PMID- 20086001
OWN - NLM
STAT- MEDLINE
DCOM- 20100422
LR  - 20220410
IS  - 1557-3265 (Electronic)
IS  - 1078-0432 (Linking)
VI  - 16
IP  - 3
DP  - 2010 Feb 1
TI  - Phase II trial of tremelimumab (CP-675,206) in patients with advanced refractory 
      or relapsed melanoma.
PG  - 1042-8
LID - 10.1158/1078-0432.CCR-09-2033 [doi]
AB  - PURPOSE: This phase II study assessed the antitumor activity of tremelimumab, a 
      fully human, anti-CTL-associated antigen 4 monoclonal antibody, in patients with 
      melanoma. EXPERIMENTAL DESIGN: Patients with refractory/relapsed melanoma 
      received 15 mg/kg tremelimumab every 90 days. After 4 doses, patients with tumor 
      response or stable disease were eligible to receive < or =4 additional doses. 
      Primary endpoint was best overall tumor response assessed by an independent 
      endpoint review committee, and secondary endpoints included duration of response, 
      overall survival, progression-free survival, and safety. RESULTS: Of 251 patients 
      enrolled, 246 (241 response-evaluable) received tremelimumab. Objective response 
      rate was 6.6% (16 partial responses); duration of response was 8.9 to 29.8 
      months. Eight (50%) objective responses occurred in patients with stage IV M(1c) 
      disease, and 11 (69%) were ongoing at last tumor assessment. Eight (3.3%) 
      patients achieved responses in target lesions (Response Evaluation Criteria in 
      Solid Tumors) despite progressive disease within the first cycle. All 8 survived 
      for >20 months; 5 (63%) remained alive. Clinical benefit rate (overall response + 
      stable disease) was 21% (16 partial responses and 35 stable disease), and median 
      overall survival was 10.0 months. Progression-free survival at 6 months was 15%, 
      and survival was 40.3% at 12 months and 22% at 24 months. Common 
      treatment-related adverse events were generally mild to moderate, and grade 3/4 
      adverse events included diarrhea (n = 28, 11%), fatigue (n = 6, 2%), and colitis 
      (n = 9, 4%). There were 2 (0.8%) treatment-related deaths. CONCLUSIONS: 
      Tremelimumab showed an objective response rate of 6.6%, with all responses being 
      durable > or =170 days since enrollment, suggesting a potential role for 
      tremelimumab in melanoma.
FAU - Kirkwood, John M
AU  - Kirkwood JM
AD  - University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA. 
      kirkwoodjm@upmc.edu
FAU - Lorigan, Paul
AU  - Lorigan P
FAU - Hersey, Peter
AU  - Hersey P
FAU - Hauschild, Axel
AU  - Hauschild A
FAU - Robert, Caroline
AU  - Robert C
FAU - McDermott, David
AU  - McDermott D
FAU - Marshall, Margaret A
AU  - Marshall MA
FAU - Gomez-Navarro, Jesus
AU  - Gomez-Navarro J
FAU - Liang, Jane Q
AU  - Liang JQ
FAU - Bulanhagui, Cecile A
AU  - Bulanhagui CA
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20100119
PL  - United States
TA  - Clin Cancer Res
JT  - Clinical cancer research : an official journal of the American Association for 
      Cancer Research
JID - 9502500
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - QEN1X95CIX (tremelimumab)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/adverse effects/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Drug Administration Schedule
MH  - Drug Resistance, Neoplasm
MH  - Female
MH  - Humans
MH  - Male
MH  - Melanoma/*drug therapy/pathology
MH  - Middle Aged
MH  - Recurrence
MH  - Skin Neoplasms/*drug therapy/pathology
EDAT- 2010/01/21 06:00
MHDA- 2010/04/23 06:00
CRDT- 2010/01/21 06:00
PHST- 2010/01/21 06:00 [entrez]
PHST- 2010/01/21 06:00 [pubmed]
PHST- 2010/04/23 06:00 [medline]
AID - 1078-0432.CCR-09-2033 [pii]
AID - 10.1158/1078-0432.CCR-09-2033 [doi]
PST - ppublish
SO  - Clin Cancer Res. 2010 Feb 1;16(3):1042-8. doi: 10.1158/1078-0432.CCR-09-2033. 
      Epub 2010 Jan 19.