1151 - Ipilimumab in older patients: Spanish Melanoma Multidisciplinary Group (GEM) experience in the expanded access programme

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anti-Cancer Agents & Biologic Therapy
Geriatric Oncology
Melanoma and other Skin Tumours
Presenter Jose A. Lopez Martin
Authors J.A. Lopez Martin1, M. Gonzalez Cao2, M. Sereno3, J. Mayordomo4, M. Hidalgo5, B. Campos6, D. Cumplido7, F. Zambrana3, J. Medina8, A. Berrocal9
  • 1Medical Oncology, "12 de Octubre" University Hospital, 28041 - Madrid/ES
  • 2Medical Oncology, Hospital Dexeus, Barcelona/ES
  • 3Medical Oncology, Hospital Infanta Sofia, Madrid/ES
  • 4Medical Oncology, H Clínico, Zaragoza/ES
  • 5Ciocc, Hospital de Txagorritxu, Vitoria/ES
  • 6Oncoloxia Médica, Hospital Universitario Lucus Augusti de Lugo, Hospital Universitario Lucus Augusti (Lugo)/ES
  • 7Medical Oncology, Hospital de Torrevieja, Alicante/ES
  • 8Medical Oncology, Hospital Virgen de la Salud, Toledo/ES
  • 9Medical Oncology, Hospital General Universitario, Valencia/ES

Abstract

Objective

To review the use of Ipilimumab (IPI) in patients with melanoma aged ≥70 years treated within the Expanded Access Programme (EAP) in Spain.

Patients and methods

The GEM distributed a questionnaire to the treating physicians, to collect data on demographics, response, survival and toxicity from patients enrolled in the EAP in Spain. IPI was administered IV at 3-weekly dose of 3 mg/kg, for 4 cycles. We have focused on patients aged 70 or more years with previously treated, advanced melanoma.

Results

Information on 30 patients is available. Median age was 75 years (70-81), 53.3% were males. Liver and CNS metastases were respectively present in 26.7% and 13.3% of the patients; 53.3% had 3 or more metastatic sites, and 51.7% had elevated LDH. Performance status (ECOG) was 0-1 in 93.3%. Up to 26.7% of the patients had received previous adjuvant treatment, which consisted of high dose interferon in 75%. All patients had received previous first line chemotherapy, including 26.7% with 2 or more lines. Medium time from the diagnosis of metastatic disease to the first dose of IPI was 14.2 months. A total of 76.7% of the patients completed the 4 intended doses of IPI. Main reasons for early discontinuation were death or progression in all patients, with no patient discontinuing due to toxicity. Responses were evaluable in 26 patients: PR: 6 (20%) -including 3 (10%) with a delayed PR after an initial PD; SD: 3 (10%), and PD: 17 (56.7%). Out of the 4 non-evaluable patients, 3 had just completed treatment and 1 was still on therapy at the time of the data collection. So far, reinduction treatment has not been offered to any patient. Estimated median survival (Kaplan -Meier) is 180 days (5.9 months) (95% CI 119.7-240.2). One year survival rate is 21%. Prognostic factors of survival at baseline were peripheral blood lymphocytes > 1000 /mL (p = 0.005) and LDH > 1.5 X ULN (p = 0.027) The reported toxicity per patient has been mild: skin: 23.3% grade I and 13.3% grade II; liver 6.7% grade I; and diarrhea 6.7% grade I, 3.3% grade III-IV. Only 4 patients experienced toxicity grade III to IV.

Conclusions

Ipilimumab efficacy in older patients, when it is used outside a clinical trial setting, is in line to published phase III data. There is no increase in toxicity, making this treatment a valid option for older patients with previously treated metastatic melanoma.

Disclosure

J.A. Lopez Martin: Participation in Avisory Boards of BMS and speaker in educational activities of BMS.

A. Berrocal: Participation in Advisory Boards and speaker in educational activities sponsored by BMS.

All other authors have declared no conflicts of interest.