7 months (range 1–34), the irDCR among 645 evaluable patients aged ≤ 70 years was 33%. Of these, 25 patients (4%) had an irCR, 58 (9%) an irPR and 131 (20%) had irSD at any time according to irRC. The irBORR in patients aged ≤ 70 years was therefore 13%. Table 2 Tumour response Patients, n (%) Response according to irRC Aged > 70 years (n = 188) Aged ≥ 80 years (n = 26) Aged ≤ 70 years (n = 645) irCR 4 (2) 0 (0) 25 (4) irPR 24 (13) 1 (4) 58 (9) irSD
44 (23) 7 (27) 131 (20) irPD 116 (62) 18 (69) 431 (67) irBORR 28 (15) 1 (4) 83 (13) irDCR 72 (38) 8 (31) 214 (33) [Note to authors: summarised these data as a table and added data for patients ≥80 years]. irBORR, immune-related best overall response rate; irCR, immune-related complete response; irDCR, immune-related disease control rate; irPD, immune-related progressive disease; check details irPR, immune-related partial response; irRC, immune-related response criteria; irSD, immune-related stable disease. Survival As of April 2013, median PFS in patients > 70 years old was 4.0 months (95% CI 3.0–5.0; Figure 1A); 1- and 2-year PFS rates were 21% and 12%, respectively. By comparison, median PFS in younger patients (≤ 70 years) was 3.7 months (95% CI 3.4–4.0), with 1- and 2-year PFS rates of 20% and 11%, respectively. In the elderly patient group (> 70 years old), median OS was 8.9 months (95% CI 7.2–10.6; Figure 1B); 1-
and 2-year OS MMP inhibitor rates were 38% and 22%, respectively. For patients aged ≤ 70 years, median OS was 7.0 months (95% CI 6.1–7.9); 1- and 2-year OS rates in the younger age group were 35% and 19%, respectively. Differences between age groups in median PFS and median OS were not statistically significant (P = 0.33 and P = 0.17, respectively). Figure 1 Kaplan-Meier estimates of progression free survival and overall survival by patient ages. A. Progression-free survival. B. OS, overall survival; PFS, progression-free survival. Safety The safety profile of ipilimumab in elderly patients was comparable to Vitamin B12 that in the wider EAP population [24]. Of the 193 patients aged > 70 years treated with ipilimumab, 96 (50%) reported an AE of any grade and among these
96 patients, 69 (36%) had AEs that were considered to be treatment-related. Respective numbers for the 662 patients aged ≤ 70 years were 303 (46%) and 217 (33%). The most frequently reported treatment-related AEs among patients aged > 70 years were pruritus, rash, diarrhoea, nausea and liver toxicity (experienced by at least 2% of patients; Table 3). Median time to onset of treatment-related AEs of any grade was 3 weeks (range 0.1–12 weeks). Grade III–IV AEs were reported by 19 patients (10%) and considered ipilimumab-related in 11 patients (6%). Median time to onset of treatment-related Grade III–IV AEs was 6 weeks (range 3–10 weeks). AEs were generally reversible with treatment as per protocol-specific guidelines. Median time to resolution of treatment-related AEs of any grade was 2.0 weeks (range 0.