development. However, internationally, regulatory complexity slows progress by increasing drug development costs (hence, fewer drugs can be assessed with available resources) and by producing numerous speed bumps that delay approval of useful drugs and that increase resources required to document that other agents are ineffective.
Methods:
We assessed cancer therapies undergoing phase III trials between 2001 and 2015. To be included, trials had to document statistically significant improvement in overall survival. We excluded adjuvant trials and trials in uncommon malignancies. To determine the number of life-years potentially lost per year required for drug approval, we multiplied the improvement in median survival in years by the estimated number of patients (North American and worldwide) dying annually from the relevant malignancy.
Results:
In the Table, we present the life-years lost per year required for approval for 21 therapies in 10 malignancies. When the combined impact of all tumor sites and drugs are considered together, there were 29 life-years lost in North America per hour of delay in therapy approval (1 for every 2 minutes of delay) and 260 life-years lost worldwide per hour of delay (1 for every 14 seconds of delay). These numbers do not take into account impact of drugs non-evaluable due to cross-over or missing survival data, drugs that were prematurely abandoned, drugs still undergoing investigation, or approaches for non-malignant lethal diseases. Figure 1
Conclusion:
Clearly, the survival gains associated with the foregoing drugs are only modest. Despite this, there would be a large negative impact associated with approval delays even if factors such as co-morbidities, performance status, ability to pay, etc, limit the number of patients treated to a fraction of the total dying from a specific malignancy. There are numerous opportunities to improve efficiency of cancer drug approval without sacrificing safety or data integrity. This requires urgent attention.
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ORAL 22 - Moving Beyond a Smoking Related-Cancer to the Young, Never-smokers and Inherited Disease (ID 117)
- Event: WCLC 2015
- Type: Oral Session
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
- Moderators:K. Suda, H.A. Wakelee
- Coordinates: 9/08/2015, 10:45 - 12:15, Mile High Ballroom 1a-1f
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ORAL22.01 - Increasing Incidence of Never Smokers in Non Small Cell Lung Cancer (NSCLC) Patients (ID 707)
10:45 - 10:56 | Author(s): J. Schiller
- Abstract
- Presentation
Background:
It is estimated that 10-15% of lung cancer cases occur in never smokers. The cause of lung cancer in these patients includes many possible environmental factors but the precise cause in a given case is often uncertain. Additionally, there has been significant debate about whether the rate of lung cancer in these never smokers is increasing. Using our institutions’ cancer registry data, our objective was to determine if the proportion of never smokers with lung cancer is increasing.
Methods:
We conducted a retrospective study using lung cancer registry data from The University of Texas Southwestern Medical Center in Dallas, Parkland Hospital in Dallas, and Vanderbilt University in Nashville. These registries were queried between 1990 and 2013 for demographic information including gender, age at diagnosis, diagnosis [non small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)], and self-reported smoking history. A total of 10,568 NSCLC cases and 1504 SCLC cases were analyzed. Logistic regression analysis was performed to assess the incidence of never smokers with lung cancer.
Results:
The percentage of never smokers increased among NSCLC pts between 1990 and 2013 [Table 1]. Univariate logistic regression demonstrated an increasing proportion of never smokers among NSCLC cases (p < 0.0001 for year) and multivariate logistic regression also demonstrates this increase (p < 0.0001 for year) after controlling for age and gender. Never smokers with NSCLC were more likely to be female (65.3%, p < 0.0001) than males. The increase in the percentage of NSCLC never smokers was seen at both university hospitals and the Dallas county hospital. In contrast, the percentage of never smokers among SCLC cases did not significantly increase during this time period. Table 1: Percentage of never smokers Figure 1
Conclusion:
This multi-institution study demonstrates an increasing proportion of never smokers with NSCLC between 1990 and 2013 in a large, geographically and demographically diverse population. Because the biology and, thus, often the treatment options of lung cancer in never smokers differs from that of smokers, further investigation is warranted as to the etiology of the increasing incidence of never-smoker lung cancer.
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PLEN 04 - Presidential Symposium Including Top 4 Abstracts (ID 86)
- Event: WCLC 2015
- Type: Plenary
- Track: Plenary
- Presentations: 1
- Moderators:T. Mok, F.R. Hirsch
- Coordinates: 9/09/2015, 10:45 - 12:15, Plenary Hall (Bellco Theatre)
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PLEN04.03 - Randomized Phase III Trial of Adjuvant Chemotherapy with or without Bevacizumab in Resected Non-Small Cell Lung Cancer (NSCLC): Results of E1505 (ID 1608)
11:07 - 11:19 | Author(s): J. Schiller
- Abstract
- Presentation
Background:
Adjuvant chemotherapy for resected early stage NSCLC provides modest survival benefit. Bevacizumab, a monoclonal antibody directed against vascular endothelial growth factor, improves outcomes when added to platinum-based chemotherapy in advanced stage non-squamous NSCLC. We conducted a phase 3 study to evaluate the addition of bevacizumab to adjuvant chemotherapy in early stage resected NSCLC. The primary endpoint was overall survival and secondary endpoints included disease-free survival and toxicity assessment.
Methods:
Patients with resected stage IB (>4 centimeters) to IIIA (AJCC 6th edition) NSCLC were enrolled within 6-12 weeks of surgery and stratified by chemotherapy regimen, stage, histology and sex. All patients were to receive adjuvant chemotherapy consisting of a planned 4 cycles of every 3 week cisplatin at 75 mg/m[2] with either vinorelbine, docetaxel, gemcitabine or pemetrexed. Patients were randomized 1:1 to arm A (chemotherapy alone) or arm B, adding bevacizumab at 15 mg/kg every 3 weeks starting with cycle 1 of chemotherapy and continuing for 1 year. Post-operative radiation therapy was not allowed. The study had 85% power to detect a 21% reduction in the overall survival (OS) hazard rate with a one-sided 0.025-level test.
Results:
From July 2007 to September 2013, 1501 patients were enrolled. Patients were 49.8% male, predominantly white (87.9%) with a median age of 61 years. Patients enrolled had tumors that were 26.2% stage IB, 43.8% stage II and 30.0% stage IIIA and 28.2% of patients had squamous cell histology. Chemotherapy options were utilized with the following distribution: vinorelbine 25.0%, docetaxel 22.9%, gemcitabine 18.9% and pemetrexed 33.2%. At a planned interim analysis, with 412 of 676 overall survival events needed for full information (60.9%), though the pre-planned futility boundary was not crossed, the Data Safety Monitoring Committee recommended releasing the trial results based on the conditional power of the logrank test. At the time of interim analysis, with a median follow-up time of 41 months, the OS hazard ratio comparing the bevacizumab containing arm (Arm B) to chemotherapy alone (Arm A) was 0.99 (95% CI: 0.81-1.21, p=0.93). The DFS hazard ratio was 0.98 (95% CI: 0.84-1.14, p=0.75). Completion of treatment per protocol was 80% on Arm A and 36% on Arm B. Statistically significantly increased grade 3-5 toxicities of note (all attributions) included: overall worst grade (67% versus 84%); hypertension (8% versus 30%), and neutropenia (33% versus 38%) on Arms A and B, respectively. There was no significant difference in grade 5 adverse events per arm with 16 (2%) on arm A and 19 (3%) on arm B.
Conclusion:
The addition of bevacizumab to adjuvant chemotherapy failed to improve survival for patients with surgically resected early stage NSCLC.
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