Journal article
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(1), pp.31-41
02/01/2017
DOI: 10.1016/j.clgc.2016.10.008
PMCID: PMC6875755
PMID: 27916626
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 ProleukinR 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. (C) 2016 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license.
Details
- Title: Subtitle
- 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)
- Creators
- Joseph I. Clark - Loyola University ChicagoMichael K. K. Wong - University of Southern CaliforniaHoward L. Kaufman - Rutgers, The State University of New JerseyGregory A. Daniels - University of California, San DiegoMichael A. Morse - Duke UniversityDavid F. McDermott - Harvard UniversitySanjiv S. Agarwala - Temple UniversityLionel D. Lewis - Dartmouth CollegeJohn H. Stewart - Duke UniversityUlka Vaishampayan - Wayne State UniversityBrendan Curti - Providence Portland Medical CenterRene Gonzalez - University of DenverJose Lutzky - Mount Sinai Medical CenterVenkatesh Rudraptna - University of MinnesotaLee D. Cranmer - Fred Hutch Cancer CenterJoanne M. Jeter - Banner - University Medical Center TucsonRalph J. Hauke - Nebraska Cancer SpecialistsGerald Miletello - Hematology\Oncology ClinicMohammed M. Milhem - University of IowaAsim Amin - Carolinas Medical CenterJohn M. Richart - Saint Louis UniversityMayer Fishman - University of South FloridaSigrun Hallmeyer - Oncology SpecialistsSapna P. Patel - The University of Texas MD Anderson Cancer CenterPeter Van Veldhuizen - University of KansasNeeraj Agarwa - Huntsman Cancer InstituteBret Taback - Columbia UniversityJonathan S. Treisman - Reiman Cancer Center, Franklin, WIMarc S. Ernstoff - Cleveland ClinicJessica C. Perritt - Prometheus ResearchHong Hua - Prometheus ResearchTharak B. Rao - Prometheus ResearchJanice P. Dutcher - National Foundation for Cancer ResearchSandra Aung - Prometheus Research
- Resource Type
- Journal article
- Publication Details
- Clinical genitourinary cancer, Vol.15(1), pp.31-41
- Publisher
- Cig Media Group, Lp
- DOI
- 10.1016/j.clgc.2016.10.008
- PMID
- 27916626
- PMCID
- PMC6875755
- ISSN
- 1558-7673
- eISSN
- 1938-0682
- Number of pages
- 11
- Grant note
- Prometheus Laboratories Inc. P30CA086862 / NATIONAL CANCER INSTITUTE; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Cancer Institute (NCI)
- Language
- English
- Date published
- 02/01/2017
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984359567402771
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