Lung Cancer Screening…The Clock is Ticking
Paul R Billings MD, PhD, CEO and Chairman of Synergenz LTD
Q: Lung cancer screening of smokers (spiral CT over 3 years) is paid for by CMS (reimbursement), has a B endorsement from USPTF (method endorsement), and lots of NEJM papers (academic evidence). As many as 8M eligibles noted since 2012. No more than 400K screened to date. There are now realistic treatments for many of these patients. What is the disconnect and how can it be corrected?
A: The practice of medicine can change. Primum non nocere happily persists but the ever-burdensome realization that patients have a plethora of unmet needs, ailments, diseases and illnesses which cannot be specifically diagnosed or effectively treated demands innovation and practice evolution–new knowledge acquired, proven in care, applied and recurrently assessed with alacrity.
For me, the situation in smokers with risk for Non-Small Cell Lung Cancer (NSCLC) is notably galling. The facts are clear and unusually well established. Lung cancer is a deadly disease in most manifestations throughout the world. While lung lesions can be indolent and small cancers may regress, most detected tumors lead to morbid outcomes. NSCLC (a common pathological type) risk is influenced by genes and by environmental factors (cigarette smoke). The risk and disease burden can be reduced by prolonged removal of the environmental trigger (smoking cessation) and the illness successfully treated by surgery after very early stage diagnosis. In a small percent of more advanced cases, with immunotherapies and/or targeted agents (possibly with additional conventional chemotherapies), prolonged remissions and cures appear possible at substantial costs.
In the USA, several years ago, over 50,000 participants were studied in a randomized prospective clinical trial (RPCT) with a 6 year follow up (National Lung Screening Trial; NLST). The study showed that in heavy smokers in their 5th decade or older, lung cancer screening with 3 years of annual spiral CT (better than plain chest xray) reduced lung cancer deaths by 20% and all cause of death by 7%. This study and various others follow on improvements/observations that were published in the NEJM (NEJM 2011;365(5):395-409), favorably reviewed and graded by the USPTF (with recommendations) and the screening was deemed reimbursable (again with recommendations) by the Center for Medicare and Medicaid Services (CMS). It is unusual to have in a brief period a very large study, great data and a slew of high profile publications, national review body endorsement, and payment for important aspects of the test’s delivery in place.
Both USPTF and CMS noted that many of the findings in this study’s cohort were not cancer, that smoking cessation was a prudent medical course in essentially all study participants, and that screening program enrollees needed to be properly informed, consented and counseled to derive optimal benefits from this screening intervention. While not a simple test and cure scheme, these requirements and others illustrated in a recent report of the VA’s experience with a lung cancer prevention and early detection effort, indicate that a widely adopted program built on this type of testing could save many lives (JAMA Intern Med. 2017;177(3):399-406. doi:10.1001/jamainternmed.2016.9022).
Work is ongoing to better identify smokers that would benefit from screening (the NLST detection rate was about 1 case detected for about 375 screened) and if other smokers (younger, fewer pack/yrs) could be successfully screened. Many lung cancers occur in younger smokers than represented in the NLST cohort. There may be as many as 35,000,000 people who should be screened in this country alone. In addition, some presenting for screening have important comorbid illnesses (COPD and/or ASCVD) which might modify a recommendation for 3 years of annual CT screening to detect early stage NSCLC.
But a key disturbing fact is that despite great clinical science, national review and discussion, attention by institutions and patient groups, and reasonable payer reimbursement, less than 10 percent of the approximately 6 million Americans who fit the original NLST inclusion criteria have been engaged and complied with the endorsed protocol. Given the difficulty in conducting large RPCTs in non-overt disease cohorts, in proving screening benefits (data is not likely to improve), and in coping with the worldwide burden of cancers with risks linked to smoking and environmental inhalants, a better understanding of why we have failed smokers so dismally deserves prompt insight.
Cancer can be a terrible and frightening disease as Susan Sontag and many others have taught us. Smokers and those chronically exposed secondhand can be addicted. They may know they are harming their health and enhancing their disease risks but may be uniquely UNABLE to save their lives. Others may want to exercise the “right to be let alone” or think they have those surely rare protective genetic elements that can favorably modify induced oncogenesis.
No matter. We ought to quickly understand this situation better, modify our approach (sharpened targeted screening yielding higher actionable tumor findings; universal stop smoking programs; improved screening effectiveness in ethnic/genetic subgroups; sensitive environmental analysis for carcinogens; etc.) and then act. The carcinogen producers appear more sophisticated at concerted action than the caring medical establishment.
A: The practice of medicine can change. Primum non nocere happily persists but the ever-burdensome realization that patients have a plethora of unmet needs, ailments, diseases and illnesses which cannot be specifically diagnosed or effectively treated demands innovation and practice evolution–new knowledge acquired, proven in care, applied and recurrently assessed with alacrity.
For me, the situation in smokers with risk for Non-Small Cell Lung Cancer (NSCLC) is notably galling. The facts are clear and unusually well established. Lung cancer is a deadly disease in most manifestations throughout the world. While lung lesions can be indolent and small cancers may regress, most detected tumors lead to morbid outcomes. NSCLC (a common pathological type) risk is influenced by genes and by environmental factors (cigarette smoke). The risk and disease burden can be reduced by prolonged removal of the environmental trigger (smoking cessation) and the illness successfully treated by surgery after very early stage diagnosis. In a small percent of more advanced cases, with immunotherapies and/or targeted agents (possibly with additional conventional chemotherapies), prolonged remissions and cures appear possible at substantial costs.
In the USA, several years ago, over 50,000 participants were studied in a randomized prospective clinical trial (RPCT) with a 6 year follow up (National Lung Screening Trial; NLST). The study showed that in heavy smokers in their 5th decade or older, lung cancer screening with 3 years of annual spiral CT (better than plain chest xray) reduced lung cancer deaths by 20% and all cause of death by 7%. This study and various others follow on improvements/observations that were published in the NEJM (NEJM 2011;365(5):395-409), favorably reviewed and graded by the USPTF (with recommendations) and the screening was deemed reimbursable (again with recommendations) by the Center for Medicare and Medicaid Services (CMS). It is unusual to have in a brief period a very large study, great data and a slew of high profile publications, national review body endorsement, and payment for important aspects of the test’s delivery in place.
Both USPTF and CMS noted that many of the findings in this study’s cohort were not cancer, that smoking cessation was a prudent medical course in essentially all study participants, and that screening program enrollees needed to be properly informed, consented and counseled to derive optimal benefits from this screening intervention. While not a simple test and cure scheme, these requirements and others illustrated in a recent report of the VA’s experience with a lung cancer prevention and early detection effort, indicate that a widely adopted program built on this type of testing could save many lives (JAMA Intern Med. 2017;177(3):399-406. doi:10.1001/jamainternmed.2016.9022).
Work is ongoing to better identify smokers that would benefit from screening (the NLST detection rate was about 1 case detected for about 375 screened) and if other smokers (younger, fewer pack/yrs) could be successfully screened. Many lung cancers occur in younger smokers than represented in the NLST cohort. There may be as many as 35,000,000 people who should be screened in this country alone. In addition, some presenting for screening have important comorbid illnesses (COPD and/or ASCVD) which might modify a recommendation for 3 years of annual CT screening to detect early stage NSCLC.
But a key disturbing fact is that despite great clinical science, national review and discussion, attention by institutions and patient groups, and reasonable payer reimbursement, less than 10 percent of the approximately 6 million Americans who fit the original NLST inclusion criteria have been engaged and complied with the endorsed protocol. Given the difficulty in conducting large RPCTs in non-overt disease cohorts, in proving screening benefits (data is not likely to improve), and in coping with the worldwide burden of cancers with risks linked to smoking and environmental inhalants, a better understanding of why we have failed smokers so dismally deserves prompt insight.
Cancer can be a terrible and frightening disease as Susan Sontag and many others have taught us. Smokers and those chronically exposed secondhand can be addicted. They may know they are harming their health and enhancing their disease risks but may be uniquely UNABLE to save their lives. Others may want to exercise the “right to be let alone” or think they have those surely rare protective genetic elements that can favorably modify induced oncogenesis.
No matter. We ought to quickly understand this situation better, modify our approach (sharpened targeted screening yielding higher actionable tumor findings; universal stop smoking programs; improved screening effectiveness in ethnic/genetic subgroups; sensitive environmental analysis for carcinogens; etc.) and then act. The carcinogen producers appear more sophisticated at concerted action than the caring medical establishment.
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