NOPR Delivers Evidence for Expanded PET Use in Oncology Imaging

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Diagnostic findings from FDG-PET imaging changed the intended care of more than one in three cancer patients, according to a study of first-year data from the National Oncologic PET Registry (NOPR), published this month in the Journal of Clinical Oncology. NOPR was launched in May 2006 in response to the Center for Medicare and Medicaid Services’ (CMS) Coverage with Evidence policy to collect data through a clinical registry to inform the Center’s FDG-PET coverage determination decisions for currently non-covered cancer indications. The registry is comprehensive, including data from 23,000 patients.

‘‘The NOPR working group sought to measure the impact of PET findings on patient management in a manner minimally intrusive to care providers,” said Bruce E. Hillner, MD, lead author for the study and professor and eminent university scholar in the department of internal medicine at Virginia Commonwealth University in Richmond, Va. “This was critical for successfully collecting the large amount of data required for a robust analysis.”

Hillner, currently chair of one of the guideline panels within the American Society of Clinical Oncology (ASCO), is also chair of the NOPR working group. NOPR is sponsored by the Academy of Molecular Imaging (AMI) and managed by the American College of Radiology (ACR) and the ACR Imaging Network (ACRIN); ASCO and SNM also have played key roles in guiding the project’s development. 

NOPR is a prospective data registry that collects information from a PET facility, from the physician requesting a PET scan, and from the interpreting physician’s PET report for cancers not currently covered by CMS. The registry was designed to meet CMS criteria for evidence development; therefore, all patients are Medicare beneficiaries. PET studies performed on Medicare beneficiaries for CMS-approved indications in breast, cervical, colorectal, esophageal, head and neck, non-small-cell lung, and thyroid cancers, or lymphoma or melanoma are not eligible.

Ovarian and abdominal cancers are two of the cancer types for which Medicare currently reimburses only through the National Oncologic PET Registry (NOPR). At left is an ovarian carcinoma in a PET with contrast CT angiography (Biograph 16 PET•CT; courtesy of the University of Tennessee Medical Center, Knoxville). Image at right shows a malignant lymphoma in the abdomen (Biograph 16 PET•CT; courtesy of Beijing Hospital, Beijing, China).

Cancer types that Medicare currently reimburses for only through NOPR include those of the ovary, uterus, prostate, pancreas, stomach, kidney and bladder. The NOPR web site, www.cancerpetregistry.org, has a complete list of the covered cancer types for the registry.   

The study analyzed data regarding nearly 23,000 patients contributed to NOPR by more than 1,200 facilities in the United States that provide PET scans. The mean patient age of the patients was 72.6 years; 9.7 percent were younger than 65 years and 5.2 percent were 85 years or older.

The primary end-point of the study was the impact of PET on physicians’ intended management. The study authors assessed a change in management in four ways:
  1. Intended management was stratified as either treatment or non-treatment.

  2. The intent of planned therapies was determined to be either curative or palliative, which allowed the researchers to assess if a meaningful change included a change in intent, even if the specific therapy did not change.

  3. Changes in the type or number of clinical actions were defined as minor or major; a major change was defined as a switch in treatment type and a minor change was defined as the addition or deletion of treatments, but where one type remained constant in the pre- and post-PET plan.

  4. The data also was scored as to whether therapy intensity increased, decreased, or was unchanged by comparing the number of modes in the pre- and post-PET plans.
Analysis of data collected found that FDG-PET utilization is associated with a 36.5 percent change in the decision of whether or how to treat a patient’s cancer. The study also found that PET is associated with a management change in almost 75 percent of patients when the addition or deletion to specific modes of therapy was included. In addition, the NOPR data revealed that for patients with a pre-PET plan of biopsy, the post-PET plan had a significant impact on care, with these patients avoiding biopsy in about 75 percent of the cases analyzed.

NOPR working group co-chair R. Edward Coleman, MD, professor of radiology and chief of the division of nuclear medicine at Duke University School of Medicine in Durham, N.C., and study author, observed, “We were especially surprised by the impact of the PET findings on patients who were originally planned to have a biopsy.”

Oncologist, NOPR working group co-chair and study author Anthony F. Shields, MD, professor of medicine and oncology at the Karmanos Cancer Institute at Wayne State University in Detroit and chair of ACRIN’s Oncology Committee said of the research findings, “These results confirm what we suspected from increasing experience with PET. However, we lacked the significant data required to prove the benefit of PET for many uncovered indications. It’s very encouraging that oncologists and other clinicians may have access to the valuable information PET affords for ensuring the best patient care.” 

“These data confirm what we have known for some time: molecular imaging is a powerful tool in diagnosing, treating, and monitoring disease and is capable of dramatically changing the course of patient care,” commented SNM President Alexander J. McEwan, MD, professor and chair of the department of oncology, faculty of medicine, at the University of Alberta and director of oncologic imaging at Cross Cancer Institute in Edmonton, Canada.

“For oncologists, we’re getting a much better idea of how to use this technology in patients with cancer,” McEwan said. “The NOPR study demonstrates that PET has a role in a number of cancers for which we now have evidence we didn’t have before.”

To further a better understanding of the NOPR results and their meaning for clinical practice, as well as the appropriate use of PET technology in cancer imaging, McEwan said that SNM is closely working with both ASCO and the American Society for Therapeutic Radiology and Oncology (ASTRO) to develop more teaching courses for their members as well as ongoing involvement in one another’s conferences.

On the basis of its research findings, NOPR has formally asked CMS to reconsider its current National Coverage Determination (NCD) on FDG-PET and requested that it provide Medicare coverage of FDG-PET for diagnosis, staging and restaging across all oncologic indications. CMS is expected to issue a formal response to the NOPR request by October this year.

“The NOPR Working Group was careful to consider the impact of including or excluding in their analysis cases where the pre-PET treatment plan was already imaging,” said AMI president Timothy McCarthy, PhD, in a letter to Steve Purrough, MD, CMS director, coverage and analysis group. “Yet, even assuming that PET provided no advantages for those patients with pre-PET imaging plans, the NOPR Working Group’s ‘worst-case estimate’ [in their words] was that PET would nevertheless be associated with a major change in treatment in nearly 20 percent of patients.”

“NOPR afforded oncologists and nuclear medicine physicians a unique opportunity to make PET available to Medicare beneficiaries and to improve our understanding of the role of PET in oncology practice,” said study author Barry A. Siegel, MD, professor of radiology and chief of the division of nuclear medicine at the Mallinckrodt Institute of Radiology at Washington University in St. Louis, chair of ACRIN’s PET Imaging Core Laboratory, and NOPR working group co-chair. “Based on these data, Medicare should strongly consider opening up the coverage to include diagnosis, staging and restaging for all cancers.”