title: Contemporary experience with high-dose interleukin-2 therapy and impact on survival in patients with metastatic melanoma and metastatic renal cell carcinoma.
abstract: High-dose interleukin-2 (HD IL-2) was approved for treatment of metastatic renal cell carcinoma (mRCC) in 1992 and for metastatic melanoma (mM) in 1998, in an era predating targeted therapies and immune checkpoint inhibitors. The PROCLAIMSMregistry was established to collect and analyze data for patients treated with HD IL-2 in the current era. This analysis includes 170 patients with mM and 192 patients with mRCC treated between 2005 and 2012 with survival data current as of July 27, 2015. For patients with mM, complete response (CR) was observed in 5 %, partial response (PR) in 10 %, stable disease (SD) in 22 %, and 63 % had progressive disease (PD). The median overall survival (mOS) for these patients was 19.6 months, with a median follow-up of 43.1 months. The mOS was not reached for patients achieving CR or PR, and was 33.4 months for patients with SD. For patients with mRCC, 6 % achieved CR, 9 % had PR, 22 % had SD, and 62 % had PD. The mOS was 41 months, with a median follow-up of 46.6 months. The mOS for patients who had CR and PR was not reached and was 49.6 months for patients with SD. There were no treatment-related deaths among 362 patients. The duration of mOS for patients with mM and mRCC is longer than historically reported. These data support a continued role for IL-2 in the treatment of eligible patients with mM or mRCC and warrant further evaluation of HD IL-2 in combination or sequence with other therapeutic agents.
authors.affiliation: University of Michigan, Ann Arbor, MI, USA.
authors.forename: Ajjai
authors.initials: A
authors.lastname: Alva
authors.affiliation: Moores Cancer Center, University of California San Diego, La Jolla, CA, USA.
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Daniels
authors.affiliation: University of Southern California, Los Angeles, CA, USA.|M.D. Anderson Cancer Center, Houston, TX, USA.
authors.forename: Michael K K
authors.initials: MK
authors.lastname: Wong
authors.affiliation: Rutgers Cancer Center Institute of New Jersey, New Brunswick, NJ, USA.
authors.forename: Howard L
authors.initials: HL
authors.lastname: Kaufman
authors.affiliation: Duke University Medical Center, Durham, NC, USA.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Morse
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, MA, USA.
authors.forename: David F
authors.initials: DF
authors.lastname: McDermott
authors.affiliation: Loyola University Medical Center, Maywood, IL, USA.
authors.forename: Joseph I
authors.initials: JI
authors.lastname: Clark
authors.affiliation: St. Luke's University Health Network and Temple University, Bethlehem, PA, USA.
authors.forename: Sanjiv S
authors.initials: SS
authors.lastname: Agarwala
authors.affiliation: Hematology/Oncology Clinic, Baton Rouge, LA, USA.
authors.forename: Gerald
authors.initials: G
authors.lastname: Miletello
authors.affiliation: Indiana University Simon Cancer Center, Indianapolis, IN, USA.
authors.forename: Theodore F
authors.initials: TF
authors.lastname: Logan
authors.affiliation: Nebraska Cancer Specialists, Omaha, NE, USA.
authors.forename: Ralph J
authors.initials: RJ
authors.lastname: Hauke
authors.affiliation: Providence Portland Medical Center, Portland, OR, USA.
authors.forename: Brendan
authors.initials: B
authors.lastname: Curti
authors.affiliation: Hillman Cancer Center Research, University of Pittsburgh Cancer Institute, Pavillion L1 32c, Pittsburgh, PA, USA.
authors.forename: John M
authors.initials: JM
authors.lastname: Kirkwood
authors.affiliation: University of Colorado Cancer Center, Aurora, CO, USA.
authors.forename: Rene
authors.initials: R
authors.lastname: Gonzalez
authors.affiliation: Levine Cancer Institute, Charlotte, NC, USA.
authors.forename: Asim
authors.initials: A
authors.lastname: Amin
authors.affiliation: Moffitt Cancer Center, Tampa, FL, USA.
authors.forename: Mayer
authors.initials: M
authors.lastname: Fishman
authors.affiliation: Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.
authors.forename: Neeraj
authors.initials: N
authors.lastname: Agarwal
authors.affiliation: Astex Pharmaceuticals, Pleasanton, CA, USA.
authors.forename: James N
authors.initials: JN
authors.lastname: Lowder
authors.affiliation: Prometheus Laboratories Inc., San Diego, CA, USA.
authors.forename: Hong
authors.initials: H
authors.lastname: Hua
authors.affiliation: Prometheus Laboratories Inc., San Diego, CA, USA.|Nektar Therapeutics, San Francisco, CA, USA.
authors.forename: Sandra
authors.initials: S
authors.lastname: Aung
authors.affiliation: Cancer Research Foundation, Chappaqua, NY, USA. jpd4401@aol.com.
authors.forename: Janice P
authors.initials: JP
authors.lastname: Dutcher
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D007376:Interleukin-2 / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008875:Middle Aged; D015996:Survival Rate; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D007376:Interleukin-2
keywords: Immunotherapy; Interleukin-2; Melanoma; Renal cell carcinoma