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Technology Assessment US. Department of Health and Human Services Public Health Service POSITRON EMISSION TESTING FOR SIX Agency for Healthcare Research and CANCERS (BRAIN, CERVICAL, SMALL CELL Quality LUNG, OVARIAN, PANCREATIC AND 540 Gaither Road TESTICULAR) Rockville, Maryland 20850 February 12, 2004 POSITRON EMISSION TESTING FOR SIX CANCERS (BRAIN, CERVICAL, SMALL CELL LUNG, OVARIAN, PANCREATIC AND TESTICULAR) Prepared for: Agency for Health Care Research and Quality U.S. Department of Health and Human Services 2101 East Jefferson Street Rockville, MD 20852 www.ahrq.gov Contract No.: 290-02-0025 Task Order: 0 Prepared by the Duke Center for Clinical Health Policy Research and Evidence Practice Center David B. Matchar, MD Shalini L. Kulasingam, PhD Laura Havrilesky, MD Lori O. Mann, MD Evan R. Myers, MD, MPH Douglas C. McCrory, MD, MHSc Meenal Patwardhan, MD Robert Prosnitz, MD Table of Contents 1 Introduction .......................................................................................... 5 1.1. Overview ........................................................................................ 5 1.2. Request by Centers for Medicare and Medicaid Services.............. 8 1.3. Structure of the Evidence Report ................................................. 14 2 Methods.............................................................................................. 15 2.1. Classification of Diagnostic Studies ............................................. 15 2.2. Literature Review ......................................................................... 22 2.2.1. Literature Identification ………………………………………..22 2.2.1.1. Search Strategy Used for Identifying Abstracts ……22 2.2.2. Literature Selection ………………………………………...….24 2.2.2.1. General Inclusion/Exclusion Criteria for Identifying Abstracts……………………………………24 2.2.2.2. Inclusion Criteria for Identifying Articles for Full Text Review ……………………………………….24 2.2.3. Data Abstraction and Quality Scores Assigned to Full Text Articles ……………………………………………….26 3 Results .............................................................................................. 28 3.1. Brain Cancer ................................................................................ 28 3.1.1. Background …………………………………………………….28 3.1.2. CMS Statement of Work Questions …………………………32 3.1.3. Importance of Questions Posed by CMS in Clinical Management ………………………………………….33 3.1.4. Results ………………………………………………………….35 3.1.5. Conclusions …………………………………………………….44 3.1.6. Tables …………………………………………………………...46 3.1.7. Figures ………………………………………………………….48 3.2. Cervical Cancer............................................................................ 52 3.2.1. Background …………………………………………………….52 3.2.2. CMS Statement of Work Questions …………………………53 3.2.3. Importance of Questions Posed by CMS in 2 Clinical Management …………………………………………53 3.2.4. Results …………………………………………………………56 3.2.5. Conclusions ……………………………………………………64 3.2.6. Tables …………………………………………………………..66 3.2.7. Figures ………………………………………………………….68 3.3. Ovarian Cancer............................................................................ 74 3.3.1. Background …………………………………………………….74 3.3.2. CMS Statement of Work Questions …………………………74 3.3.3. Importance of Questions Posed by CMS in Clinical Management ………………………………………….75 3.3.4. Results ………………………………………………………….78 3.3.5. Conclusions …………………………………………………….86 3.3.6. Tables …………………………………………………………...88 3.3.7. Figures ………………………………………………………….90 3.4. Pancreatic Cancer........................................................................ 92 3.4.1. Background …………………………………………………….92 3.4.2. CMS Statement of Work Questions …………………………93 3.4.3. Importance of Questions Posed by CMS in Clinical Management ………………………………………….94 3.4.4. Results ………………………………………………………….96 3.4.5. Conclusions …………………………………………………...121 3.4.6. Tables …………………………………………………………124 3.4.7. Figures ………………………………………………………...130 3.5. Small Cell Lung Cancer ............................................................. 136 3.5.1. Background …………………………………………………..136 3.5.2. CMS Statement of Work Questions ……………………….137 3.5.3. Importance of Questions Posed by CMS in Clinical Management ………………………………………..137 3.5.4. Results ………………………………………………………..140 3.5.5. Conclusions …………………………………………………..148 3.5.6. Tables …………………………………………………………151 3 3.5.7. Figures ………………………………………………………..153 3.6. Testicular Cancer ....................................................................... 159 3.6.1. Background …………………………………………………..159 3.6.2. CMS Statement of Work Questions ……………………….160 3.6.3. Importance of Questions Posed by CMS in Clinical Management ………………………………………..160 3.6.4. Results ………………………………………………………..164 3.6.5. Conclusions …………………………………………………..178 3.6.6. Tables …………………………………………………………182 3.6.7. Figures ………………………………………………………..186 4 General Limitations of the Literature Reviewed................................ 192 5 Bibliography ..................................................................................... 193 6 Appendices ...................................................................................... 204 6.1. Appendix A – Neuroepithelial Tumors of the CNS .................... 204 6.2. Appendix B – Glossary............................................................... 210 6.3. Appendix C – Data Abstraction Form …………………………….213 6.4. Appendix D – Evidence Tables ……………………………………221 6.5. Appendix E – References…………………………………………..302 4 1. INTRODUCTION 1.1 Overview Computed tomography (CT) and magnetic resonance (MRI) are anatomic, high-resolution imaging techniques currently used in oncology to detect or confirm the presence of a tumor; to provide information about the size and location of the tumor and whether it has spread; to guide a biopsy; to help plan radiation therapy or surgery; and to determine whether the cancer is responding to treatment. Despite widespread use, concerns remain that use of these imaging techniques may result in false negatives due to their inability to resolve small volumes (diameter < 1cm) of disease and false positives due to their inability to distinguish between viable tumor masses and masses consisting of necrotic or scar tissue. Functional imaging methods such as positron emission tomography (PET) can establish the metabolic or functional parameters of tissue that may aid in these distinctions. Instead of using anatomical deviations to identify areas of abnormality, PET uses positron-emitting radioactive tracer that accumulates in abnormal tissue. Therefore, it primarily measures metabolism and function as opposed to structure. The process involves release of a 5 positron from a radioisotope (e.g. 18-fluorine), which subsequently collides with an electron, forming two photons in a process called annihilation. The two photons travel away from each other at 180° angles and are picked up by detectors placed around the body. The source of the photons is then spatially determined. Areas with increased photon activity are areas of radioisotope accumulation. Quantitative measurements can be made when photon attenuation, which occurs during passage through the body, is corrected using a transmission scan. Semi-quantitative measurement is performed using the standardized uptake value (SUV) of a region of interest. The SUV is calculated by measuring the tissue radioactivity concentration (μCi/mL) and dividing by the total injected dose (μCi/kg), normalized to the body weight. Results may be variable depending upon the scanner image resolution (should be small enough to adequately visualize the organ or region of interest), time of image acquisition after radioisotope injection (later images will have higher SUVs as FDG accumulates), the presence of hyperglycemia, method of normalization (use of body surface area or lean body mass) and the method of quantitative measurement. 6 The most commonly used radioisotope tracer is 18Fluro-deoxy glucose (FDG), a glucose analog. Like glucose FDG is taken up into cells through glucose transport proteins (GLUT) and then phosphorylated by a hexokinase. At this point glucose is further metabolized while deoxyglucose is not, leaving the 18FDG to accumulate intra-cellularly as 18F-FDG-6-phosphate. Some tissues contain glucose-6-phosphatase, which can dephosphorylate the molecule returning it to its original form as 18FDG. Tumor cells have both an overexpression of GLUT and an under expression of glucose-6-phosphatase, permitting a relatively large localized accumulation of tracer molecules within the tumor cells. In addition, depending on the area or organ under study, baseline glucose metabolism may be low, further establishing the difference between normal background tissue and tumor. Thus, compared to structural imaging techniques, FDG-PET may be a more accurate technique for diagnosis, staging and treatment decisions in oncology. PET is currently approved for coverage by the Center for Medicaid and Medicare Services (CMS) for use, for certain indications, in non-small cell lung cancer, esophageal cancer, colorectal cancer, lymphoma, melanoma, breast cancer, head and 7 neck cancers and thyroid cancer (http://www.cms.hhs.gov/coverage/ accessed September 27th, 2003). 1.2. Request by the Centers for Medicare and Medicaid Services The Centers for Medicare & Medicaid Services (CMS) requested a technology assessment by the Agency for Health Care Research and Quality (AHRQ) to evaluate the performance of FDG PET when compared to conventional imaging (such as CT and MRI) and when used as an adjunct to conventional imaging for patient management of