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Efficacy and safety of high-dose interleukin-2 treatment in patients with a history of brain metastases from renal cell carcinoma
  1. Ashwin Chandar1,
  2. Ann W Silk2,
  3. Joseph I Clark3,
  4. Gregory A Daniels4,
  5. David F McDermott5,
  6. Michael Morse6,
  7. Michael KK Wong7,
  8. Mark Stein2,
  9. Janice Mehnert2,
  10. Shabbar Danish8,
  11. Sandra Aung9 and
  12. Howard L Kaufman2
  1. Aff1 grid.430387.b0000000419368796Rutgers-Robert Wood Johnson Medical School New Brunswick NH USA
  2. Aff2 grid.430387.b0000000419368796Cancer Institute of New JerseyRutgers-Robert Wood Johnson Medical School New Brunswick NJ USA
  3. Aff3 grid.411451.40000 0001 2215 0876Loyola University Medical CenterDivision of Hematology Oncology Maywood IL USA
  4. Aff4 grid.266100.30000000121074242Moores Cancer CenterUniversity of California San Diego La Jolla CA USA
  5. Aff5 grid.239395.70000000090118547The Cytokine Working Group; Division of Hematology/OncologyBeth Israel Deaconess Medical Center Boston MA USA
  6. Aff6 grid.414179.e0000 0001 2232 0951Duke Cancer Center Durham NC USA
  7. Aff7 grid.42505.360000000121566853University of Southern California, Los Angeles Los Angeles CA USA
  8. Aff8 grid.430387.b0000000419368796Department of NeurosurgeryRutgers-Robert Wood Johnson Medical School New Brunswick NJ USA
  9. Aff9 grid.437284.ePrometheus Laboratories Inc. San Diego CA USA

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Meeting abstracts

Background

The efficacy and safety of high dose IL-2 therapy in patients with brain metastases due to renal cell carcinoma is not well characterized.

Methods

Data were prospectively collected in a registry of 371 patients with RCC receiving high-dose IL-2, including 18 patients with a history of brain metastases who had undergone treatment for the brain metastases with radiation therapy or surgery. The median interval between the diagnosis of brain metastases and the start of IL-2 therapy was 7.0 months (range 1-116 months). Median overall survival in patients with brain metastases was 15.3 (95% CI 8.0 to not evaluable) months, as compared to 48.0 (95% CI 39.2 to 61.5) months in RCC patients without any history of brain metastases.

Results

The response to IL-2 in the extra-cranial disease was assessed. In patients with brain metastases, 0/18 (0%) had a complete response, 1/18 (5.6%) had a partial response, and 4/18 (22.2%) had stable disease, whereas in patients without brain metastases, 15/353 (4.5%) achieved a complete response, 45/353 (13.4%) achieved a partial response, and 117/353 (34.8%) had stable disease. During the first course of IL-2, neurologic adverse events were reported in 6 subjects (2 events of confusion, 2 events of mental fatigue, 1 event of rigors, and 1 event of anxiety), but no seizures or intracranial hemorrhages were reported.

Conclusions

While the efficacy of IL-2 in this population is limited, the neurologic adverse event rate is acceptably low; in carefully selected patients with brain metastases, IL-2 may be considered as a therapeutic option but response rates may be lower than in patients without CNS disease based on this limited cohort analysis.