1150 - Spanish Melanoma Multidisciplinary Group (GEM) Experience with Ipilimumab (IPI) in the Expanded Access Programme (EAP)

• Published in: Annals of oncology Vol. 23; p. ix374
• Main Authors: Algarra, S. Martin, Alonso, L., Valdivia, J., Castaño, A. Garcia, Escrig, V., Mut, P., Ballesteros, A., Puertolas, T., Ortega, E., Berrocal, A.
• Format: Journal Article
• Language: English
• Published: Elsevier Ltd 01.09.2012
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1016/S0923-7534(20)33706-6

Retrospective review of the IPI-EAP experience in Spain. Demographics were provided by BMS. Response (R), survival (S) and toxicity (T) were collected from a questionnaire (Q) distributed by the GEM to EAP treating physicians. IPI dose was 3mg/kg q 3w x 4. Patients (pts) progressing after objective R were eligible for reinduction. 355 EAP requests result in 288 treated pts. Median age: 59y (24-83); Male 57%; Stage: IVa 28.8%, IVb 20%, IVc 51.2%; CNS metastases (mts) 15%, liver 37%, lung 21%. ECOG (PS): 0 48%, 1 41%, 2 11%; Prior treatment (thx): chemotherapy (chx) 94%, immunotherapy 37%, radiotherapy 28%. At the time of this report, information from 138 treated pts (48%), collected using the GEM Q, was available for a preliminary analysis Median age: 58y (24-81); Male 57.2%; CNS mts 18.8%, Liver 47.1%. >2 metastatic sites: 53.6%. PS 0-1: 81.8%. Prior adjuvant thx: 44.9% pts (79% high dose interferon). All except 2 pts, received chx (34.8% >1 line). Median time from metastases to 1st dose of IPI was 11.2 months (m). 60.9% pts completed 4 doses of IPI. Reinduction was requested for 17 pts (12.1%) and 8 received 4 cycles (5.8%). Discontinuation was due to death or progression (P) in 87% and T in 3.7%. R was evaluable in 129 pts: CR: 2 (1.4%); PR: 23 (16.6%) including 11 (7.9%) with initial P and delayed PR; SD: 18 (13%); P: 86 (62.3%). Of the 9 non-evaluable pts, 6 just finished thx and 3 were still on IPI. Reinduction was done in 13 pts, 8 received 4 doses: 2 pts with prior PR achieved a new PR, 3 with prior PR had SD, and 3 with prior SD progressed. Median S: 6,1 m (95% CI:125.3-272.6); 1y S: 32.9%; 18 m S: 28.8%. Prognostic factors for S were baseline lymphocytes >1000/ml (p = 0.0008) and LDH >1.5xULN (p = 0.003) T was mild. Skin: grade (G) I 21.7%, GII 3.6%; liver: GI 5.8%, GII 1.4%, GIII 2.2%; diarrhoea: GI 14.5%, GII 3.6%, GIII-IV 1.7%. 9 pts had GIII-IV T. IPI can be safely used by trained oncologists in a non-clinical trial setting. In this series, activity and T profile in is similar to the phase III data. Although this preliminary analysis is limited by its numbers (<50% of included pts) and retrospective nature, the fact that only 60% of treated pts completed induction suggest that better results could be obtained refining selection requirement. S. Martin Algarra: Participation in BMS advisory boards and sponsored lectures. A. Berrocal: Participation in BMS advisory boards and sponsored lectures. All other authors have declared no conflicts of interest.