Marketing PET’s Role in Lung Cancer Management Welcome! Marketing PET’s Role in Lung Cancer Management PET Marketing Forum – Accelerating Practice Growth May 17, 2006 Dr. Patrick Peller

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Dr. Patrick J. Peller Over 15 years of PET experience Read over 15,000 clinical PET scans MRP team member 3 marketing reps, 15+ staff MRP Volume > 500 PET/CTs per month

What Does a Referring Physician Want? Quality PET/CT imaging PET/CT the easy way Easy to order, promptly reported, has easy to understand results and provides a specific answer Reliable and expert source of answers on PET and/or PET/CT-- Your team

Targeted Specialists “The Select Seven” Medical Medical Oncologists Pulmonologists Gastroenterologists Surgical Oncologic Surgeons Thoracic Surgeons Colorectal Surgeons Radiation Oncologists

What Does a Referring Physician Want? Quality PET/CT imaging PET/CT the easy way Reliable and expert source of answers on PET/CT Understand clinical uses for PET/CT in Lung Cancer Understand where PET/CT is reimbursed in Lung Cancer

Estimated US Cancer Deaths Men 295,280 Women 275,000 Lung and bronchus 31% Prostate 10% Colon and rectum 10% Pancreas 5% Leukemia 4% Esophagus 4% Liver and intrahepatic 3% bile duct Non-Hodgkin 3% Lymphoma Urinary bladder 3% Kidney 3% All other sites 24% 27% Lung and bronchus 15% Breast 10% Colon and rectum 6% Ovary 6% Pancreas 4% Leukemia 3% Non-Hodgkin lymphoma 3% Uterine corpus 2% Multiple myeloma 2% Brain/ONS 22% All other sites Lung cancer is the most common fatal cancer in men (31%), followed by prostate cancer (10%), and colon & rectum cancer (10%). In women, lung (27%), breast (15%), and colon & rectum (10%) are the leading sites of cancer death. Source: American Cancer Society, 2006.

Lung Cancer First and best reimbursed PET indication Pulmonary nodule/density Lung cancer staging Lung cancer restaging

Pulmonary Nodule Standard evaluation Role of PET and PET/CT Physician audience Pulmonologist Internist Interventional Radiologist

Diagnostic Evaluation of a Lung Nodule Risk stratification Patient: smoker, >70yr, hx of Ca CT nodule: spiculated, growth, calcifications, >3cm Risk of biopsy or surg complications Tissue sample: FNA, needle bx, bronchoscopy, VATS, thoracotomy OR “watchful waiting” serial CT scans

PET Evaluation of a Lung Nodule History 45 YOM Pulmonary nodule on CXR Biopsy (several) negative PET Findings Hyper-metabolic focus No metastases Outcome Surgical resection, stage I squamous cell carcinoma 20% of all biopsies come back non-diagnostic due to sampling of too few cells. Sampling this suspicious nodule in the lung is difficult. The biopsy needle is trying to “stab a marble in a bowl of jello.” The nodule can move when you try to take a sample. It can be hard to penetrate to collect cells.

Diagnostic Evaluation of a Lung Nodule Risk stratification PET or PET/CT Tissue sample: FNA, needle bx, bronchoscopy, VATS, thoracotomy

Diagnostic Evaluation of a Lung Nodule Risk stratification PET or PET/CT Tissue sample: FNA, needle bx, bronchoscopy, VATS, thoracotomy OR “watchful waiting” serial CT scans

PET for Diagnosis of Pulmonary Nodules Meta-analysis--40 published studies 1474 focal lung lesions (≥1cm) FDG PET compared to histology High sensitivity (96.8%) and intermediate specificity (77.8%) High negative predictive value 97.6% Gould JAMA 2001; 285:914-924.

PET Evaluation of a Lung Nodule History 62 YOF Pulmonary nodule on CXR Anti-coagulation PET Findings No abnormality Outcome No change on CXR for 2 years

Approaching the Pulmonologist Bronchoscopy and PET are complementary PET greater sensitivity (94% sens, 70% spec) Bronch provides tissue diagnosis (53% of pts) If nodule >1cm and BOTH Bronch and PET neg--benign nodule Chhajed P. Chest 2005; 128:3558.

Bronchoscopy and PET for Pulmonary Nodules Chhajed P. Chest 2005; 128:3558.

Approaching the Generalist Must defeat 3 myths: PET is used only by specialists PET is too technical for me to understand PET does not have a role in my practice PET provides a management strategy for the evaluation of pulmonary nodules

Management Strategies for Pulmonary Nodules Risk stratification approach Patient chance of lung cancer CT chance of lung cancer Surgical complication risk PET especially useful when patient risk and CT results diverge PET for patients intolerant of “watchful waiting” Gould Ann Intern Med. 2003;138:725.

Management Strategies for Pulmonary Nodules * * Gould Ann Intern Med. 2003;138:725.

Educational Tools Overview brochure Case studies Patient brochures Clinical Technical Emotional Case studies Patient brochures

Approaching the Interventional Radiologist Difficult patient: anticoagulation, nodule location, severe COPD Prior biopsy nondiagnostic Multiple abnormalities: Best choice CT suggests advanced disease

PET in Pulmonary Nodules Prospective evaluation of 40 patients 15 biopsy not possible 25 biopsy results not helpful 24 cancers--23 detected by PET Sensitivity 96%; Specificity 81% Negative predictive value 93% Pitman MJA 2001; 175:303.

PET Evaluation of Pulmonary Nodules . Patients Sensitivity Specificity 14 studies 1078 97% 77% Lowe 1997 197 96% 77% Multicenter 89 98% 69% MRP 112 98% 60% Lowe V et al Radiology 1997; 202:435. Lowe V et al J Clin Onc 1998; 16:1075.

Lung Cancer Staging Conventional NSCLC staging Role of PET and PET/CT Physician audience Pulmonologist Thoracic Surgeon Radiation Oncologist

Lung Cancer Staging Stage I No nodal metastases and totally resectable Stage II Adds hilar nodes or resectable chest wall involvement Stage IIIA Extensive mediastinal nodes Stage IIIB Distant nodal metastasis Stage IV Distant metastases

Lung Cancer Staging Mediastinoscopy Chamberlain Bronchoscopy

Preoperative Staging with PET PET versus CT--Mediastinal Nodes Sensitivity Specificity CT 75% 66% 16% 20% PET 91% 86% Pieterman N Engl J Med 2000; 343:254-61.

Approaching the Pulmonologist PET/CT Staging of NSCLC T stage 88% acc (≥23% better) N stage 81% acc (≥21% better) PET-CT faster and more certain Integrated PET/CT provided additional info in 41% of pts Lardinois N Engl J Med 2003; 348:2500.

Extra-thoracic Staging History 61 YOM Smoker Known lung cancer, stage I, small 1 cm nodule Bone scan negative PET Findings Primary and distant metastasis in right femur Outcome Biopsy proved bone metastasis Chemotherapy and XRT In this case, the CT missed the single focus in poroximal of the right humorus because the CT stops at the adrenal gland (top of the kidneys)

Approaching the Thoracic Surgeon PET Impact on Surgical Staging PET directed staging away from customary in 25% of patients PET allows for directed and sensitive surgical staging PET and surgical staging complementary and together more accurate Vesselle J Thorac Cardiovasc Surg 2002; 124:511.

Approaching the Thoracic Surgeon Staging Accuracy in NSCLC PET/CT better predicts stage I and II PET/CT shows T and N status N1 accuracy 90%, N2 accuracy 96% Cerfolio R. Ann Thorac Surg. 2004; 78:1017.

More Accurate Guided Biopsy CT shows LUL mass consistent with Lung Cancer and no nodal metastases PET shows right paratracheal uptake suggesting nodal metastasis PET/CT shows metastasis to normal sized right paratracheal node Proven by surgical biopsy

Approaching the Radiation Oncologist Safe delivery of high dose of radiation to tumors require a high level of geometric accuracy. PET/CT allows differentiation of tumor from nontumor, e.g. atelectasis PET/CT’s greatest impact--showing nodal involvement PET/CT reduces variability between rad oncologists Steenbakkers R. Int J Radiat Oncol Biol Phys. 2006;64:435.

Tumor Volume Delineated With PET-CT Steenbakkers R. Int J Radiat Oncol Biol Phys. 2006;64:435.

Lung Cancer Staging of the Mediastinum .. Patients Sensitivity Specificity PET CT PET CT 9 studies 488 88% 63% 93% 73% Pieterman 102 91% 75% 86% 66% Kiernan 94 88% 64% 86% 94% MRP 158 90% 68% 86% 66% Pieterman et al NEJM 2000; 343:254. Kiernan et al S. Med. J. 2002, 95:1168.

Lung Cancer Restaging Standard evaluation Role of PET and PET/CT Physician audience Pulmonologist Medical Oncologist

Lung Cancer Restaging Serial Chest CT scans every 3-6 months Surgery and radiation therapy leave scarring

Detecting Lung Cancer Recurrence History 49 YOM Lung cancer resected 6 months earlier Prior stage I lesion CT post resection showed some changes and scarring PET Findings Small hyper-metabolic focus Outcome Recurrent cancer resected XRT This patient wanted to be really sure he was cured. He insisted on PET. Only PET found the residual disease. It is advised to wait 3-4 weeks following surgery to avoid false reads, however scarring is generally easily recognized.

Approaching the Pulmonologist Non-Small Cell Lung Cancer 126 patients; stage I-IIIB Histopathology or clinical progression PET and CT every 6 months PET CT Sensitivity 100% 71% Specificity 92% 95% PET was compared to biopsy (histopathology) or follow-up (clinical progression) Bury Eur Respir J 1999;14:1374.

Approaching the Medical Oncologist Advanced stage NSCLC receiving neoadjuvant chemotherapy 12wks PET/CT before and after therapy Measured SUV decline in tumor and dominant node Compared to histology of surgical specimen Pöttgen Clin Cancer Res 2006;12:97.

Neoadjuvant Chemotherapy in NSCLC SUV decline ≤50% SUV decline >50% Pöttgen Clin Cancer Res 2006;12:97.

Neoadjuvant Chemotherapy in NSCLC Drop in SUV >50%-- 40% of pts disease free at 36 months PET/CT could predict response and avoid unsuccessful resections PET/CT improves clinical management of NSCLC pts Pöttgen Clin Cancer Res 2006;12:97.

What Does a Referring Physician Want? Quality PET/CT imaging PET/CT the easy way Reliable and expert source of answers on PET/CT Understand clinical uses for PET/CT in Lung Cancer Understand that PET/CT is reimbursed in Lung Cancer

New Articles Bunyaviroch T. Coleman E. PET evaluation of lung cancer. J Nucl Med 2006;47:451. Lardinois D. etal. Staging of non-small cell lung cancer with integrated positron emission tomography and computed tomography. N Engl J Med 2003; 348:2500. Pöttgen C. etal. Value of 18fluoro-2-deoxy-glucose positron emission tomography/computed tomography in non-small cell lung cancer for prediction of pathologic response and time to relapse after neoadjuvant chemotherapy. Clin Cancer Res 2006;12:97. Gould M. etal. Cost-effectiveness of alternative management strategies for patients with solitary pulmonary nodules. Ann Intern Med. 2003;138:725.

New Articles Chhajed P. etal. Combining bronchoscopy and positron emission tomography for the diagnosis of the small pulmonary nodule ≤3cm. Chest 2005; 128:3558. Steenbakkers R. etal. Reduction of observer variation using matched CT-PET for lung cancer delineation: a three dimensional analysis. Int J Radiat Oncol Biol Phys. 2006;64:435. Cerfolio R. etal. The accuracy of integrated PET- CT compared with dedicated PET alone for staging of patients with nonsmall cell lung cancer. Ann Thorac Surg. 2004; 78:1017.

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