Comment Letter on Draft Report Regarding Imaging for Pretreatment Staging of Small Cell Lung Cancer

Richard Kronick, Ph.D.
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850

RE: Draft Report: Imaging for Pretreatment Staging of Small Cell Lung Cancer

Dear Dr. Kronick:

The Medical Imaging & Technology Alliance (MITA) is pleased to submit comments on the Agency for Healthcare Research and Quality (AHRQ) Draft Report: Imaging for Pretreatment Staging of Small Cell Lung Cancer (“Draft Report”).1 MITA has extensive knowledge of the substantial benefits afforded by medical imaging and radiation therapy to the health of Americans due to our role as the leading trade association representing medical imaging and radiopharmaceutical manufacturers. We support quality efforts that foster appropriate use of these technologies for the early detection, diagnosis, staging, therapy monitoring, and surveillance of many diseases.

Medical imaging encompasses X-ray imaging, computed tomography (CT) scans, diagnostic ultrasound, nuclear imaging (including positron emission tomography (PET)), magnetic resonance imaging (MRI), and related imaging acquisitions. Medical imaging is used to diagnose patients with disease, often reducing the need for costly medical services and invasive surgical procedures.2 In addition, medical imaging equipment often is used to select, guide, and facilitate effective treatment, for example, by using image guidance for surgical or radiotherapeutic interventions.3

With lung cancer and other complex diseases, there are multiple decision nodes during the course of diagnosis and treatment. We believe PET/CT is informative and value-additive at all stages including diagnosis and treatment planning strategy. During the course of treatment, “the results of PET/CT studies can affect the treatment plan, resulting in a change in treatment strategy in up to one third (30.12%) of the patients.”4 After initial diagnosis, PET/CT can provide ongoing data on the effectiveness of a treatment plan, thereby allowing for changes in treatment strategy to be implemented so as to provide the patient with the most appropriate treatment.

As such, MITA agrees with the conclusions of the Draft Report:
(1) FDG PET/CT is more sensitive than MDCT for detecting osseous metastases;
(2) FDG PET/CT is more sensitive than bone scintigraphy for detecting osseous metastases;
(3) Standard staging plus PET/CT is more sensitive than standard staging alone for detecting any distant metastases

While we are supportive of the conclusions, we are, however, disappointed in the low strength of evidence grading for these conclusions. The Draft Report states: “The higher sensitivity of FDG PET/CT would result in accurate determination of extent of disease, providing clinicians the confidence to offer a comprehensive stage-based treatment plan. Second, earlier detection of extensive disease would spare patients from more aggressive chemotherapy and radiation protocols used for patients with LD. Earlier initiation of palliative measures may result in improved quality of life, an important consideration given the current poor prognosis of this disease. Third, improved sensitivity and timeliness of staging may potentially improve the ability of ongoing research trials to prognosticate and detect therapeutic efficacy.”

In light of this analysis, we feel that the strength of evidence has been graded too low and the evaluation methodology used may not be applicable to diagnostic imaging tests. Diagnostic imaging tests help inform the clinical decision-makers (referring physicians, patients, and caregivers) about the extent of the disease and evaluation of the effectiveness of treatment. Therefore, we submit that the appropriate subsequent outcomes in diagnostic imaging should be limited to management strategies, not survival time or quality of life. To reinforce this assertion, in 2011 MITA convened a workshop on research endpoints, which AHRQ participated in. The conclusions of this workshop follow:

  • With respect to diagnostic technologies, it is often difficult to parse the specific benefit derived from the test from the chain of diagnostic and therapeutic maneuvers that comprise the totality of clinical care. Diagnostic technologies should be considered differently than therapeutic
  • The outcomes, or endpoints, appropriate to assessing whether diagnostic interventions are reasonable and necessary are best characterized as “change in clinical management.” This is distinct from the outcomes, or endpoints, classically applied in assessing whether therapeutic interventions are reasonable and necessary. 5
    In summary, MITA supports the findings of the Draft Report, and we encourage AHRQ to re-evaluate the criterion by which the evidence base is graded when evaluating diagnostic imaging tests.

* * * *

MITA appreciates this opportunity to comment on the Draft Report. We would be pleased to answer any questions you might have about these comments. Please contact me at (703) 841-3258 if MITA can be of any assistance.

Terri Wilson
Director, PET & Molecular Imaging

1 Agency for Healthcare Research and Quality. Draft Report: Imaging for Pretreatment Staging of Small Cell Lung Cancer Online:
2 See, e.g., Perrier, et al., “Multidetector-Row Computed Tomography in Suspected Pulmonary Embolism,” New England Journal of Medicine, 352(2005): 1760-1768.
3 See, e.g., Jelinek, JS et al., “Diagnosis of Primary Bone Tumors with Image-Guided Percutaneous Biopsy: Experience with 110 Tumors.” Radiology. 223(2002): 731-37.
4 Ibid, pp. 207
interventions because of the incremental benefit the diagnostics provide in therapeutic decision making.
5 Hillman, BJ, Frank, RA, Abraham, BC., “The Medical Imaging & Technology Alliance Conference on Research Endpoints Appropriate for Medicare Coverage of New PET Radiopharmaceuticals.” The Journal of Nuclear Medicine. 54(2013): 1675-1679.

Click here to read the full comment letter.