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Open Access

Long-term progression-free survival of patients with metastatic melanoma or renal cell carcinoma following high-dose interleukin-2

Joseph I Clark, Brendan Curti, Elizabeth J Davis, Howard Kaufman, Asim Amin, Ajjai Alva, Theodore F Logan, Ralph Hauke, Gerald P Miletello, Ulka Vaishampayan, Douglas B Johnson, Richard L White, Peter H Wiernik, Janice P Dutcher
DOI: 10.1136/jim-2020-001650 Published 1 April 2021
Joseph I Clark
1 Medicine, Loyola University Chicago Stritch School of Medicine, Maywood, Illinois, USA
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Brendan Curti
2 Earle A. Chiles Research Institute, Providence Medical Center, Portland, Oregon, USA
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Elizabeth J Davis
3 Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA
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Howard Kaufman
4 Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA
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Asim Amin
5 Medicine, Levine Cancer Institute, Charlotte, North Carolina, USA
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Ajjai Alva
6 Medicine, University of Michigan Health System, Ann Arbor, Michigan, USA
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Theodore F Logan
7 Medicine, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, USA
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Ralph Hauke
8 Medicine, Nebraska Cancer Specialists, Omaha, Nebraska, USA
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Gerald P Miletello
9 Medicine, Hematology/Oncology Clinic, Baton Rouge, Louisiana, USA
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Ulka Vaishampayan
10 Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA
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Douglas B Johnson
3 Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA
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Richard L White
5 Medicine, Levine Cancer Institute, Charlotte, North Carolina, USA
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Peter H Wiernik
11 Medicine, New York Medical College, Valhalla, New York, USA
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Janice P Dutcher
11 Medicine, New York Medical College, Valhalla, New York, USA
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  • Table 1

    Contemporary multi-institutional reports—HD IL-2 outcome

    ReportResponseSurvival
    Clark et al 4
    RCC (2011–2015), sequenced with targeted therapy
    N=352 (328 with response data)
    PROCLAIM registry database
    CR 4%, PR 13%, SD 39%, PD 43%
    CR+PR+SD 53%
    Median OS—NR for CR, PR, SD
    Median OS—PD—15.5 months
    PD followed by TT—med OS 29.7 months; PD no TT—med OS 8.5 months
    2.5-year OS—CR 100%; PR 75%, SD 78%, PD 39%
    McDermott et al 5
    RCC n=120
    Multi-institution, prospective trial
    ORR 25%, CR 3, PR 27
    13 (11%) progression-free at 3 years
    Median OS 42.8 months
    80% TT after IL-2
    Alva et al 6
    mM (2005–2012)—n=170
    RCC (2005–2012)—n=192
    Survival current 2015
    PROCLAIM registry database
    mM: CR 5% PR 10% SD 22%
    CR+PR+SD 58% median f/u 43.1 months
    RCC: CR 6%, PR 9%, SD 22%
    CR+PR+SD 70% median f/u 46.6 months
    Median OS 19.6 months
    Median OS—NR for CR, PR
    Median OS 33.4 months—SD
    Median OS 41 months
    Median OS—NR for CR, PR
    Median OS 49.6 months—SD
    Stenehjem et al 7
    RCC n=391
    U Utah 1988–2013
    U Mich 1997–2013
    CR 9% PR 10%, SD 32% PD 42%
    CR+PR+SD 51%
    Median OS CR—13+ years
    Median OS PR—37.8 months
    Median OS SD—34.4 months
    • CR, complete response; f/u, follow-up; IL, interleukin; mM, metastatic melanoma; N, number; NR, not reached; ORR, overall response rate; OS, overall survival; PD, progressive disease; PR, partial response; RCC, renal cell carcinoma; SD, stable disease; TT, targeted therapy; U, university.

  • Table 2

    Patient outcomes and long-term toxicity (A) response and survival, (B) long-term toxicity

    (A) Best responseMetastatic melanomaMetastatic renal cell
    (n=54)(n=46)
    CR4338
    Surgical/SRS CRs95
    PR
    No further treatment
    23
    Median follow-up10+ years10.5+ years
    Range follow-up5+ to 15+ years5+ to 30+ years
    Alive >10 years after IL-2 with no subsequent therapy32 patients27 patients
    (B) Event# Patients
    Hypothyroidism—requiring replacement medication (grade 2)5
    Arthralgias/Arthritis (grade 1–2)6
    Vitiligo (grade 1–2)3
    Neuropathy (grade 2)1
    Premature ventricular contractions (grade 1)1
    Normal pressure hydrocephalus (grade 1)1
    • CR, complete response; DFS, disease-free survival; IL-2, interleukin-2; PR, partial response; SRS, stereotactic radiosurgery.

Supplementary Materials

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    [jim-2020-001650supp001.pdf]

Additional Files

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    This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

    • Data supplement 1
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Journal of Investigative Medicine: 69 (4)
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Long-term progression-free survival of patients with metastatic melanoma or renal cell carcinoma following high-dose interleukin-2
Joseph I Clark, Brendan Curti, Elizabeth J Davis, Howard Kaufman, Asim Amin, Ajjai Alva, Theodore F Logan, Ralph Hauke, Gerald P Miletello, Ulka Vaishampayan, Douglas B Johnson, Richard L White, Peter H Wiernik, Janice P Dutcher
Journal of Investigative Medicine Apr 2021, 69 (4) 888-892; DOI: 10.1136/jim-2020-001650

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Long-term progression-free survival of patients with metastatic melanoma or renal cell carcinoma following high-dose interleukin-2
Joseph I Clark, Brendan Curti, Elizabeth J Davis, Howard Kaufman, Asim Amin, Ajjai Alva, Theodore F Logan, Ralph Hauke, Gerald P Miletello, Ulka Vaishampayan, Douglas B Johnson, Richard L White, Peter H Wiernik, Janice P Dutcher
Journal of Investigative Medicine Apr 2021, 69 (4) 888-892; DOI: 10.1136/jim-2020-001650
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Long-term progression-free survival of patients with metastatic melanoma or renal cell carcinoma following high-dose interleukin-2
Joseph I Clark, Brendan Curti, Elizabeth J Davis, Howard Kaufman, Asim Amin, Ajjai Alva, Theodore F Logan, Ralph Hauke, Gerald P Miletello, Ulka Vaishampayan, Douglas B Johnson, Richard L White, Peter H Wiernik, Janice P Dutcher
Journal of Investigative Medicine Apr 2021, 69 (4) 888-892; DOI: 10.1136/jim-2020-001650
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