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- W1965196707 abstract "8 . 1 Sint-Augustinus, Iridiumkankernetwerk, Antwerp, Belgium; 2 Background: The Hedgehog (Hh) signaling pathway is implicated in pathogenesis of BCC. While most BCCs are mostly surgically managed, rare BCCs can become locally advanced (laBCC) or metastatic (mBCC), leaving no effective therapeutic alternatives. Vismodegib (GDC-0449) is a first-in-class small-molecule inhibitor of Hh signaling. In a phase 1 trial, a 55% response rate was seen in 33 patients (pts) with advanced BCC, and treatment was generally well tolerated (Von Hoff, NEJM 2009), leading to this pivotal trial of vismodegib. Materials and Methods: This pivotal, multicenter, 2-cohort (laBCC and mBCC) nonrandomized study (NCT00833417; ERIVANCE BCC, SHH4476g; sponsored by Genentech; closed to enrollment). Pts with laBCC had histologically-confirmed BCC that was inoperable or for whom surgery would be significantly disfiguring. Pts with mBCC had histologically-confirmed RECIST-measurable disease. Pts received 150 mg oral vismodegib daily until disease progression. The primary endpoint is overall response rate (ORR) by independent review (IRF), using RECIST for mBCC and a composite endpoint for laBCC including improvements in tumor dimension and ulceration, pathologic clearance of BCC, and RECIST if applicable. Primary hypotheses tested are that ORR is significantly >20% for laBCC and >10% for mBCC. Secondary endpoints include duration of response, response per investigator (INV), and safety. Results: 104 pts (71 laBCC/33 mBCC) were enrolled at 31 sites in US, Europe and Australia. For laBCC, the IRF ORR was 43% (95% CI 31−56%; p 30% of pts were muscle spasms, alopecia, taste disturbance, weight loss and fatigue. Serious AEs were reported in 26 pts (25%); 4 patients (4%) experienced serious AEs considered related to vismodegib. Fatal AEs were reported in 7 pts (7%), none considered related to vismodegib. Duration of response, histopathology, and detailed safety will be presented. Conclusions: This pivotal study confirms the significant clinical benefit of vismodegib in both laBCC and mBCC, as measured by tumor response, and further characterizes the AE profile. These results demonstrate the potential role of vismodegib for the treatment of advanced BCC." @default.
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- W1965196707 date "2011-09-01" @default.
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- W1965196707 title "A Pivotal Multicenter Trial Evaluating Efficacy and Safety of the Hedgehog Pathway Inhibitor (HPI) Vismodegib in Patients With Advanced Basal Cell Carcinoma (BCC)" @default.
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- W1965196707 doi "https://doi.org/10.1016/s0959-8049(11)70096-x" @default.
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