PMID- 23535954
OWN - NLM
STAT- MEDLINE
DCOM- 20131211
LR  - 20240322
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Print)
IS  - 0923-7534 (Linking)
VI  - 24
IP  - 7
DP  - 2013 Jul
TI  - Ipilimumab alone or in combination with radiotherapy in metastatic 
      castration-resistant prostate cancer: results from an open-label, multicenter 
      phase I/II study.
PG  - 1813-1821
LID - S0923-7534(19)36653-0 [pii]
LID - 10.1093/annonc/mdt107 [doi]
AB  - BACKGROUND: This phase I/II study in patients with metastatic 
      castration-resistant prostate cancer (mCRPC) explored ipilimumab as monotherapy 
      and in combination with radiotherapy, based on the preclinical evidence of 
      synergistic antitumor activity between anti-CTLA-4 antibody and radiotherapy. 
      PATIENTS AND METHODS: In dose escalation, 33 patients (>/=6/cohort) received 
      ipilimumab every 3 weeks x 4 doses at 3, 5, or 10 mg/kg or at 3 or 10 mg/kg + 
      radiotherapy (8 Gy/lesion). The 10-mg/kg cohorts were expanded to 50 patients 
      (ipilimumab monotherapy, 16; ipilimumab + radiotherapy, 34). Evaluations included 
      adverse events (AEs), prostate-specific antigen (PSA) decline, and tumor 
      response. RESULTS: Common immune-related AEs (irAEs) among the 50 patients 
      receiving 10 mg/kg +/- radiotherapy were diarrhea (54%), colitis (22%), rash (32%), 
      and pruritus (20%); grade 3/4 irAEs included colitis (16%) and hepatitis (10%). 
      One treatment-related death (5 mg/kg group) occurred. Among patients receiving 10 
      mg/kg +/- radiotherapy, eight had PSA declines of >/=50% (duration: 3-13+ months), 
      one had complete response (duration: 11.3+ months), and six had stable disease 
      (duration: 2.8-6.1 months). CONCLUSIONS: In mCRPC patients, ipilimumab 10 mg/kg +/- 
      radiotherapy suggested clinical antitumor activity with disease control and 
      manageable AEs. Two phase III trials in mCRPC patients evaluating ipilimumab 10 
      mg/kg +/- radiotherapy are ongoing. ClinicalTrials.gov identifier: NCT00323882.
FAU - Slovin, S F
AU  - Slovin SF
AD  - Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York. 
      Electronic address: slovins@mskcc.org.
FAU - Higano, C S
AU  - Higano CS
AD  - Department of Medicine, Seattle Cancer Care Alliance, University of Washington, 
      Seattle.
FAU - Hamid, O
AU  - Hamid O
AD  - Department of Translational Research/Immunotherapy, The Angeles Clinic and 
      Research Institute, Santa Monica.
FAU - Tejwani, S
AU  - Tejwani S
AD  - Department of Hematology-Oncology, Henry Ford Health System, Detroit.
FAU - Harzstark, A
AU  - Harzstark A
AD  - Department of Medicine, Helen Diller Family Comprehensive Cancer Center, 
      University of California, San Francisco.
FAU - Alumkal, J J
AU  - Alumkal JJ
AD  - Division of Hematology and Medical Oncology, Knight Cancer Institute, Oregon 
      Health and Science University, Portland.
FAU - Scher, H I
AU  - Scher HI
AD  - Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York.
FAU - Chin, K
AU  - Chin K
AD  - Department of Oncology Global Clinical Research, Bristol-Myers Squibb, 
      Wallingford, USA.
FAU - Gagnier, P
AU  - Gagnier P
AD  - Department of Oncology Global Clinical Research, Bristol-Myers Squibb, 
      Wallingford, USA.
FAU - McHenry, M B
AU  - McHenry MB
AD  - Department of Oncology Global Clinical Research, Bristol-Myers Squibb, 
      Wallingford, USA.
FAU - Beer, T M
AU  - Beer TM
AD  - Division of Hematology and Medical Oncology, Knight Cancer Institute, Oregon 
      Health and Science University, Portland.
LA  - eng
SI  - ClinicalTrials.gov/NCT00323882
GR  - P50 CA092629/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20130327
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Ipilimumab)
RN  - EC 3.4.21.77 (Prostate-Specific Antigen)
SB  - IM
MH  - Adenocarcinoma/blood/mortality/*therapy
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Antineoplastic Agents/*therapeutic use
MH  - Chemoradiotherapy
MH  - Humans
MH  - Immunotherapy
MH  - Ipilimumab
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Prostate-Specific Antigen/blood
MH  - Prostatic Neoplasms/blood/mortality/*therapy
MH  - Treatment Outcome
PMC - PMC3707423
OTO - NOTNLM
OT  - immunotherapy
OT  - ipilimumab
OT  - metastatic castration-resistant prostate cancer
OT  - phase I/II trial
OT  - prostate-specific antigen and radiotherapy
EDAT- 2013/03/29 06:00
MHDA- 2013/12/16 06:00
PMCR- 2014/07/01
CRDT- 2013/03/29 06:00
PHST- 2013/03/29 06:00 [entrez]
PHST- 2013/03/29 06:00 [pubmed]
PHST- 2013/12/16 06:00 [medline]
PHST- 2014/07/01 00:00 [pmc-release]
AID - S0923-7534(19)36653-0 [pii]
AID - mdt107 [pii]
AID - 10.1093/annonc/mdt107 [doi]
PST - ppublish
SO  - Ann Oncol. 2013 Jul;24(7):1813-1821. doi: 10.1093/annonc/mdt107. Epub 2013 Mar 
      27.