Jack Rostas1, Alda Tam2, Takami Sato3, Larry Kelly4, Cliff Tatum4, Charles Scoggins1, Kelly McMasters1, Robert C G Martin5. 1. Division of Surgical Oncology, Department of General Surgery, University of Louisville, 315 E. Broadway M10 Rm #312, Louisville, KY, 40202, USA. 2. Department of Radiology, MD Anderson Cancer Center, Houston, TX, USA. 3. Department of Medical Oncology, Thomas Jefferson University Hospital, Philadelphia, PA, USA. 4. Department of Radiology and Interventional Radiology, Norton Healthcare, Louisville, KY, USA. 5. Division of Surgical Oncology, Department of General Surgery, University of Louisville, 315 E. Broadway M10 Rm #312, Louisville, KY, 40202, USA. Robert.martin@louisville.edu.
Abstract
PURPOSE: Hepatic metastasis from melanoma represents a therapeutic dilemma, with limited effective options for the 85% of cases deemed unresectable. Systemic agents confer toxicity and, along with traditional local hepatic arterial-directed therapies such as transarterial chemoembolization, have not led to a significant increase in survival. The aim of this study was to investigate the safety and dose-limiting toxicity of DEBDOX for the treatment of unresectable hepatic metastases from melanoma. METHODS: A multicenter (University of Louisville, Thomas Jefferson University, MD Anderson Cancer Center), prospective, non-controlled treatment trial (NCT01010984) of hepatic-directed therapy with DEBDOX for the treatment of melanoma liver metastasis was reviewed. Primary endpoints were response rates by modified response evaluation criteria in solid tumors, hepatic progression-free survival (PFS), and overall survival (OS). RESULTS: Twenty patients received a total of 61 DEBDOX treatments from January 2010 to March 2013. The median hepatic tumor burden was 40% (range 20-55), 18 patients (90%) had bilobar disease, and 13 patients (65%) had concomitant extrahepatic disease. At median assessment of 2.5 months, 11 patients (55%) exhibited a tumor response and 16 (80%) exhibited disease control. Median follow-up was 5 months (range 1.1-34.3 months). Median hepatic PFS was 3 months (95% CI 1.4, 3.4), and OS was 5 months (95% CI 3.3, 10.5). CONCLUSIONS: Directed arterial therapy with DEBDOX is effective in managing unresectable liver-dominant metastasis from melanoma and should be considered a therapeutic option in the multidisciplinary treatment of this disease. Concurrent systemic therapy is merited given the high rate of extrahepatic progression. CLINICAL TRIAL: NCT01010984.
PURPOSE: Hepatic metastasis from melanoma represents a therapeutic dilemma, with limited effective options for the 85% of cases deemed unresectable. Systemic agents confer toxicity and, along with traditional local hepatic arterial-directed therapies such as transarterial chemoembolization, have not led to a significant increase in survival. The aim of this study was to investigate the safety and dose-limiting toxicity of DEBDOX for the treatment of unresectable hepatic metastases from melanoma. METHODS: A multicenter (University of Louisville, Thomas Jefferson University, MD Anderson Cancer Center), prospective, non-controlled treatment trial (NCT01010984) of hepatic-directed therapy with DEBDOX for the treatment of melanoma liver metastasis was reviewed. Primary endpoints were response rates by modified response evaluation criteria in solid tumors, hepatic progression-free survival (PFS), and overall survival (OS). RESULTS: Twenty patients received a total of 61 DEBDOX treatments from January 2010 to March 2013. The median hepatic tumor burden was 40% (range 20-55), 18 patients (90%) had bilobar disease, and 13 patients (65%) had concomitant extrahepatic disease. At median assessment of 2.5 months, 11 patients (55%) exhibited a tumor response and 16 (80%) exhibited disease control. Median follow-up was 5 months (range 1.1-34.3 months). Median hepatic PFS was 3 months (95% CI 1.4, 3.4), and OS was 5 months (95% CI 3.3, 10.5). CONCLUSIONS: Directed arterial therapy with DEBDOX is effective in managing unresectable liver-dominant metastasis from melanoma and should be considered a therapeutic option in the multidisciplinary treatment of this disease. Concurrent systemic therapy is merited given the high rate of extrahepatic progression. CLINICAL TRIAL: NCT01010984.
Authors: Michal Mauda-Havakuk; Michael T Kassin; Andrew S Mikhail; Juan A Esparza-Trujillo; Ivane Bakhutashvili; David L Woods; Paul G Wakim; Matthew F Starost; John W Karanian; Bradford J Wood; William F Pritchard Journal: J Vasc Interv Radiol Date: 2021-11-17 Impact factor: 3.464
Authors: Rino S Seedor; David J Eschelman; Carin F Gonsalves; Robert D Adamo; Marlana Orloff; Anjum Amjad; Erin Sharpe-Mills; Inna Chervoneva; Carol L Shields; Jerry A Shields; Michael J Mastrangelo; Takami Sato Journal: Cancers (Basel) Date: 2020-01-01 Impact factor: 6.639