Durability of responses in patients with metastatic renal cell carcinoma treated with high-dose interleukin-2 (HD IL-2).

Authors

null

Joseph Clark

Loyola University Medical Center, Maywood, IL

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

Organizations

Loyola University Medical Center, Maywood, IL, Duke University Medical Center, Durham, NC, University of Southern California, Los Angeles, CA, Beth Israel Deaconess Medical Center, Boston, MA, Rush University Medical Center, Chicago, IL, UC San Diego Moores Cancer Center, La Jolla, CA, Prometheus Laboratories Inc., San Diego, CA

Research Funding

Pharmaceutical/Biotech Company

Background: HD IL-2 is FDA approved for advanced renal cell carcinoma (mRCC), however, the data supporting its use is 23 years old. In 2011, a HD IL-2 patient database was established called PROCLAIMSM, and comprises the largest active prospective collection of data from mRCC and metastatic melanoma (MM) patients receiving HD IL-2 treatment and provides longitudinal real-time insights into the clinical impact of sequencing drug treatments. These data report on the outcomes and interactions with prior targeted therapies in mRCC patients in the current era. Methods: Inclusion criteria require patients to receive at least one dose of HD IL-2. Patients who received HD IL-2 and had already undergone a post-treatment scan were not eligible. Survival analysis was performed by the method of Kaplan and Meier using datasets as of July 27, 2015. Results: The overall response rate (ORR) and median overall survival (mOS) are described in Table 1. The mOS was not reached (NR) for 364 patients. The 1, 2 and 3 year survival rates were 79%, 63%, and 51%, respectively. For patients with stable disease (SD), the mOS was not reached and the 1, 2 and 3 year survival rates were 96%, 80%, and 60% respectively. There was a significant difference in mOS between SD and progressive disease (PD) patients, NR vs 15.5 months, P<.0001. The mOS was not reached for patients regardless of whether or not they received targeted therapy (TT) prior to HD IL-2. There were 4 reported treatment-related deaths in 364 patients (1.1%), none of these patients had prior TT. Conclusions: PROCLAIM data demonstrate that SD, previously grouped with the non-responders, is associated with extended survival rates. HD IL-2 is an active 2ndline treatment option for patients who have failed TT. These data support that HD IL-2 has a favorable safety profile and remains an effective therapy for eligible patients with mRCC. Clinical trial information: NCT01415167

Updated July 27, 2015Prospective Cohort (2011-2015)
N=364, 31 sites
mOS, monthsNR
Median follow-up, months18.8
1,2,3 year survival rate in CR/PR patients100%, 86%, 81%
1,2,3 year survival rate in SD patients96%, 80%, 60%
ORR17% (CR: 4%, PR: 13%)
CR+PR+SD56%
mOS no prior TT/prior TTNR(n=304)/NR(n=60)

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

2016 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Renal Cell Cancer

Track

Renal Cell Cancer

Sub Track

Renal Cell Cancer

Clinical Trial Registration Number

NCT01415167

Citation

J Clin Oncol 34, 2016 (suppl 2S; abstr 511)

DOI

10.1200/jco.2016.34.2_suppl.511

Abstract #

511

Poster Bd #

D16

Abstract Disclosures