PMID- 24708900
OWN - NLM
STAT- MEDLINE
DCOM- 20140826
LR  - 20211021
IS  - 1756-9966 (Electronic)
IS  - 0392-9078 (Print)
IS  - 0392-9078 (Linking)
VI  - 33
IP  - 1
DP  - 2014 Apr 4
TI  - Efficacy and safety of ipilimumab in elderly patients with pretreated advanced 
      melanoma treated at Italian centres through the expanded access programme.
PG  - 30
LID - 10.1186/1756-9966-33-30 [doi]
AB  - BACKGROUND: Elderly patients with metastatic melanoma have different disease 
      characteristics and a poorer prognosis than younger patients. Data from clinical 
      trials and expanded access programmes (EAPs) suggest ipilimumab confers a 
      consistent survival benefit and has a similar safety profile across different age 
      groups of patients with metastatic melanoma. Here we report the efficacy and 
      safety of ipilimumab 3 mg/kg in elderly patients enrolled in an EAP in Italy. 
      METHODS: Patients aged > 70 years with pretreated melanoma received ipilimumab 
      3 mg/kg every 3 weeks for four doses through an EAP. Tumour response was 
      evaluated at baseline and after completion of induction therapy using 
      immune-related response criteria and patients were monitored throughout the 
      treatment period for adverse events (AEs), including immune-related AEs. RESULTS: 
      The immune-related disease control rate among 188 evaluable patients was 38%, 
      including four patients with an immune-related complete response, 24 with an 
      immune-related partial response and 44 with immune-related stable disease. Median 
      progression-free survival (PFS) was 4.0 months and the 1- and 2-year PFS rates 
      were 21% and 12%, respectively. Median overall survival (OS) was 8.9 months; 1- 
      and 2-year OS rates were 38% and 22%, respectively. The safety profile of 
      ipilimumab was consistent with that observed in the general population of the 
      Italian EAP and treatment-related AEs generally resolved within a median of 
      2 weeks with treatment as per protocol-specific guidelines. CONCLUSIONS: These 
      results suggest ipilimumab is a feasible treatment option in elderly patients 
      with metastatic melanoma. Ipilimumab treatment was generally well tolerated and 
      resulted in clinical benefit and extended survival in elderly patients treated at 
      centres in Italy.
FAU - Chiarion Sileni, Vanna
AU  - Chiarion Sileni V
AD  - Melanoma Cancer Unit, Oncology Institute of Veneto IRCCS, Via Gattamelata, 64, 
      35128 Padua, Italy. mgaliz@tiscali.it.
FAU - Pigozzo, Jacopo
AU  - Pigozzo J
FAU - Ascierto, Paolo Antonio
AU  - Ascierto PA
FAU - Grimaldi, Antonio Maria
AU  - Grimaldi AM
FAU - Maio, Michele
AU  - Maio M
FAU - Di Guardo, Lorenza
AU  - Di Guardo L
FAU - Marchetti, Paolo
AU  - Marchetti P
FAU - de Rosa, Francesco
AU  - de Rosa F
FAU - Nuzzo, Carmen
AU  - Nuzzo C
FAU - Testori, Alessandro
AU  - Testori A
FAU - Cocorocchio, Emilia
AU  - Cocorocchio E
FAU - Bernengo, Maria Grazia
AU  - Bernengo MG
FAU - Guida, Michele
AU  - Guida M
FAU - Marconcini, Riccardo
AU  - Marconcini R
FAU - Merelli, Barbara
AU  - Merelli B
FAU - Parmiani, Giorgio
AU  - Parmiani G
FAU - Rinaldi, Gaetana
AU  - Rinaldi G
FAU - Aglietta, Massimo
AU  - Aglietta M
FAU - Grosso, Marco
AU  - Grosso M
FAU - Queirolo, Paola
AU  - Queirolo P
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20140404
PL  - England
TA  - J Exp Clin Cancer Res
JT  - Journal of experimental & clinical cancer research : CR
JID - 8308647
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Ipilimumab)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/adverse effects/*therapeutic use
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Ipilimumab
MH  - Italy
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Melanoma/*drug therapy/mortality
MH  - Middle Aged
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC3996509
EDAT- 2014/04/09 06:00
MHDA- 2014/08/27 06:00
PMCR- 2014/04/04
CRDT- 2014/04/09 06:00
PHST- 2013/12/11 00:00 [received]
PHST- 2014/03/17 00:00 [accepted]
PHST- 2014/04/09 06:00 [entrez]
PHST- 2014/04/09 06:00 [pubmed]
PHST- 2014/08/27 06:00 [medline]
PHST- 2014/04/04 00:00 [pmc-release]
AID - 1756-9966-33-30 [pii]
AID - 10.1186/1756-9966-33-30 [doi]
PST - epublish
SO  - J Exp Clin Cancer Res. 2014 Apr 4;33(1):30. doi: 10.1186/1756-9966-33-30.