Elevated rates of transaminitis during ipilimumab therapy for metastatic melanoma
| Autor: | Harleen K. Sidhu, Philip Friedlander, Rui Chang, Shaily Shah, Michael Pan, Marina Moskalenko, Serge Sicular, Yvonne M. Saenger, Sebastian Bernardo, Sara Harcharik |
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| Rok vydání: | 2013 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty Skin Neoplasms Ipilimumab Kaplan-Meier Estimate Dermatology Internal medicine medicine Humans Immunologic Factors Aspartate Aminotransferases Adverse effect Melanoma Retrospective Studies Hepatitis Chi-Square Distribution business.industry Antibodies Monoclonal Cancer Alanine Transaminase Common Terminology Criteria for Adverse Events Middle Aged medicine.disease Oncology Transaminitis Female Chemical and Drug Induced Liver Injury Skin cancer business medicine.drug |
| Zdroj: | Melanoma Research. 23:47-54 |
| ISSN: | 0960-8931 |
| DOI: | 10.1097/cmr.0b013e32835c7e68 |
| Popis: | Melanoma is the deadliest form of skin cancer. Ipilimumab, a novel immunotherapy, is the first treatment shown to improve survival in patients with metastatic melanoma in large randomized controlled studies. The most concerning side effects reported in clinical studies of ipilimumab fall into the category of immune-related adverse events, which include enterocolitis, dermatitis, thyroiditis, hepatitis, hypophysitis, uveitis, and others. During the course of routine clinical care at Mount Sinai Medical Center, frequent hepatotoxicity was noted when ipilimumab was administered at a dose of 3 mg/kg according to Food and Drug Administration (FDA) guidelines. To better characterize these adverse events, we conducted a retrospective review of the first 11 patients with metastatic melanoma treated with ipilimumab at the Mount Sinai Medical Center after FDA approval. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) elevation, as defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events, each occurred in six of 11 cases (≥grade 1), a notably higher frequency than could be expected on the basis of the FDA licensing study where elevations were reported in 0.8 and 1.5% of patients for AST and ALT, respectively. Grade 3 elevations in AST occurred in three of 11 patients as compared with 0% in the licensing trial. All cases of transaminitis resolved when ipilimumab was temporarily withheld without administration of immunosuppressive medication. During routine clinical care of late-stage melanoma patients with ipilimumab, physicians should monitor patients closely for hepatotoxicity and be aware that toxicity rates may differ across populations during ipilimumab therapy. |
| Databáze: | OpenAIRE |
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