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Lung Cancer Screening For The Primary Care Physician: See Spot, Now What ?!?!? Brad Vincent, MD, FCCP Interventional Pulmonary Clinic Critical Care Medicine Service Our Lady of the Lake RMC Mary Bird Perkins Cancer Center Disclosure Dr. Vincent has no relevant financial relationships with commercial interest to disclose. His presentation will include discussion of commercial products and or services. Linda Lee, Cancer Center Administrator, OLOL RMC/ Mary Bird Perkins is the activity planner. She has no relevant financial relationships with commercial interest to disclose. The OLOL CME Committee has no relevant financial relationships with commercial interest to disclose. Thank you! Our Lady of the Lake Regional Medical Center Doc, I was told I have a Spot on my lung. What does this mean??? Characteristics of solitary pulmonary nodules What to do?? Patients can be very fearful (obviously) The main question is obviously : Is this a lung cancer ? With advent of near universal imaging in healthcare setting more and more nodules are being detected The difficulty is avoiding invasive procedures on benign entities while maximizing early intervention on malignancy With recent recommendations regarding lung cancer screening, the above scenario will only become more common Primum non nocere First, do no harm Reassure patient that they will be treated appropriately Compile a symptoms review with focus on constitutional symptoms such as weight loss and pulmonary specific symptoms such as cough, hemoptysis and dyspnea Physical examination with careful attention to chest findings and digital clubbing Obtain an accurate history of tobacco use and occupational history to screen for exposure to radon or asbestos Most common symptom with early lung cancer?? NONE!!!! Additional Initial Steps Obtain family history Schedule CT imaging if appropriate AVOID the temptation to refer them to an oncologist DO make a referral to a pulmonologist Overview of Lung Cancer Largest cancer killer of men and women in the USA for over three decades Occurs almost exclusively in smokers Louisiana has one of the highest incidences of lung cancer in the country (roughly 90 cases per 100,000 yearly) Cancer Statistics 2014 Lung Cancer American Cancer Society, Cancer Statistics; 2014 Lung Cancer Incidence Stage vs Survival Dr. Alton Ochsner was one of the first physicians to make the link between cigarette smoking and lung cancer Stage I non -small cell cancer Stage II non -small cell cancer Stage III (a and b) Stage IV Any tumor size with any node involvement with extrathoracic metastasis Growth Model of Lung Cancer Bach BP et al. Chest 2007 Cancer Screening Fundamentals of Screening Definition Screening can be defined as the systematic testing of individuals who are asymptomatic with respect to some target disease. The purpose of screening is to prevent, interrupt, or delay the development of advanced disease in the subset with a pre-clinical form of the target disease through early detection and treatment. Hillman et al. JACR 2004;1(11):861-864 Fundamentals of Screening Characteristics of a good screening test and program: Reasonable sensitivity and specificity Accessible with a low cost Low associated morbidity There should be an effective treatment at an early stage of the disease Timeline of Disease PRECLINICAL CLINICAL DPCP Onset of Disease Detectable by Test DPCP= Detectable pre-clinical phase Signs or Symptoms Death from Disease or Other causes Screening Effective DPCP Onset of Disease Detectable by Test Signs or Symptoms Critical Point Death from Disease or Other causes Screening Ineffective DPCP Onset of Disease Detectable by Test Critical Point Signs or Symptoms Death from Disease or Other causes Screening Unnecessary DPCP Onset of Disease Detectable by Test Signs or Symptoms Death from Disease or Other causes Critical Point Patient Population High risk for preclinical disease No clinical signs or symptoms of disease Willing and able to undergo screening or not Willing and able to undergo workup and treatment Willing and able to undergo follow-up Cancer Screening Principles Problems with cancer screening: Bias (lead time, length bias, overdiagnosis,etc) Involves cost to a large group of people who do not need treatment Stress and anxiety of a false positive test Unnecessary testing following false positive False sense of security of a negative test which may delay diagnosis Potential HARM due to effects of test (radiation exposure) or procedures done as a result of screening test (unnecessary surgery or biopsy) Screening Bias Patz EF et al. New Eng J Med 2000 Screening Bias Black WC. Cancer 2007 The Studies 3 Randomized controlled trials comparing CT to annual chest radiograph (CXR) The largest of any trial to date is the NLST (National Lung Screening Trial) Multiple center study over five years Enrolled 53,454 patients 3 annual rounds of screening (baseline, T+1 year and T+ 2 years) 20% relative decrease in lung cancer death compared to chest radiograph over a median of 6.5 years of follow up (443 cancer deaths in control group compared to 356 cancer deaths in CT group) Both groups had similar rates of death NOT attributable to lung cancer Four Main Questions Posed What are the potential benefits of screening with LDCT in patients with elevated risk of lung cancer? What are the potential harms of screening with LDCT in patients with elevated risk of lung cancer? Which groups are most likely to benefit or not benefit from screening? In what setting is screening most likely to be effective? Totals 142,520 Patients screened 29,567 Nodules 1,298 Lung cancer nodules 1,838 Patients diagnosed with lung cancer over the study period Bottom Line Potential Benefits Effect on Mortality: The NLST showed that three rounds of screening with LDCT reduced the relative risk of death due to lung cancer by 20% versus chest radiograph over a 6.5 year period In absolute terms the risk of cancer death was 33% less over the study period in the LDCT group (87 deaths avoided in over 26000 patients) meaning 310 individuals must participate in at least three rounds of screening to prevent one death Potential Harms Actual detection of abnormalities. The average nodule detection rate was 20% but varied greatly amongst the many studies Complications of diagnostic procedures. Major complication frequency in LDCT screened individuals was 33 per 10,000 individuals. Rate of major complications in those who underwent surgery for lung cancer was 14% Overdiagnosis: diagnosis of histologic abnormality that otherwise would not have altered the patient’s life if left untreated. Radiation exposure: Estimate is 1 cancer death due to radiation per 2500 persons screened Radiation Procedure Effective dose (mSv) Chest radiograph (PA view) 0.02 Low Dose CT chest 0.7 Mammography 0.4 Nuclear bone imaging 6.3 Chest CT 7 Abdomen CT 8 Chest angio-CT 15 Diagnostic cardiac cath. 15 Radiation Low dose CT Baldwin DR et al. Thorax 2011 Patients likely to benefit Enrollment criteria for studies varied widely NLST “high risk” criteria previously decribed Controversy over how to best identify the at risk population and screen them in the critical period where screening may be beneficial Effective Setting Recommended setting is one with a multidisciplinary approach including: Interventional pulmonology Thoracic surgery Radiation oncology Thoracic radiology Medical oncology Overview of Treatment for Early Stage Lung Cancer Standard treatment for stage I and II lung cancer has traditionally been surgical resection Chemotherapy is added post resection based on pathologic stage Mortality rate very low overall (roughly 2%) but increases with pneumonectomy significantly Non-surgical treatment For patients with inadequate lung function to tolerate surgery, stereotactic radiosurgery is recommended For small tumors may have an equivalent result when compared to surgery For larger and more central tumors has a higher failure rate Often combined with chemotherapy For patients with Stage III and IV disease, chemoradiotherapy is primary treatment modality Future Directions Potential Biomarkers for Screening Airway epithelial cells Gene expression profiling Chromosomal aneusomy – FISH Gene methylation Blood biomarkers Serum proteins Autoantibodies to tumor antigens Gene expression profiles Breath analysis Urine markers of carcinogens Lung Cancer Risk Prediction: PLCO Model Age Education Body Mass Index Family History Lung Cancer History of COPD Chest x-Ray Past Three Years Smoking Status (NS, F, C) Pack-Years Smoked Smoking Duration Quit Time in Former Smokers Tammemagi et al. JNCI 2011; 103: 1058-68 What are we doing at OLOLMBPCC? LDCT screening offered to population of patients similar to NLST Cost is 99$ CT interpreted by radiologist Any positive findings are followed up based upon Fleichsner Society guidelines Will be plugged into pathway including consultation with a pulmonologist Patient navigator will ensure proper follow up Fleischner Society Guidelines McMahon, Swenson et al. Radiology 2005 What diagnostic modalities are available at OLOL-MBPCC? CT guided trans-thoracic biopsy of nodules/masses Endobronchial ultrasound guided biopsy Navigational bronchoscopy Thoracic surgery CT-Guided FNA/Biopsy 90% accuracy 15% Risk of pneumothorax 1-5% Risk of major bleeding Typically an outpatient procedure Limited in patients with deeper/more central lesions and those with emphysema/bleb disease Mass Lymph node EBUS-TBNA EBUS-TBNA Real-time visualization of lymph nodes Much better diagnostic yield compared to blind TBNA Very low risk (<1% risk of major complications) Outpatient On-site cytopath can give patients and physician a rapid preliminary report Can biopsy nodes of very small size Can biopsy masses more centrally located (even small ones) Navigational Bronchoscopy So-caled “GPS” for lung biopsy 80% yield in nodules over 1.2cm Lower risk of pneumothorax compared to CT guided FNA Uses 3-D reconstruction to guide instruments to lesion Needle, brush and forceps available Getting with the program… Societies Endorsing Screening with LDCT: American Cancer Society (ACS) American College of Chest Physicians (ACCP) National Comprehensive Cancer Network (NCCN) American Society of Clinical Oncology (ASCO) U.S. Preventative Task Force (USPTF) Summary General principles of good screening tests must be adhered to when considering screening for any cancer Individuals at high risk for lung cancer may benefit from LDCT screening yearly There are potential harms and pitfalls to consider with LDCT screening for lung cancer LDCT screening is best performed where all available diagnostic and therapeutic modalities are available Disagreement remains even amongst experts as to whether or not LDCT screening will be beneficial We must continue to search for more effective ways to better identify who will benefit from screening and improve test modalities