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Single-center real-life experience with low-dose ipilimumab monotherapy in adjuvant setting for patients with stage III melanoma


Mangana, Joanna; Dimitriou, Florentia; Braun, Ralph; Ludwig, Sabine; Dummer, Reinhard; Barysch, Marjam J (2019). Single-center real-life experience with low-dose ipilimumab monotherapy in adjuvant setting for patients with stage III melanoma. Melanoma research:Epub ahead of print.

Abstract

Ipilimumab is approved for adjuvant melanoma treatment at a dose of 10 mg/kg, but its use is limited owing to high toxicity and treatment-associated costs. We retrospectively analyzed 29 patients who underwent complete resection of stage IIC–III melanoma and were treated with ipilimumab 3 mg/kg in an adjuvant setting. The aim was to assess development of adverse events (primary endpoint) and to evaluate survival outcomes (secondary endpoint) under adjuvant treatment with ipilimumab in a real-life setting. Immune-related adverse events (irAE) of all grades were reported in 72.4% of patients, grade 3 in 5.3% (n=2), and none for grade 4 or 5. Immune-related hypophysitis resolved in 3/8 (37.5%) and immune-related thyroiditis in 7/10 (70%) cases, whereas the others remained on substitution drugs. The rest irAEs affected the gut (n=8), skin (n=5), liver (n=2), and uvea (n=2) and resolved completely. Only one patient required tumor necrosis factor-α owing to grade 3 colitis. Hospitalization was required in five cases owing to irAE (four colitis and one hypophysitis). At a median follow-up of 9.7 (1.7–16.8) months, 65.5% of the patients were free of disease. Median progression-free survival was 15.1 months, and median overall survival was not reached yet. Ipilimumab 3 mg/kg for the adjuvant treatment of high-risk patients with fully resected melanoma favors a better safety profile compared with the approved dose of 10 mg/kg in the same setting. Although its limited application owing lately promising data of antiprogrammed cell death protein-1 treatment, it may be considered as additional option or second-line treatment after fully resected disease recurrence under antiprogrammed cell death protein-1 treatment.

Abstract

Ipilimumab is approved for adjuvant melanoma treatment at a dose of 10 mg/kg, but its use is limited owing to high toxicity and treatment-associated costs. We retrospectively analyzed 29 patients who underwent complete resection of stage IIC–III melanoma and were treated with ipilimumab 3 mg/kg in an adjuvant setting. The aim was to assess development of adverse events (primary endpoint) and to evaluate survival outcomes (secondary endpoint) under adjuvant treatment with ipilimumab in a real-life setting. Immune-related adverse events (irAE) of all grades were reported in 72.4% of patients, grade 3 in 5.3% (n=2), and none for grade 4 or 5. Immune-related hypophysitis resolved in 3/8 (37.5%) and immune-related thyroiditis in 7/10 (70%) cases, whereas the others remained on substitution drugs. The rest irAEs affected the gut (n=8), skin (n=5), liver (n=2), and uvea (n=2) and resolved completely. Only one patient required tumor necrosis factor-α owing to grade 3 colitis. Hospitalization was required in five cases owing to irAE (four colitis and one hypophysitis). At a median follow-up of 9.7 (1.7–16.8) months, 65.5% of the patients were free of disease. Median progression-free survival was 15.1 months, and median overall survival was not reached yet. Ipilimumab 3 mg/kg for the adjuvant treatment of high-risk patients with fully resected melanoma favors a better safety profile compared with the approved dose of 10 mg/kg in the same setting. Although its limited application owing lately promising data of antiprogrammed cell death protein-1 treatment, it may be considered as additional option or second-line treatment after fully resected disease recurrence under antiprogrammed cell death protein-1 treatment.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Dermatology Clinic
Dewey Decimal Classification:610 Medicine & health
Uncontrolled Keywords:Cancer Research, Oncology, Dermatology
Language:English
Date:1 March 2019
Deposited On:21 Aug 2019 11:25
Last Modified:25 Sep 2019 00:42
Publisher:Lippincott Williams & Wilkins
ISSN:0960-8931
OA Status:Closed
Publisher DOI:https://doi.org/10.1097/cmr.0000000000000593

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