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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.

Publication ,  Journal Article
Clark, JI; Wong, MKK; Kaufman, HL; Daniels, GA; Morse, MA; McDermott, DF; Agarwala, SS; Lewis, LD; Stewart, JH; Vaishampayan, U; Curti, B ...
Published in: Clin Genitourin Cancer
February 2017

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.

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Published In

Clin Genitourin Cancer

DOI

EISSN

1938-0682

Publication Date

February 2017

Volume

15

Issue

1

Start / End Page

31 / 41.e4

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Recombinant Proteins
  • Oncology & Carcinogenesis
  • Neoplasm Metastasis
  • Molecular Targeted Therapy
  • Middle Aged
  • Male
  • Kidney Neoplasms
  • Interleukin-2
 

Citation

APA
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Clark, J. I., Wong, M. K. K., Kaufman, H. L., Daniels, G. A., Morse, M. A., McDermott, D. F., … 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. Clin Genitourin Cancer, 15(1), 31-41.e4. https://doi.org/10.1016/j.clgc.2016.10.008
Clark, Joseph I., Michael K. K. Wong, Howard L. Kaufman, Gregory A. Daniels, Michael A. Morse, David F. McDermott, Sanjiv S. Agarwala, et al. “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.Clin Genitourin Cancer 15, no. 1 (February 2017): 31-41.e4. https://doi.org/10.1016/j.clgc.2016.10.008.
Clark JI, Wong MKK, Kaufman HL, Daniels GA, Morse MA, McDermott DF, Agarwala SS, Lewis LD, Stewart JH, Vaishampayan U, Curti B, Gonzalez R, Lutzky J, Rudraptna V, Cranmer LD, Jeter JM, Hauke RJ, Miletello G, Milhem MM, Amin A, Richart JM, Fishman M, Hallmeyer S, Patel SP, Van Veldhuizen P, Agarwal N, Taback B, Treisman JS, Ernstoff MS, Perritt JC, Hua H, Rao TB, Dutcher JP, Aung S. 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. Clin Genitourin Cancer. 2017 Feb;15(1):31-41.e4.
Journal cover image

Published In

Clin Genitourin Cancer

DOI

EISSN

1938-0682

Publication Date

February 2017

Volume

15

Issue

1

Start / End Page

31 / 41.e4

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Recombinant Proteins
  • Oncology & Carcinogenesis
  • Neoplasm Metastasis
  • Molecular Targeted Therapy
  • Middle Aged
  • Male
  • Kidney Neoplasms
  • Interleukin-2