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, Aleksandar Sekulic

*Corresponding author for this work

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)76118-76124
Number of pages7
JournalOncotarget
Volume7
Issue number46
DOIs
StatePublished - Jan 1 2016

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Basal Cell Carcinoma
Safety
Compassionate Use Trials
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Keywords

  • Age
  • Basal cell carcinoma
  • Hedgehog pathway inhibitor
  • Locally advanced basal cell carcinoma
  • Vismodegib

ASJC Scopus subject areas

  • Oncology

Cite this

Chang, A. L. S., Lewis, K. D., Arron, S. T., Migden, M. R., Solomon, J. A., Yoo, S., ... Sekulic, A. (2016). Safety and efficacy of vismodegib in patients aged ≥65 years with advanced basal cell carcinoma. Oncotarget, 7(46), 76118-76124. https://doi.org/10.18632/oncotarget.12660
Chang, Anne Lynn S. ; Lewis, Karl D. ; Arron, Sarah T. ; Migden, Michael R. ; Solomon, James A. ; Yoo, Simon ; Day, Bann Mo ; McKenna, Edward F. ; Sekulic, Aleksandar. / Safety and efficacy of vismodegib in patients aged ≥65 years with advanced basal cell carcinoma. In: Oncotarget. 2016 ; Vol. 7, No. 46. pp. 76118-76124.
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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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Chang, ALS, Lewis, KD, Arron, ST, Migden, MR, Solomon, JA, Yoo, S, Day, BM, McKenna, EF & Sekulic, A 2016, 'Safety and efficacy of vismodegib in patients aged ≥65 years with advanced basal cell carcinoma', Oncotarget, vol. 7, no. 46, pp. 76118-76124. https://doi.org/10.18632/oncotarget.12660

Safety and efficacy of vismodegib in patients aged ≥65 years with advanced basal cell carcinoma. / Chang, Anne Lynn S.; Lewis, Karl D.; Arron, Sarah T.; Migden, Michael R.; Solomon, James A.; Yoo, Simon; Day, Bann Mo; McKenna, Edward F.; Sekulic, Aleksandar.

In: Oncotarget, Vol. 7, No. 46, 01.01.2016, p. 76118-76124.

Research output: Contribution to journalArticle

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AU - Chang, Anne Lynn S.

AU - Lewis, Karl D.

AU - Arron, Sarah T.

AU - Migden, Michael R.

AU - Solomon, James A.

AU - Yoo, Simon

AU - Day, Bann Mo

AU - McKenna, Edward F.

AU - Sekulic, Aleksandar

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AB - 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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