Efficacy and safety of ipilimumab in elderly patients with pretreated advanced melanoma treated at Italian centres through the expanded access programme.
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.
Melanoma Cancer Unit, Oncology Institute of Veneto IRCCS, Via Gattamelata, 64, 35128 Padua, Italy. mgaliz@tiscali.it.
Vanna
V
Chiarion Sileni
Jacopo
J
Pigozzo
Paolo Antonio
PA
Ascierto
Antonio Maria
AM
Grimaldi
Michele
M
Maio
Lorenza
L
Di Guardo
Paolo
P
Marchetti
Francesco
F
de Rosa
Carmen
C
Nuzzo
Alessandro
A
Testori
Emilia
E
Cocorocchio
Maria Grazia
MG
Bernengo
Michele
M
Guida
Riccardo
R
Marconcini
Barbara
B
Merelli
Giorgio
G
Parmiani
Gaetana
G
Rinaldi
Massimo
M
Aglietta
Marco
M
Grosso
Paola
P
Queirolo
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000074324:Ipilimumab; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D000074324:Ipilimumab