Michele Del Vecchio1, Lorenza Di Guardo2, Paolo A Ascierto3, Antonio M Grimaldi3, Vanna Chiarion Sileni4, Jacopo Pigozzo4, Virginia Ferraresi5, Carmen Nuzzo5, Gaetana Rinaldi6, Alessandro Testori7, Pier F Ferrucci8, Paolo Marchetti9, Federica De Galitiis10, Paola Queirolo11, Elena Tornari11, Riccardo Marconcini12, Luana Calabrò13, Michele Maio13. 1. Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. Electronic address: michele.delvecchio@istitutotumori.mi.it. 2. Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. 3. Melanoma, Cancer Immunotherapy and Innovative Therapy Unit, Istituto Nazionale Tumori Fondazione "G. Pascale", Naples, Italy. 4. Melanoma Cancer Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy. 5. Department of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy. 6. "Paolo Giaccone" Polyclinic University Hospital, Palermo, Italy. 7. Divisione Melanoma e Sarcomi Muscolo-Cutanei, Istituto Europeo di Oncologia IEO-IRCCS, Milan, Italy. 8. Unità di Ricerca Traslazionale sul Melanoma, Divisione di Oncologia Medica del Melanoma, Istituto Europeo di Oncologia IEO-IRCCS, Milan, Italy. 9. Medical Oncology, Dermopathic Institute of the Immaculate IDI-IRCCS, Rome, Italy; Medical Oncology, Sant'Andrea Hospital, Sapienza University of Rome, Italy. 10. Medical Oncology, Dermopathic Institute of the Immaculate IDI-IRCCS, Rome, Italy. 11. San Martino Hospital, National Institute for Cancer Research, Genoa, Italy. 12. University Hospital Pisa, "Gathered Hospitals of Santa Chiara", Pisa, Italy. 13. Department of Medical Oncology and Immunotherapy, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy.
Abstract
BACKGROUND: Mucosal melanoma is an extremely rare and aggressive malignancy that often remains undetected until it reaches an advanced stage, when effective treatment options are limited. The activity and safety of ipilimumab were assessed in an Expanded Access Programme (EAP) that included patients with metastatic, mucosal melanoma. METHODS: Ipilimumab was available upon physician request for patients aged ⩾16years with stage III (unresectable) or IV skin, ocular or mucosal melanoma, who had failed or did not tolerate previous treatments and had no other therapeutic option available. Patients received ipilimumab 3mg/kg every 3weeks for four doses. Patients with stable disease or an objective response to ipilimumab were eligible for retreatment upon disease progression. Tumour assessments were conducted at baseline and week 12 using immune-related response criteria. Patients were monitored for adverse events (AEs), including immune-related AEs, within 3 to 4days of each scheduled visit. RESULTS: Of 855 patients participating in the EAP in Italy, 71 (8%) had metastatic, mucosal melanoma. With a median follow-up of 21.8months, the response rate was 12% and the immune-related disease control rate was 36%. Median progression-free survival and overall survival were 4.3 and 6.4months, respectively. In total, 34% of patients reported treatment-related AEs of any grade, which were grade 3 or 4 in 9% of patients. AEs were generally manageable as per protocol-specific guidelines. CONCLUSION/ INTERPRETATION: Ipilimumab may be a feasible treatment option in pretreated patients with metastatic mucosal melanoma, and warrants further investigation in prospective clinical trials.
BACKGROUND:Mucosal melanoma is an extremely rare and aggressive malignancy that often remains undetected until it reaches an advanced stage, when effective treatment options are limited. The activity and safety of ipilimumab were assessed in an Expanded Access Programme (EAP) that included patients with metastatic, mucosal melanoma. METHODS:Ipilimumab was available upon physician request for patients aged ⩾16years with stage III (unresectable) or IV skin, ocular or mucosal melanoma, who had failed or did not tolerate previous treatments and had no other therapeutic option available. Patients received ipilimumab 3mg/kg every 3weeks for four doses. Patients with stable disease or an objective response to ipilimumab were eligible for retreatment upon disease progression. Tumour assessments were conducted at baseline and week 12 using immune-related response criteria. Patients were monitored for adverse events (AEs), including immune-related AEs, within 3 to 4days of each scheduled visit. RESULTS: Of 855 patients participating in the EAP in Italy, 71 (8%) had metastatic, mucosal melanoma. With a median follow-up of 21.8months, the response rate was 12% and the immune-related disease control rate was 36%. Median progression-free survival and overall survival were 4.3 and 6.4months, respectively. In total, 34% of patients reported treatment-related AEs of any grade, which were grade 3 or 4 in 9% of patients. AEs were generally manageable as per protocol-specific guidelines. CONCLUSION/ INTERPRETATION:Ipilimumab may be a feasible treatment option in pretreated patients with metastatic mucosal melanoma, and warrants further investigation in prospective clinical trials.
Authors: Zafar Sayed; Jocelyn C Migliacci; Jennifer R Cracchiolo; Christopher A Barker; Nancy Y Lee; Sean M McBride; Viviane S Tabar; Ian Ganly; Snehal G Patel; Luc T Morris; Benjamin R Roman; Alexander N Shoushtari; Marc A Cohen Journal: JAMA Otolaryngol Head Neck Surg Date: 2017-12-01 Impact factor: 6.223
Authors: Douglas B Johnson; Chengwei Peng; Richard G Abramson; Fei Ye; Shilin Zhao; Jedd D Wolchok; Jeffrey A Sosman; Richard D Carvajal; Charlotte E Ariyan Journal: Oncologist Date: 2015-05-11
Authors: Fernando López; Juan P Rodrigo; Antonio Cardesa; Asterios Triantafyllou; Kenneth O Devaney; William M Mendenhall; Missak Haigentz; Primož Strojan; Phillip K Pellitteri; Carol R Bradford; Ashok R Shaha; Jennifer L Hunt; Remco de Bree; Robert P Takes; Alessandra Rinaldo; Alfio Ferlito Journal: Head Neck Date: 2015-05-22 Impact factor: 3.147