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FDG-PET Lung and Lymphoma Projects: Questions and Answers
1. What is The Biomarkers Consortium?
The Biomarkers Consortium is a major public-private biomedical research partnership launched in October 2006. The consortium, which is being managed by the Foundation for the National Institutes of Health (FNIH), will initiate its activities by conducting the fluorodeoxyglucose-positron emission tomography (FDG-PET) lung and lymphoma clinical trials, in addition to other projects.
Consortium founding organizations include FNIH, the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA).
Additional organizations participating on The Biomarkers Consortium Executive Committee include: the National Cancer Institute (NCI), the National Institute of Mental Health, and the National Institute of Dental and Craniofacial Research, all part of the National Institutes of Health; the Centers for Medicare & Medicaid Services (CMS); and GlaxoSmithKline, Johnson & Johnson, and Pfizer Inc. (See The Biomarkers Consortium press release at www.biomarkersconsortium.org for the membership of the Executive Committee.)
To date, $1.2 million has been committed by the consortium's funding members to support the operations of the consortium. Those supporters include the Alzheimer's Association; AstraZeneca; the Biotechnology Industry Organization; Bristol-Myers Squibb; GlaxoSmithKline; The Leukemia & Lymphoma Society; Johnson & Johnson; Eli Lilly and Company; Pfizer Inc; PhRMA; and F. Hoffmann-La Roche.
Additional information about the administrative structure of The Biomarker Consortium and the roles that public and private sector participants will play in this public-private partnership can be found at www.biomarkersconsortium.org.
2. What are biomarkers?
Biomarkers are biologic indicators of disease or of the therapeutic effects of treatments. These indicators can be measured through a variety of means, including dynamic imaging tests and laboratory tests on blood, tissue, and other biologic samples. The prostate-specific antigen (PSA) test is an example of a biomarker currently in wide use to aid in the diagnosis of prostate cancer, as well as to monitor treatment response.
3. What is FDG-PET?
The rationale for the use of FDG-PET relies on the difference in basic energy requirements between tumor and normal cells, i.e., tumor cells require more energy to survive and spread. For this procedure, the patient is injected with FDG - a molecule very similar to glucose (a type of sugar), but with a radioactive tracer (F18) attached to it - and then is imaged in a PET machine. Tumor cells, particularly those from especially aggressive tumors, will consume significantly larger amounts of the FDG than normal cells from surrounding tissue. The result is that FDG's presence can be detected by PET imaging in tumors as small as one centimeter.
Researchers have been investigating whether FDG-PET results can predict treatment response early (in the first two to six weeks) after treatment. In these studies, the levels of "tumor uptake" of FDG are measured before treatment and then again a short time later to see if that uptake has decreased, which would signal a decline in the number of tumor cells.
4. What is the origin of the FDG-PET Lung and Lymphoma Projects?
In early 2003, the NCI and the FDA established the Interagency Oncology Task Force (IOTF) to focus on optimizing and streamlining the process of cancer drug development. Through the IOTF, the NCI, FDA, and CMS planned the Oncology Biomarkers Qualification Initiative (OBQI), announced in early 2006. OBQI is designed to improve cancer drug development and outcomes for cancer patients through biomarker identification and evaluation.
Both the FDG-PET non-small cell lung cancer and non-Hodgkin's lymphoma clinical trials are designed to provide sufficient data to indicate whether FDG-PET could serve as an outcome measure for the evaluation of treatment responses in these two tumors. Thus, these FDG-PET clinical trials could have a significant impact on patient management by validating a tool for assessing therapeutic response, and also facilitate new drug development. In addition, the projects are designed to provide CMS with evidence-based measures to help the agency make informed reimbursement decisions.
5. What is the FDG-PET Lung Project?
The FDG-PET Lung Project is a phase II study to assess the value of FDG-PET as a marker to predict tumor response and patient outcome for patients with non-small cell lung cancer (NSCLC). This clinical trial will be coordinated by the American College of Radiology Imaging Network (ACRIN), an NCI-funded cooperative group. Numerous clinical studies have revealed that lung cancer cells show very high rates of glucose consumption and can be imaged efficiently by FDG-PET. In addition, data from small clinical trials in NSCLC patients - which accounts for two-thirds of all lung cancer cases - demonstrated that FDG-PET images can provide an early indication of therapeutic response that is strongly correlated with clinical outcome. The availability of such a sensitive measurement could streamline clinical trials of new treatments for lung cancer and, thus, accelerate new drug approvals. More information about the FDG-PET Lung Project is available at http://www.cancer.gov/clinicaltrials/ACRIN-6668.
6. What is the FDG-PET Lymphoma Project?
The FDG-PET Non-Hodgkin's Lymphoma Project is a phase III clinical trial to assess the value of FDG-PET in evaluating and comparing R-CHOP - the standard chemotherapy for diffuse large B-cell lymphomas (DLBCL) - with dose-adjusted (DA)-EPOCH-R. EPOCH-R is a new regimen for DLBCL developed from studies examining drug schedule, resistance, and pharmacokinetics (the activity of the treatments in the body over a period of time). The "DA" refers to the adjustment of the treatment schedule based on whether the patient's disease progresses and whether the treatment leads to unacceptable toxicity. The study will be coordinated by the Cancer and Leukemia Group B (CALGB), a national clinical research group sponsored by NCI. Considerable evidence supports the association of post-therapy FDG-PET results with outcome in lymphoma patients. Specifically, FDG uptake has been a significant early predictor of residual or recurrent disease and disease progression, as well as progression-free survival and overall survival. The trial will focus on the establishment of standardized criteria for PET imaging, such as quality assurance and analysis of PET images. This project is one of the first steps toward developing the standardized protocols and endpoints that will be needed for the use of FDG-PET as a potential biomarker in clinical trials. More information about the FDG-PET Lymphoma Project is available at http://www.cancer.gov/clinicaltrials/CALGB-50303.
7. What are the funding levels for the FDG-PET projects and how much will be provided by the public and private partners?
The Foundation for NIH is seeking to raise $7.5 million in private funds for these two projects. Thus far, $3.75 million in commitments have been received from Amgen, AstraZeneca, Bristol-Myers Squibb, Pfizer Inc, and Merck & Co., Inc., and additional funders are anticipated to join the effort. Public funds devoted to these projects include NCI funding of approximately $1.5 million for the non-small cell lung study and $2.25 million for the non-Hodgkin's lymphoma study.
8. Will results and data from the FDG-PET projects be publicly available?
One of the goals of The Biomarkers Consortium is to make the research results and data publicly available as rapidly as possible. It is anticipated that the data generated from these non-small cell lung and non-Hodgkin's lymphoma projects will be made publicly available through the Web-based NCI Cancer Biomedical Informatics Grid (caBIG) at https://cabig.nci.nih.gov, which enables the accessing and sharing of clinical trial data. A specific data-sharing and access plan will define which data arising from the projects will be made publicly available and how and when the data can be accessed.
9. How can I find additional information?
For more information about The Biomarkers Consortium, please contact David Lee, MPA, FNIH Senior Partnership Development Officer for Research Initiatives, at 301-496-1518 or dlee@fnih.org.
For more information about the FDG-PET Lung and Lymphoma Projects, please contact the NCI Media Relations Branch at 301-496-6641 or ncipressofficers@mail.nih.gov.
For more information about the Foundation for the National Institutes of Health, please visit the FNIH Web site at http://www.fnih.org or call 301-402-5311.
For more information about cancer and the National Cancer Institute, please visit the NCI Web site at http://www.cancer.gov, or call NCI's Cancer Information Service at 1-800-4-CANCER
(1-800-422-6237).
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