PMID- 24695951
OWN - NLM
STAT- MEDLINE
DCOM- 20140930
LR  - 20240426
IS  - 1432-0851 (Electronic)
IS  - 0340-7004 (Print)
IS  - 0340-7004 (Linking)
VI  - 63
IP  - 7
DP  - 2014 Jul
TI  - Immunological and biological changes during ipilimumab treatment and their 
      potential correlation with clinical response and survival in patients with 
      advanced melanoma.
PG  - 675-83
LID - 10.1007/s00262-014-1545-8 [doi]
AB  - BACKGROUND: Ipilimumab can induce durable disease control and long-term survival 
      in patients with metastatic melanoma. Identification of a biomarker that 
      correlates with clinical benefit and potentially provides an early marker of 
      response is an active area of research. PATIENTS AND METHODS: Ipilimumab was 
      available upon physician request for patients aged >/=16 years with stage III 
      (unresectable) or IV cutaneous, ocular or mucosal melanoma, who had failed or did 
      not tolerate previous treatments and had no other therapeutic option available. 
      Patients received ipilimumab 3 mg/kg every 3 weeks for four doses. Tumour 
      assessments were conducted at baseline, Week 12 and Week 24 using immune-related 
      response criteria. Patients were monitored continuously for adverse events (AEs), 
      including immune-related AEs. Candidate immunological markers were evaluated in 
      peripheral blood and sera samples collected at baseline and Weeks 4, 7, 10 and 
      12. RESULTS: Among 95 patients treated with ipilimumab 3 mg/kg, the 
      immune-related disease control rate at Week 24 was 38 %. With a median follow-up 
      of 24 months, median overall survival was 9.6 months. Both disease control and 
      survival were significantly associated with decreasing levels of lactate 
      dehydrogenase, C-reactive protein and FoxP3/regulatory T cells, and increasing 
      absolute lymphocyte count, between baseline and the end of dosing (Week 12). 
      CONCLUSION: Ipilimumab is a feasible treatment option for heavily pretreated 
      patients with metastatic melanoma. Changes in some immunological markers between 
      baseline and the fourth ipilimumab infusion appear to be associated with disease 
      control and survival, but verification in prospective clinical trials is 
      required.
FAU - Simeone, Ester
AU  - Simeone E
AD  - Unit of Melanoma, Cancer Immunotherapy and Innovative Therapy, IRCCS, Istituto 
      Nazionale Tumori Fondazione "G. Pascale", Via Mariano Semmola, 80131, Naples, 
      Italy.
FAU - Gentilcore, Giusy
AU  - Gentilcore G
FAU - Giannarelli, Diana
AU  - Giannarelli D
FAU - Grimaldi, Antonio M
AU  - Grimaldi AM
FAU - Caraco, Corrado
AU  - Caraco C
FAU - Curvietto, Marcello
AU  - Curvietto M
FAU - Esposito, Assunta
AU  - Esposito A
FAU - Paone, Miriam
AU  - Paone M
FAU - Palla, Marco
AU  - Palla M
FAU - Cavalcanti, Ernesta
AU  - Cavalcanti E
FAU - Sandomenico, Fabio
AU  - Sandomenico F
FAU - Petrillo, Antonella
AU  - Petrillo A
FAU - Botti, Gerardo
AU  - Botti G
FAU - Fulciniti, Franco
AU  - Fulciniti F
FAU - Palmieri, Giuseppe
AU  - Palmieri G
FAU - Queirolo, Paola
AU  - Queirolo P
FAU - Marchetti, Paolo
AU  - Marchetti P
FAU - Ferraresi, Virginia
AU  - Ferraresi V
FAU - Rinaldi, Gaetana
AU  - Rinaldi G
FAU - Pistillo, Maria Pia
AU  - Pistillo MP
FAU - Ciliberto, Gennaro
AU  - Ciliberto G
FAU - Mozzillo, Nicola
AU  - Mozzillo N
FAU - Ascierto, Paolo A
AU  - Ascierto PA
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20140403
PL  - Germany
TA  - Cancer Immunol Immunother
JT  - Cancer immunology, immunotherapy : CII
JID - 8605732
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Ipilimumab)
SB  - IM
EIN - Cancer Immunol Immunother. 2014 Nov;63(11):1233
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Eye Neoplasms/*drug therapy/*immunology/pathology
MH  - Female
MH  - Humans
MH  - Ipilimumab
MH  - Male
MH  - Melanoma/*drug therapy/*immunology/pathology
MH  - Middle Aged
MH  - Skin Neoplasms/*drug therapy/*immunology/pathology
MH  - Survival Analysis
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC11028686
EDAT- 2014/04/04 06:00
MHDA- 2014/10/01 06:00
PMCR- 2014/04/03
CRDT- 2014/04/04 06:00
PHST- 2013/11/07 00:00 [received]
PHST- 2014/03/22 00:00 [accepted]
PHST- 2014/04/04 06:00 [entrez]
PHST- 2014/04/04 06:00 [pubmed]
PHST- 2014/10/01 06:00 [medline]
PHST- 2014/04/03 00:00 [pmc-release]
AID - 1545 [pii]
AID - 10.1007/s00262-014-1545-8 [doi]
PST - ppublish
SO  - Cancer Immunol Immunother. 2014 Jul;63(7):675-83. doi: 10.1007/s00262-014-1545-8. 
      Epub 2014 Apr 3.