Spanish experience with the ipilimumab Expanded Access Program.

Melanoma/Skin Cancers
Session Type and Session Title: 
This abstract will not be presented at the 2012 ASCO Annual Meeting but has been published in conjunction with the meeting.
Abstract Number: 


J Clin Oncol 30, 2012 (suppl; abstr e19023)
Alfonso Berrocal, Jose A. Lopez-Martin, Ana Maria Arance, V. Soriano, Enrique Espinosa, M Pilar Lopez Criado, Eva Muñoz, Jose Pablo Berros, A Soria, I Marquez, P Sancho, I Gil, Grupo Español Multidisciclinar de Melanoma GEM; Consorcio Hospital General Universitario de Valencia, Valencia, Spain; Hospital 12 de Octubre, Madrid, Spain; H Clinic I Provincial, Barcelona, Spain; Instituto Valenciano de Oncologia, Valencia, Spain; Hospital Universitario La Paz, Madrid, Spain; M. D. Anderson Madrid, Madrid, Spain; H Vall d'Hebron, Barcelona, Spain; Hospital Universitario Central de Asturias-IUOPA, Oviedo, Spain; Hospital Ramon y Cajal, Madrid, Spain; H Gregorio Marañon, Madrid, Spain; Hospital Reina Sofia, Sevilla, Spain; Hospital Reina Sofia, Navarra, Spain

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Abstract Disclosures


Background: Second line ipilimumab has proven efficacy in clinical trial but few is known outside this setting. Methods: We have retrospectively reviewed experience with the Expanded Access Program for Ipilimumab in Spain. We have collected data on demographics, response survival and toxicity. Ipilimumab was administered at a 3 mg/kg dose for four induction courses. Results: We have retrieved 99 expanded access ipilimumab applications that represent 40% of all possible applications. Five patients are not evaluable because they never received ipilimumab 4 due to progression and 1 declined consent. Median age is 58.5 years (30-81) and 54.3% of the patients are males. 59.6% have 3 or more metastatic locations, 50% have liver metastases, 16% have CNS metastasis and 74.6% have elevated LDH. ECOG performance status was 0 to 1 in 91.9%. Previous adyuvant treatment was received by 43.6% of the patients and consisted in high dose interferon in 85.4%. All except one patient have received previous first line chemotherapy and 34.2% have received 2 or more chemotherapy lines. Medium time from the start of metastatic disease to the start of ipilimumab was 11.2 months. 58.5% of the patients completed 4 doses of ipilimumab main reason for not completion was death or progression in 84.6% and toxicity in 5.1%. 8 patients are not evaluable for response, 5 have just completed the treatment and 3 are still on treatment. Responses are 1 (1.1%) CR, 6 (6.4%) PR, 6 (6.4%) PR with previous progression or new lesions, 13 (13.8%) SD, and 60 (63.8%) progressive disease. Reinduction treatment was offered to 5 patients 2 PR patients achieved a new PR, one PR patients a SD and 2 SD patients progressed after reinduction. Kaplan and Meier median survival is 150 days (95% CI 110,5-189.4). One year survival is 32.4% and 18 months survival 21.6%. Toxicity has been mild, skin, 20.2% grade I and 5.3% grade II, liver 7.4% grade I, 2.1% grade II, 3.2 grade III, and diarrhea 19.1% gI, 3.2% grade II and 1.1% grade IV. Only 7 patients experienced toxicity grade III to IV. Conclusions: Ipilimumab efficacy when it is used outside clinical trial is similar to the reported. There is room for improvement in patient selection as 40% of them did not completed treatment. Toxicity of the 3 mg/kg schedule is mild.