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OtherSPECIAL CONTRIBUTION

The National Oncologic PET Registry (NOPR): Design and Analysis Plan

Bruce E. Hillner, Dawei Liu, R. Edward Coleman, Anthony F. Shields, Ilana F. Gareen, Lucy Hanna, Sharon Hartson Stine and Barry A. Siegel
Journal of Nuclear Medicine November 2007, 48 (11) 1901-1908; DOI: https://doi.org/10.2967/jnumed.107.043687
Bruce E. Hillner
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Dawei Liu
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R. Edward Coleman
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Anthony F. Shields
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Ilana F. Gareen
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Lucy Hanna
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Sharon Hartson Stine
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Barry A. Siegel
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    FIGURE 1. 

    NOPR schema. See text for details.

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    FIGURE 2. 

    Primary endpoint: change in intended management strategy.

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    TABLE 1

    Question Timing and Types in NOPR Case Report Forms

    QuestionPre-PETPost-PET
    Clinical indication*×
    If known cancer, primary site† and working stage‡2
    Questions specific to clinical indication2–4
    Patient performance status§×
    Did PET scan enable you to avoid more tests or procedures?×
    Intended management¶××
    If ordering physician is treating physician××
    Ordering physician consent for research use of data by NOPR×
    • ↵* Clinical indication: Cancer diagnosis, initial staging, restaging, suspected recurrence, or treatment monitoring. Cancer diagnosis includes assessment of patients with cancer of unknown primary and suspected paraneoplastic syndromes as well as assessment of those with lesions suspected to be cancer.

    • ↵† Cancer site: 30 different sites listed alphabetically with corresponding ICD-9 code (ICD is International Classification of Diseases). If not listed, cancer type and ICD-9 code may be entered under “other.”

    • ↵‡ Working stage: No evidence of disease/in remission; localized disease only; regional by direct extension or lymph node involvement or both; metastatic (distant) with a single suspected site; metastatic (distant) with multiple suspected sites; unknown or uncertain.

    • ↵§ Performance status (Eastern Cooperative Oncology Group [ECOG]): 0, asymptomatic; 1, symptomatic, fully ambulatory; 2, symptomatic in bed < 50% of the day; 3, symptomatic in bed > 50% of the day, but not bedridden; 4, bedridden.

    • ↵¶ Intended management: See Figure 2.

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    TABLE 2

    95% Confidence Intervals for Different Probability Estimates of Minimally Important Difference in Change in Management

    Lower bound of 1-sided 95% confidence intervals
    Sample sizeP = 5%P = 10%P = 20%P = 30%P = 50%
    n = 2002.56.515.324.644.2
    n = 5003.47.817.126.646.3
    n = 1,0003.98.417.927.647.4
    n = 5,0004.59.319.128.948.8
    • P = “True” probability of change in intended patient management between Pre-PET and Post-PET forms.

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    TABLE 3

    NOPR Working Group's Priority Areas for Early Evaluation

    Priority and relative frequencyDiagnosisStagingRestaging and suspected recurrenceTherapeutic monitoring
    1Pancreatic cancerPancreatic cancerOvarian cancerLymphoma
    2Cancer of unknown primary siteSmall cell lung cancerBrain tumorsNon–small cell lung cancer
    3Ovarian cancerCervical cancerMetastatic colorectal cancer
    4Multiple myelomaMultiple myelomaHead and neck cancer
    5Esophageal cancer
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    TABLE 4

    Approaches to Defining Change in Management

    Approach 1Approach 2Approach 3
    Nontreatment*Nontreatment*Nontreatment*
    Treatment†Treatment with curative intent‡Treatment including same mode of therapy§
    Treatment with palliative intent‡Treatment with a change in mode of therapy§
    • ↵* Nontreatment strategies: combination of watch, imaging, biopsy, or supportive care.

    • ↵† Treatment strategies: All forms of treatment strategies were equal without considering therapeutic goal or changes in mode of therapy.

    • ↵‡ Curative or palliative intent: A change in therapeutic intent (e.g., curative to palliative) considered an important change without considering mode of therapy.

    • ↵§ Change in mode of therapy: A major change (e.g., from surgery to chemotherapy) without consideration of curative or palliative intent. See Table 5.

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    TABLE 5

    Supplemental Data: Matrix of Combinations of Pre-PET and Post-PET Management Plans and Their Classification

    Pre-PET plan
    Post-PET planWatchMore imagingTissue biopsyCurative surgeryPalliative surgeryCurative chemotherapyPalliative chemotherapyCurative radiationPalliative radiationSupportive care
    WatchNo changeMinorMinorMajorMajorMajorMajorMajorMajorMinor
    More imagingMinorNo changeMinorMajorMajorMajorMajorMajorMajorMinor
    Tissue biopsyMinorMinorNo changeMajorMajorMajorMajorMajorMajorMinor
    Curative surgeryMajorMajorMajorNo changeMinorMajor modeMajor modeMajor modeMajor modeMajor
    Palliative surgeryMajorMajorMajorMinorNo changeMajor modeMajor modeMajor modeMajor modeMajor
    Curative chemotherapyMajorMajorMajorMajor modeMajor modeNo changeMinorMajor modeMajor modeMajor
    Palliative chemotherapyMajorMajorMajorMajor modeMajor modeMinorNo changeMajor modeMajor modeMajor
    Curative radiationMajorMajorMajorMajor modeMajor modeMajor modeMajor modeNo changeMinorMajor
    Palliative radiationMajorMajorMajorMajor modeMajor modeMajor modeMajor modeMinorNo changeMajor
    Supportive careMinorMinorMinorMajorMajorMajorMajorMajorMajorNo change
    • Minor = trivial change scored; Major = substantial increase or decrease in intensity of care between management plans; Major mode = substantial change in type of therapy even if treatment goal is unchanged.

    • 2-category scoring: No change and Major (collapsing no change and Minor as well Major and Major mode); 3-category scoring: No change, Minor, and Major (collapsing Major and Major mode); 4-category scoring: No change, Minor, Major, and Major mode.

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Journal of Nuclear Medicine: 48 (11)
Journal of Nuclear Medicine
Vol. 48, Issue 11
November 2007
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The National Oncologic PET Registry (NOPR): Design and Analysis Plan
Bruce E. Hillner, Dawei Liu, R. Edward Coleman, Anthony F. Shields, Ilana F. Gareen, Lucy Hanna, Sharon Hartson Stine, Barry A. Siegel
Journal of Nuclear Medicine Nov 2007, 48 (11) 1901-1908; DOI: 10.2967/jnumed.107.043687

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The National Oncologic PET Registry (NOPR): Design and Analysis Plan
Bruce E. Hillner, Dawei Liu, R. Edward Coleman, Anthony F. Shields, Ilana F. Gareen, Lucy Hanna, Sharon Hartson Stine, Barry A. Siegel
Journal of Nuclear Medicine Nov 2007, 48 (11) 1901-1908; DOI: 10.2967/jnumed.107.043687
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