Safety of Percutaneous Hepatic Perfusion with Melphalan in Patients with Unresectable Liver Metastases from Ocular Melanoma Using the Delcath Systems’ Second-Generation Hemofiltration System: A Prospective Non-randomized Phase II Trial
| Autor: | Eleonora M. de Leede, C.H. Martini, Alexander L. Vahrmeijer, Lioe-Fee de Geus-Oei, Marta Fiocco, T. Susanna Meijer, Ellen Kapiteijn, Rutger W. van der Meer, Mark C. Burgmans, Fred G.J. Tijl |
|---|---|
| Přispěvatelé: | Biomedical Photonic Imaging |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Melphalan
Adult Male medicine.medical_specialty medicine.medical_treatment Phases of clinical research Neutropenia Percutaneous hepatic perfusion Gastroenterology 030218 nuclear medicine & medical imaging 03 medical and health sciences 0302 clinical medicine Internal medicine Hemofiltration medicine Humans Radiology Nuclear Medicine and imaging Prospective Studies Clinical Investigation Antineoplastic Agents Alkylating Liver metastasis Melanoma Aged Leukopenia business.industry Eye Neoplasms Liver Neoplasms Common Terminology Criteria for Adverse Events Middle Aged medicine.disease Chemosaturation Chemotherapy Cancer Regional Perfusion Female medicine.symptom Cardiology and Cardiovascular Medicine business Febrile neutropenia medicine.drug |
| Zdroj: | CardioVascular and Interventional Radiology, 42(6), 841-852. Springer CardioVascular and Interventional Radiology, 42(6), 841-852 Cardiovascular and Interventional Radiology |
| ISSN: | 0174-1551 |
| Popis: | Purpose: To investigate the safety and toxicity of percutaneous hepatic perfusion with melphalan (M-PHP) with the Delcath Systems’ second-generation (GEN 2) filter and compare the outcomes with historical data from studies using the first-generation filter. Materials and Methods: A prospective, single-arm, single-center phase II study was carried out including 35 patients with unresectable, histologically confirmed liver metastases from ocular melanoma between February 2014 and June 2017. Main exclusion criteria were extrahepatic disease and age > 75 years. M-PHP was performed with melphalan 3 mg/kg (maximum dose 220 mg). Safety and toxicity were assessed according to the Common Terminology Criteria for Adverse Events version 4.03. Results: A total of 67 M-PHPs were performed in 35 patients (median 2 procedures). Although hematologic grade 3/4 events were seen in the majority of patients (thrombocytopenia 54.5%, leukopenia 75.6%, neutropenia 66.7%, anemia (only grade 3) 18.1%), these were all well manageable or self-limiting. Of the non-hematologic grade 3 events (n = 14), febrile neutropenia (n = 3), pulmonary emboli (n = 2) and post-procedural hemorrhage (n = 2) were most common. A case of sepsis with bacterial pharyngitis was the only non-hematologic grade 4 event. Prior therapy for liver metastases was found to be a predictor of late grade 3/4 neutropenia with an odds ratio of 5.5 (95% CI 1.4–21.7). Conclusions: M-PHP using the GEN 2 filter has an acceptable safety and toxicity profile, and seems to reduce hematologic toxicity when compared to M-PHP with a first-generation filter. Prior therapy of liver metastases is a possible predictive factor in developing grade 3/4 hematologic toxicity. |
| Databáze: | OpenAIRE |
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