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

Oncotarget. 2016 Nov 15;7(46):76118-76124. doi: 10.18632/oncotarget.12660.

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.

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

MeSH terms

  • Age Factors
  • Aged
  • Aged, 80 and over
  • Anilides / administration & dosage
  • Anilides / adverse effects
  • Anilides / therapeutic use*
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Carcinoma, Basal Cell / drug therapy*
  • Carcinoma, Basal Cell / metabolism
  • Carcinoma, Basal Cell / pathology*
  • Carcinoma, Basal Cell / therapy
  • Combined Modality Therapy
  • Female
  • Hedgehog Proteins / metabolism
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Pyridines / administration & dosage
  • Pyridines / adverse effects
  • Pyridines / therapeutic use*
  • Signal Transduction / drug effects
  • Skin Neoplasms / drug therapy
  • Skin Neoplasms / metabolism
  • Skin Neoplasms / pathology
  • Treatment Outcome

Substances

  • Anilides
  • Antineoplastic Agents
  • Hedgehog Proteins
  • HhAntag691
  • Pyridines