Biologic mesh spacer placement facilitates safe delivery of dose-intense radiation therapy: A novel treatment option for unresectable liver tumors.

INTRODUCTION: Patients with unresectable liver tumors who fail initial treatment modalities have a poor prognosis (<1 yr). Although effective, delivery of high dose radiation therapy to these tumors is limited by proximity of radiosensitive bowel. We have previously reported that placement of a biologic mesh spacer (BMS) can effectively displace the bowel allowing for dose-intense radiation to be delivered with low short-term toxicity. The purpose of this study was to assess and report the long-term safety and oncologic outcomes of this cohort.

METHODS: From 2012 to 2014 seven patients with unresectable hepatic malignancy (6 IHCC, 1 CRLM) underwent BMS (acellular human dermis) placement (2 open, 5 MIS) prior to radiation therapy. Prospective registry data were reviewed for tumor and treatment details, progression, metastasis and survival. RTOG guidelines were used to define radiation toxicities.

RESULTS: Mean patient age was 50.4 years (30-62 years) and 4 patients were male (57.1%). Prior to surgery, all patients had been treated for an average of 12.5 months with surgery, chemotherapy, radiation and/or TACE. After surgery, all patients recovered well and received a mean radiation dose of 76.1 Gy (58.1-100 Gy) over 13-25 fractions. 1 patient received SBRT; 4 fractions, 10 Gy each. Maximum dose delivered was 100 Gy (Biologic Equivalent Dose of 140 Gy, α/β = 10). Mean time to initiation of radiation therapy was 24 days (12-48 days) from surgery. No significant GI toxicity was recorded, and no GI bleeding or ulcers were observed. Mean follow-up after XRT was 18.2 months (5.5-31 months). Three patients had no loco-regional progression of disease. 2 patients had infield progression of liver disease and another had progressive lymphadenopathy. 3 patients developed pulmonary metastasis, at a mean time to distant failure of 3 months. There are 4 survivors over 2-years from surgery.

CONCLUSION: For patients with unresectable liver tumors, placement of a BMS enhances the safety and efficacy of high-dose radiotherapy, providing a survival benefit via delay in time to progression compared to traditional treatments with no significant short or long term GI toxicity.