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Research ArticleClinical Investigations

Clinical Evaluation of 99mTc-Rituximab for Sentinel Lymph Node Mapping in Breast Cancer Patients

Nan Li, Xuejuan Wang, Baohe Lin, Hua Zhu, Cheng Liu, Xiaobao Xu, Yan Zhang, Shizhen Zhai, Tao OuYang, Jinfeng Li and Zhi Yang
Journal of Nuclear Medicine August 2016, 57 (8) 1214-1220; DOI: https://doi.org/10.2967/jnumed.115.160572
Nan Li
1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Nuclear Medicine, Peking University Cancer Hospital & Institute, Beijing, China; and
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Xuejuan Wang
1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Nuclear Medicine, Peking University Cancer Hospital & Institute, Beijing, China; and
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Baohe Lin
1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Nuclear Medicine, Peking University Cancer Hospital & Institute, Beijing, China; and
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Hua Zhu
1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Nuclear Medicine, Peking University Cancer Hospital & Institute, Beijing, China; and
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Cheng Liu
1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Nuclear Medicine, Peking University Cancer Hospital & Institute, Beijing, China; and
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Xiaobao Xu
1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Nuclear Medicine, Peking University Cancer Hospital & Institute, Beijing, China; and
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Yan Zhang
1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Nuclear Medicine, Peking University Cancer Hospital & Institute, Beijing, China; and
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Shizhen Zhai
1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Nuclear Medicine, Peking University Cancer Hospital & Institute, Beijing, China; and
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Tao OuYang
2Breast Center, Peking University Cancer Hospital & Institute, Beijing, China
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Jinfeng Li
2Breast Center, Peking University Cancer Hospital & Institute, Beijing, China
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Zhi Yang
1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Nuclear Medicine, Peking University Cancer Hospital & Institute, Beijing, China; and
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  • FIGURE 1.
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    FIGURE 1.

    SLN imaging of breast cancer patients after injection of 99mTc-rituximab (black arrow, point source on patient body surface to mark sternal notch, contralateral sternal margin, and metasternum; red arrow, SLNs; hollow arrow, injection site). (A) One SLN in axilla and 1 SLN in intramammary. (B) Two SLNs in axilla.

  • FIGURE 2.
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    FIGURE 2.

    Lymphoscintigraphy and SLNB frequency distribution results in these 2,217 breast cancer patients.

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    TABLE 1

    Quality Control of 99mTc-Rituximab for Clinical Application

    ParameterQC specificationQC result
    AppearanceClear, colorlessPass
    Volume0.5–1.0 mL0.5 mL
    Injection dose18.5–37 MBq37 MBq
    pH4.0–8.07.0
    Radio–thin-layer chromatography>95%>99%
    Radio–high-performance liquid chromatography>95%>99%
    Ethanol<5%0
    Endotoxins<15 EU/mLPass
    SterilitySterilePass
    Specific activity111 GBq/μmolPass
    • View popup
    TABLE 2

    Clinical Pathologic Characteristics of 100 Breast Cancer Patients

    CharacteristicNo. of patients
    Sex
     Female100
    Age (y)
     ≤5049
     >5051
    Left or right side breast cancer
     Left45
     Right55
    Imaging time after injection of tracer
     2–4 h28
     16–18 h72
    Primary tumor location
     Upper inner quadrant26
     Lower inner quadrant7
     Upper outer quadrant49
     Lower outer quadrant16
     Central portion2
    Histopathologic type
     Invasive ductal carcinoma88
     Invasive lobular carcinoma4
     Other8
    Clinical T stage
     Tis1
     T125
     T265
     T39
    ER/PR/HER2
     +/+/+23
     −/−/+11
     +/−/− or −/+/− or +/+/−49
     +/−/+ or −/+/+11
     −/−/−6
    • ER = estrogen receptor; PR = progesterone receptor; HER2 = human epidermal growth factor receptor-2.

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    TABLE 3

    Pathologic Comparison Between SLNs and LNs in ALND

    GroupMetastatic SLNNonmetastatic SLNTotal
    Metastatic LNs in ALND26228
    Nonmetastatic LNs in ALND492372
    Total7525100
    • View popup
    TABLE 4

    Analysis of 27 Patients in Whom Lymphoscintigraphy Failed to Identify LNs

    CharacteristicPatientPercentage
    Sex
     Female27100%
    Age
     ≤501037.04%
     >501762.96%
    Left or right cancer
     Left1762.96%
     Right1037.04%
    Imaging time
     2–4 h after injection1348.15%
     16–18 h after injection1451.85%
    Primary tumor site
     Upper inner quadrant2696.30%
     Lower inner quadrant725.93%
     Upper outer quadrant49181.48%
     Lower outer quadrant1659.26%
     Central portion27.41%
    Histopathologic type
     Ductal2488.89%
     Lobular13.70%
     Other27.41%
    Clinical T stage
     T11037.04%
     T21659.26%
     T313.70%
    ER/PR/HER2
     +/+/+518.52%
     −/−/+414.81%
     +/−/− or −/+/− or +/+/−1451.85%
     +/−/+ or −/+/+311.11%
     −/−/−13.70%
    Pathology of SLN
     Metastatic SLN1970.37%
     Nonmetastatic SLN829.63%
    • ER = estrogen receptor; PR = progesterone receptor; HER2 = human epidermal growth factor receptor-2.

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    TABLE 5

    Lymphoscintigraphy and SLNB of 2,217 Breast Cancer Patients

    LymphoscintigraphyIntraoperative SLN detectionSLN pathology
    CharacteristicNo. of patientsSLNs (Embedded Image ± s)SignificanceSLNs (Embedded Image ± s)SignificancePatients with metastatic SLNSSignificance
    Total2,2171.76 ± 1.082.85 ± 1.86
    SexP = 0.377P = 0.613P = 0.411
     Female2,2151.76 ± 1.082.50 ± 0.71560
     Male22.50 ± 0.712.85 ± 1.870
    AgeP = 0.000P = 0.002P = 0.355
     ≤501,1821.85 ± 1.132.96 ± 1.89308
     501,0351.65 ± 1.002.72 ± 1.83252
    Left or right cancerP = 0.651P = 0.719P = 0.371
     Bilateral42 ± 0.823.00 ± 1.162
     Left1,1401.74 ± 1.022.82 ± 1.84279
     Right1,0731.78 ± 1.132.88 ± 1.89279
    Imaging timeP = 0.275P = 0.897P = 0.834
     2–4 h after injection9221.73 ± 1.042.85 ± 1.80235
     16–18 h after injection1,2951.78 ± 1.102.84 ± 1.91325
    Primary tumor siteP = 0.080P = 0.316P = 0.166
     Upper inner quadrant3021.85 ± 0.982.66 ± 1.7066
     Lower inner quadrant2541.67 ± 0.892.83 ± 1.9054
     Upper outer quadrant8821.79 ± 1.192.89 ± 1.94243
     Lower outer quadrant4381.75 ± 1.132.94 ± 1.76110
     Central portion3411.65 ± 0.892.81 ± 1.9087
    Histopathologic subtypeP = 0.178P = 0.398P = 0.000
     Ductal1,8211.74 ± 1.062.83 ± 1.84484
     Lobular1791.90 ± 1.222.85 ± 1.8549
     Other2171.76 ± 1.093.01 ± 2.0727
    Clinical T stageP = 0.098P = 0.191P = 0.002
     Tis581.90 ± 1.073.10 ± 2.264
     T11,1791.73 ± 1.052.79 ± 1.84294
     T29071.77 ± 1.092.88 ± 1.85249
     T3732.01 ± 1.233.16 ± 2.1013
    ER/PR/HER2P = 0.311P = 0.973P = 0.000
     +/+/+6341.78 ± 1.122.81 ± 1.86187
     −/−/+3291.83 ± 1.042.87 ± 1.5668
     +/−/− or −/+/− or +/+/−9021.70 ± 1.042.85 ± 1.95243
     +/−/+ or −/+/+1501.86 ± 1.092.86 ± 1.8931
     −/−/−2021.79 ± 1.222.92 ± 1.9331

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Journal of Nuclear Medicine: 57 (8)
Journal of Nuclear Medicine
Vol. 57, Issue 8
August 1, 2016
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Clinical Evaluation of 99mTc-Rituximab for Sentinel Lymph Node Mapping in Breast Cancer Patients
Nan Li, Xuejuan Wang, Baohe Lin, Hua Zhu, Cheng Liu, Xiaobao Xu, Yan Zhang, Shizhen Zhai, Tao OuYang, Jinfeng Li, Zhi Yang
Journal of Nuclear Medicine Aug 2016, 57 (8) 1214-1220; DOI: 10.2967/jnumed.115.160572

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Clinical Evaluation of 99mTc-Rituximab for Sentinel Lymph Node Mapping in Breast Cancer Patients
Nan Li, Xuejuan Wang, Baohe Lin, Hua Zhu, Cheng Liu, Xiaobao Xu, Yan Zhang, Shizhen Zhai, Tao OuYang, Jinfeng Li, Zhi Yang
Journal of Nuclear Medicine Aug 2016, 57 (8) 1214-1220; DOI: 10.2967/jnumed.115.160572
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Keywords

  • 99mTc-Rituximab
  • Sentinel Lymph Node Mapping
  • breast cancer
  • lymphoscintigraphy
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