1150 - Spanish melanoma multidisciplinary group (GEM) experience with ipilimumab (IPI) in the Expanded Access Programme (EAP)

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anti-Cancer Agents & Biologic Therapy
Melanoma and other Skin Tumours
Presenter Salvador Martin Algarra
Authors S. Martin Algarra1, L. Alonso2, J. Valdivia3, A. Garcia Castaño4, V. Escrig5, P. Mut6, A. Ballesteros7, T. Puertolas8, E. Ortega9, A. Berrocal10
  • 1Clinica Universitaria de Navarra, 31008 - Pamplona/ES
  • 2Medical Oncology, Hospital Clínico Victoria, Málaga/ES
  • 3Medical Oncology, Hospital Virgen de las Nieves, Granada/ES
  • 4Hospitalmedical Oncology, Hospital Marqués de Valdecilla, Santander/ES
  • 5Medical Oncology, Hospital Clínico Valencia, Valencia/ES
  • 6Medical Oncology, Hospital Son Llazer Mallorca, Mallorca/ES
  • 7Medical Oncology, Hospital Universitario La Princesa, Madrid/ES
  • 8Medical Oncology, Hospital Miguel Servet, Zaragoza/ES
  • 9Medical Oncology, Hospital Armau de Villanova, Lérida/ES
  • 10Medical Oncology, Hospital General Universitario, Valencia/ES

Abstract

Objective

Retrospective review of the IPI-EAP experience in Spain.

Patients and methods

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.

Results

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.

Conclusions

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.

Disclosure

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.