Rostas Jack, Tam Alda, Sato Takami, Kelly Larry, Tatum Cliff, Scoggins Charles, McMasters Kelly, Martin Robert C G
Division of Surgical Oncology, Department of General Surgery, University of Louisville, 315 E. Broadway M10 Rm #312, Louisville, KY, 40202, USA.
Department of Radiology, MD Anderson Cancer Center, Houston, TX, USA.
Cardiovasc Intervent Radiol. 2017 Sep;40(9):1392-1400. doi: 10.1007/s00270-017-1651-z. Epub 2017 May 15.
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.
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).
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).
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.
NCT01010984.
黑色素瘤肝转移是一个治疗难题，对于85%被认为无法切除的病例，有效的治疗选择有限。全身用药会带来毒性，并且与传统的局部肝动脉导向治疗（如经动脉化疗栓塞）一样，并未显著提高生存率。本研究的目的是调查DEBDOX治疗无法切除的黑色素瘤肝转移的安全性和剂量限制性毒性。
回顾了一项多中心（路易斯维尔大学、托马斯·杰斐逊大学、MD安德森癌症中心）、前瞻性、非对照治疗试验（NCT01010984），该试验采用DEBDOX进行肝导向治疗黑色素瘤肝转移。主要终点是根据实体瘤改良反应评估标准的反应率、肝无进展生存期（PFS）和总生存期（OS）。
2010年1月至2013年3月，20例患者共接受了61次DEBDOX治疗。肝肿瘤负担中位数为40%（范围20 - 55），18例患者（90%）有双侧病变，13例患者（65%）有肝外伴随病变。在中位评估时间2.5个月时，11例患者（55%）出现肿瘤反应，16例患者（80%）疾病得到控制。中位随访时间为5个月（范围1.1 - 34.3个月）。肝PFS中位数为3个月（95%CI 1.4，3.4），OS为5个月（95%CI 3.3，10.5）。
DEBDOX直接动脉治疗对处理无法切除的以肝脏为主的黑色素瘤转移有效，应被视为该疾病多学科治疗的一种选择。鉴于肝外进展率高，同时进行全身治疗是值得的。
NCT01010984
