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Durability of responses in patients with metastatic renal cell carcinoma treated with high dose interleukin-2 (HD IL-2)
  1. Joseph I Clark1,
  2. Michael A Morse2,
  3. Michael KK Wong3,
  4. David F McDermott4,
  5. Howard L Kaufman5,
  6. Gregory A Daniels6,
  7. Jessica C Perritt7,
  8. Hong Hua7 and
  9. Sandra Aung7
  1. Aff1 grid.411451.40000000122150876Division of Hematology OncologyLoyola University Medical Center Maywood IL USA
  2. Aff2 grid.189509.c0000000100241216Duke University Medical Center Durham NC USA
  3. Aff3 grid.42505.360000000121566853University of Southern California Los Angeles, Los Angeles CA USA
  4. Aff4 grid.239395.70000000090118547The Cytokine Working Group; Division of Hematology/OncologyBeth Israel Deaconess Medical Center Boston MA USA
  5. Aff5 Rutgers Cancer Center Institute of New Jersey New Brunswick NJ USA
  6. Aff6 grid.266100.30000000121074242Moores Cancer CenterUniversity of California San Diego La Jolla CA USA
  7. Aff7 grid.437284.ePrometheus Laboratories Inc. San Diego CA USA

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Meeting abstracts


HD IL-2 was FDA approved for advanced mRCC, but the data supporting its use dates to the 1990's. We designed the PROCLAIMSM registry, including retrospective and prospective cohorts, to study modern outcomes and interactions with prior or subsequent targeted therapies. We now report survival analysis from the Registry and the effect of prior TT therapy.


Inclusion criteria required patients receive at least one dose of IL-2. Survival for both cohorts (N=408) is current to March 16, 2015.


The overall response rate (ORR) and mOS are described in Table 1. In the retrospective cohort, the 1, 2, and 3 year survival rates were 89%, 69%, and 61% respectively for patients with stable disease (SD). Similarly, in the prospective cohort, 1 and 2 year survival rates for patients with SD were 95% and 76%, respectively. The mOS was not reached for patients with SD in both cohorts. There was a significant difference in mOS between SD and PD patients in the prospective cohorts, NR vs 13.9 months, p < 0.0001, there was no significant difference in mOS between SD and PD in the retrospective cohort. For patients in the retrospective and prospective cohorts who had prior targeted therapy (TT), the mOS was 15.3 and 22.1 months, respectively. Patients who did not receive TT before HD IL-2 therapy, the mOS was 48.9 months and NR, in the retrospective and prospective cohorts, respectively. There were 4 treatment-related deaths in 408 patients.

Table 1


PROCLAIM data demonstrate that SD, previously grouped with the non-responders, has extended survival rates. TT prior to HD IL-2 therapy was associated with a lower mOS. These data support that HD IL-2 has favorable safety profile compared to data in the original package insert and remains an effective first line therapy for eligible patients with mRCC.