Efficacy and safety of ipilimumab 3 mg/kg in patients with pretreated,metastatic, mucosal melanoma |
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| Institution: | 1. Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy;2. Melanoma, Cancer Immunotherapy and Innovative Therapy Unit, Istituto Nazionale Tumori Fondazione “G. Pascale”, Naples, Italy;3. Melanoma Cancer Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy;4. Department of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy;5. “Paolo Giaccone” Polyclinic University Hospital, Palermo, Italy;6. Divisione Melanoma e Sarcomi Muscolo-Cutanei, Istituto Europeo di Oncologia IEO-IRCCS, Milan, Italy;7. Unità di Ricerca Traslazionale sul Melanoma, Divisione di Oncologia Medica del Melanoma, Istituto Europeo di Oncologia IEO-IRCCS, Milan, Italy;8. Medical Oncology, Dermopathic Institute of the Immaculate IDI-IRCCS, Rome, Italy;9. Medical Oncology, Sant’Andrea Hospital, Sapienza University of Rome, Italy;10. San Martino Hospital, National Institute for Cancer Research, Genoa, Italy;11. University Hospital Pisa, “Gathered Hospitals of Santa Chiara”, Pisa, Italy;12. Department of Medical Oncology and Immunotherapy, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy;1. Department of Dermatology and Allergy, University Hospital Munich (LMU), Frauenlobstr. 9-11, 80337 Munich, Germany;2. Department of Dermatology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Ulmenweg 18, 91054 Erlangen, Germany;3. Department of Dermatology, University Hospital Schleswig-Holstein, Campus Kiel, Rosalind-Franklin-Str. 7, 24105 Kiel, Germany;4. Department of Dermatology, Center for Dermatooncology, University Hospital Tübingen, Liebermeisterstr. 25, 72076 Tübingen, Germany;5. Department of Dermatology, University Medical Center Mainz, Langenbeckstr. 1, 55131 Mainz, Germany;6. Department of Dermatology, Venereology and Allergology, Goethe University, Theodor-Stern Kai 7, 60590 Frankfurt am Main, Germany;7. Department of Dermatology, Skin Cancer Center, National Center for Tumor Diseases, Medical Faculty and University Hospital Carl Gustav Carus, TU Dresden, Fetscherstr. 74, 01307 Dresden, Germany;8. Department of Dermatology, University of Lübeck, Ratzeburger Allee 160, 23538 Lübeck, Germany;9. Department of Dermatology, SRH Wald-Klinikum Gera GmbH, Str. des Friedens 122, 07548 Gera, Germany;10. HELIOS Skin Cancer Center Erfurt, HELIOS Clinic Erfurt, Nordhäuser Str. 74, 99089 Erfurt, Germany;11. Department of Dermatology and Allergology, Justus Liebig University, University Medical Center Gießen and Marburg, Gaffkystr. 14, 35392 Gießen, Germany;12. Department of Dermatology and Allergy, Skin Cancer Center, Charité Universitätsmedizin, Charitéplatz 1, 10117 Berlin, Germany;13. Department of Dermatology, Medical Center – University of Freiburg, Hauptstr. 7, 79104 Freiburg, Germany;14. Department of Dermatology, University Hospital Regensburg, Franz-Josef-Strauß-Allee 11, 93053 Regensburg, Germany;15. Department of Dermatology and Allergic Diseases, Ulm University, Albert-Einstein-Allee 23, 89081 Ulm, Germany;p. Skin Cancer Unit, German Cancer Research Center (DKFZ) and Department of Dermatology, Venereology and Allergology, University Medical Center Mannheim, Ruprecht-Karl University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany;q. Department of Dermatology, Venereology, and Allergology, University Hospital Leipzig, Philipp-Rosenthal-Str. 23, 04103 Leipzig, Germany;r. Clinic of Internal Medicine, University Hospital Munich (LMU), Ziemssenstr. 1, 80336 Munich, Germany;s. Department of Dermatology, Klinikum Augsburg, Sauerbruchstr. 6, 86179 Augsburg, Germany;t. Department of Dermatology and Venereology, University Medical Center Rostock, Strempelstr.13, 18057 Rostock, Germany;u. Institute for Clinical Radiology, University Hospital Munich (LMU), Ziemssenstr. 1, 80336 Munich, Germany;1. Icon Cancer Centre Adelaide, Kurralta Park, South Australia 5037, Australia;2. School of Medicine, University of Adelaide, Adelaide, South Australia, Australia;3. Medical Oncology department, Flinders Medical Centre, Adelaide, South Australia, Australia;4. Medical Oncology Department, CHUV - Oncologie, Rue du Bugnon 46, 1011, Lausanne, Switzerland;1. Department of Oral and Maxillofacial Surgery, Aristotle University of Thessaloniki, “G. Papanikolaou” General Hospital, Thessaloniki, Greece;2. Department of Oral and Maxillofacial Surgery, University of Rochester, Rochester, New York, USA;1. Department of Dermatology and Allergy, Munich University Hospital (LMU), Frauenlobstr. 9-11, 80337 Munich, Germany;2. Department of Dermatology, University Hospital Essen, Hufelandstr. 55, 45122 Essen, Germany;3. German Cancer Consortium (DKTK), Germany;4. Department of Dermatology, Center for Dermatooncology, University Hospital Tübingen, Liebermeisterstr. 25, 72076 Tübingen, Germany;5. Department for Dermatology and Allergy, Skin Cancer Center Hannover (HTZH), Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany;6. Department of Dermatology, Skin Cancer Center, National Center for Tumor Diseases, Medical Faculty and University Hospital Carl Gustav Carus, TU Dresden, Fetscherstr. 74, 01307 Dresden, Germany;7. Department of Dermatology, University Medical Center Mainz, Langenbeckstr. 1, 55131 Mainz, Germany;8. Department of Dermatology, University Hospital Schleswig-Holstein, Campus Kiel, Rosalind-Franklin-Str. 7, 24105 Kiel, Germany;9. Department of Dermatology, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany;10. Department of Dermatology, Venereology and Allergology, Goethe University, Theodor-Stern Kai 7, 60590 Frankfurt am Main, Germany;11. Department of Dermatology, Medical Center – University of Freiburg, Hauptstr. 7, 79104 Freiburg, Germany;12. Department of Dermatology and Allergology, Justus Liebig University, University Medical Center Gießen and Marburg, Gaffkystr. 14, 35392 Gießen, Germany;13. Department of Dermatology and Venereology, Skin Cancer Center at the Center of Integrated Oncology (CIO) Köln Bonn, University Hospital of Cologne, Kerpener Str. 62, 50937 Cologne, Germany;14. Saarland University Medical School, Department of Dermatology, Kirrberger Str. 100, 66421 Homburg, Saar, Germany;15. Skin Cancer Unit, German Cancer Research Center (DKFZ) and Department of Dermatology, Venereology and Allergology, University Medical Center Mannheim, Ruprecht-Karl University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany;p. Department of Dermatology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Ulmenweg 18, 91054 Erlangen, Germany;q. Munich Cancer Registry (MCR) of the Munich Tumor Centre (TZM), Department of Medical Information Processing, Biometry and Epidemiology (IBE), University Hospital of Munich, Ludwig-Maximilian-University (LMU), Marchioninistr. 15, 81337 Munich, Germany;1. Department of Surgery (Section of Otolaryngology), Yale University School of Medicine, 800 Howard Ave, 4th Floor, New Haven, CT 0519, United States;2. Yale Cancer Center, PO Box 208028, New Haven, CT 06520-8028, United States;1. University of Vermont, College of Medicine, Burlington, Vermont;2. Department of Radiation Oncology, Mount Sinai Medical Center, New York, New York;3. Beth Israel Medical Center, St. Luke’s-Roosevelt Hospital Center, New York, and Ear Infirmary, New York, New York |
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| Abstract: | BackgroundMucosal 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.MethodsIpilimumab was available upon physician request for patients aged ?16 years 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 3 mg/kg every 3 weeks 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 4 days of each scheduled visit.ResultsOf 855 patients participating in the EAP in Italy, 71 (8%) had metastatic, mucosal melanoma. With a median follow-up of 21.8 months, 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 6.4 months, 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/interpretationIpilimumab may be a feasible treatment option in pretreated patients with metastatic mucosal melanoma, and warrants further investigation in prospective clinical trials. |
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| Keywords: | Efficacy Expanded access programme Ipilimumab Metastatic melanoma Mucosal Safety |
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