Prognostic factors for survival in patients with mucosal and ocular melanoma treated with ipilimumab: Turkish Oncology Group study

Yaşar, Hatime Arzu; Turna, Hande; Esin, Ece; Sedef, Ali Murat; Alkan, Ali; Öksüzoğlu, Berna; Özdemir, Nuriye; Şendur, Mehmet Ali Nahit; Sezer, Ahmet; Kılıçkap, Saadettin; Utkan, Güngör; Akbulut, Hakan; Çeli̇k, İsmai̇l; Abalı, Hüseyin; Ürün, Yüksel

doi:10.1177/1078155219840796

Cited by 9 publications

(6 citation statements)

References 27 publications

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“…Ipilimumab was assessed in 13 studies with a total of 303 patients (Table 1). 17–29 A pooled analysis of 36 patients with MM treated with ipilimumab monotherapy showed efficacy with an ORR of 23.3% and median PFS of 3.0 months. 17 DeCOG was an open-label, multi-center, single-arm phase II study that included patients with melanoma irrespective of the primary melanoma location.…”

Section: Resultsmentioning

confidence: 99%

“…23 In a multicenter, retrospective analysis of 33 patients with unresectable or metastatic MM treated with ipilimumab at a dose of 3 or 10 mg/kg, one immune-related CR, one immune-related PR, six immune-related stable disease, and 22 immune-related progressive disease cases were observed at approximately 12 weeks after initiation of therapy. 24 A multicenter retrospective study included 11 patients with MM receiving ipilimumab at seven different medical oncology departments in Turkey and the median OS was 6.9 months (95% CI 25 A single-center, prospective cohort analyzed 24 patients with unresectable locally advanced or metastatic MM who received ipilimumab. 26 The ORR was 8.2% with a median PFS of 5 months (95% CI 2.6-33.1) and a median OS of 16.2 months (95% CI 5.3-42.6).…”

Section: Anti-ctla-4 Monoclonal Antibodiesmentioning

confidence: 99%

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Immune checkpoint inhibitors in advanced or metastatic mucosal melanoma: a systematic review

Kan

Zhao

et al. 2020

Ther Adv Med Oncol

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Background: Conventional cytotoxic chemotherapy offers minor benefit to patients with mucosal melanoma (MM). Although immune checkpoint inhibitors (ICIs) have become the preferred approach in patients with advanced or metastatic cutaneous melanoma, the evidence of their clinical use for MM is still limited. This systematic review aims to summarize the efficacy and safety of ICIs in advanced or metastatic MM. Methods: We searched electronic databases, conference abstracts, clinical trial registers and reference lists for relevant studies. The primary outcomes included the overall response rate (ORR), median progression-free survival (PFS), median overall survival (OS), one-year PFS rate, and one-year OS rate. Results: This review identified 13 studies assessing anti-CTLA-4 monotherapy, 22 studies assessing anti-PD-1 monotherapy, two studies assessing anti-CTLA-4 and anti-PD-1 combination therapy, one study assessing anti-PD-1 antibodies combined with axitinib, and three studies assessing anti-PD-1 antibodies combined with radiotherapy. For most patients who received ipilimumab monotherapy, the ORR ranged from 0% to 17%, the median PFS was less than 5 months, and the median OS was less than 10 months. For patients who received nivolumab or pembrolizumab monotherapy, most studies showed an ORR of more than 15% and a median OS of more than 11 months. The combined administration of anti-CTLA-4 and anti-PD-1 agents showed benefits over single-agent therapy with an ORR of more than 33.3%. In a phase Ib trial of toripalimab in combination with axitinib, approximately half of patients had complete or partial responses. Three retrospective studies that investigated anti-PD-1 antibodies combined with radiotherapy showed an ORR of more than 50%, which was higher than each single modality treatment. Conclusions: Immune checkpoint inhibitors, especially anti-PD-1 monoclonal antibodies alone and in combination with anti-CTLA-4 monoclonal antibodies or other modalities, are promising treatment options for advanced or metastatic MM. However, high-level evidence is still needed to support the clinical application.

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Section: Resultsmentioning

confidence: 99%

Section: Anti-ctla-4 Monoclonal Antibodiesmentioning

confidence: 99%

Immune checkpoint inhibitors in advanced or metastatic mucosal melanoma: a systematic review

Kan

Zhao

et al. 2020

Ther Adv Med Oncol

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“…Since 2013, 12 studies with 6-76 patients with MM treated with ipilimumab were reported (Table 2). [70][71][72][73][74][75][76][77][78][79][80][81] As for prospective trials, a pooled analysis of CheckMate 067 and CheckMate 069 trials including 36 MM patients demonstrated a poor ORR of 8.3% and a median PFS of 2.7 months. 76 Another multi-center, single-arm phase II prospective study conducted in Germany reported an ORR of 17% and a median OS of 9.6 months with 1-year OS rate of 14% in 6 patients with MM.…”

Section: Anti-ctla-4 Antibodymentioning

confidence: 99%

Immune checkpoint inhibitor‐based therapy for advanced acral and mucosal melanoma

Mori

Izumi

Doi

et al. 2022

Experimental Dermatology

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The advent of immune checkpoint inhibitors (ICIs) including anti-PD-1 (pembrolizumab and nivolumab) and anti-CTLA-4 (ipilimumab) antibodies drastically changed treatment modalities for patients with various kinds of cancers, including lung cancer, 1 breast cancer, 2 oesophageal cancer, 3 urothelial cancer, 4 cervical cancer, 5 endometrial cancer, 6 renal cell carcinoma, 7,8 head and neck cancer, 9 Hodgkin lymphoma, 10 high microsatellite instability/ mismatch repair-deficient cancer, 11,12 tumour mutational burden (TMB)-high solid cancer, 13 and melanoma, 14,15 in advanced and/or adjuvant stage. ICIs are commonly used for treating advanced cutaneous melanoma (CM). In the phase III KEYNOTE-006 clinical trial, pembrolizumab resulted in an objective response rate (ORR) of 42% and a longer overall survival (OS) than ipilimumab (median OS: 32.7 months vs. 15.9 months; p < 0.001). 16 Likewise, the randomized phase III CheckMate-067 clinical trial demonstrated that nivolumab plus ipilimumab resulted in a better ORR and prolonged survival than nivolumab alone (ORR, 58% vs. 45%; median progression-free survival (PFS), 11.5 months vs. 6.9 months; median OS, not reached vs. 36.9 months). 17 Moreover, the 5-year OS has improved from <10% in patients with advanced stage CM treated with conventional chemotherapy, such as dacarbazine, to 30%-50%, especially in patients treated with anti-PD-1 antibody alone or in combination with ipilimumab. 16,18,19 CM is predominantly manifested in the sun-exposed skin of the Caucasian population. 20 However, melanomas rarely

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“…Because of this success ipilimumab has been tested in patients with UM. In a retrospective analysis of 11 patients with mucosal melanoma and 20 with UM, the median OS after ipilimumab treatment was found to be 5 [131]. The efficacy and tolerability of ipilimumab was also assessed retrospectively in an Australian clinical setting with 104 melanoma patients who were followed over a median period of 7 months [132].…”

Section: (B) Cancer Immunotherapymentioning

confidence: 99%

“…In a retrospective analysis of 11 patients with mucosal melanoma and 20 with UM, the median OS after ipilimumab treatment was found to be five months in the UM group (95% CI 1–17 months). This study suggested that ipilimumab may have benefits as a first/second line treatment over alternate treatments (median OS of 12.3 months; 95% CI 3.8–20.8 months for ipilimumab, compared to 3.3 months; 95% CI 0–8.4 months for other treatments) [129]. The efficacy and tolerability of ipilimumab was also assessed retrospectively in an Australian clinical setting with 104 melanoma patients who were followed over a median period of seven months [130].…”

Section: Evaluation Of Drug Treatments For Primary and Metastatic Ummentioning

confidence: 99%

Development of new therapeutic options for the treatment of uveal melanoma

et al. 2021

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Uveal melanoma (UM) is the most common primary intraocular malignancy in adults. Important cytogenetic and genetic risk factors for the development of UM include chromosome 3 monosomy, mutations in the guanine nucleotide-binding proteins GNAQ/GNA11, and loss of the BRACA1-associated protein 1 (BAP 1). Most primary UMs are treated conservatively with radiotherapy, but enucleation is necessary for large tumours. Despite the effectiveness of local control, up to 50% of UM patients develop metastasis for which there are no effective therapies.Attempts to utilize the targeted therapies that have been developed for the treatment of other cancers, including a range of signal transduction pathway inhibitors, have rarely produced significant outcomes in UM. Similarly, the application of immunotherapies that are effective in cutaneous melanoma to treat UM have also been disappointing. Other approaches that have been initiated involve proteasomal inhibitors and histone deacetylase inhibitors that are approved for the treatment of other cancers. Nevertheless, there have been occasional positive outcomes from these treatments in UM. Moreover, combination approaches in UM have also yielded some positive developments. It would be valuable to identify how to apply such therapies efficiently in UM, potentially via individualized tumour profiling. It would also be important to characterize UM tumours to differentiate the potential drivers of progression from those in other types of cancers.The recent identification of novel kinases and metastatic genes in UM tumours makes the development of new UM-specific treatments feasible. Accepted ArticleThis article is protected by copyright. All rights reserved A) Uveal Melanoma: Background and risk factors Uveal melanoma (UM) is the most common primary intraocular malignancy in adults and represents ~5 % of melanoma diagnoses in the US annually [1-3]. UM originates from ocular melanocytes with 85% of cases arising from the choroid region and the remainder from the ciliary body and iris [4]. The prognosis in UM is poor, in particular because around 50% of patients develop metastatic disease. Hepatic metastases occur in up to 90% of individuals, followed by metastases in lung and bones, and after establishment of metastatic disease the median survival time is only 4-5 months [5]. At the time of diagnosis, systemic metastases are reported in only 3%of patients, but it is likely that micro-metastases have already developed in many cases [6,7].Currently there are no effective systemic drug therapies for primary or metastatic UM [8,9].The median age at diagnosis is 62 years and the incidence of UM in males and females, and whether there is right or left eye involvement, is similar [10]. Underlying risk factors for UM include melanocytosis, melanocytoma, neurofibromatosis and the presence of atypical nevi [11][12][13][14]. Race is also a significant risk factor with a 150-fold greater incidence in fair-skinned over dark-skinned populations [15]. The incidence of UM in European countries varies wi...

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Prognostic factors for survival in patients with mucosal and ocular melanoma treated with ipilimumab: Turkish Oncology Group study

Cited by 9 publications

References 27 publications

Immune checkpoint inhibitors in advanced or metastatic mucosal melanoma: a systematic review

Immune checkpoint inhibitors in advanced or metastatic mucosal melanoma: a systematic review

Immune checkpoint inhibitor‐based therapy for advanced acral and mucosal melanoma

Development of new therapeutic options for the treatment of uveal melanoma

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