Abstract
Purpose
Clinical management decisions arising from the baseline round for lung cancer screening are the most challenging, as findings have accumulated over a lifetime and may be of no clinical concern. To minimize unnecessary harms and costs of workup prior to the first, annual repeat screening, workup should be limited to participants with the highest suspicion of lung cancer while still aiming to identify small, early lung cancers.
Methods
We compared recommendations for immediate, delayed (by 3 or 6 months) workup to assess growth at a malignant rate, and the resulting overall and potential biopsies of three baseline screening protocols: I-ELCAP, the two scenarios of ACR-LungRADS, and the European Consortium. For each protocol, the efficiency ratio (ER) of each recommendation was calculated by dividing the number of participants recommended for that workup by the number of resulting lung cancer diagnoses. The ER for potential biopsies was calculated, assuming that biopsies were performed on all participants recommended for immediate workup as well as those diagnosed with lung cancer after delayed workup.
Results
For I-ELCAP, ACR-LungRADS Scenario 1, ACR-LungRADS Scenario 2, and the European consortium, the overall ER was 13.9, 18.3, 18.3, and 31.9, respectively, and for potential biopsies, it was 2.2, 8.1, 3.2, and 4.4, respectively. ER for immediate workup was 2.9, 8.6, 3.9, and 5.6, respectively, and for delayed workup was 36.1, 160.3, 57.8, and 111.9, respectively.
Conclusions
I-ELCAP recommendations had the lowest ER values for overall, immediate, and delayed workup, and for potential biopsies.
Key Points
• Small differences in protocol thresholds can lead to many unnecessary diagnostic workups.
• I-ELCAP recommendations were the most efficient for immediate and overall workup, and potential biopsies.
• Definition of a “positive result” and recommendations for further workup in the baseline round needs to be continually reevaluated and updated.
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Change history
04 February 2019
The original version of this article, published on 03 December 2018, unfortunately contained a mistake.
Abbreviations
- AAPM:
-
American Association of Physicists in Medicine
- ACR:
-
American College of Radiology
- CMS:
-
Centers for Medicare and Medicaid Services
- ER:
-
Efficiency ratio
- I-ELCAP:
-
International Early Lung Cancer Action Program
- LDCT:
-
Low-dose computed tomography
- LungRADS:
-
Lung Imaging Reporting and Data System
- NCN:
-
Noncalcified nodules
- NELSON:
-
The Dutch-Belgian Lung Cancer Screening Trial
- PET:
-
Positron emission tomography
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Acknowledgements
I-ELCAP Investigators
Mount Sinai School of Medicine, New York, NY: Claudia I. Henschke, Principal Investigator, David F. Yankelevitz, Rowena Yip, Dongming Xu, Mary Salvatore, Raja Flores, Andrea Wolf; Weill Cornell Medical College: Dorothy I. McCauley, Mildred Chen, Daniel M. Libby, Olli S. Miettinen, James P. Smith, Mark Pasmantier; Cornell University: A. P. Reeves; CBNS, City University of New York at Queens College, Queens, NY; Steven Markowitz, Albert Miller; Fundacion Instituto Valenciano de Oncologia, Valencia, Spain: Jose Cervera Deval; University of Toronto, Princess Margaret Hospital, Toronto, Canada: Heidi Schmidt, Demetris Patsios; Azumi General Hospital, Nagano, Japan: Shusuke Sone, Takaomi Hanaoka; Clinica Universitaria de Navarra, Pamplona, Spain: Javier Zulueta, Luis Montuenga, Maria D. Lozano; Swedish Medical Center, Seattle, WA: Ralph Aye; Christiana Care, Helen F. Graham Cancer Center, Newark, DE: Thomas Bauer; National Cancer Institute Regina Elena, Rome, Italy: Stefano Canitano, Salvatore Giunta; St.Agnes Cancer Center, Baltimore, MD: Enser Cole; LungenZentrum Hirslanden, Zurich, Switzerland: Karl Klingler; Columbia University Medical Center, New York, NY: John H.M. Austin, Gregory D. N. Pearson; Hadassah Medical Organization, Jerusalem, Israel: Dorith Shaham; Holy Cross Hospital Cancer Institute, Silver Spring, MD: Cheryl Aylesworth; Nebraska Methodist Hospital, Omaha NE: Patrick Meyers; South Nassau Communities Hospital, Long Island, NY: Shahriyour Andaz; Eisenhower Lucy Curci Cancer Center, Rancho Mirage, CA; Davood Vafai; New York University Medical Center, New York, NY: David Naidich, Georgeann McGuinness; Dorothy E. Schneider Cancer Center, Mills-Peninsula Health Services, San Mateo, CA: Barry Sheppard; State University of New York at Stony Brook, Stony Brook, NY: Matthew Rifkin; ProHealth Care Regional Cancer Center, Waukesha & Oconomowoc Memorial Hospitals, Oconomowoc, WI: M. Kristin Thorsen, Richard Hansen; Maimonides Medical Center, Brooklyn, NY: Samuel Kopel; Wellstar Health System, Marietta GA: William Mayfield; St. Joseph Health Center, St. Charles, MO: Dan Luedke; Roswell Park Cancer Institute, Buffalo, NY: Donald Klippenstein, Alan Litwin, Peter A. Loud; Upstate Medical Center, Syracuse, NY: Leslie J. Kohman, Ernest M. Scalzetti; Jackson Memorial Hospital, University of Miami, Miami, FL; Richard Thurer; State University of New York, North Shore-Long Island Jewish Health System, New Hyde Park, NY: Arfa Khan, Rakesh Shah; The 5th Affiliated Hospital of Sun Yat-Sen University, Zhuhai, China: Xueguo Liu; Mercy Medical Center, Rockville Center, NY: Gary Herzog; Shin Kong Wu Ho-Su memorial Hospital, Taipei, Taiwan: Diane Yeh; National Cancer Institute of China, Beijing, China: Ning Wu; Staten Island University Hospital, Staten Island NY: Joseph Lowry, Mary Salvatore; Central Main Medical Center: Carmine Frumiento; Mount Sinai School of Medicine, New York, NY: David S. Mendelson; Georgia Institute for Lung Cancer Research, Atlanta, GA: Michael V. Smith; The Valley Hospital Cancer Center, Paramus NJ: Robert Korst; Health Group Physimed/McGill University, Montreal, CA: Jana Taylor; Memorial Sloan-Kettering Cancer Center, New York, NY: Robert T. Heelan, Michelle S. Ginsberg; John Muir Cancer Institute, Concord CA: Michaela Straznicka; Atlantic Health Morristown Memorial Hospital, Morristown NJ: Mark Widmann; Alta Bates Summit Medical Center, Berkeley CA: Gary Cecchi; New York Medical College, Valhalla, NY: Terence A.S. Matalon; St. Joseph’s Hospital, Atlanta GA: Paul Scheinberg; Mount Sinai Comprehensive Cancer Center, Miami Beach, FL: Shari-Lynn Odzer; Aurora St. Luke’s Medical Center, Milwaukee WI: David Olsen; City of Hope National Medical Center, Duarte, CA: Fred Grannis, Arnold Rotter; Evanston Northwestern Healthcare Medical Group, Evanston, IL: Daniel Ray; Greenwich Hospital, Greenwich, CT: David Mullen; Our Lady of Mercy Medical Center, Bronx, NY: Peter H. Wiernik; Baylor University Medical Center, Dallas TX: Edson H. Cheung; Sequoia Hospital, Redwood City CA: Melissa Lim; Glens Falls Hospital, Glens Falls NY: Louis DeCunzo; Atlantic Medical Imaging, Atlantic City NJ: Robert Glassberg; Karmanos Cancer Institute, Detroit, MI: Harvey Pass, Carmen Endress; Rush University, Chicago IL: Mark Yoder, Palmi Shah; Building Trades, Oak Ridge TN: Laura Welch; Sharp Memorial Hospital, San Diego, CA: Michael Kalafer; Newark Beth Israel Medical Center, Newark NJ Jeremy Green; Guthrie Cancer Center, Sayre PA: Comprehensive Cancer Centers of the Desert, Palm Springs CA: Elmer Camacho; Dickstein Cancer Treatment Center, White Plains Hospital, White Plains NY: Cynthia Chin; Presbyterian Healthcare, Charlotte NC: James O’Brien; SUNY Downstate, Brooklyn NY: David Gorden; Bend Memorial Hospital, Bend OR: Albert Koch; University of Toledo, Toledo OH: James Wiley. The conclusions stated in this report are those of the authors and do not represent the views or policies of the Department of Veterans Affairs and the U.S. Government.
Funding
This study was partially funded by the Flight Attendants Medical Research Institute and the U. S. Department of Veterans Affairs.
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The scientific guarantor of this publication is Dr. Claudia Henschke.
Conflict of interest
The authors of this manuscript declare relationships with the following companies:
Dr. Yankelevitz is a named inventor on a number of patents and patent applications relating to the evaluation of diseases of the chest including measurement of nodules. Some of these, which are owned by Cornell Research Foundation (CRF), are non-exclusively licensed to General Electric. As an inventor of these patents, Dr. Yankelevitz is entitled to a share of any compensation which CRF may receive from its commercialization of these patents. He is also an equity owner in Accumetra, a privately held technology company committed to improving the science and practice of image-based decision making. Dr. Yankelevitz also serves on the advisory board of GRAIL.
Dr. Henschke is the President and serves on the board of the Early Diagnosis and Treatment Research Foundation. She receives no compensation from the Foundation. The Foundation is established to provide grants for projects, conferences, and public databases for research on early diagnosis and treatment of diseases. Dr. Claudia Henschke is also a named inventor on a number of patents and patent applications relating to the evaluation of pulmonary nodules on CT scans of the chest which are owned by Cornell Research Foundation (CRF). Since 2009, Dr. Henschke does not accept any financial benefit from these patents including royalties and any other proceeds related to the patents or patent applications owned by CRF.
The other authors of this manuscript declare no relationships with any companies, whose products or services may be related to the subject matter of the article.
Statistics and biometry
Two of the authors have significant statistical expertise (Claudia Henschke and Rowena Yip).
Informed consent
Written informed consent was obtained from all subjects (patients) in this study.
Ethical approval
Institutional Review Board approval was obtained.
Study subjects or cohorts overlap
Some study subjects have been previously reported for lung findings but comparison of the three protocols and recommendations for invasive workup and resulting diagnoses have never been reported.
Methodology
• Retrospective
• Observational (cohort)
• Multicenter study
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The original version of this article was revised: The presentation of Table 3 was incorrect.
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Henschke, C.I., Yip, R., Ma, T. et al. CT screening for lung cancer: comparison of three baseline screening protocols. Eur Radiol 29, 5217–5226 (2019). https://doi.org/10.1007/s00330-018-5857-5
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DOI: https://doi.org/10.1007/s00330-018-5857-5