Lung Cancer Screening Study

Hartford HealthCare Cancer Institute

Andrew L. Salner, MD FACR
Medical Director, Hartford HealthCare Cancer Institute at Hartford Hospital


Background

Launched in 2002 by the National Cancer Institute, the National Lung Screening Trial (NLST) compared two ways of detecting lung cancer: low-dose helical (spiral) computed tomography (CT) and standard chest X-ray, for their effects on lung cancer death rates in a high-risk population of former and current smokers. Both chest X-rays and helical CT scans have been used as a means to find lung cancer early, but the effects of these screening techniques on lung cancer mortality rates had not been determined definitively. Over a 21 month period, 53,454 current or former heavy smokers ages 55 to 74 joined the NLST at study centers across the United States. (1)

The NLST researchers found approximately 15 percent to 20 percent fewer lung cancer deaths among trial participants screened with low-dose helical CT relative to chest X-ray. This finding was highly significant from a statistical viewpoint, meaning it was due not to chance but rather to screening with helical CT. An additional finding, which was not the main endpoint of the trial's design, showed that all-cause mortality (deaths due to any factor, including lung cancer) was 6.7 percent lower in those screened with low-dose helical CT relative to those screened with chest X-ray. This difference was largely due to the decrease in lung cancer mortality. (1)

Considering the notion that tobacco use is the largest cause of cancer mortality, accounting for nearly 1/3 of all cancer deaths, and that tobacco use is a the major preventable cause of disease and death in our society by increasing risk of cardiac, pulmonary, vascular and other diseases, the researchers felt a compelling need to look for a screening modality which could detect the disease early. In the non- screened population, approximately 75% of patients present with a more advanced stage of lung cancer, stages III and IV. In the NLST trial, approximately 75% of patients presented with early and much more curable disease, primarily stage I. Indeed, we have successful screening strategies for other common cancers such as breast and colon cancer, but historically no good screening strategy for the largest cause of cancer mortality, lung cancer.

Questions

Upon publication of these exciting results, but prior to routine insurance coverage of such screening studies, Hartford HealthCare researchers and clinicians discussed how we might explore determining the feasibility of initiating a lung cancer screening program in Connecticut. The following cogent questions were asked:

  1. Can we initiate a PCP referral based study?
  2. Can we implement it across our system?
  3. Can the clients (patients) be representative of our community in terms of ethnic, racial and socioeconomic diversity?
  4. Will clients (patients) participate?
  5. Will radiologists standardize reporting?
  6. Can we link tobacco cessation efforts?
  7. Might results mimic NLST?

Research Study

As a result of these very good questions, our research team visited colleagues at Lahey Clinic, an early adopter and research center for lung cancer screening. In collaboration, we designed a research study amongst the Hartford HealthCare hospitals that could answer these questions and allow us to develop standards for lung cancer screening in Connecticut. Co-investigators were designated at each of the 4 participating sites as follows:

Given the lack of insurance coverage for the study, and our desire to discover how well we could adopt a screening program to serve our community, our hospitals and radiologists agreed to provide the low dose CT scans and interpretations at no charge to the patient as part of the research study. This helped to eliminate a potential barrier of patient cost.

Eligibility

Eligibility for our study included

  1. Group 1-54-74 current or former smoker within 15 years, 30+ pack years
  2. Group 2-54-74 current or former smoker within 15 years, 20+ pack years + 1 risk factor-personal history smoking related cancer, family history of lung cancer in a first degree relative, chronic lung disease such as emphysema or pulmonary fibrosis, carcinogen exposure, i.e.: arsenic, asbestos, cadmium, chromium, diesel fumes, nickel, radon and silica
  3. Asymptomatic
  4. No active cancer in 5 years
  5. No CT chest in past 18 months
  6. Able to lie on back with arms above head
  7. Must have a PCP
  8. We will help identify a new PCP for those without one

Flow diagrams were developed for patient entry as well as for results handling and patient scheduling and are seen in figure 1 and figure 2.

A standardized and nationally accepted radiology reporting system was adopted, and a limited core of thoracic radiologists form each hospital agreed to interpret all of the CT scans in the study.

Formal Institutional Review Board Approval of our study was obtained.

A multifaceted marketing program to hospital based and private practice MDs was developed, consisting of:

  1. Letters and emails
  2. Grand rounds presentations
  3. PCP marketing teams
  4. No direct to patient marketing

As compared with screening for breast cancer and other cancers which can be self-referred, we determined that there needed to be a discussion with a physician and patient about the pros and cons of the screening. In addition, there needed to be a responsible provider who could receive the results and explain them to the patient to suggest further action if needed. Results not only include the presence or absence of a specific suspicious nodule or mass, but also a host of other abnormalities which could occur in other tissues such as thyroid, breast tissue, aorta, heart, mediastinum, kidney, rib and chest wall, or liver. These so called “S” findings also need appropriate followup for patients with such abnormalities.

Free tobacco cessation counseling was offered and made available to all participating patients who wer active smokers.

Accrual

In 2014-6, a total of 976 eligible individuals were accrued to the study and underwent annual CT screening. Demographics are seen in table 1. A relatively equal number of men and women entered the study. 4.2% and 4.4% of the patients were African American and Hispanic respectively. 10% and 13% of patients had Medicaid coverage or were uninsured respectively. These numbers demonstrated our ability to reach underserved members of our communities in a fairly representative number of the community as a whole. 88% of patients had group 1 eligibility criteria, and 12% with group 2.

Study Findings

6% of patients had suspicious (lungrad 4) findings, and 124 patients had S findings. S findings include a variety of abnormalities, the large majority of which were benign, including adrenal lesion, coronary artery calcification, aortic aneurysm, mediastinal mass, thyroid nodule, liver mass, breast mass, and renal mass. Sixteen patients (1.6%) were found t have a new primary lung malignancy. Twelve of these sixteen, or 75% had stage 1 disease. This percentage matches findings from NLST. Three of 16 had group 2 disease, suggesting that the group 2 criteria are also a high risk group. Thus far, CMS (Medicare and Medicaid) have accepted group 1 criteria for eligibility for insurance coverage only, and we are amongst a group of researchers advocating to add group 2. Two of the sixteen started as lungrad 3 and progressed, supporting the notion of annual screening of this high risk group. Three patients had other cancers involving the lung, two metastatic from other previously unknown primary cancer sites outside the thorax, and one lymphoma.

Conclusions

An essential philosophy of cancer investigation is to recognize that in order to learn something we must ask the right question. In order to answer it we must design the right research strategy. In starting a new program there are always questions to ask, and important learnings to provide new data and strategies. Our research project not only allowed us to gain the needed experience with this new modality, but also helped us to implement a new program under the rigor of a research project.

A primary care physician referral based model works in the community setting amongst a system of hospitals, and can be successfully implemented with system wide standards and protocols. Clients will participate from various racial, ethnic, and socioeconomic strata, representing the communities we serve. In particular, barriers to screening medically underserved populations did not hinder this work. Radiologists and departments from four different hospitals can collaborate effectively. Our Hartford HealthCare system study data provides similar outcomes to NLST in terms of primary lung cancer incidence and early stage, again supporting the potential for reducing mortality in this high risk population. Tobacco cessation can be linked to screening and perhaps can be enhanced in terms of participation given the notion that screening represents a “teachable moment”.

Lung cancer screening is now available at all HHC hospitals for eligible patients. It is routinely covered by most insurance plans. It takes 10 minutes, is painless, and can save lives. For more information about lung cancer screening at Hartford HealthCare, please call Cancer Connect 855.255.6181.


(1) https://www.cancer.gov/types/lung/research/nlst-qa

Hartford HealthCare Cancer Institute


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