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 Amin; John 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

doi:10.1016/j.clgc.2016.10.008

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: PROCLAIM^SM

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

Melanoma Medical Oncology

Research output: Contribution to journal › Article › peer-review

32 Scopus citations

Abstract

Proleukin^R Observational Study to Evaluate the Treatment Patterns and Clinical Response in Malignancy (PROCLAIM^SM) 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 Proleukin^R Observational Study to Evaluate the Treatment Patterns and Clinical Response in Malignancy (PROCLAIM^SM) 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 language	English (US)
Pages (from-to)	31-41.e4
Journal	Clinical Genitourinary Cancer
Volume	15
Issue number	1
DOIs	https://doi.org/10.1016/j.clgc.2016.10.008
State	Published - 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: PROCLAIM^SM. Clinical Genitourinary Cancer, 15(1), 31-41.e4. https://doi.org/10.1016/j.clgc.2016.10.008

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: PROCLAIM^SM. / Clark, Joseph I.; Wong, Michael K.K.; Kaufman, Howard L. et al.
In: Clinical Genitourinary Cancer, Vol. 15, No. 1, 01.02.2017, p. 31-41.e4.

Research output: Contribution to journal › Article › peer-review

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 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: PROCLAIM^SM', Clinical Genitourinary Cancer, vol. 15, no. 1, pp. 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 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: PROCLAIM^SM. Clinical Genitourinary Cancer. 2017 Feb 1;15(1):31-41.e4. doi: 10.1016/j.clgc.2016.10.008

Clark, Joseph I. ; Wong, Michael K.K. ; Kaufman, Howard L. 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: PROCLAIM^SM. In: Clinical Genitourinary Cancer. 2017 ; Vol. 15, No. 1. pp. 31-41.e4.

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title = "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",

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.",

keywords = "Anti-VEGF therapy, Cytokine, Kidney cancer, Therapy trends, Toxicity",

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

note = "Publisher Copyright: {\textcopyright} 2016 The Authors",

year = "2017",

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day = "1",

doi = "10.1016/j.clgc.2016.10.008",

language = "English (US)",

volume = "15",

pages = "31--41.e4",

journal = "Clinical Genitourinary Cancer",

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publisher = "Elsevier",

number = "1",

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TY - JOUR

T1 - Impact of Sequencing Targeted Therapies With High-dose Interleukin-2 Immunotherapy

T2 - An Analysis of Outcome and Survival of Patients With Metastatic Renal Cell Carcinoma From an On-going Observational IL-2 Clinical Trial: PROCLAIMSM

AU - Clark, Joseph I.

AU - Wong, Michael K.K.

AU - Kaufman, Howard L.

AU - Daniels, Gregory A.

AU - Morse, Michael A.

AU - McDermott, David F.

AU - Agarwala, Sanjiv S.

AU - Lewis, Lionel D.

AU - Stewart, John H.

AU - Vaishampayan, Ulka

AU - Curti, Brendan

AU - Gonzalez, René

AU - Lutzky, Jose

AU - Rudraptna, Venkatesh

AU - Cranmer, Lee D.

AU - Jeter, Joanne M.

AU - Hauke, Ralph J.

AU - Miletello, Gerald

AU - Milhem, Mohammed M.

AU - Amin, Asim

AU - Richart, John M.

AU - Fishman, Mayer

AU - Hallmeyer, Sigrun

AU - Patel, Sapna P.

AU - Van Veldhuizen, Peter

AU - Agarwal, Neeraj

AU - Taback, Bret

AU - Treisman, Jonathan S.

AU - Ernstoff, Marc S.

AU - Perritt, Jessica C.

AU - Hua, Hong

AU - Rao, Tharak B.

AU - Dutcher, Janice P.

AU - Aung, Sandra

PY - 2017/2/1

Y1 - 2017/2/1

N2 - 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.

AB - 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.

KW - Anti-VEGF therapy

KW - Cytokine

KW - Kidney cancer

KW - Therapy trends

KW - Toxicity

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