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Efficacy and safety profile of vismodegib in a real‐world setting cohort of patients with advanced basal cell carcinoma in Argentina
Author(s) -
Cozzani Romina,
Aguila Roxana,
Carrizo Mariano,
Sanchez Sergio,
Gonzalez Abel
Publication year - 2020
Publication title -
international journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.677
H-Index - 93
eISSN - 1365-4632
pISSN - 0011-9059
DOI - 10.1111/ijd.14780
Subject(s) - vismodegib , medicine , dysgeusia , basal cell carcinoma , tolerability , adverse effect , radiation therapy , cohort , surgery , oncology , basal cell
Abstract Introduction and Objectives Vismodegib (Erivedge ® ), a hedgehog pathway inhibitor, is approved to treat metastatic or locally advanced basal cell carcinoma (BCC) not suitable for surgery or radiotherapy. Our main objectives were to study the objective response rate (ORR) assessed by treating physicians and safety of vismodegib in a real‐world practice setting in Argentina. Material and Methods This is a prospective cohort study in real‐world practice. We included consecutive adult patients treated in Argentina with locally advanced or metastatic BCC not suitable for surgery or radiotherapy. Patients were followed until the end of the study, death, or loss to follow‐up, whichever occurred first. Patients received 150 mg vismodegib PO daily. Result We included in the analysis 63 patients who received treatment. Locally advanced BCC was present in 57 (90.4%) and metastatic disease in two (3.2%). ORR was observed in 46 patients (73%; 95% CI: 60.3–83.4), with partial response in 36 (57%; 95% CI: 44‐69.5) and complete response in 10 (16%; 95% CI: 7.8‐27.2). As to safety, 48 (76.2%) patients had at least one adverse event (AE). The most frequently observed AEs were muscular spasms in 25 (39.6%); dysgeusia in 23 (36.5%); alopecia in nine (14.2%); weight loss in seven (11.1%); and ageusia in (9.5%) patients. Serious AEs were observed in 11 (17%) patients with one episode of deep vein thrombosis and pulmonary embolism resulting in death. Conclusion Our study provides additional evidence of the efficacy and tolerability of vismodegib in patients with locally advanced or metastatic BCC in a real‐world practice.