title: Safety and efficacy of vismodegib in patients aged ≥65 years with advanced basal cell carcinoma.
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.
authors.affiliation: Stanford University, Redwood City, CA, USA.
authors.forename: Anne Lynn S
authors.initials: AL
authors.lastname: Chang
authors.affiliation: University of Colorado, Aurora, CO, USA.
authors.forename: Karl D
authors.initials: KD
authors.lastname: Lewis
authors.affiliation: University of California, San Francisco, San Francisco, CA, USA.
authors.forename: Sarah T
authors.initials: ST
authors.lastname: Arron
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Migden
authors.affiliation: Ameriderm Research, Ormond Beach, FL, USA.|University of Central Florida, Orlando, FL, USA.|University of Illinois, Urbana, IL, USA.
authors.forename: James A
authors.initials: JA
authors.lastname: Solomon
authors.affiliation: Northwestern University, Chicago, IL, USA.
authors.forename: Simon
authors.initials: S
authors.lastname: Yoo
authors.affiliation: Genentech, Inc., South San Francisco, CA, USA.
authors.forename: Bann-Mo
authors.initials: BM
authors.lastname: Day
authors.affiliation: Genentech, Inc., South San Francisco, CA, USA.
authors.forename: Edward F
authors.initials: EF
authors.lastname: McKenna
authors.affiliation: Mayo Clinic, Scottsdale, AZ, USA.
authors.forename: Aleksandar
authors.initials: A
authors.lastname: Sekulic
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000813:Anilides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002280:Basal Cell Carcinoma / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology* / Q000628:therapy; D003131:Combined Modality Therapy; D005260:Female; D053823:Hedgehog Proteins / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015398:Signal Transduction / Q000187:drug effects; D012878:Skin Neoplasms / Q000188:drug therapy / Q000378:metabolism / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D000813:Anilides; D000970:Antineoplastic Agents; D053823:Hedgehog Proteins; C538724:HhAntag691; D011725:Pyridines
keywords: age; basal cell carcinoma; locally advanced basal cell carcinoma; vismodegib; Hedgehog pathway inhibitor