Impact of FDG PET on Defining the Extent of Disease and on the Treatment of Patients with Recurrent or Metastatic Breast Cancer

Eubank, William B.; Mankoff, David A.; Bhattacharya, Mallar; Gralow, Julie R.; Linden, Hannah M.; Ellis, Georgiana K.; Lindsley, Skyler K.; Austin-Seymour, Mary; Livingston, Robert B.

doi:10.2214/ajr.183.2.1830479

Cited by 108 publications

(56 citation statements)

References 20 publications

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“…The treatment plan was altered in 32% and supported in 27% of patients. A change was most likely in patients with suspected locoregional recurrence (124).…”

Section: Fdg-pet Validated For Staging and Diagnosis: A Biomarker Ofmentioning

confidence: 99%

Progress and Promise of FDG-PET Imaging for Cancer Patient Management and Oncologic Drug Development

Kelloff

Hoffman

Johnson

et al. 2005

Clinical Cancer Research

605

382

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2-[ 18 F]Fluoro-2-deoxyglucose positron emission tomography (FDG-PET) assesses a fundamentalpropertyof neoplasia, theWarburgeffect.This molecularimaging technique offers acomplementary approach to anatomic imaging that is more sensitive and specific in certain cancers. FDG-PET has been widely applied in oncology primarily as a staging and restaging tool that can guide patient care. However, because it accurately detects recurrent or residual disease, FDG-PETalso has significant potential for assessing therapy response. In this regard, it canimprove patient management by identifying responders early, before tumor size is reduced; nonresponders could discontinue futile therapy. Moreover, a reductioninthe FDG-PETsignal withindays or weeks of initiating therapy (e.g., in lymphoma, non^small cell lung, and esophageal cancer) significantly correlates with prolonged survival and other clinical end points now usedin drug approvals.These findings suggest that FDGPETcould facilitate drug development as an early surrogate of clinicalbenefit.This article reviews the scientificbasis ofFDG-PETandits development andapplicationasavaluableoncologyimagingtool. Its potential to facilitate drug development in seven oncologic settings (lung, lymphoma, breast, prostate, sarcoma, colorectal, and ovary) is addressed. Recommendations include initial validation against approved therapies, retrospective analyses to define the magnitude of change indicative of response, further prospective validation as a surrogate of clinical benefit, and application as a phase II/III trial end point to accelerate evaluation and approval of novel regimens and therapies. FDG-PET (2-[18 F]Fluoro-2-deoxyglucose positron emission tomography) is an accepted and widely used clinical imaging tool in oncology. U.S. Medicare reimbursement of FDG-PET recently expanded to encompass all cancer patients participating in certain prospective studies or registries in addition to more general coverage in 10 defined oncologic settings. Primarily covered are disease diagnosis, staging, and restaging, but FDG-PET is also approved for monitoring response to therapy in locally advanced and metastatic breast cancers when a change in therapy is anticipated. Clinical trials in breast cancer and other settings [e.g., non -small cell lung cancer (NSCLC) and esophageal cancer] have shown that FDG-PET imaging can provide an early indication of therapeutic response that is well correlated with clinical outcome. FDG-PET thus has the potential to improve patient management, particularly by signaling the need for early therapeutic changes in nonresponders, thereby obviating the side effects and costs of ineffective treatment. As an early surrogate for clinical benefit, the modality also has the potential to facilitate oncologic drug development by shortening phase II trials and detecting clinical benefit earlier in phase III investigations. Studies to further explore and validate these approaches are needed and can be conducted in parallel with those employing end points now use...

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“…The treatment plan was altered in 32% and supported in 27% of patients. A change was most likely in patients with suspected locoregional recurrence (124).…”

Section: Fdg-pet Validated For Staging and Diagnosis: A Biomarker Ofmentioning

confidence: 99%

Progress and Promise of FDG-PET Imaging for Cancer Patient Management and Oncologic Drug Development

Kelloff

Hoffman

Johnson

et al. 2005

Clinical Cancer Research

605

382

View full text Add to dashboard Cite

show abstract

“…National Comprehensive Cancer Network guidelines state that the use of 18 F-FDG PET or PET/CT scanning is optional, is indicated only for inoperable advanced breast cancer or MBC, and is most helpful when the results of standard imaging studies are equivocal or suspect. Limited evidence supports the use of 18 F-FDG PET to evaluate the extent of disease in selected patients with recurrent or metastatic disease (11,12,27,28) (LoE: 3). When 18 F-FDG PET/CT clearly shows bone metastases, no bone scan is needed, because of the high concordance between the modalities for bone metastases (29).…”

Section: Stagingmentioning

confidence: 99%

Translation of New Molecular Imaging Approaches to the Clinical Setting: Bridging the Gap to Implementation

Venema

Glaudemans

et al. 2016

J Nucl Med

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Molecular imaging with PET is a rapidly emerging technique. In breast cancer patients, more than 45 different PET tracers have been or are presently being tested. With a good rationale, after development of the tracer and proven feasibility, it is of interest to evaluate whether there is a potential meaningful role for the tracer in the clinical setting-such as in staging, in the (early) prediction of a treatment response, or in supporting drug choices. So far, only 18 F-FDG PET has been incorporated into breast cancer guidelines. For proof of the clinical relevance of tracers, especially for analysis in a multicenter setting, standardization of the technology and access to the novel PET tracer are required. However, resources for PET implementation research are limited. Therefore, next to randomized studies, novel approaches are required for proving the clinical value of PET tracers with the smallest possible number of patients. The aim of this review is to describe the process of the development of PET tracers and the level of evidence needed for the use of these tracers in breast cancer. Several breast cancer trials have been performed with the PET tracers 18 F-FDG, 3′-deoxy-3′-18 F-fluorothymidine ( 18 F-FLT), and 18 F-fluoroestradiol ( 18 F-FES). We studied them to learn lessons for the implementation of novel tracers. After defining the gap between a good rationale for a tracer and implementation in the clinical setting, we propose solutions to fill the gap to try to bring more PET tracers to daily clinical practice. Mol ecular imaging with PET is a rapidly emerging approach in oncology. This approach offers the potential to noninvasively determine tumor staging, make tumor response measurements, and characterize relevant drug targets in the tumor. Moreover, the wholebody 3-dimensional image provides information about all tumor lesions within a patient. This information is increasingly of potential interest because of progressive awareness of the existence of tumor heterogeneity for several clinical relevant characteristics (1,2). Interestingly, the development of tracers for most hallmarks of cancer allows the imaging of key characteristics of tumors in the research setting (3). More than 30 different PET tracers have been analyzed for their contributions to staging or early response measurements in breast cancer (Table 1). In addition, in the past 5 y, information on 15 different breast cancer tracers has been published. Many more are expected. However, at present, only the visualization of glucose uptake with 18 F-FDG PET is part of standard care and has been incorporated into breast cancer guidelines (4,5). New initiatives are attempting to bridge the gap between new chemical entities and clinical-grade radiopharmaceuticals, which then must be brought to the clinical setting. This process requires proof-of-concept feasibility studies; when sufficient evidence has accumulated, the tracer should be implemented in the clinical setting.The aims of this review are to summarize the steps from preclinical to ...

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“…Eubank et al (Eubank et al, 2004) retrospectively analysed 125 consecutive patients with breast cancer with the aim of 1) evaluating the impact of FDG PET on defining the extent of disease and 2) evaluating the impact of FDG PET on patient management. The patients were referred for FDG PET for the following reasons: evaluation of disease response or viability after therapy (n=43; 35%), local recurrence with intent of aggressive local treatment (n=39; 31%), equivocal findings on conventional imaging (n=25; 20%), evaluation of the extent of the disease in patients with known metastases (n=13; 10%) and elevated tumour markers with unknown disease site (n=5; 4%).…”

Section: Tumour Markers and Pet Alonementioning

confidence: 99%

Tumour Markers and Molecular Imaging with FDG PET/CT in Breast Cancer: Their Combination for Improving the Prediction of Disease Relapse

Evangelista¹,

Baretta²,

Vinante³

et al. 2012

Positron Emission Tomography - Current Clinical and Research Aspects

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Impact of FDG PET on Defining the Extent of Disease and on the Treatment of Patients with Recurrent or Metastatic Breast Cancer

Abstract: FDG PET contributes significantly to defining the extent of disease and deciding on treatment of patients with advanced breast cancer.

Cited by 108 publications

References 20 publications

Progress and Promise of FDG-PET Imaging for Cancer Patient Management and Oncologic Drug Development

Progress and Promise of FDG-PET Imaging for Cancer Patient Management and Oncologic Drug Development

Translation of New Molecular Imaging Approaches to the Clinical Setting: Bridging the Gap to Implementation

Tumour Markers and Molecular Imaging with FDG PET/CT in Breast Cancer: Their Combination for Improving the Prediction of Disease Relapse

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