7 weeks (0.1–11.1) among all patients treated in the EAP in Italy [24]. Table 3 Treatment-related AEs experienced by at least 2% of patients aged > 70 or ≤ 70 years   Patients aged > 70 years (n = 193), n (%) Patients aged ≤ 70 years (n = 662), n (%) Treatment-related selleck chemical AEs experienced by at least 2% of patients Any grade Grade III–IV Any grade Grade III–IV Pruritus 11 (6) 0 47 (7) 1 (<1) Rash 19 (10) 1 (<1) 45 (7) 3 (<1) Diarrhoea 9 (5) 2 (1) 51 (8) 17 (3) Nausea 5 (3) 0 42 (6) 2 (<1) Liver toxicity 3 (2) 2 (1) 16 (2) 13 (2) AEs, adverse events. Discussion Elderly

patients with metastatic melanoma have higher rates of overall and disease-specific mortality than younger patients [7]. Furthermore, selleck older patients are more likely to have existing comorbidities, which often result in their exclusion from clinical trials of investigative new therapies [25]. The EAP in Italy provided the opportunity to assess the efficacy and safety of ipilimumab 3 mg/kg in elderly patients with advanced melanoma outside of a clinical

trial setting. Most other subgroup analyses have used a cut-off age of 65 years when reporting the use of ipilimumab in elderly patients [12, 19, 20, 26]. Our results suggest ipilimumab treatment is equally effective and safe in patients with advanced melanoma who are aged over or under 70 years. This higher cut-off age may be more relevant to the challenges associated with cancer treatment in an aging society. Indeed, the cut-off for many clinical cancer studies is now

70 years and this is expected to be revised upwards so that 75 years may soon be the standard upper age limit for inclusion in a clinical trial [27, 28]. Among the 855 patients who participated in the EAP in Italy, almost one quarter were aged > 70 years and were eligible for treatment. This figure is consistent with the proportion of patients > 70 years diagnosed with melanoma in Italy as recorded in the Italian cancer registry, demonstrating that the elderly patients treated as part of the EAP can be considered as representative of the general population of patients > 70 years new with melanoma. Elderly patients had long-lasting clinical responses and prolonged survival with ipilimumab 3 mg/kg. The irBORR and irDCR in patients aged > 70 years were similar to those observed in the wider population of the Italian EAP [24] and in 30 elderly patients (≥ 70 years old) treated at Spanish centres www.selleckchem.com/products/th-302.html through the EAP [20]. One- and 2-year survival rates of 38% and 22% are also comparable with those reported for the total population and consistent with results from the US EAP, in which 1-year survival rates for patients < 65 years or ≥ 65 years were 38% and 37%, respectively [18]. In the Italian EAP, PFS and OS survival curves were comparable between older and younger patients.