Impact of Sequencing Targeted Therapies With High-dose Interleukin-2 Immunotherapy: An Analysis of Outcome and Survival of Patients With Metastatic Renal Cell Carcinoma From an On-going Observational IL-2 Clinical Trial: PROCLAIMSM

Joseph I. Clark, Michael K.K. Wong, Howard L. Kaufman, Gregory A. Daniels, Michael A. Morse, David F. McDermott, Sanjiv S. Agarwala, Lionel D. Lewis, John H. Stewart, Ulka Vaishampayan, Brendan Curti, René Gonzalez, Jose Lutzky, Venkatesh Rudraptna, Lee D. Cranmer, Joanne M. Jeter, Ralph J. Hauke, Gerald Miletello, Mohammed M. Milhem, Asim AminJohn M. Richart, Mayer Fishman, Sigrun Hallmeyer, Sapna P. Patel, Peter Van Veldhuizen, Neeraj Agarwal, Bret Taback, Jonathan S. Treisman, Marc S. Ernstoff, Jessica C. Perritt, Hong Hua, Tharak B. Rao, Janice P. Dutcher, Sandra Aung

Research output: Contribution to journalArticle

18 Scopus citations

Abstract

ProleukinR Observational Study to Evaluate the Treatment Patterns and Clinical Response in Malignancy (PROCLAIMSM) is the largest observational clinical database of high-dose interleukin-2 (HD IL-2)-treated patients in the US. Herein, the survival and outcome for patients with renal cell carcinoma receiving HD IL-2 in sequence with targeted therapy are described. HD IL-2 has an acceptable efficacy and safety profile in current clinical practice and remains a valuable therapy for patients with renal cell carcinoma. Background This analysis describes the outcome for patients who received targeted therapy (TT) prior to or following high-dose interleukin-2 (HD IL-2). Patients and Methods Patients with renal cell carcinoma (n = 352) receiving HD IL-2 were enrolled in ProleukinR Observational Study to Evaluate the Treatment Patterns and Clinical Response in Malignancy (PROCLAIMSM) beginning in 2011. Statistical analyses were performed using datasets as of September 24, 2015. Results Overall, there were 4% complete response (CR), 13% partial response (PR), 39% stable disease (SD), and 43% progressive disease (PD) with HD IL-2. The median overall survival (mOS) was not reached in patients with CR, PR, or SD, and was 15.5 months in patients with PD (median follow-up, 21 months). Sixty-one patients had prior TT before HD IL-2 with an overall response rate (ORR) to HD IL-2 of 19% (1 CR, 9 PR) and an mOS of 22.1 months. One hundred forty-nine patients received TT only after HD IL-2 with an mOS of 35.5 months. One hundred forty-two patients had no TT before or after HD IL-2, and mOS was not reached. The mOS was 8.5 months in PD patients who received HD IL-2 without follow-on TT and 29.7 months in PD patients who received follow-on TT after HD IL-2. Conclusions HD IL-2 as sole front-line therapy, in the absence of added TT, shows extended clinical benefit (CR, PR, and SD). Patients with PD after HD IL-2 appear to benefit from follow-on TT. Patients who progressed on TT and received follow-on HD IL-2 experienced major clinical benefit. HD IL-2 therapy should be considered in eligible patients.

Original languageEnglish (US)
Pages (from-to)31-41.e4
JournalClinical Genitourinary Cancer
Volume15
Issue number1
DOIs
StatePublished - Feb 1 2017

Keywords

  • Anti-VEGF therapy
  • Cytokine
  • Kidney cancer
  • Therapy trends
  • Toxicity

ASJC Scopus subject areas

  • Oncology
  • Urology

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    Clark, J. I., Wong, M. K. K., Kaufman, H. L., Daniels, G. A., Morse, M. A., McDermott, D. F., Agarwala, S. S., Lewis, L. D., Stewart, J. H., Vaishampayan, U., Curti, B., Gonzalez, R., Lutzky, J., Rudraptna, V., Cranmer, L. D., Jeter, J. M., Hauke, R. J., Miletello, G., Milhem, M. M., ... Aung, S. (2017). Impact of Sequencing Targeted Therapies With High-dose Interleukin-2 Immunotherapy: An Analysis of Outcome and Survival of Patients With Metastatic Renal Cell Carcinoma From an On-going Observational IL-2 Clinical Trial: PROCLAIMSM. Clinical Genitourinary Cancer, 15(1), 31-41.e4. https://doi.org/10.1016/j.clgc.2016.10.008