![]() In this pilot study, we show that preoperative treatment with ipilimumab alone or in combination with cryoablation is feasible and safe in early-stage breast cancer. ![]() ©2016 AACR.īecause most breast cancers may not exhibit inherent immunogenicity, and clinical responses to immune checkpoint blockade may be limited to more immunologically active or inflamed tumors, a strategy that combines physical tumor disruption as a means of enhancing antigen presentation with checkpoint blockade may overcome relative resistance to immunotherapy. Potentially favorable intratumoral and systemic immunologic effects were observed with the combination, suggesting the possibility for induced and synergistic antitumor immunity with this strategy. Combination therapy was associated with sustained peripheral elevations in: Th1-type cytokines, activated (ICOS +) and proliferating (Ki67 +) CD4 + and CD8 + T cells, and posttreatment proliferative T-effector cells relative to T-regulatory cells within tumor.Ĭonclusions: Preoperative cryoablation and single-dose ipilimumab are safe alone or in combination with no surgical delays incurred. Grade III toxicity was seen in 1 of 19 (unrelated rash after ipilimumab). Results: Preoperative cryoablation and/or ipilimumab were safe and tolerable, with no delays in pre-planned surgery. Exploratory studies of immune activation were performed on peripheral blood and tumor. The primary outcome for this pilot study was safety/tolerability as defined as freedom from delays in pre-planned, curative-intent mastectomy. ![]() Purpose: To assess the safety and tolerability of preoperative cryoablation-mediated tumor antigen presentation and/or ipilimumab-mediated immune modulation in women with operable breast cancer.Įxperimental Design: In this pilot study, 19 women with breast cancer for whom mastectomy was planned were treated with preoperative tumor cryoablation ( n = 7), single-dose ipilimumab at 10 mg/kg ( n = 6), or both ( n = 6).
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