PMID- 24532241
OWN - NLM
STAT- MEDLINE
DCOM- 20141231
LR  - 20240321
IS  - 1573-7373 (Electronic)
IS  - 0167-594X (Print)
IS  - 0167-594X (Linking)
VI  - 118
IP  - 1
DP  - 2014 May
TI  - Efficacy and safety of ipilimumab in patients with advanced melanoma and brain 
      metastases.
PG  - 109-16
LID - 10.1007/s11060-014-1400-y [doi]
AB  - Patients with melanoma brain metastases have a poor prognosis and historically 
      have been excluded from clinical trials. The Expanded Access Program (EAP) 
      provided an opportunity to evaluate the feasibility of ipilimumab (3 mg/kg every 
      3 weeks for four doses) in patients with stage 3 (unresectable) or 4 melanoma and 
      asymptomatic brain metastases, who had failed or did not tolerate previous 
      treatments and had no other therapeutic option available. Tumor assessments were 
      conducted at baseline and week 12 using immune-related response criteria and 
      patients were monitored for adverse events (AEs). Of 855 patients participating 
      in the EAP in Italy, 146 had asymptomatic brain metastases. With a median 
      follow-up of 4 months, the global disease control rate was 27%, including 4 
      patients with a complete response and 13 with a partial response. Median 
      progression-free survival and overall survival were 2.8 and 4.3 months, 
      respectively and approximately one-fifth of patients were alive 1 year after 
      starting ipilimumab. In total, 29% of patients reported a treatment-related AE of 
      any grade, which were grade 3/4 in 6% of patients. AEs were generally reversible 
      with treatment as per protocol-specific guidelines. Ipilimumab shows durable 
      benefits in some patients with advanced melanoma metastatic to the brain, with 
      safety results consistent with those previously reported in clinical trials.
FAU - Queirolo, Paola
AU  - Queirolo P
AD  - Medical Oncology, IRCCS Azienda Ospedaliera Universitaria San Martino - IST 
      Istituto Nazionale per la Ricerca sul Cancro, Largo Rosanna Benzi, 10, 16132, 
      Genova, Italy, paola.queirolo@hsanmartino.it.
FAU - Spagnolo, Francesco
AU  - Spagnolo F
FAU - Ascierto, Paolo Antonio
AU  - Ascierto PA
FAU - Simeone, Ester
AU  - Simeone E
FAU - Marchetti, Paolo
AU  - Marchetti P
FAU - Scoppola, Alessandro
AU  - Scoppola A
FAU - Del Vecchio, Michele
AU  - Del Vecchio M
FAU - Di Guardo, Lorenza
AU  - Di Guardo L
FAU - Maio, Michele
AU  - Maio M
FAU - Di Giacomo, Anna Maria
AU  - Di Giacomo AM
FAU - Antonuzzo, Andrea
AU  - Antonuzzo A
FAU - Cognetti, Francesco
AU  - Cognetti F
FAU - Ferraresi, Virginia
AU  - Ferraresi V
FAU - Ridolfi, Laura
AU  - Ridolfi L
FAU - Guidoboni, Massimo
AU  - Guidoboni M
FAU - Guida, Michele
AU  - Guida M
FAU - Pigozzo, Jacopo
AU  - Pigozzo J
FAU - Chiarion Sileni, Vanna
AU  - Chiarion Sileni V
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20140216
PL  - United States
TA  - J Neurooncol
JT  - Journal of neuro-oncology
JID - 8309335
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Immunologic Factors)
RN  - 0 (Ipilimumab)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Brain Neoplasms/*drug therapy/*secondary
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Immunologic Factors/*therapeutic use
MH  - Ipilimumab
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Melanoma/*drug therapy/*pathology
MH  - Middle Aged
MH  - Retrospective Studies
MH  - Young Adult
PMC - PMC4023079
EDAT- 2014/02/18 06:00
MHDA- 2015/01/01 06:00
PMCR- 2014/02/16
CRDT- 2014/02/18 06:00
PHST- 2013/10/03 00:00 [received]
PHST- 2014/01/31 00:00 [accepted]
PHST- 2014/02/18 06:00 [entrez]
PHST- 2014/02/18 06:00 [pubmed]
PHST- 2015/01/01 06:00 [medline]
PHST- 2014/02/16 00:00 [pmc-release]
AID - 1400 [pii]
AID - 10.1007/s11060-014-1400-y [doi]
PST - ppublish
SO  - J Neurooncol. 2014 May;118(1):109-16. doi: 10.1007/s11060-014-1400-y. Epub 2014 
      Feb 16.