low dose ct lung cancer screening update

Low Dose CT Lung Cancer

Screening Update

2015

Clay H. Napper, M.D.

LET’S START OFF WITH A TEST

We’re going to look at some radiographs to see if we can detect lung cancer.

ENEMY • Easy • Even without

the annotations.

THERE IS A 1.2 CM LUNG CANCER IN

THE RIGHT LOWER LOBE

It is imperceptibl

e

Facts Regarding Chest Radiographs

– Chest radiographs are limited in sensitivity

– Lesions are rarely seen if < 1 cm

– Lesions are reliably seen ONLY if > 2.5 cm

– Many lung cancers are not detected by CXR until they are advanced stage, often with nodal involvement and distant metastases.

Facts Regarding Chest Radiographs

– Many lung cancers are not detected by

CXR until they are advanced stage, often with nodal involvement and distant metastases.

So if CXR can’t reliably detect

small lung cancers at an early,

treatable stage,…

So if CXR can’t reliably detect

small lung cancer at an early,

treatable stage,…

Shouldn’t we come up with a more reliable

screening tool?

Low Dose Computed Tomography

Low Dose Computed Tomography

LDCT

O

Remember the 1.2 cm RLL nodule?

Remember the 1.2 cm RLL nodule? Imperceptible on CXR…

O

Plain as day by LDCT

What we know and what we have known for a long time:

What we know and what we have known for a long time.

1. Lung Cancer is not rare.

Projected New Lung Cancer Diagnoses in the United States

for 2015 Lung Cancer Diagnoses: > 220,000 Men: > 115,000 Women: > 105,000 Lung Cancer Deaths: >155,000 Men: > 86,000 Women: >71,000

What we know and have known for a long time.

2. Lung cancer is common. It is the second most common cancer diagnosis for women and men in the United States.

2015 Estimated U.S. New Cancer Diagnoses

in Men and Women

Prostate 26% 29% Breast Lung and Bronchus 14% 13% Lung and Bronchus

Colon and Rectum 8% 8% Colon and Rectum

Urinary Bladder 7% 7% Uterine Corpus

Melanoma 5% 6% Thyroid

NHL 5% 4% NHL

Kidney & Renal Pelvis 5% 4% Melanoma

Oral Cavity &Pharynx 4% 3% Pancreas

Leukemia 4% 3% Leukemia

Liver and Biliary 3% 3% Kidney & Renal Plvis

All other sites 23% 23% All other sites

MEN WOMEN

What we know and what we have known for a long time:

• Lung cancer is the second most common cancer in both women and men

3. LUNG CANCER IS DEADLY

• The leading cause of lung cancer in both men and women is first hand smoke.

Projected Lung Cancer Deaths in the United States for 2015

Lung Cancer Deaths: >157,000 Men: > 86,000 Women: >71,000

Projected Lung Cancer Deaths in the United States for 2015

Lung cancer is currently the leading cause of cancer deaths for both women and men in the United States

2015 Estimated U.S. Cancer Death in Men and Women

Lung & bronchus 28% 26% Lung & bronchus Prostate 9% 15% Breast

Colon and Rectum 8% 9% Colon & rectum Pancreas 7% 7% Pancreas

Leukemia 5% 5% Ovary

Liver and Biliary 5% 4% Leukemia

Esophagus 4% 4% NHL

NHL 4% 4% Uterine corpus

Urinary Bladder 4% 3% Liver and Biliary

Kidney 3% 2% Brain/CNS

All other sites 23% 23% All other sites

MEN WOMEN

What we know and have known for a long time

1. Lung cancer is not uncommon 2. Lung cancer is common 3. Lung cancer is deadly

4. Smoking cigarettes causes lung cancer.

What we know and have known for a long time

1. Lung cancer is not uncommon 2. Lung cancer is common 3. Lung cancer is deadly

4. The number one cause of lung cancer is first hand smoke.

Smoking Cigarettes Kills

Tobacco and Lung Cancer

Risk

– Lung Cancer is the leading cause of cancer death in both men and women.

– 85% of lung cancer in the United states can be directly related to smoking.

– There is a large population of smokers in the United States.

– There are approximately 60 million current smokers and 30 million former smokers in the United States

Tobacco and Lung Cancer

Risk

There are approximately 60 million current smokers

and 30 million former smokers

in the United States

Smoking Cigarettes Kills

In the U.S, approximately 443,000 Deaths

will be attributed to

cigarette smoking this

year

129,000 Lung Cancer 126,000 Ischemic Heart Disease 93,000 COPD 35,300 Other Cancers 15,900 Stroke 44,000 Other Diagnoses

Those are the issues

What should we do?

What should we do?

Campaign against smoking by providing information and tools to help our patients quit smoking and encourage them to stay quit.

Establish an effective screening tool to detect lung cancer early, at a stage when treatment can be successful.

What should we do?

Campaign against smoking by providing information and tools to help our patients quit smoking and encourage them to stay quit.

Establish effective screening tools to detect lung cancer early, at a stage when treatment can be successful.

History of Lung Cancer Screening

Lung Cancer Screening

In the 1970’s and 1980’s randomized and nonrandomized trials and retrospective studies were performed using CXRs to try to screen for early, treatable lung cancer. None of these trial showed a survival benefit for screening CXRs. Lung cancer death rates for patients screened with an annual PA chest radiograph were essentially equal to the lung cancer death rates for patients who received no screening at all.


In the 1980’s with the development of CT imaging, it became apparent that some very small lung nodules could be reliably detected, and there was hope that CT screening for lung cancer might be an effective tool some day.


In the 1980’s with the development of CT imaging, it became apparent that some very small lung nodules could be reliably detected and that CT screening for lung cancer might be an effective tool some day. But CT imaging was not yet widely available, and it was neither time nor cost efficient.


In the 1990’s, with the advent of more available and faster CT scanners, some nonrandomized trials and retrospective analyses showed that CT could indeed detect early, treatable lung cancer.


In the 1990’s some nonrandomized trials and retrospective analyses showed that CT could indeed detect early, treatable lung cancer. However, there had been no large, randomized clinical trials to absolutely prove the survival benefits of lung cancer screening with CT


• Then, in the early 2000’s, several large trials were crafted to prove the efficacy of CT for lung cancer screening.

I-ELCAP Early Lung Cancer Action Program

MPHS was a participant

NLST National Lung Screening Trial

I-ELCAP

• Non-randomized trial involving 31,000 patient screened with LDCT that showed significant 10 year survival benefit due to detection of small lung cancers at an early stage.

• Criticized for being non-randomized

I-ELCAP

• Non-randomized trial involving 31,000 patient screened with LDCT that showed a significant 10 year survival benefit due to detection of small lung cancers at an early stage.

• Criticized for being non-randomized

NLST

Randomized trial beginning in 2002 studying 53,454 subjects, randomized to be screened with either annual LDCT or annual CXR for 3 years. The patients were then followed clinically for an additional 3.5 years. The goal was to prove a survival benefit of screening with LDCT

NLST

In November of 2010, the NLST closed early because the study had reached its endpoint. There was evidence of a 20% lung cancer mortality reduction using LDCT vs CXR. There was also evidence of a 6.7 % all cause mortality reduction.

NLST In November of 2010, the NSLT was closed early because the study had reached its endpoint. There was evidence of a 20% lung cancer mortality reduction using LDCT vs. CXR There was evidence of a 6.7 % all cause mortality reduction (including additional findings such as coronary artery disease, thyroid cancer, renal cancers).

NLST It was shown that screening for lung cancer with LDCT could prevent one lung cancer death for every 320 patients screened.

NSLT It was shown that screening for lung cancer with LDCT could prevent one lung cancer death for every 320 patients screened. In comparison, it takes 1339 individuals screened with mammography to prevent one breast cancer death. For flexible colonoscopy it takes 817 screened patients to prevent one colorectal cancer death.

NSLT It was shown that screening for lung cancer with LDCT could prevent one lung cancer death for every 320 patients screened. In comparison, it takes 1339 individuals screened with mammography to prevent one breast cancer death. It takes 817 patients screened with flexible colonoscopy to prevent one colorectal cancer death.

NLST

The original results showing the survival benefit of LDCT screening for lung cancer were published in the NEJM in August 2011 In November 2011, an article outlining the cost effectiveness of LDCT was published in the NEJM siting a cost of $81,000 per QALY gained.

NLST

The original results showing the survival benefit of LDCT screening for lung cancer were published in the NEJM in August 2011 In November 2011, an article outlining the cost effectiveness of LDCT was published in the NEJM, siting a cost of $81,000 per QALY gained. (similar to or less than many other currently used screening tools)

NLST

In November 2011, an article outlining the cost effectiveness of LDCT was published in the NEJM siting a cost of $81,000 per QALY gained. In the second article, it stated that the final costs of a LDCT lung cancer screening program could be significantly decreased with only modest changes to the assumptions made in the original study .

USPSTF December 2013 U.S. Preventative Services Task Force issued a recommendation of screening for lung cancer with LDCT with criteria only slightly modified from NLST: 55-80 years of age 30-pack-year (or greater) smoking history Current smoker or quit smoking within the past 15 years. Asymptomatic (no signs/sxs of lung cancer)

USPSTF December 2013 U.S. Preventative Services Task Force issued a recommendation of screening for lung cancer with LDCT with criteria only slightly modified from NSLT:

Adults 55-80 years of age 30-pack-year (or greater) smoking history Current smoker or quit smoking within the past 15 years. Asymptomatic (no signs/sxs of lung cancer)

USPSTF

The recommendation was issued with a Grade B favorable rating:

USPSTF

The recommendation was issued with a Grade B favorable rating: “There is either a high certainty that the net benefit of screening is positive Or There is a moderate certainty that the net benefit of screening is substantial.”

USPSTF

The recommendation was issued with a Grade B favorable rating. Under the Affordable Care Act (ACA) private insurers must provide coverage for LDCT lung screening to qualified patients, and the screening must be provided without a co-payment

USPSTF did not make a statement regarding CMS

CMS

• In March 2015 (15 months later), Centers for Medicare and Medicaid Services approved similar coverage (with slight modifications) for qualifying Medicare and Medicaid patients.

CMS

• In March 2015 (15 months later), Centers for Medicare and Medicaid Services approved similar coverage (with slight modifications) for qualifying Medicare and Medicaid patients.

• According to some, the most important news in Radiology this year.

Let’s Review

LDCT – Who do we screen?


• First, we try to adhere to USPSTF guidelines:



• Adults age 55-80



• Adults age 55-80 • 30-pack-year (or greater) smoking history



• Adults age 55-80 • 30-pack-year (or greater) smoking history • Current smoker or having quit smoking

within the last 15 years.



• Adults age 55-80 • 30-pack-year (or greater) smoking history • Current smoker or having quit smoking

within the last 15 years. • Asymptomatic – meaning without signs or

symptoms suggestive of lung cancer

LDCT – Who do we screen? We also make allowances for patients nearly meeting criteria who also possess another known risk factor as laid out in the NCCN guidelines, including: • Personal history of cancer • Family history of lung cancer • History of asbestos exposure • History of radon exposure • Dx of COPD or Pulmonary Fibrosis

LDCT – Who do we screen? Age 55-80 30-pack-year (or greater) smoking history Current smoker or quit smoking within the last 15 years. Without current signs or symptoms suggestive of lung cancer

Of the 60 million current smokers and 30 million former smokers in the U.S., somewhere between 7 million and 10 million individuals qualify for screening with LDCT

LDCT – How is the study performed?

• Simple for the patient • No oral or intravenous contrast. • Time in the Radiology Department is

usually less than an hour spent mostly checking in, changing into a gown and being escorted to and positioned on the CT scanner.

• Actual scan time is 3-7 seconds, an easy breath hold for almost all patients.


The actual scan time is 3-7 seconds (an easy breath hold for almost all patients)


• The examination is performed with a low dose protocol using the lowest radiation dose possible to obtain a diagnostic scan.

• Radiation dose from a Low Dose CT falls in the range of 0.61 – 1.5 mSv


• Radiation dose from a LDCT falls in the range of 0.61 – 1.5 mSv


• Radiation dose from a LDCT falls in the range of 0.61 – 1.5 mSv

What does that mean?

Radiation dose from the LDCT falls in the range of 0.61 – 1.5 mSv

• What does that mean? – For reference, the background average

annual radiation dose in the U.S. is approximately 3.1 mSv

– Background radiation dose is affected by terrestrial and celestial sources of background radiation


• What does that mean?

• The atmosphere offers some protection from celestial radiation; so living at lower altitude has an intrinsically protective effect and reduces our dose of background radiation.



• Living at lower altitude results in a lower annual background radiation dose.



• The difference in annual background radiation dose between living in San Francisco (at sea level) and living in Denver (mile high) is approximately 1.5 mSv



•The dose is very low.



•The dose is very low. •The dose is less than background differences between living in Denver and living in San Francisco.

LDCT – How is the study interpreted and reported?

• We use LungRADS structured reporting and guidelines for recommendations regarding followup and treatment.

LungRADS • LungRADS was devised along a

framework similar to BIRADS, the Breast Imaging reporting system that has been in use for over 20 years.

LungRADS

• To determine the significance of detected lung nodules and to determine the appropriate surveillance or action needed, LungRADS attends to :

• (1) nodule size • (2) nodule consistency • (3) nodule stability

LungRADS

• (1) nodule size

– Larger nodules are more concerning than smaller nodules

• Smaller nodules are more likely to be postinflammatory or benign

LungRADS

• (2) nodule consistency

LungRADS

• (2) nodule consistency – Solid – Part solid – Non-solid (ground glass)

• The more solid a nodule or the larger the solid

component of a nodule, the more worrisome the finding

LungRADS

• (3) nodule stability

– Stability is a marker of benignity

• Growing or changing nodules or nodules that have

newly developed since previous imaging are more concerning

LungRADS

• (3) nodule

stability

2013 2015

LungRADS

• (3) nodule

stability

2013 2015

Adenocarcinoma in situ

LungRADS

• (3) nodule

stability

2013 2015

Adenocarcinoma in situ

Minimally invasive adenocarcinoma

LungRADS

• LungRADS categorizes the findings of a LDCT lung screening examination with a numeric value (0 to 4, increasing in level of concern) with a corresponding established recommendation for followup imaging or other action.

reported? BASIC CHART showing LungRADS categories and corresponding recommendations

Complete Chart including nodule size, consistency and stability

LungRADS Categories

LungRADS

• CATEGORY 0: “INCOMPLETE”

LungRADS


– Images degraded by motion – The region of interest is not entirely included

LungRADS


– Images degraded by motion – The region of interest is not entirely included

PATIENT NEEDS TO BE RECALLED FOR COMPLETION OF IMAGING

LungRADS

• CATEGORY 1: “NEGATIVE”

LungRADS


– EITHER NO LUNG NODULES OR ONLY DEFINITELY BENIGN NODULES

(granulomas, hamartomas, etc.)

LungRADS


– EITHER NO LUNG NODULES OR ONLY DEFINITELY BENIGN NODULES

(granulomas, hamartomas, etc.)

FOLLOWUP LDCT IN ONE YEAR

LungRADS

• CATEGORY 2: “BENIGN”

LungRADS


– VERY SMALL NODULES (<6mm) OR NODULES THAT ARE KNOWN TO BE STABLE OR DECREASING IN SIZE

LungRADS


– SMALL LUNG NODULES AND NODULES WITH PROVEN STABILITY

FOLLOWUP LDCT IN ONE YEAR

LungRADS

• CATEGORY 3: “PROBABLY BENIGN”

LungRADS


– SLIGHTLY LARGER BUT STILL SMALL NODULES WITHOUT PROVEN STABILITY

LungRADS


– SLIGHTLY LARGER BUT STILL SMALL NODULES WITHOUT PROVEN STABILITY

SHORTER TERM FOLLOWUP LDCT IN 6 MONTHS

To establish stability or regression and exclude lesion growth

LungRADS

• CATEGORY 4: “SUSPICIOUS”

LungRADS


– LARGER NODULES OR SUSPICIOUS APPEARING NODULES WITHOUT PROVEN STABILITY

LungRADS


– LARGER NODULES OR SUSPICIOUS APPEARING NODULES WITHOUT PROVEN STABILITY

3-MONTH CT FOLLOWUP, ADDITIONAL CHARACTERIZATION WITH PET-CT OR

TISSUE SAMPLING (BRONCHOSCOPY, PERCUTANEOUS NEEDLE BIOPSY,

EXCISIONAL BIOPSY, VATS, MEDIASTINOSCOPY)

LungRADS


The vast majority of these findings are followed with imaging alone.

LungRADS


The vast majority of these findings are followed with imaging alone. Only about 1% of initial CT lung screens result in a need for tissue sampling.

What Constitutes a NEGATIVE Screen?


• Any LDCT for which annual LDCT followup is recommended



• LungRADS categories 1 and 2 • “Negative” or “Benign”



• LungRADS categories 1 and 2 • “Negative” or “Benign”

• >90% of all initial screens

What Constitutes a Positive Screen?


• Any LDCT finding for which follow up other than annual screening is recommended.

What Constitutes a Positive Screen? –LungRADS 3 “Probably Benign”

• (6 mos f/u LDCT) • ~5% of initial screens

–LungRADS 4 “Suspicious” • (3 mos f/u, PET-CT, and/or tissue

sampling) • ~4% total, most being followed with

LDCT in 3 mos or with CT or PET-CT

What Constitutes a Positive Screen? –LungRADS 3 “Probably Benign”

• (6 mos f/u LDCT) • ~5%

–LungRADS 4 “Suspicious” • (3 mos f/u CT, PET-CT, and/or tissue

sampling) • ~4% of initial screens, most being followed

with imaging


–LungRADS 4 “Suspicious” • (3 mos f/u, PET-CT, and/or tissue

sampling) • ~4% total, most being followed with

LDCT in 3 mos or with CT or PET-CT • Only approximately 1% of initial

screenings result in a recommendation for tissue sampling. The rest are further evaluated with imaging alone.

Practice Parameters for the performance and interpretation of LDCT for Lung Cancer Screening

Established by ACR and STR Designated Lung Screening Center under CT accreditation program for equipment, imaging protocols, and interpreting radiologists. LungRADS structured reporting and management tool Participate in a Lung Cancer Screening Registry Follow patient selection guidelines

Practice Parameters were established by agreement between many interested

organizations


Screening should be performed at a designated Lung Screening Center under a CT accreditation program that specifies CT equipment, imaging protocols, and experience and skills of the interpreting radiologists. LungRADS structured reporting and management tool should be employed Participate in a Lung Cancer Screening Registry Follow patient selection guidelines


Screening should be performed at a designated Lung Screening Center under a CT accreditation program for equipment, imaging protocols, and interpreting radiologists. LungRADS structured reporting and management tool should be employed for reporting and decision making. Participate in a Lung Cancer Screening Registry Patient selection guidelines should be followed


Screening should be performed at a designated Lung Screening Center under a CT accreditation program for equipment, imaging protocols, and interpreting radiologists. LungRADS structured reporting and management tool The screening center should participate in a Lung Cancer Screening Registry Patient Selection guidelines should be followed


Screening should be performed at a designated Lung Screening Center under a CT accreditation program for equipment, imaging protocols, and interpreting radiologists. LungRADS structured reporting and management tool The screening center should participate in a Lung Cancer Screening Registry Patient selection guidelines should be followed

LDCT: Referring Provider

What are the roles of the referring provider?

LDCT: Referring Provider

• Complete an order for LDCT

• Affirm the patient’s eligibility (usually a checkbox form)

• Provide shared decision making with the patient prior to the first screening LDCT

LDCT: Shared Decision Making

• What is shared decision making?


• Information sharing between the patient and physician regarding the potential benefits and harms of undergoing LDCT.

Benefits: • Detecting early lung cancer in it’s treatable

stages. • Detecting other unknown treatable findings • Encouragement of smoking cessation


• Information sharing between the patient and physician regarding the potential benefits and harms of undergoing LDCT.

Benefits: • Detecting early lung cancer in it’s treatable

stages. • Detecting other treatable findings • Encouragement of smoking cessation


Potential Harms: •Radiation exposure (as little as possible -- similar to the difference between living in SF versus Denver for a year •False positive results – findings that require additional follow up, imaging, or tissue sampling that do not eventually prove to be lung cancer.


Potential Harms: •Overdiagnosis – the phenomenon of detecting a lung cancer that is so indolent that it would not go on to result in lung cancer death if it remained undetected and untreated.


Several excellent tools provide guidance regarding shared decision making and provide patients with useful information regarding potential benefits and harms of lung cancer screening with LDCT

LDCT: Shared Decision Making Should I Screen?

http://www.shouldiscreen.com/ Web based decision making aid with a risk calculator that patients can use to determine their risk of developing lung cancer based on factor including age, smoking history, personal cancer history, family lung cancer history, history of COPD or pulmonary fibrosis

http://www.shouldiscreen.com

LDCT: Shared Decision Making Should I Screen?

http://www.shouldiscreen.com/ Web based decision making aid that describes lung cancer, lung cancer screening, the dangers of smoking and provides a risk calculator that patients can use to determine their risk of developing lung cancer based on their age and personal risk factor profile.

http://www.shouldiscreen.com

Should I Screen?

NCCN Lung Cancer Screening Booklet


http://www.nccn.org/patients/guidelines/lung_screening/

Web based booklet provided by the National Comprehensive Cancer Network that can be navigated online or printed. Provides patients with educational materials to help inform them of the potential benefits and harms of lung cancer screening with LDCT

http://www.nccn.org/patients/guidelines/lungscreening/

http://www.nccn.org/patients/guidelines/lungscreening/

What’s do we do next?

• Talk to your patients about smoking cessation and help them decide if LDCT screening for lung cancer is right for them

• Refer appropriate patients for LDCT at a reputable, accredited screening facility.

• Stay informed.

What’s do we do next?

• Talk to your patients about smoking cessation and help them decide if LDCT screening for lung cancer is right for them

• Refer appropriate patients for LDCT at a reputable, accredited screening facility.

• Stay informed. The landscape is changing daily, and there new information and new ideas are emerging all the time.

Low Dose CT Lung Cancer

Screening Update

2015

Clay H. Napper, M.D.

Thank you for your

attention

Stay Informed - Changing Landscape

• Journal of the National Cancer Institute – October 19, 2015 (hot off the press)

“CT lung cancer screening may benefit

even those with fewer than 30 pack-years of smoking history.” After reviewing the “records of more than 30,000 smokers and former smokers who participated in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) and had smoking histories ranging from 20 to 29 pack-years,” researchers found that “their risk of developing cancer was very similar to that of patients eligible for screening in the National Lung Screening Trial (NLST), which focused on individuals with smoking histories of 30 pack-years or more.”

Radiographic Differential Diagnosis • Post-inflammatory granuloma (80%) • Benign neoplasm (e.g. hamartoma) • Pulmonary AVM • Solitary lung metastasis • Primary lung cancer • Other miscellaneous nodules (nodular sarcoid,

rheumatoid nodule, pulmonary-renal syndrome granuloma, bronchogenic cyst, hematoma, abscess, others…)

• Solitary pulmonary nodule • Rates of Growth

– Volume doubling time for most bronchial /lung carcinomas is 1-18 months.

– A 26% increase in diameter is equivalent to a doubling in volume

• 5 mm --> 6.3 mm --> 7.7 mm • 10 mm --> 12.6 mm --> 15 • For small lesions, growth may not be perceptible until the

tumor has doubled or even quadrupled in volume

• Solitary pulmonary nodule • Rates of Growth

– Volume doubling time for most bronchial/lung carcinomas is 1-18 months.

– Volume doubling is equivalent to only a 26% increase in diameter

For small lesions, growth may not be perceptible until the tumor has doubled or even quadrupled in volume

• 5 mm --> 6.3 mm --> 7.7 mm • 10 mm --> 12.6 mm --> 15

Applications

• Solitary pulmonary nodule: Percutaneous BX • Risks of Percutaneous Biopsy

– Pneumothorax 20-25% – Chest tube required 5-10% – Hemoptysis 5% – Malignant seeding 0.01% – Air embolism 0.1% – Death 0.2%

low dose ct lung cancer screening update

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