A lot of the irAEs were reversible when managed as per protocol-specific treatment guidelines and resolved with systemic glucocorticosteroid therapy
A lot of the irAEs were reversible when managed as per protocol-specific treatment guidelines and resolved with systemic glucocorticosteroid therapy. cutaneous, mucosal and occult melanoma were 38?%, 14?% and 27?%, respectively. Median OS Epirubicin HCl was 6.8?months (95?% CI 5.3C9.9) for cutaneous, 9.6?months (95?% CI 1.6C11.1) for mucosal, and 9.9?months (lower 95?% CI 2.3, upper 95?% CI non-existent) for occult melanoma. Overall response rates for cutaneous, mucosal and occult melanoma were 16?%, 17?% and 11?%, respectively. Eleven patients had partial response (16?%) and ten patients experienced stable disease (14?%), none achieved a complete response. Treatment-related AEs were observed in 71 patients (69?%), including 20 grade 3C4 events (19?%). No new and unexpected safety findings were noted. Conclusions Ipilimumab is usually a treatment option for pretreated patients with advanced cutaneous melanoma seen in daily routine. Toxicity was manageable when treated as per protocol-specific guidelines. Trial registration: Clinical Trials.gov “type”:”clinical-trial”,”attrs”:”text”:”NCT01355120″,”term_id”:”NCT01355120″NCT01355120 Electronic supplementary material The online version of this article (doi:10.1186/s12967-015-0716-5) contains supplementary material, which is available to authorized users. Eastern Cooperative Oncology Group, lactate dehydrogenase Table?2 Outcomes of patients with ipilimumab re-induction therapy response evaluation criteria in solid tumors, partial response, stable disease, progressive disease Efficacy The 1-12 months rate for OS was 38?% (95?% CI 27C49) for cutaneous melanoma, 14?% (95?% CI 1C47) for Epirubicin HCl mucosal melanoma, and 27?% (95?% CI 5C57) for occult melanoma. 2-12 months OS rates for cutaneous and occult melanoma were 22?% (95?% CI 13C33) and 27?% (95?% CI 5C57), respectively. All of the patients with mucosal melanoma died before month 24 after the first ipilimumab administration. Six-month rate for PFS were 16?% (95?% CI 9C25) for cutaneous melanoma, 14?% (95?% CI 1C47) for mucosal melanoma, and 17?% (95?% CI 3C41) for occult melanoma. Median OS from the first dose of ipilimumab for cutaneous, mucosal and occult melanoma were 6.8 (95?% CI 5.3C9.9; Fig.?1a), 9.6 (95?% CI 1.6C11.1; Fig.?1b) and 9.9 (lower 95?% CI 2.3, upper 95?% CI non-existent; Fig.?1c) months, respectively. Seventy of 103 patients were evaluable for efficacy assessment (Table?3). Among the 33 patients (32?%) who were not assessable, 22 died before the assessment of change in tumor burden (including 13 with brain metastases), three developed PD (including two with brain metastases), three had intolerable AEs, one had no measurable disease at baseline, three withdrew their informed consent (including one with brain metastases) and one was lost to follow-up. The DCR was 29?% for cutaneous, 50?% for mucosal and 22?% for occult melanoma (Table?3). Overall response rates for cutaneous, mucosal and occult melanoma were 16?%, 17?% and 11?%, respectively (Table?3). Among the 70 patients evaluable for response, the overall response rate for 15 patients with brain CEACAM8 metastases was 13?%: a response rate similar to the one found for the remaining 55 patients without brain metastases (16?%). Of the 15 patients with brain metastases seven patients had intracranial Epirubicin HCl SD, seven intracranial PD and one patient experienced intracranial CR. In total, ten patients showed comparable response pattern in intracranial and extracranial metastases and five patients had Epirubicin HCl different response pattern, e.g. in Epirubicin HCl one patient an intracranial response (CR) was observed, unfortunately associated with extracranial PD (Additional file 3: Table S3). Open in a separate windows Fig.?1 KaplanCMeier curves for 1-year overall survival (OS) rates of different melanoma subtypes. Pretreated patients with a metastatic cutaneous melanoma (1-12 months OS rate: 38?%), b mucosal melanoma (1-12 months OS rate: 14?%), and c occult.