Safety and efficacy of vismodegib in patients aged ≥65 years with advanced basal cell carcinoma
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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
Karl D. Lewis, email: [email protected]
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
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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