Initiative for Early Lung Cancer Research on Treatment: Development of Study Design and Pilot Implementation

doi:10.1016/j.jtho.2018.03.009

Journal of Thoracic Oncology

Volume 13, Issue 7, July 2018, Pages 946-957

Presented multiple abstracts related to this article at IASLC 17^th World Conference on Lung Cancer in Vienna 2016 and in Yokohama 2017.

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Abstract

Introduction

To maximize the benefits of computed tomographic screening for lung cancer, optimal treatment for small, early lung cancers is needed. Limiting the extent of surgery spares lung tissue, preserves pulmonary function, and decreases operative time, complications, and morbidities. It also increases the likelihood of resecting future new primary lung cancers. The goal is to assess alternative treatments in a timely manner.

Methods

The focus sessions with patients and physicians separately highlighted the need to consider their perceptions. Literature reviews and analyses of treatment results using large databases were performed to formulate critical questions about long-term treatment outcomes, recurrence, and quality of life of alternative treatments. Based on these analyses, the investigators developed a prospective multi-institutional cohort study, the Initiative for Early Lung Cancer Research for Treatment, to compare treatments for stage I NSCLC. HIPAA compliant institutional review board approval was obtained and we performed a feasibility study of the first 206 surgical patients.

Results

Lobectomy was performed in 89 (43.2%) patients, and sublobar resection was performed in 117 (56.7%) patients. Mediastinal lymph node resection was performed in 173 (84.0%) patients, 8 had N1 and 3 N2 lymph node metastases. Patients stated that both the surgeon’s opinion (93%) and the patient’s own opinion (93%) were extremely important, followed by the patients’ view that the chosen procedure would provide the best quality of life (90%).

Conclusions

It was feasible to obtain pre- and postsurgical information from patients and surgeons. We anticipate statistically meaningful results about treatment alternatives in 3 to 5 years.

Keywords

stage I treatment

surgery

radiotherapy

mediastinal lymph nodes

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: Disclosures: 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. Reeves 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 CRF, are non-exclusively licensed to General Electric. As an inventor of these patents, Dr. Reeves is entitled to a share of any compensation which CRF may receive from its commercialization of these patents. Dr. Reeves is the President of D4Vision and has stock ownership in Visiongate, Inc. 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. 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 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 remaining authors declare no conflict of interest.

^∗∗: See Appendix for the Initiative for Early Lung Cancer Research on Treatment Investigators.