Oncotarget

Research Papers:

Safety and efficacy of vismodegib in patients aged ≥65 years with advanced basal cell carcinoma

Anne Lynn S. Chang _, Karl D. Lewis, Sarah T. Arron, Michael R. Migden, James A. Solomon, Simon Yoo, Bann-Mo Day, Edward F. McKenna and Aleksandar Sekulic

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Oncotarget. 2016; 7:76118-76124. https://doi.org/10.18632/oncotarget.12660

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Abstract

Anne Lynn S. Chang1, Karl D. Lewis2, Sarah T. Arron3, Michael R. Migden4, James A. Solomon5,6,7, Simon Yoo8, Bann-Mo Day9, Edward F. McKenna9, Aleksandar Sekulic10

1Stanford University, Redwood City, CA, USA

2University of Colorado, Aurora, CO, USA

3University of California, San Francisco, San Francisco, CA, USA

4The University of Texas MD Anderson Cancer Center, Houston, TX, USA

5Ameriderm Research, Ormond Beach, FL, USA

6University of Central Florida, Orlando, FL, USA

7University of Illinois, Urbana, IL, USA

8Northwestern University, Chicago, IL, USA

9Genentech, Inc., South San Francisco, CA, USA

10Mayo Clinic, Scottsdale, AZ, USA

Correspondence to:

Karl D. Lewis, email: Karl.Lewis@ucdenver.edu

Keywords: basal cell carcinoma, vismodegib, age, Hedgehog pathway inhibitor, locally advanced basal cell carcinoma

Received: March 21, 2016    Accepted: September 24, 2016    Published: October 14, 2016

ABSTRACT

Because many patients with unresectable basal cell carcinoma (BCC) are aged ≥65 years, this study explores the efficacy and safety of vismodegib in these patients with locally advanced (la) or metastatic (m) basal cell carcinoma (BCC) in the ERIVANCE BCC trial and the expanded access study (EAS).We compared patients aged ≥65 years to patients aged <65 years taking vismodegib 150 mg/day, using descriptive statistics for response and safety. Patients aged ≥65 years (laBCC/mBCC) were enrolled in ERIVANCE BCC (33/14) and EAS (27/26). Investigator-assessed best overall response rate in patients ≥65 and <65 years was 46.7%/35.7% and 72.7%/52.6% (laBCC/mBCC), respectively, in ERIVANCE BCC and 45.8%/33.3% and 46.9%/28.6%, respectively, in EAS. These differences were not clinically meaningful. Safety was similar in both groups, although those aged ≥65 years had a higher percentage of grade 3-5 adverse events than those aged <65 years. Vismodegib demonstrated similar clinical activity and adverse events regardless of age.


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