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Cancer Therapy: Clinical

Durable Complete Responses in Heavily Pretreated Patients with Metastatic Melanoma Using T-Cell Transfer Immunotherapy

Steven A. Rosenberg, James C. Yang, Richard M. Sherry, Udai S. Kammula, Marybeth S. Hughes, Giao Q. Phan, Deborah E. Citrin, Nicholas P. Restifo, Paul F. Robbins, John R. Wunderlich, Kathleen E. Morton, Carolyn M. Laurencot, Seth M. Steinberg, Donald E. White and Mark E. Dudley
Steven A. Rosenberg
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James C. Yang
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Richard M. Sherry
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Udai S. Kammula
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Marybeth S. Hughes
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Giao Q. Phan
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Deborah E. Citrin
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Nicholas P. Restifo
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Paul F. Robbins
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John R. Wunderlich
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Kathleen E. Morton
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Carolyn M. Laurencot
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Seth M. Steinberg
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Donald E. White
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Mark E. Dudley
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DOI: 10.1158/1078-0432.CCR-11-0116 Published July 2011
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  • Figure 1.
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    Figure 1.

    Overall survival of patients receiving TILs with the chemotherapy preparative regimen alone (no TBI) or plus 2 or 12 Gy TBI.

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    Figure 2.

    Overall survival of patients receiving cell transfer based on prior treatment received.

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    Figure 3.

    Mean telomere length, the number of CD27+CD8+ cells, and the percentage persistence of the infused cells in peripheral blood at 1 month after cell infusion are significantly different in objective responders (CR + PR) compared with nonresponders (all P2 < 0.001). anti-CTLA4, a-CTLA4. Data updated as of January 1, 2011.

Tables

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  • Table 1.

    Cell transfer therapy

    Treatmentn (%) of patients (duration in mo)OR (%)
    TotalPRCR
    No TBI4316 (37)5 (12)21 (49)
    84, 36, 29, 28, 14, 12, 11, 7, 7, 7, 7, 4, 4, 2, 2, 282+, 81+, 79+, 78+, 64+
    200 TBI258 (32)5 (20)13 (52)
    14, 9, 6, 6, 5, 4, 3, 368+, 64+, 60+, 57+, 54+
    1,200 TBI258 (32)10 (40)18 (72)
    21, 13, 7, 6, 6, 5, 3, 248+, 45+, 44+, 44+, 39+, 38+, 38+, 38+, 37+, 19
    Total9332 (34)20 (22)52 (56)

    NOTE: Data updated as of August 1, 2010.

    • Table 2.

      Patient and treatment characteristics

      Number of patientsP2
      CRPRNRTotalCR vs. (PR + NR)(CR + PR) vs. NR
      Total20324193
      Patients
       Sex
        Male132029621.0<0.51
        Female7121231
       Age
        16–30354120.840.79
        31–457111432
        46–6010162147
        61–750022
       HLA
        A2152832750.530.61
        Non-A254918
       Stage
        M1a346130.550.56
        M1b3418
        M1c14243472
      Treatments
       TBI, Gy
        051622430.0070.08
        2581225
        12108725
       Cells (×10−10)
        <3451019
        3.1–5.0341219
        5.1–7.0712726
        7.1–9.024410
        >947819
        Mean ± SEM6.5 ± 0.76.1 ± 0.55.5 ± 0.60.250.07
        % CD3CD8+86 ± 279 ± 474 ± 40.590.14
        % CD3CD4+10 ± 220 ± 424 ± 40.300.15
       Telomere length, kb6.7 ± 0.36.4 ± 0.25.1 ± 0.20.006<0.001
       CD8+CD27+ cells (×10−10)2.0 ± 0.31.5 ± 0.20.8 ± 0.10.001<0.001
       Persistence at 1 mo (%)30.2 ± 5.528 ± 5.910.5 ± 3.50.003<0.001
       IL-2 doses
        <51315
        5–815221956
        9–11472132
        Mean ± SEM7.1 ± 0.47.7 ± 0.58.8 ± 0.40.110.003

      Abbreviations: M1a, skin, subcutaneous, or nodal metastases; M1b, lung; M1c all other visceral sites or elevated LDH levels.

      • Table 3.

        Impact of prior treatment on response to cell transfer therapy using selected TILs

        n (%)aORb
        TotalCRPR
        All patients9320 (22)32 (34)52 (56)
        Prior treatment
         None5 (5)2 (40)1 (20)3 (60)
         IL-277 (83)14 (18)28 (36)42 (54)
         Chemotherapy40 (43)7 (18)16 (40)23 (58)
         IFN52 (56)11 (21)17 (33)28 (54)
         Anti-CTLA411 (12)5 (45)2 (18)7 (64)
         IL-2+ chemotherapy37 (40)6 (16)16 (43)22 (59)
         IL-2+ anti-CTLA48 (9)3 (38)1 (13)4 (50)
         IL-2+ anti-CTLA4+ chemotherapy6 (7)2 (33)1 (17)3 (50)
        • ↵aThe percentage of patients with a CR, PR, or OR in each group who had received the prior treatment.

        • ↵bNo group is statistically different from any other.

      Additional Files

      • Figures
      • Tables
      • CCR Translation for This Article

        This article refers to the following CCR Translation:
        Getting Personal with Melanoma
        Helen Heslop

        • Supplementary Data

          Supplementary Figures S1-S2; Supplementary Tables S1-S2.

          Files in this Data Supplement:

          • Supplementary Data - Supplementary Figures S1-S2; Supplementary Tables S1-S2.
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        Clinical Cancer Research: 17 (13)
        July 2011
        Volume 17, Issue 13
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        Durable Complete Responses in Heavily Pretreated Patients with Metastatic Melanoma Using T-Cell Transfer Immunotherapy
        Steven A. Rosenberg, James C. Yang, Richard M. Sherry, Udai S. Kammula, Marybeth S. Hughes, Giao Q. Phan, Deborah E. Citrin, Nicholas P. Restifo, Paul F. Robbins, John R. Wunderlich, Kathleen E. Morton, Carolyn M. Laurencot, Seth M. Steinberg, Donald E. White and Mark E. Dudley
        Clin Cancer Res July 1 2011 (17) (13) 4550-4557; DOI: 10.1158/1078-0432.CCR-11-0116

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        Durable Complete Responses in Heavily Pretreated Patients with Metastatic Melanoma Using T-Cell Transfer Immunotherapy
        Steven A. Rosenberg, James C. Yang, Richard M. Sherry, Udai S. Kammula, Marybeth S. Hughes, Giao Q. Phan, Deborah E. Citrin, Nicholas P. Restifo, Paul F. Robbins, John R. Wunderlich, Kathleen E. Morton, Carolyn M. Laurencot, Seth M. Steinberg, Donald E. White and Mark E. Dudley
        Clin Cancer Res July 1 2011 (17) (13) 4550-4557; DOI: 10.1158/1078-0432.CCR-11-0116
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