Impact of targeted therapy (TT) on survival of metastatic renal cell carcinoma (mRCC) patients treated with high dose interleukin-2 (HD IL-2): Analysis of the PROCLAIMHD IL-2 National Registry.

Authors

null

Joseph Clark

Loyola Univ Medical Center, Maywood, IL

Joseph Clark , Michael Morse , Michael K.K. Wong , David F. McDermott , Howard Kaufman , Gregory A. Daniels , Hong Hua , Sandra Aung

Organizations

Loyola Univ Medical Center, Maywood, IL, Duke University Medical Center, Durham, NC, University of Southern California, Los Angeles, CA, Beth Israel Deaconess Medical Center, Boston, MA, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, UC San Diego Moores Cancer Center, La Jolla, CA, Prometheus Laboratories, Inc, San Diego, CA, Prometheus Laboratories, San Diego, CA

Research Funding

Pharmaceutical/Biotech Company

Background: PROCLAIMSM (www.proclaimregistry.com) is an IL-2 registry with over 40 participating sites with a retrospective (retro) (N = 97, locked) and prospective cohort (N > 400 on-going). Previously, we reported a median overall survival (mOS) of 50.9 months (mo) with a median follow-up of 37.1 mo in mRCC patients treated with HD IL-2 between 2007 and 2012 from the retro cohort (ASCO 2014). Here we update survival and report on the prospective cohort. Methods: Inclusion criteria required patients receive at least one dose of IL-2. IRBs waived consent for retro patients, therefore post IL-2 treatment data is unavailable. Prospective patients received their first dose of HD IL-2 prior to 2013 with post IL-2 treatment data collected. Survival for both cohorts is current to January 2015. Results: The overall response rate (ORR) for the 123 patients in the prospective cohort is 17.9%. Complete response (CR), partial response (PR), and stable disease (SD) patients have a 2.5 year survival rate of 100%, 87%, and 73% respectively. The mOS is 29.6 mo at a median follow-up of 23.2 mo. The mOS was not reached (NR) in patients treated with only HD IL-2 and was 13.1, and 29.6 mo in those who had prior or post TT (Table 1). The treatment-related mortality rate in the combined retro and prospective cohorts is 0.9% (4/435). Conclusions: PROCLAIM prospective and retro cohorts demonstrate that SD, previously grouped with the non-responders, has high survival rates. Although limited by numbers (15 patients), TT prior to IL-2 data appears less desirable. These data support that HD IL-2 has favorable safety profile compared to data in the original package insert and is effective first line therapy for eligible patients with mRCC. Clinical trial information: NCT00686959

Updated January 2015Retrospective
Cohort (2007-2012)
N = 97, 11 sites
Prospective
Cohort (2011-2012)
N = 123, 23 sites
Median Overall Survival
(mOS) months
48.8 months29.6 months
Median follow-up43.1 months23.2 months
2.5 year survival rate
CR/PR/SD (%)
100/85/69100/87/73
ORR (CR+PR)21.5%17.9%
CBR (CR+PR+SD)45.5%55.3%
mOS no prior TT/prior
TT (months)
48.8(n = 82)/
15.3(n = 15) (p = 0.06)
NR(n = 111)/
13.1(n = 12) (p = 0.01)

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Genitourinary (Nonprostate) Cancer

Track

Genitourinary Cancer

Sub Track

Kidney Cancer

Clinical Trial Registration Number

NCT00686959

Citation

J Clin Oncol 33, 2015 (suppl; abstr e15609)

DOI

10.1200/jco.2015.33.15_suppl.e15609

Abstract #

e15609

Abstract Disclosures