The purpose of this study was to evaluate the efficacy of image-guided delivery of locoregional chemotherapy to breast cancer hepatic metastases using doxorubicin-loaded drug-eluting beads (DEBDOX). An IRB-approved multi-center, prospective, open, non-controlled repeat treatment registry to investigate the safety and efficacy of doxorubicin microspheres in the treatment of patients with unresectable liver metastasis from breast cancer was reviewed. Statistical analysis was performed with differences of P < 0.05 considered significant. About 40 patients with metastatic breast cancer (MBC) to the liver underwent a total of 75 image-guided procedures with hepatic arterial drug-eluting beads loaded with doxorubicin (DEBDOX). Treatment was well tolerated with a total of eight patients sustaining 13 adverse events within the 30 days of each treatment session. All adverse events were either a grade I or grade II in toxicity. After a median follow-up of 12 months in all patients, the hepatic progression-free survival was a median of 26 months and overall survival was a median of 47 months. The treatment of hepatic metastasis from MBC using DEBDOX is an effective local therapy with very high response rates and a very safe toxicity profile. In comparison to chemotherapy alone, consideration of hepatic-directed therapy is warranted in patients with liver-dominant metastatic disease.
Hepatocellular carcinoma (HCC) is a challenging malignancy as a result of the advanced course at presentation. Recent interventional advances have improved treatment of lesions unamenable to resection using drug-eluting microbeads delivered into the hepatic circulation. We hypothesize that the use of hepatic arterial therapy (HAT) will safely identify appropriate patients who can proceed to ablation and/or transplantation. We evaluated our open-label, multicenter, multinational, single-arm study including 240 patients with intermediate-staged HCC who received drug-eluting beads and were not initial candidates for transplantation or resection. We reviewed the resulting clinical data to determine factors leading to possible ablation or transplant. Of 240 patients undergoing HAT, 14 (5.8%) received ablation or transplant. We compared those receiving ablation or transplant with those receiving only HAT. Groups were similar regarding sex, age, median number of tumors (one; range, 1 to 25), Child's score, tobacco and alcohol abuse, and treatment type. Patients who were downstaged were more likely to have: hepatitis-related tumors (76 to 66%, P = 0.02), distinct lesions on imaging (92 to 76%, P = 0.004), and less than 25 per cent parenchymal involvement (84 to 59%, P = 0.0001). These patients typically had one tumor frequently in the left lobe (58.8 vs 30.9%, P = 0.0001), accessible through segmental arteries (47 vs 17%, P = 0.001), with increased segmental branch occlusion (57 vs 39%, P = 0.02). HAT should be considered a potential bridging therapy to eventual ablation or transplant in the multimodal treatment of HCC.
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