The Third International Conference on Screening for Lung Cancer
Locations:
Morning Session Weiss Dinning Hall, 17th Floor Rockefeller University 1230 York Avenue, New York NY 10021
All Other Sessions
(Locations for different meetings will be posted outside of the Uris Auditorium) Weill Medical College of Cornell University 1300 York Avenue, New York NY 10021
Friday, October 27, 2000 to Sunday, October 29, 2000.
Workshops Summaries
Workshop I: "Ground-glass opacities": Definition, Detection, Workup, Diagnosis and Treatment (Imaging, Biopsy, Pathology, Surgery):
Background:
CT screening for lung cancer leads to radiographic detection not only of previously familiar focal opacities ('nodules') but also of abnormalities peculiar to this novel type of imaging: 'ground-glass opacities,' equally focal. These constitute, at present, quite a confusing topic for the 'screening' -- early diagnosis -- itself, and also for decisions about early intervention following the diagnosis of malignancy for such a lesion.
Mission:
Most broadly, the workshop's mission is to seek proposed consensus statement(s) for the conference on at least some of the issues surrounding diagnosis and intervention in the context of these lesions. Among the issues that might be addressed are these:
1. What is a suitable definition (descriptive) for this finding on CT, and what would be a suitable term referring to it?
2. What are the principal subtypes to be distinguished in these CT findings, and what would be suitable terms referring to them?
3. At this stage of understanding the significance of these CT findings, what would be a reasonable approach to the use of further diagnostics?
A. Guidelines for CT documentation of growth, and rate of growth, before biopsy.
B. Guidelines for carrying out biopsy, and for adequacy of the biopsy sample.
C. Guidelines for documenting pathologic findings and for making pathologic diagnosis, based on an adequate biopsy sample.
D. Guidelines for combining the growth and pathologic findings into final diagnosis about malignancy.
4. Given a diagnosis of malignancy, and the relevant particulars of this, what are the intervention options to consider and the relative merits of these?
Workshop I Participants
Trond Mogens Aalokken, Nasser Altorki (co-chair), Samuel G. Armato III, Giovanni Artho, Hisao Asamura (co-chair), Peter Bach, Roy Bremnes, William Butler, Anat Caspi, Darryl Carter, Robert Clark, Asper Dirksen, Orly Goitein, Salvatore Guinta, James Herman, Fred Hirsh, Ryutaro Kakinuma (co-chair), Shinji Kato, Marek Kimmel, Ara Klijian, Karl Klingler, William Kostis, John Lechner, Daniel Libby, Dorothy McCauley, Georgeann McGuinness, Cristopher A. Meyer, David Naidich (co-chair), Masayuki Noguchi (co-chair), Jesper Holst Pedersen, Armin Pfoh, Meyer Rosen, Selma Rosen, Valerie Rusch, Joseph Schoepf, Alexander Schneider, Dorith Shaham, Shusuke Sone, John Stanley, David Stav, Richard Thurer, Irena Tocino, Madeleine Vazquez (co-chair), Thelma Calo Villanueva, Deborah Walter, Stephen Walter, David Yankelevitz (co-chair), Tomoyuki Yokose (co-chair), Xiaolan Zeng and Javier Zulueta Frances.
Workshop I Summary
The participants of Workshop 1 defined the term "ground-glass opacity" as a CT finding of a partially-opaque region that does not obscure the structures contained within (e.g. vessels). It was generally understood that the term "ground-glass opacity" (GGO) is a very non-specific term used in general radiologic practice and does not accurately reflect what is actually seen in the CT image. Additionally more specific terminology would be helpful in the context of CT screening. Two terms were suggested: Focal Translucencies (FT) and Focal Partial Opacity (FPO). It was also recognized that the term Focal Ground-Glass Opacity (FGGO) would be widely understood and easily accepted into the medical community. Two principal subtypes were identified: simple and complex. A simple 'GGO' is a focal translucency which is homogeneous in appearance, without the presence of solid or linear components or distortion of the lung parenchyma (e.g. convergence of vessels). A complex 'GGO' is a focal translucency which has at least one of the following features: heterogeneous appearance, the presence of solid or linear components, or distortion of the lung parenchyma (e.g. convergence of vessels).
It was suggested that tools should be developed for growth estimation in both simple and complex subtypes, including those able to quantitate change in density, as this may represent the filling in of air spaces, thus internal growth. Computer-aided methods will play an important role as even the borders of these lesions are difficult to delineate with conventional methods. In particular, it was noted that methods able to quantitate the size, density, mass, and change in each over time should be studied. Furthermore, methods able to separately quantitate these metrics for the solid and non-solid components of these lesions would be especially useful. Until such methods are available, it was suggested that the relative size of the solid components to the entire lesion be estimated, if possible.
It was generally recognized that the simple subtypes are more indolent than the complex. The complex subtype should be managed using the current standards for solid nodules. No preference was noted between transthoracic fine needle aspiration (FNA) and core biopsy. It was determined, however, that in the case of the complex subtype, the biopsy should include the solid components of the lesion. In the case of an focal area of ground-glass density, a transthoracic needle biopsy may be used to differentiate between benign inflammatory lesions, aggressive carcinomas, and borderline bronchioloaveloar lesions in the spectrum of atypical adenomatous hyperplasia (AAH) and bronchioloalveolar carcinoma (BAC), for which further open-lung biopsy may be indicated. It was suggested that pathologic findings (cytologic and histologic) should be documented using a common format to facilitate data pooling, as well as the development of a database (teaching file) for the study of these lesions. It was determined that there is not sufficient information at this point to specify guidelines for the combination of growth and pathologic information in all cases, although the correlation of changes in the overall size, as well as the size of the solid components in complex lesions should be correlated with changes in pathology. It was also noted that BAC, which can appear as a simple subtype, may not demonstrate significant growth over long periods of time. Pathologic diagnosis of the simple subtype based on biospy may lead to three broad categories of findings: inflammatory, atypical bronchioloalveolar proliferation, and adenocarcinoma. Inflammatory lesions should continue to be followed radiologically without immediate intervention. Atypical bronchioloalveolar proliferation is a less-specific category and the initial intervention should be wedge resection whereupon an attempt is made to evaluate for invasion (e.g. with elastic stains) and, if found, converted to standard lobectomy. Although participants felt that limited resection such as wedge resection and segmentectomy would be curative for such non-invasive bronchioloalveolar lesions, there is no sufficiently well-developed database to prove this, so that prudent management, especially for larger lesions, should be taken at present. Adenocarcinoma should be managed in the standard fashion. .
It was recognized that there is a clear need to learn more about the natural history of these abnormalities. This entails the development of large databases containing documentation of the relevant radiologic and pathologic features of these lesions. In addition, teaching files should be made available, along with an attempt to more clearly define common data elements. It is also recognized as further knowledge is gained, we may be able to identify which lesions may be followed at longer intervals without the need for intervention. These lesions are often multiple and further information is needed to define management of multifocal lesions.
Workshop II: Pooling of Research Data
Background:
Data relevant to the advancement of the knowledge-base of practice in screening for lung cancer derive, most broadly, from three types of source:
RCTs contrasting screening with no screening, or one type of screening with another, experimental screening outside RCTs, and practice of screening. Rapid advancement of the requisite knowledge calls for timely pooling of the evidence from those different sources -- insofar as this is scientifically justifiable and practically feasible. The pursuit of this already is the mission of the I-ELCAP.
Mission:
Most broadly, the workshop's mission is to seek proposed consensus statement(s) for the Conference on the issues surrounding the pooling of evidence from various sources. Among the issues that might be addressed are these:
1. What would be the most natural institution to manage the repository of pooled data?
2. What guidelines should, in the main, govern that institution's relations with the other institutions that contribute data?
A. Should the guidelines be developed and/or adopted by that repository institution alone, upon consultations with institutions/groups/experts of its own choosing? If not, then what?
B. What should the guidelines address?
Eligibility for becoming a contributing project/program/institution? Eligibility for continuation? Ownership of data? Publication policies? Other?
3. How should the pooling program be financed, centrally and as for the contributors?
Workshop II Participants
Nathaniel Berlin, Nancy Breen, David Burns, Ray Donnelly, John Field, Olga Gorlova, Claudia Henschke, Janet Husband, Fred Grannis, Barbara Kimmel, Marek Kimmel (co-chair), Anthony Reeves, E.R. Salomaa, Stefan Schaller, Michael V. Smith, Daniel Sullivan (co-chair), Melvyn S. Tockman, Stephen Walter and Denise Warzel
Workshop II Summary
Workshop II, addressed pooling of research data, recommended that a cooperative group be formed for the purpose of timely pooling data on screen-detected lung cancers and their long-term follow-up, with a special emphasis on incidence data. The highest priority issue is to answer the public policy question of whether lung-cancer screening is effective.
It recommended that a review be made of the organizational structure of other relevant cooperative groups. Participation in the group should include: IRB approval for participation, Membership Committee approval of the screening program, acceptance of technical guidelines and standards of diagnosis and treatment, commitment to use the common data system. Along these lines, it was recommended that the already functioning I-ELCAP Membership Committee be expanded to constitute the initial Cooperative Group Membership Committee. Other suggested committees were the Informatics Committee. This committee should be convened as soon as possible but before the next meeting in order to refine the existing I-ELCAP Database by assessing current databases, identifying additional components, developing international informatics requirements, and defining the system configuration and report the progress of their efforts at the 4th International Conference on Screening for Lung Cancer. It was decided that a Subcommittee consisting of the PI's and informaticians of the Cornell, Mayo and Moffitt CT-screening studies will meet within the next month to identify the opportunity for pooling their existing data and the resources needed. This group will identify and solicit sources of funding to accomplish these tasks. Charter membership: Informatics Committee consists of: Denise Warzel (advisor), Michael Smith, representatives from Europe, a representative from Japan, and the members of the Subcommittee.
Workshop III: Outlook for Screening Research
Background:
In directly practice-oriented research on screening for lung cancer there is, at present, a profound duality of outlooks as to what needs to be addressed in the research and what type of research is needed. The ELCAP outlook is delineated in a brief document included in the Conference folder. The alternative to this calls for addressing screening's effect on lung-cancer 'mortality' by means of a randomized controlled trial (RCT) contrasting screening with no screening, or one type of screening with another.
Mission:
Most broadly, the workshop's mission is to seek proposed consensus statement(s) for the Conference on the issues involved in this duality of outlooks. Among the issues that might be addressed are these:
1. Is a given regimen of 'screening' best understood as encompassing not only the initial test (replacing symptoms and signs) but the entire algorithm of early (before symptoms/signs) diagnosis?
2. Related to this, is it reasonable in screening research to sharply distinguish between the issues of early diagnosis and those of early intervention -- between the domain of disciplines such as radiology and pathology and that of disciplines such as surgery?
3. Is the core idea in the pursuit of early diagnosis of lung cancer that of providing for reduced fatality of the disease through early intervention?
4. What is the relation of the RCT focus on lung-cancer 'mortality' and the clinical concern for fatality.
5. Does the RCT approach lend itself for studying the relative merits of early and late intervention in preventing death from lung cancer?
Workshop III Participants:
We had invited a senior NCI epidemiologist to co-chair this workshop with the aim of having a scientific discussion of the juxtaposition of two very different outlooks in terms of screening practice - one by the NCI on the RCT with mortality endpoint and the other the ELCAP outlook and moving towards convergence between the two outlooks. As this invitation was not accepted, we canceled the workshop.
Workshop IV: Recommendations for Screening Practice
Background:
Practice of CT screening for lung cancer has suddenly become a rather widespread reality in the United States. Moreover, in a recent paper included in the Conference folder (Miettinen, CMAJ 2000) it is argued that, with suitable specifications of the regimen of 'screening' (early diagnosis), the organization of its 'delivery' and the indication for this, the practice can already be deemed to be cost-effective.
Mission:
Most broadly, the workshop's mission is to seek proposed consensus statement(s) for the Conference on the justifiability of lung-cancer screening practice in the context of what is known at the present stage of the relevant knowledge. Among the issues that might be addressed are these:
1. Has the advent of helical CT -- for use in the initial test and also in the definitive diagnostics following a positive result of the initial test -- created a new situation such that the possibility of defining justifiable practice, to a limited extent, already needs to be seriously considered?
2. If so, should a suitable group of experts be brought together to address this issue?
3. If so, how should this group be constituted?
4. If the answers to these questions are negative, what consensus statement to this effect should the Conference adopt?
Workshop IV Participants
Raji Ayinla, Joel J. Bechtel, Christian Brambilla, Peter Canaday, Robert Clark, Li Fan, Matthew Freedman, Robert Ginsberg, David H. Gordon, David Gruen, Randall Hughes, Junpei Ikezoe, Patti Jamieson-Baker, James Jett, Michael Kalafer, Hyae Young Kim, Ernst Klotz, Meir Krupsky, Jeffrey Miller, James Mulshine, Takesh Nawa, Carol Novak, Dennis Nowak, Meenakshi Pandit, Harvey Pass, Armin Pfoh, JianZhong Qian, Stephen Raskin, John Ruckdeschel (co-chair), Carol Satchell, Jeff Schragin, James P Smith (co-chair), Robert Smith (co-chair), John Stanley, David Stav, Gary M. Strauss, Ethan Tarasov, Alvin Teirstein, Terry Tyler, Michael Unger, Manuel Valdivieso, Daniel R. Vlock, Gitta von Woellenwarth, Susan Wood, Michael Yeh, Junji Yoshida, Robb Young and Heidi Zhang.
Workshop IV Summary
People should be made aware of what is knows about the benefits and limitations and risks associated with CT screening for diagnosis of early lung cancer. Individuals who choose to undergo testing should have access to testing and follow-up that meets state-of-the-art standards, and informed decision making should take place at every step of an ongoing process. While they felt that the recommendation for screening should be through an individual's primary care physician, that in the absence of referral due to lack of provider or lack of the provider endorsement of screening should not be a barrier. In such cases, the radiologist who provides the screening test must become the physician of record until proper alternative care arrangements can be made. Specialty societies should develop professional standards related to unique specialty responsibilities and collaborative roles in the early diagnosis and treatment of lung cancer in order to insure state-of-the-art care.
The workshop participants endorse the role of the American Cancer Society updating their narrative related to informed decision making about screening for early lung cancer detection in individuals at increased risk of lung cancer. The participants endorsed the role of professional societies of radiology to develop a Lung CT Accreditation Program. The participants also endorsed the creation of an international consortium (to be named) which should organize individuals and organizations who are interested in early lung cancer in the broadest sense, should have very strong, collaborating ties to other organization in order to be inclusive, foster productive collaborations, and avoid splintering. This consortium should have a head and an executive committee. Its mission in its broadest sense would be dual: 1) Advancement of policy-relevant research on early lung cancer with emphasis on collaboration among research groups including pooling of research data, 2) fostering translation of up-to-date evidence into guidelines for practice.
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