The Fifth International Conference on Screening for Lung Cancer
Location: Weill Medical College of Cornell University
1300 York Avenue, New York NY 10021
Friday, October 26, 2001 to Sunday, October 28, 2001
Summaries of Workshops
Workshop I: I-ELCAP protocol.
Chairs: Donald Klippenstein and Claudia Henschke
Mission: To identify any possibly needed amendments to the I-ELCAP protocol, and to present the respective rationales for these.
Workshop Attendees: Nathaniel Berlin, Michael Kalafer, Margaret McCarthy, Dorothy McCauley, Albert Miller, Arnie Rotter, Robert Swanson, Carman Endress.
Recommendations:
1. For non-calcified nodules 3 mm or less in diameter (average of length and width) detected on the initial screening CT, change the follow up period from 6 months to one year. Nodules on the initial screening CT that are greater than 3 mm but less than 5 mm would continue to receive a 6-month follow-up CT, and the recommendations for nodules 5 mm or larger would not change.
This protocol change would avoid a large number of unnecessary 6-month follow-up CT scans. This recommendation is based on the large number of tiny non-calcified nodules detected on thin-slice low-dose CT, the very low likelihood of any one of these nodules representing cancer (based on the original ELCAP and other studies), and the high probability that any non-small cell lung cancer 3 mm or less in diameter initially would still be 10 mm or less in diameter at one year follow up.
2. Flow charts should be added to the protocol as references for follow up studies to be performed when there is a positive CT scan.
3. If collimation of 5 mm or less is used on a single slice CT scanner for the initial screening exam, an additional immediate "diagnostic CT" is not needed for positive CT exams. This may be performed with two breath holds to cover the entire chest as long as there is no gap in the images created by the two breath holds. If the collimation for the low-dose screening CT is greater than 5 mm, a "diagnostic CT" of the chest will still be required for any subject with a positive exam.
This change is to encourage smaller collimation on the initial screening exam for more accurate detection of nodules, to make the exam more comparable with the thin section multi-slice CT exams, and to reduce the number of CT scans the subject receives.
4. Follow up 3 and 6 month CT scans should be performed by localizing the nodule(s) using the same low-dose method as in the initial screening CT followed by high resolution, small field of view 1-1.25 mm imaging through each nodule as currently described in the protocol.
5. Subjects with sub-solid nodules 5 mm or larger in diameter on the initial screening CT should be considered for antibiotic therapy and early follow-up CT.
Workshop II: Study design issues for sub-solid nodules.
Chairs: James P. Smith and David Yankelevitz
Workshop Attendees: Hisao Asamura, Jim Beattie, Douglas Flieder, John Gohagen, Fred Grannis, William Kostis, Ara Klijian, Olli S. Miettinen, Margaret McCarthy, James Mulshine, Harvey Pass, Kayomary Sethna, Mel Tockman, Richard Thurer, Michael Unger, Junji Yoshida and Javier Zulueta..
Mission: Given that there is a need to know the significance of various types of sub-solid nodules with diagnosis of malignancy (misdiagnosis/overdiagnosis perhaps), significance in the sense of course without and with resection, a) to develop a recommendation aobut the desirability to form a retrospective registry of such cases together with documentation of their prospective course; and b) to develop a sense of whether some segment of such cases represent 'equipoise' in respect to justifiability of resection (immediate), thus calling for an RCT.
Workshop Attendees: John Gohagen, Olli S. Miettinen, James Mulshine, Harvey Pass, Fred Grannis, William Kostis, Hisao Asamura, Mel Tockman and Douglas Flieder.
Recommendations:
1. Develop a registry, retrospective and prospective in enrollments, of instances of first detection of sub-solid nodule on CT in order to better understand their natural history. For each instance, document particulars of imaging itself and the nodule finding, as well as the person's risk indicator profile, including most recent CT imaging and its result (in retrospect). Prospectively, document each further CT and its findings, and also biopsy and its result, as well as interventions. Outcome of principal interest is evidence of presence/absence of cancer (progressive by definition).
2. Form a committee of thoracic surgeons and pulmonologists to define types of situation (mainly results from imaging and cytology/histology) such that advisability of resection is equivocal (equipoise). For these situations, the committee also is to define intervention options - to be evaluated in an RCT.
Workshop III: Behavioral research in the I-ELCAP framework.
Chairs: Jamie Ostroff and Suzanne Miller
Mission: To address:1) key psychological and behavioral issues in lung cancer screening as it introduces both opportunities and challenges for promoting lung cancer prevention and control, 2) emerging clinical data examining recruitment and retention strategies for reaching high-risk individuals adherence to follow-up recommendations, 3) the magnitude and management of psychological distress and patterns of smoking behavior change, and 4) the tailoring of evidence-based smoking cessation interventions for seeking CT scanning.
Workshop Attendees: David Burns, Bill Butler, Kim Calder, Matthew Freedman, Irwin Feurstein, Janet Healy, Claire Foley, Anita Johnston, Margaret McCarthy, Mary Mites-Campbell, Karen Parles, Victoria Rosenwald, Tom Simon and Paula Trief.
Recommendations:
Recent advances in lung cancer screening and early detection have heralded new opportunities for lung cancer control. However, translating gains in the field of lung cancer screening and early detection requires the development and evaluation of effective cancer risk communication and behavior change approaches for applying these discoveries to promote cancer prevention and control outcomes, particularly given the observed disparities in lung cancer outcomes in ethnic/racial minority groups. Therefore, in order to enhance recruitment and retention of high risk individuals in lung cancer screening programs, to provide information needed to inform health decision making and to promote positive patient-centered outcomes such as smoking cessation and attenuation of cancer worry, we strongly urge ongoing assessment and targeted interventions to promote positive psychological and behavioral outcomes. Based on emerging descriptive data, clinical observation and theory driven models of health behavior, the following recommendations were made:
1. Assessment of Key Psychological and Behavioral Outcomes
In recognition of the likely variation in the psychological and behavioral impact of lung cancer screening, we recommend culturally sensitive measurement of patient-centered outcomes to reflect the diversity of the high risk cohort. Due to the emerging evidence regarding potential psychological and behavioral risks of lung cancer screening and risk notification, we advocate assessment of several key psychological and behavioral outcomes: a) Magnitude of non-adherence to diagnostic work-up and annual repeat scan as well as reasons for non-enrollment and attrition in lung cancer screening research program; b) Smoking cessation and c) Quality of life/distress.
2. Given the feasibility of reaching active smokers, emerging data documenting continued smoking following CT scan and the existence of evidence-based smoking cessation interventions guidelines, I-ELCAP sites should integrate at least brief, evidence based, tobacco use cessation advice and assistance into the routine screening protocol and standard of care.
3. Provide appropriate written information and referral to education and support services related to lung cancer prevention and treatment (e.g., I-ELCAP brochures and ALCASE Lung Cancer Manual depending on CT scan findings) to facilitate patient's informed decision-making and access to optimal lung cancer care.
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