Extension of overall survival (OS) beyond objective responses (OR) in patients (pts) with metastatic renal cell carcinoma (mRCC) treated with high dose interleukin-2 (HD IL-2).

Authors

null

David D. Stenehjem

Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT

David D. Stenehjem , Michael Toole , Joseph Merriman , Kinjal Parikh , Stephanie Daignault , Sarah Scarlett , Peg Esper , Katherine Skinner , Aaron Udager , Srinivas Kiran Tantravahi , Alli M. Straubhar , Archana M. Agarwal , Joan Van Atta , Kenneth F. Grossmann , Wolfram E. Samlowski , Bruce G. Redman , Neeraj Agarwal , Ajjai Shivaram Alva

Organizations

Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT, University of Michigan, Ann Arbor, MI, University of Utah, Salt Lake City, UT, University of Utah Huntsman Cancer Institute, Salt Lake City, UT, Department of Biostatistics, University of Michigan, Ann Arbor, MI, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, Wayne State University, Detroit, MI, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, Department of Pathology and ARUP Laboratories, University of Utah, Salt Lake City, UT, Comp Cancer Ctrs of Nevada, Las Vegas, NV, Division of Hematology/Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI

Research Funding

No funding sources reported

Background: The aim of this study is to determine if achievement of stable disease as a best response to HD IL-2 may improve survival outcomes. Recent data suggest that immunotherapy may improve survival even in those pts who do not experience objective responses (CR+PR). Methods: All sequential mRCC pts treated with HD IL-2 at the University of Utah (1988-2013) and University of Michigan (1997-2013) were included. Best responses to HD IL-2 were correlated with survival outcomes using landmark analysis at 2 months—the median time to first disease assessment. Results: A total of 391 pts (75% male; median age 55 yrs, range 13-77) were included and belonged to the following risk categories: 80 (20%) good, 251 (64%) intermediate, and 60 (15%) poor. A CR was identified in 35 (9%), PR in 39 (10%), SD in 125 (32%), progressive disease (PD) in 164 (42%), and not evaluable for response (NE) in 28 (7%) pts. Median OS for the favorable, intermediate and poor risk groups were 53.8 (p=0.0015 vs intermediate), 26.4 (p<0.0001 vs poor), and 12.2 (p<0.0001 vs favorable) months, respectively. Table shows correlation of response to survival. Conclusions: Stable disease as best response to HD IL-2 was achieved in 32% of pts and survival outcomes were not statistically different in these pts from those achieving PR, however significantly greater than those with PD. Stable disease is an important response criterion for treatment with HD IL-2, and may be discussed with the pts.

Correlation of best responses with survival outcomes in mRCC pts treated with HD IL-2: Landmark analysis at 2 months.

Median PFS, monthsMedian OS, months
Overall6.949.2
CR vs PR113.8 vs 11.8 (HR 0.18, CI 0.09-0.37)156.7 vs 37.8 (HR 0.21, CI 0.09-0.47)
CR vs SD113.8 vs 9.0 (HR 0.13, CI 0.06-0.23)156.7 vs 38.4 (HR 0.13, CI 0.05-0.26)
SD vs PD9.0 vs 3.9 (HR 0.19, CI 0.12-0.31)38.4 vs 19.9 (HR 0.41, CI 0.24-0.72)
OR vs (SD
and PD)
26.4 vs 4.9 (HR 0.26, CI 0.18-0.36)101.2 vs 24.1 (HR 0.24, CI 0.15-0.37)
(CR, PR, SD)
vs PD
10.4 vs 2.6 (HR 0.10, CI 0.07-0.14)53.9 vs 12.2 (HR 0.23, CI 0.16-0.33)
PR vs SD11.8 vs 9.0 (HR 0.69, CI 0.44-1.04)37.8 vs 38.4 (HR 0.60, CI 0.34-1.01)

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Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Genitourinary (Nonprostate) Cancer

Track

Genitourinary Cancer

Sub Track

Kidney Cancer

Citation

J Clin Oncol 33, 2015 (suppl; abstr 4565)

DOI

10.1200/jco.2015.33.15_suppl.4565

Abstract #

4565

Poster Bd #

239

Abstract Disclosures