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- W2912594541 abstract "Introduction Severe acute graft-versus-host disease (aGVHD) is characterized by an imbalance of circulating tissue repair factors, with elevated amphiregulin (AREG) and very low ( Patients and Methods Twenty-six patients received hCG/EGF in addition to standard aGVHD therapy (13 with Minnesota high risk aGVHD and 13 receiving 2nd line therapy). In both cohorts, patients with a complete or partial response (CR/PR) at the end of the initial dosing period were eligible to receive maintenance hCG/EGF SQ twice weekly for up to 5 weeks. Initial hCG dosing was at 500 units hCG/m2 SQ, escalating to 2,000 units hCG/m2 in cohorts of 2, with dose assignment by the continual reassessment method. We analyzed GVHD-associated plasma biomarkers during therapy. Results HCG/EGF was well tolerated, with no dose-limiting toxicities. At day 28 of study, responses for initial therapy were 8/13 CR (62%), 0/13 PR (0%), and 5/13 NR (38%), higher than institutional historical (n=269) 26% CR, 16% PR, 57% NR (Figure 1A). Responses for 2nd line therapy were 7/13 CR (54%), 1/13 PR (8%), 5/13 NR (38%), 4 of which were deaths (31%), improved relative to historical outcomes (n=85) of 18% CR, 19% PR, 63% NR (including 16% deaths, Figure 1A). In initial therapy patients, plasma EGF rose from baseline 3 pg/ml to 25.4 pg/ml at 6 hours post-hCG/EGF dose (p=0.02), while in 2nd line patients, plasma EGF never rose from baseline 5 pg/ml. Patients with a day 28 CR/PR had a 4.6-fold reduction in plasma AREG over time (Figure 1B). Conclusions HCG/EGF is a novel adjunct therapy in life-threatening aGVHD. The mechanisms of benefit may include facilitation of tissue repair with detectable increases in circulating EGF. The optimal dose and duration of hCG/EGF are under investigation, with ongoing dose escalation in patients with steroid-refractory aGVHD based upon these results. Decreasing plasma AREG may reflect successful treatment of severe aGVHD." @default.
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- W2912594541 date "2019-03-01" @default.
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- W2912594541 title "Facilitating Resolution of Life-Threatening Acute Graft-Versus-Host Disease By Supplementation of Human Chorionic Gonadotropin and Epidermal Growth Factor (Pregnyl®): A Phase I Study" @default.
- W2912594541 doi "https://doi.org/10.1016/j.bbmt.2018.12.236" @default.
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