Local and disease control for nasal melanoma treated with radiation and concomitant anti‐programmed death 1 antibody

Hanaoka, Yuma; Tanemura, Atsushi; Takafuji, Madoka; Kiyohara, Eiji; Arase, Noriko; Сузукі, Осаму; Isohashi, Fumiaki; Ogawa, Kazuhiko; Fujimoto, Manabu

doi:10.1111/1346-8138.15256

Cited by 13 publications

(20 citation statements)

References 15 publications

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“…54,55 In this review, we identified three single-center, retrospective studies that investigated radiotherapy combined with anti-PD-1 antibody. [49][50][51] The ORRs of the multimodal therapy were more than 50%, which were much higher than each single modality treatment. In addition, no grade 3 or more AEs occurred in patients receiving multimodal therapy.…”

Section: Discussionmentioning

confidence: 95%

“…The local control rate of the primary lesion and regional lymph nodes was 100% with a median PFS of 7.4 months. 50 Another retrospective study reported the efficacy and safety of combined radiotherapy and anti-PD-1 monoclonal antibodies for MM. 51 Four of the seven patients with MM achieved CR and PR (ORR = 57.1%) and grade 3 or more severe AEs were not observed.…”

Section: Anti-pd-1 Monoclonal Antibodies Combined With Radiotherapymentioning

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: Discussionmentioning

confidence: 95%

Section: Anti-pd-1 Monoclonal Antibodies Combined With Radiotherapymentioning

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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“…To improve the lower clinical efficacy of PD1 in MCM, additional treatment options with PD1 should be explored; however, very few studies have examined PD1 in combination with other treatment modalities, and they have used small sample sizes. Four studies have tested the efficacy of PD1 plus radiotherapy, including a study recently reported by our group, 22 , 23 , 24 , 25 two studies have tested PD1 plus a vascular endothelial growth factor receptor (VEGFR) inhibitor, 26 , 27 and four studies explored the efficacy of PD1 + CTLA4. 6 , 16 , 17 , 28 , 29 …”

Section: Discussionmentioning

confidence: 99%

“… 22 Another retrospective study of 10 Japanese MCM patients that evaluated pembrolizumab plus radiotherapy showed an ILC rate of 100% and a median PFS of 7.4 months. 24 A retrospective study that evaluated the efficacy of PD1 plus radiotherapy in seven Japanese MCM patients noted an ORR of 57.1% and a 1-year PFS of 50%. 23 These studies mainly focused on ILC rate and did not include sufficient data regarding survival compared with PD1.…”

Section: Discussionmentioning

confidence: 99%

Anti-PD-1 antibody monotherapy versus anti-PD-1 plus anti-CTLA-4 combination therapy as first-line immunotherapy in unresectable or metastatic mucosal melanoma: a retrospective, multicenter study of 329 Japanese cases (JMAC study)

Nakamura

Namikawa²,

Yoshikawa

et al. 2021

ESMO Open

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Background Anti-programmed cell death protein 1 (PD-1) antibody monotherapy (PD1) has led to favorable responses in advanced non-acral cutaneous melanoma among Caucasian populations; however, recent studies suggest that this therapy has limited efficacy in mucosal melanoma (MCM). Thus, advanced MCM patients are candidates for PD1 plus anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) combination therapy (PD1 + CTLA4). Data on the efficacy of immunotherapy in MCM, however, are limited. We aimed to compare the efficacies of PD1 and PD1 + CTLA4 in Japanese advanced MCM patients. Patients and methods We retrospectively assessed advanced MCM patients treated with PD1 or PD1 + CTLA4 at 24 Japanese institutions. Patient baseline characteristics, clinical responses (RECIST), progression-free survival (PFS), and overall survival (OS) were estimated using Kaplan–Meier analysis, and toxicity was assessed to estimate the efficacy and safety of PD1 and PD1 + CTLA4. Results Altogether, 329 patients with advanced MCM were included in this study. PD1 and PD1 + CTLA4 were used in 263 and 66 patients, respectively. Baseline characteristics were similar between both treatment groups, except for age (median age 71 versus 65 years; P < 0.001). No significant differences were observed between the PD1 and PD1 + CTLA4 groups with respect to objective response rate (26% versus 29%; P = 0.26) or PFS and OS (median PFS 5.9 months versus 6.8 months; P = 0.55, median OS 20.4 months versus 20.1 months; P = 0.55). Cox multivariate survival analysis revealed that PD1 + CTLA4 did not prolong PFS and OS (PFS: hazard ratio 0.83, 95% confidence interval 0.58-1.19, P = 0.30; OS: HR 0.89, 95% confidence interval 0.57-1.38, P = 0.59). The rate of ≥grade 3 immune-related adverse events was higher in the PD1 + CTLA4 group than in the PD1 group (53% versus 17%; P < 0.001). Conclusions First-line PD1 + CTLA4 demonstrated comparable clinical efficacy to PD1 in Japanese MCM patients, but with a higher rate of immune-related adverse events.

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“…Due to the low incidence rate of disease and the limited number of published articles and clinical trials, this review has included all of the relevant articles and clinical trials available [10][11][12][13][14][15][16][17][18]. Because the radiotherapy methods and prognosis for patients with advanced brain metastases are poor, and there are relevant literature to systematically analyze studies on patients with brain metastases of melanoma [9,19], this meta-analysis does not include those studies.…”

Section: Study Selectionmentioning

confidence: 99%

Efficacy of radiotherapy combined with immune checkpoint inhibitors in patients with melanoma: a systemic review and meta-analysis

et al. 2022

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The purpose of this study is to review the efficacy of radiotherapy combined with immune checkpoint inhibitors (ICIs) in the treatment of melanoma and systematically evaluate the efficacy and safety of this combined treatment compared with ICIs alone. We searched a number of online databases up to 1 July 2021. Comprehensive Meta-Analysis 2.0 and RevMan 5.0 were used for summary analysis. The overall survival (OS), progression-free survival (PFS), overall response rate (ORR) and treatment adverse effects (AEs) were calculated. In total, 624 patients were included from 12 studies, including nine published studies and the results of three clinical trials. Radiotherapy combined with ICIs had a higher ORR compared with ICIs alone (35.00 vs. 20.39%). In terms of survival effect, radiotherapy combined with ICIs had no obvious advantage in OS. There was no statistically significant difference between 6-month and 12-month OS (P = 0.13; P = 0.69). There was no significant difference in PFS at 6 months (P = 0.08), but there was a significant difference in PFS at 12 months (P = 0.005). For patients with melanoma, radiotherapy combined with ICIs can improve the effective rate of treatment. Although there is no obvious OS advantage, it can improve PFS without serious adverse effects. Most of the studies included in this article are retrospective analyses, and there are few randomized controlled studies at present. Therefore, more prospective studies are still needed to explore the efficacy of radiotherapy combined with immunotherapy in melanoma.

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Local and disease control for nasal melanoma treated with radiation and concomitant anti‐programmed death 1 antibody

Cited by 13 publications

References 15 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

Anti-PD-1 antibody monotherapy versus anti-PD-1 plus anti-CTLA-4 combination therapy as first-line immunotherapy in unresectable or metastatic mucosal melanoma: a retrospective, multicenter study of 329 Japanese cases (JMAC study)

Efficacy of radiotherapy combined with immune checkpoint inhibitors in patients with melanoma: a systemic review and meta-analysis

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