1130P - Efficacy and safety of ipilimumab in patients with pretreated, mucosal melanoma: experience from Italian clinics participating in the European Expan...

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Immunotherapy
Skin cancers
Presenter Michele Del Vecchio
Authors M. Del Vecchio1, E. Simeone2, V. Chiarion Sileni3, C. Nuzzo4, G. Rinaldi5, A. Testori6, F. De Galitiis7, P. Queirolo8, R. Marconcini9, M. Maio10
  • 1Oncologia Medica, Fondazione IRCCS Istituto Nazionale dei tumori, Milan/IT
  • 2Fondazione Pascale, Instituto Nazional per lo Studio, 80131 - Napoli/IT
  • 3Medical Oncology, Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
  • 4Department Of Medical Oncology, Regina Elena National Cancer Institute, Rome/IT
  • 5Discipliniche Chirurgiche Ed Oncologiche, Azienda Ospedaliera UniversitariaPoliclinico Paolo Giaccone, IT-90127 - Palermo/IT
  • 6Melanoma Muscle Cutaneous Sarcoma Division, European Institute of Oncology, Milan/IT
  • 7Department Of Oncology, Dermopathic Institute of the Immaculate IDI-IRCCS, Rome/IT
  • 8National Institute For Cancer Research, San Martino Hospital, Genova/IT
  • 9Department Of Oncology, University Hospital Pisa " Gathered Hospitals of Santa Clara", Pisa/IT
  • 10Division Of Medical Oncology And Immunotherapy, Medical Oncology and Immunotherapy,University Hospital of Siena, 53100 - Siena/IT



Mucosal melanoma is an extremely rare and aggressive malignancy associated with a poor prognosis. Because of its rarity and the challenges associated with each anatomical location, mucosal melanoma often remains undetected until it is at an advanced stage, when effective treatment options are limited. The EAP provided an opportunity to assess the activity and safety of ipilimumab in patients with mucosal melanoma outside of controlled clinical trials from the EAP in Italy.


Ipilimumab was available upon physician request for patients aged ≥16 years with stage III (unresectable) or stage IV skin, ocular or mucosal melanoma, who had failed or did not tolerate previous treatments and for whom no therapeutic option was available. Patients were treated with ipilimumab 3 mg/kg every 3 weeks for 4 doses. Tumour assessments were conducted at baseline and after completion of induction therapy using immune-related response criteria. Patients were monitored for adverse events (AEs), including immune-related AEs, within 3 to 4 days of each scheduled visit using Common Terminology Criteria for Adverse Events v.3.0.


Of 848 Italian patients participating in the EAP, 70 (8.2%) had mucosal melanoma. Of these, data are available for 50 patients. With a median follow-up of 2.5 months, the disease control rate among 39 evaluable patients was 23.1%, including one patient with a complete response, two patients with a partial response and six with stable disease. As of April 2012, median progression-free survival and overall survival among patients with mucosal melanoma were 3.9 months and 6.2 months, respectively. In total, 40.0% patients reported an AE of any grade, most of which were drug-related (32.0%). Grade 3/4 AEs were reported by 18.0% patients and considered drug-related in 12.0%. AEs were generally manageable and most resolved with treatment as per protocol-specific guidelines.


Results from the EAP suggest that ipilimumab is active in some patients with mucosal melanoma and warrants further investigation in prospective clinical trials.


E. Simeone: Ester Simeone has received honoraria from Bristol-Myers Squibb.

V. Chiarion Sileni: Vanna Chiaron Sileni has acted as an advisor for Bristol-Myers Squibb, Roche, GlaxoSmithKline, Merck Sharp & Dohme and Schering-Plough.

P. Queirolo: Paola Queirolo has acted as an advisor for Roche, GlaxoSmithKline, Bristol-Myers Squibb and Schering-Plough and received honoraria from Bristol-Myers Squibb and Roche.

M. Maio: Michele Maio has acted as an advisor for Bristol-Myers Squibb and Roche.

All other authors have declared no conflicts of interest.