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Research ArticleClinical Investigation

Effectiveness and Safety of Retreatment with 177Lu-DOTATATE in Patients with Progressive Neuroendocrine Tumors: A Retrospective Real-World Study in the United States

Ebrahim S. Delpassand, Soheil M. Yazdi, Shashank Ghantoji, Antonio Nakasato, Corinne Strickland, Rodolfo Nunez, Afshin Shafie, Susan Cork, Clare Byrne, Jackson Tang and Jeetvan Patel
Journal of Nuclear Medicine May 2024, 65 (5) 746-752; DOI: https://doi.org/10.2967/jnumed.123.265703
Ebrahim S. Delpassand
1Excel Diagnostics and Nuclear Oncology Center, Houston, Texas;
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Soheil M. Yazdi
1Excel Diagnostics and Nuclear Oncology Center, Houston, Texas;
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Shashank Ghantoji
2Novartis Pharmaceuticals Corp., East Hanover, New Jersey; and
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Antonio Nakasato
2Novartis Pharmaceuticals Corp., East Hanover, New Jersey; and
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Corinne Strickland
2Novartis Pharmaceuticals Corp., East Hanover, New Jersey; and
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Rodolfo Nunez
1Excel Diagnostics and Nuclear Oncology Center, Houston, Texas;
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Afshin Shafie
1Excel Diagnostics and Nuclear Oncology Center, Houston, Texas;
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Susan Cork
1Excel Diagnostics and Nuclear Oncology Center, Houston, Texas;
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Clare Byrne
3Asclepius Analytics, New York, New York
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Jackson Tang
3Asclepius Analytics, New York, New York
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Jeetvan Patel
2Novartis Pharmaceuticals Corp., East Hanover, New Jersey; and
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  • FIGURE 1.
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    FIGURE 1.

    PFS from start of initial treatment (A) and retreatment (B) with 177Lu-DOTATATE. PFS was calculated postindex and postindex retreatment.

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    FIGURE 2.

    OS from start of initial treatment (A) and retreatment with 177Lu-DOTATATE. OS was calculated postindex and postindex retreatment.

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    TABLE 1.

    Patient Characteristics at Initial Treatment and Retreatment with 177Lu-DOTATATE

    CharacteristicInitial treatment (n = 31)Retreatment (n = 31)
    Age (y)59.8 ± 9.062.2 ± 8.9
    Male19 (61.3%)19 (61.3%)
    Race
     White29 (93.5%)29 (93.5%)
     Black1 (3.2%)1 (3.2%)
     Asian1 (3.2%)1 (3.2%)
    Weight
     Median79 kg (175 lb)78 kg (172 lb)
     Interquartile range60–92 kg (132–203 lb)64–93 kg (140–205 lb)
    Primary tumor type
     Gastrointestinal12 (38.7%)12 (38.7%)
     Pancreatic16 (51.6%)16 (51.6%)
     Lung2 (6.5%)2 (6.5%)
     Adrenal1 (3.2%)1 (3.2%)
    Time since primary diagnosis (y)6.2 ± 5.38.5 ± 5.8
    Number of metastatic sites3.1 ± 1.43.5 ± 1.3
    Location of metastatic sites
     Bone18 (58.1%)26 (83.9%)
     Liver30 (96.8%)31 (100%)
     Lung5 (16.1%)6 (19.4%)
     Spleen5 (16.1%)6 (19.4%)
     Mesentery8 (25.8%)9 (29.0%)
     Distant lymph nodes18 (58.1%)19 (61.3%)
     Other8 (25.8%)10 (32.2%)
    Laboratory values
     WBC (103/μL)5.7 ± 1.76.0 ± 2.8
     Hemoglobin (g/dL)12.6 ± 1.411.3 ± 1.5
     ANC (cells/μL)3,914 ± 1,4474,306 ± 2,388
     Platelet count (103/μL)236.1 ± 177.2205.2 ± 117.9
     Lymphocyte count (cells/μL)1,060 ± 495.1929.7 ± 377.3
     ALP (U/L)175.7 ± 128.8279.9 ± 227.5
     ALT (U/L)49.3 ± 52.836.0 ± 23.1
     AST (U/L)49.6 ± 64.235.7 ± 21.4
     Creatinine (mg/dL)1.0 ± 0.41.0 ± 0.2
     eGFR (mL/min/1.73 m2)80.1 ± 18.577.6 ± 19.0
    • WBC = white blood cell count; ANC = absolute neutrophil count; ALP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate aminotransferase; eGFR = estimated glomerular filtration rate.

    • Qualitative data are number and percentage; quantitative data are mean ± SD, except for weight. Laboratory values were based on measurements on or up to 2 wk before date of first cycle in each of initial treatment and retreatment phases.

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    TABLE 2.

    177Lu-DOTATATE Treatment Distribution by Treatment Phase

    Treatment phase
    ParameterInitial treatment (n = 31)Retreatment (n = 31)Additional retreatment (n = 2)
    Number of cycles received by treatment phase
     106 (19.4%)1 (50.0%)
     2024 (77.4%)1 (50.0%)
     32 (6.5%)1 (3.2%)0
     429 (93.5%)00
    Administered 177Lu-DOTATATE by treatment phase (GBq)28.8 ± 2.413.1 ± 3.610.6 ± 4.7
    Cumulative number of cycles—5.8 ± 0.47.5 ± 0.7
    Cumulative administered 177Lu-DOTATATE (GBq)—41.9 ± 4.455.3 ± 5.3
    • Qualitative data are number and percentage; continuous data are mean ± SD.

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    TABLE 3.

    Best Overall Response to 177Lu-DOTATATE After Initial Treatment and Retreatment

    ResponseInitial treatment (n = 31)Retreatment (n = 31)
    Complete response00
    Partial response11 (35%)7 (23%)
    Stable disease20 (65%)14 (45%)
    Progressive disease03 (10%)
    Unknown07 (23%)
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    TABLE 4.

    Comparison of Hematologic Parameters at Start of Each Treatment Phase

    Index*Index retreatment†Difference‡
    Hematologic parameternLaboratory valuenLaboratory valuenLaboratory valueP
    WBC count (103/μL)235.7 ± 1.7166.0 ± 2.8120.4 ± 2.50.567
    Hemoglobin (g/dL)2312.6 ± 1.41511.3 ± 1.511−2.1 ± 2.10.008
    ANC (cells/μL)233,914 ± 1,447164,306 ± 2,38812430.4 ± 1,7560.414
    Lymphocyte count (cells/μL)231,060 ± 495.116929.7 ± 377.312−72.0 ± 676.40.719
    Platelet count (103/μL)23236.1 ± 177.216205.2 ± 117.912−22.8 ± 220.30.727
    • ↵* Measured on or up to 2 wk before date of first cycle in each treatment phase.

    • ↵† Measured from 2 wk before 8 wk after date of last cycle in each treatment phase.

    • ↵‡ Includes only patients who had measurement at both baseline and end of treatment.

    • WBC = white blood cell count; ANC = absolute neutrophil count.

    • Laboratory values are mean ± SD.

    • View popup
    TABLE 5.

    AEs During Treatment with 177Lu-DOTATATE

    AEInitial treatment (n = 31)Retreatment (n = 31)
    Any key hematologic AE*
     Any grade28 (90%)26 (84%)
     Grade 3/41 (3%)4 (13%)
    Leukopenia
     Any grade15 (48%)15 (48%)
     Grade 3/401 (3%)
    Anemia
     Any grade24 (77%)23 (74%)
     Grade 3/401 (3%)
    Neutropenia
     Any grade5 (16%)5 (16%)
     Grade 3/41 (3%)0
    Thrombocytopenia
     Any grade20 (65%)19 (61%)
     Grade 3/402 (6%)
    Lymphopenia
     Any grade29 (94%)26 (84%)
     Grade 3/414 (45%)8 (26%)
    High ALP
     Any grade15 (48%)15 (48%)
     Grade 3/41 (3%)0
    High ALT
     Any grade16 (52%)10 (32%)
     Grade 3/401 (3%)
    High AST
     Any grade14 (45%)8 (26%)
     Grade 3/401 (3%)
    Hypercreatininemia
     Any grade6 (19%)6 (19%)
     Grade 3/400
    Low eGFR
     Any grade21 (68%)19 (61%)
     Grade 3/400
    • ↵* Key hematologic AEs included any leukopenia, anemia, neutropenia, and thrombocytopenia.

    • ALP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate aminotransferase; eGFR = estimated glomerular filtration rate.

    • AEs were measured from the date of the first cycle to 8 wk after the last cycle for each treatment phase.

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Journal of Nuclear Medicine: 65 (5)
Journal of Nuclear Medicine
Vol. 65, Issue 5
May 1, 2024
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Effectiveness and Safety of Retreatment with 177Lu-DOTATATE in Patients with Progressive Neuroendocrine Tumors: A Retrospective Real-World Study in the United States
Ebrahim S. Delpassand, Soheil M. Yazdi, Shashank Ghantoji, Antonio Nakasato, Corinne Strickland, Rodolfo Nunez, Afshin Shafie, Susan Cork, Clare Byrne, Jackson Tang, Jeetvan Patel
Journal of Nuclear Medicine May 2024, 65 (5) 746-752; DOI: 10.2967/jnumed.123.265703

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Effectiveness and Safety of Retreatment with 177Lu-DOTATATE in Patients with Progressive Neuroendocrine Tumors: A Retrospective Real-World Study in the United States
Ebrahim S. Delpassand, Soheil M. Yazdi, Shashank Ghantoji, Antonio Nakasato, Corinne Strickland, Rodolfo Nunez, Afshin Shafie, Susan Cork, Clare Byrne, Jackson Tang, Jeetvan Patel
Journal of Nuclear Medicine May 2024, 65 (5) 746-752; DOI: 10.2967/jnumed.123.265703
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Keywords

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