Jack W Rostas1, Alda L Tam2, Takami Sato3, Charles R Scoggins1, Kelly M McMasters1, Robert C G Martin4. 1. University of Louisville, Department of General Surgery, Division of Surgical Oncology, Louisville, KY, USA. 2. Department of Interventional Radiology, University of Texas, MD Anderson Cancer Center, Houston, TX, USA. 3. Department of Medical Oncology, Thomas Jefferson University Hospital, Philadelphia, PA, USA. 4. University of Louisville, Department of General Surgery, Division of Surgical Oncology, Louisville, KY, USA. Electronic address: Robert.martin@louisville.edu.
Abstract
BACKGROUND: We have previously reported favorable response and survival rates using drug-eluting beads loaded with doxorubicin (DEBDOX) for unresectable hepatic metastases. This study investigates the quality of life (QoL) impact of DEBDOX for the treatment of unresectable hepatic metastases from melanoma. METHODS: A multi-center, prospective, non-controlled clinical trial was reviewed. QoL was assessed at baseline and after each treatment, and doxorubicin-specific effects were assessed after each treatment. RESULTS: Twenty patients received 61 DEBDOX treatments. After each treatment, at least 83% of patients reported "little" to "none" doxorubicin-related symptoms. For the 8 FACT-Hep subscales, QoL scores were unchanged through 3 treatments for 18 of 24 total time points by ANOVA, with a small-to-moderate ES change through the last treatment in 36 of 40 time points. CONCLUSIONS: Hepatic arterial therapy with DEBDOX is safe with minimal QOL changes in treating unresectable liver-dominant melanoma metastasis. CLINICAL TRIAL: NCT01010984.
BACKGROUND: We have previously reported favorable response and survival rates using drug-eluting beads loaded with doxorubicin (DEBDOX) for unresectable hepatic metastases. This study investigates the quality of life (QoL) impact of DEBDOX for the treatment of unresectable hepatic metastases from melanoma. METHODS: A multi-center, prospective, non-controlled clinical trial was reviewed. QoL was assessed at baseline and after each treatment, and doxorubicin-specific effects were assessed after each treatment. RESULTS: Twenty patients received 61 DEBDOX treatments. After each treatment, at least 83% of patients reported "little" to "none" doxorubicin-related symptoms. For the 8 FACT-Hep subscales, QoL scores were unchanged through 3 treatments for 18 of 24 total time points by ANOVA, with a small-to-moderate ES change through the last treatment in 36 of 40 time points. CONCLUSIONS: Hepatic arterial therapy with DEBDOX is safe with minimal QOL changes in treating unresectable liver-dominant melanoma metastasis. CLINICAL TRIAL: NCT01010984.