Abstract
Immunoembolization (IE) is an effective treatment for uveal melanoma (UM) hepatic metastases [1]. The purpose of this study is to determine the efficacy and safety of IE combined with systemic Ipilimumab (Ipi). IRB approval was obtained for this single institution, retrospective review of 27 patients (mean 59 years [range 31–78]; 14 men) with <20% tumor burden from UM liver metastases who underwent initial IE between 9/2012 and 9/2015. Lobar IE was used as first-line liver-directed therapy and generally performed at 4 week intervals. Ipi was given at standard dosing and schedule. 2 patients completed 4 doses of Ipi immediately before IE treatments. The remaining 25 patients initiated Ipi treatment from 8 weeks before to 4 weeks after (median/mode <1 week before) the first IE. Best radiologic response (RECIST) for metastases was determined using CT and MRI after every 2 IE treatments. Overall survival (OS) and progression-free survival of liver (PFS-L) and extrahepatic (PFS-S) metastases were evaluated with Kaplan-Meier analysis. CTCAE v4.0 was used to assess toxicity. Median OS from first IE was 20.1 months (range 2.5-71.0); (95% CI, 14.9-26.0). 3-year survival was 26%; these 7 patients remain alive 42–71 months (median 46) after initial IE. Median PFS-L was 4.0 months (range 1.5-47.2); (95% CI, 2.7-7.6). 9 patients had pre-existing extrahepatic metastases on baseline imaging, and 16/18 developed extrahepatic disease. Median PFS-S in patients without pre-existing extrahepatic metastases was 9.3 months (range 0.5-25.4); (95% CI 5.8-18.3). No patient had regression of extrahepatic metastases. Most common toxicities included diarrhea ≥G2 (4/27, 14.8%), rash/pruritus ≥G2 (4/27, 14.8%), and hypothyroidism ≥G2 (4/27, 14.8%). Hepatic toxicity was observed in 4 patients: G1 (1/27, 3.7%), G2 (2/27, 7.4%) and G3 (2/27, 7.4%). No G4/G5 toxicity was seen. Combination treatment with IE and Ipi is a feasible approach for patients with metastatic UM. Patients experienced Ipi-related toxicities which were not previously seen with IE alone. However, no significant increase in serious immune-related hepatic toxicity was noted.
Published Version
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have