Cohort analysis of safety and efficacy of vismodegib in Italian patients from the Phase II, multicenter STEVIE study

P. Bossi; Ketty Peris; P. Calzavara-Pinton; P. Queirolo; S. Alfieri; M. Palla; M. T. Rossi; F. Spagnolo; S. Tambone; C. Astolfi; P. A. Ascierto

doi:10.2217/fon-2019-0664

Cohort analysis of safety and efficacy of vismodegib in Italian patients from the Phase II, multicenter STEVIE study

P. Bossi^*
, Ketty Peris
, P. Calzavara-Pinton
, P. Queirolo
, S. Alfieri
, M. Palla
, M. T. Rossi
, F. Spagnolo
, S. Tambone
, C. Astolfi
, P. A. Ascierto

^*Corresponding author

University of Brescia
IRCCS Istituto Europeo di Oncologia - Milano
IRCCS Fondazione Istituto Nazionale per lo studio e la cura dei tumori - Milano
IRCCS Istituto nazionale tumori Fondazione Giovanni Pascale - Napoli
San Martino Hospital Genoa
F. Hoffmann-La Roche AG

Research output: Contribution to journal › Article

Abstract

Aim: To assess safety and efficacy of vismodegib in the Italian cohort from the SafeTy Events in VIsmodEgib study. Materials & methods: Data from Italian patients with locally advanced basal cell carcinoma (laBCC) or metastatic BCC were analyzed. Results: Among 182 Italian patients, adverse events occurred with similar incidence to the overall population. Overall response rate was 67.1% in laBCC, 20% in metastatic BCC; complete response rate was 33.1% overall and 37.4% in laBCC. Median time to response was 2 months in complete responders versus 3.6 months overall. Quality of life improved from baseline. Conclusion: In the Italian cohort of STEVIE, vismodegib showed a safety profile consistent with the whole population; older age did not affect safety or efficacy. ClinicalTrials.gov registration: NCT0136766.

Original language	English
Pages (from-to)	1091-1100
Number of pages	10
Journal	Future Oncology
Volume	16
Issue number	16
DOIs	https://doi.org/10.2217/fon-2019-0664
Publication status	Published - 2020

All Science Journal Classification (ASJC) codes

Oncology
Cancer Research

Keywords

Gorlin syndrome
HhAntag691
basal cell
carcinoma
vismodegib

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@article{1922d9d06a5c4d349799991b3c73967c,

title = "Cohort analysis of safety and efficacy of vismodegib in Italian patients from the Phase II, multicenter STEVIE study",

abstract = "Aim: To assess safety and efficacy of vismodegib in the Italian cohort from the SafeTy Events in VIsmodEgib study. Materials \& methods: Data from Italian patients with locally advanced basal cell carcinoma (laBCC) or metastatic BCC were analyzed. Results: Among 182 Italian patients, adverse events occurred with similar incidence to the overall population. Overall response rate was 67.1\% in laBCC, 20\% in metastatic BCC; complete response rate was 33.1\% overall and 37.4\% in laBCC. Median time to response was 2 months in complete responders versus 3.6 months overall. Quality of life improved from baseline. Conclusion: In the Italian cohort of STEVIE, vismodegib showed a safety profile consistent with the whole population; older age did not affect safety or efficacy. ClinicalTrials.gov registration: NCT0136766.",

keywords = "Gorlin syndrome, HhAntag691, basal cell, carcinoma, vismodegib, Gorlin syndrome, HhAntag691, basal cell, carcinoma, vismodegib",

author = "P. Bossi and Ketty Peris and P. Calzavara-Pinton and P. Queirolo and S. Alfieri and M. Palla and Rossi, \{M. T.\} and F. Spagnolo and S. Tambone and C. Astolfi and Ascierto, \{P. A.\}",

year = "2020",

doi = "10.2217/fon-2019-0664",

language = "English",

volume = "16",

pages = "1091--1100",

journal = "Future Oncology",

issn = "1479-6694",

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TY - JOUR

T1 - Cohort analysis of safety and efficacy of vismodegib in Italian patients from the Phase II, multicenter STEVIE study

AU - Bossi, P.

AU - Peris, Ketty

AU - Calzavara-Pinton, P.

AU - Queirolo, P.

AU - Alfieri, S.

AU - Palla, M.

AU - Rossi, M. T.

AU - Spagnolo, F.

AU - Tambone, S.

AU - Astolfi, C.

AU - Ascierto, P. A.

PY - 2020

Y1 - 2020

N2 - Aim: To assess safety and efficacy of vismodegib in the Italian cohort from the SafeTy Events in VIsmodEgib study. Materials & methods: Data from Italian patients with locally advanced basal cell carcinoma (laBCC) or metastatic BCC were analyzed. Results: Among 182 Italian patients, adverse events occurred with similar incidence to the overall population. Overall response rate was 67.1% in laBCC, 20% in metastatic BCC; complete response rate was 33.1% overall and 37.4% in laBCC. Median time to response was 2 months in complete responders versus 3.6 months overall. Quality of life improved from baseline. Conclusion: In the Italian cohort of STEVIE, vismodegib showed a safety profile consistent with the whole population; older age did not affect safety or efficacy. ClinicalTrials.gov registration: NCT0136766.

AB - Aim: To assess safety and efficacy of vismodegib in the Italian cohort from the SafeTy Events in VIsmodEgib study. Materials & methods: Data from Italian patients with locally advanced basal cell carcinoma (laBCC) or metastatic BCC were analyzed. Results: Among 182 Italian patients, adverse events occurred with similar incidence to the overall population. Overall response rate was 67.1% in laBCC, 20% in metastatic BCC; complete response rate was 33.1% overall and 37.4% in laBCC. Median time to response was 2 months in complete responders versus 3.6 months overall. Quality of life improved from baseline. Conclusion: In the Italian cohort of STEVIE, vismodegib showed a safety profile consistent with the whole population; older age did not affect safety or efficacy. ClinicalTrials.gov registration: NCT0136766.

KW - Gorlin syndrome

KW - HhAntag691

KW - basal cell

KW - carcinoma

KW - vismodegib

KW - Gorlin syndrome

KW - HhAntag691

KW - basal cell

KW - carcinoma

KW - vismodegib

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U2 - 10.2217/fon-2019-0664

DO - 10.2217/fon-2019-0664

M3 - Article

SN - 1479-6694

VL - 16

SP - 1091

EP - 1100

JO - Future Oncology

JF - Future Oncology

IS - 16

ER -

Cohort analysis of safety and efficacy of vismodegib in Italian patients from the Phase II, multicenter STEVIE study

Abstract

All Science Journal Classification (ASJC) codes

Keywords

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