Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC

    Authors

    A. Sekulic; M. R. Migden; K. Lewis; J. D. Hainsworth; J. A. Solomon; S. Yoo; S. T. Arron; P. A. Friedlander; E. Marmur; C. M. Rudin; A. L. S. Chang; L. Dirix; J. Hou; H. B. Yue; A. Hauschild;Erivance Bcc Investigators

    Comments

    Authors: contact us about adding a copy of your work at STARS@ucf.edu

    Abbreviated Journal Title

    J. Am. Acad. Dermatol.

    Keywords

    advanced basal cell carcinoma; ERIVANCE BCC study; Hedgehog pathway; inhibitor; locally advanced basal cell carcinoma; metastatic basal cell; carcinoma; vismodegib; HEDGEHOG-PATHWAY; INHIBITORS; MUTATIONS; Dermatology

    Abstract

    Background: Primary analysis from the pivotal ERIVANCE BCC study resulted in approval of vismodegib, a Hedgehog pathway inhibitor indicated for treatment of adults with metastatic or locally advanced basal cell carcinoma (BCC) that has recurred after surgery or for patients who are not candidates for surgery or radiation. Objective: An efficacy and safety analysis was conducted 12 months after primary analysis. Methods: This was a multinational, multicenter, nonrandomized, 2-cohort study in patients with measurable and histologically confirmed locally advanced or metastatic BCC taking oral vismodegib (150 mg/d). Primary outcome measure was objective response rate (complete and partial responses) assessed by independent review facility. Results: After 12 months of additional follow-up, median duration of exposure to vismodegib was 12.9 months. Objective response rate increased from 30.3% to 33.3% in patients with metastatic disease, and from 42.9% to 47.6% in patients with the locally advanced form. Median duration of response in patients with locally advanced BCC increased from 7.6 to 9.5 months. No new safety signals emerged with extended treatment duration. Limitations: Limitations include low prevalence of advanced BCC and challenges of designing a study with heterogenous manifestations. Conclusion: The 12-month update of the study confirms the efficacy and safety of vismodegib in management of advanced BCC.

    Journal Title

    Journal of the American Academy of Dermatology

    Volume

    72

    Issue/Number

    6

    Publication Date

    1-1-2015

    Document Type

    Article

    Language

    English

    First Page

    1021

    Last Page

    +

    WOS Identifier

    WOS:000354604200031

    ISSN

    0190-9622

    Share

    COinS