Real-Life Effectiveness of Vismodegib in Patients with Metastatic and Advanced Basal Cell Carcinoma: Characterization of Adverse Events and Assessment of Health-Related Quality of Life using the Dermatology Life Quality Index (DLQI) Test

Villani, Alessia; Fabbrocini, Gabriella; Cappello, Milena; Costa, Cláudia; Scalvenzi, Massimiliano

doi:10.1007/s13555-019-0303-4

Cited by 26 publications

(29 citation statements)

References 19 publications

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“…Although it has low risk of metastasis, it is a slow-growing tumor that causes morbidity, via its usual proximity to critical facial structures, and lowers patients' quality of life. It also has a tendency to relapse, occur in multiple locations, and invade and destroy local tissues [3][4][5]. BCCs are classified according to prognostic factors, including tumor size, location, histologic characteristics, margins, and rate of recurrence.…”

Section: Introductionmentioning

confidence: 99%

Sonidegib: Safety and Efficacy in Treatment of Advanced Basal Cell Carcinoma

Villani

Fabbrocini

Costa

et al. 2020

Dermatol Ther (Heidelb)

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Hedgehog inhibitors are promising alternative treatments for patients with advanced basal cell carcinomas. Sonidegib (Odomzo Ò ), an oral smoothened (SMO) antagonist, is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) who present recurrence following surgery or radiation therapy, or those who are not candidates for surgery or radiotherapy. Several studies and randomized controlled trials have been conducted to evaluate the efficacy, safety, and tolerability of this new molecule that has demonstrated a good response rate (44%). Grade 1-2 adverse events have also been repor-ted. Further studies of real-world experiences are needed to better understand the correct management of the drug, alternative dosing regimens, and differences with other hedgehog inhibitors. This article provides a complete overview of the pharmacology and pharmacokinetics of sonidegib and a report of the trials and studies conducted. The most frequent adverse events and their correct management are also discussed.

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Section: Introductionmentioning

confidence: 99%

Sonidegib: Safety and Efficacy in Treatment of Advanced Basal Cell Carcinoma

Villani

Fabbrocini

Costa

et al. 2020

Dermatol Ther (Heidelb)

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“…In our study, we assessed patient overall QoL using FACT-G questionnaire, as it is an effective scale that has been validated for use with cancer patients and it is one of the most widely used measures of cancer-speci c health-related QoL. Patient perceiving of QoL was assessed using PRO measures related to cutaneous adverse events, such as DLQI, Skindex-16, and FACT-EGFRI-18 [16][17][18][19][20][21][22][23][24][25][26][27][28][29].…”

Section: Discussionmentioning

confidence: 99%

“…The main study variable was the impact of cutaneous adverse effects of anticancer drugs on (QoL). Different QoL questionnaires were selected according to previous clinical experience [16][17][18][19][20][21][22][23][24][25][26][27][28].…”

Section: -Study Procedures and Variablesmentioning

confidence: 99%

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Impact of cutaneous adverse events on the quality of life in patients receiving anticancer agents: Results from an observational, cross-sectional study

Oh¹,

Menéndez²,

Santos³

et al. 2020

Preprint

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Background: despite the growing interest in cutaneous adverse events (CAEs) and their management in oncology patients, they are often under-reported and there are no extensive data on their impact on quality of life. Health care professionals should pay attention to this issue in order to minimize its negative impact on quality of life (QoL) and improve patient outcome. The aim of this study was to evaluate the impact of CAEs on QoL in patients receiving anticancer drugs and to determine differences in QoL between conventional chemotherapy versus targeted therapies. Methods: 114 cancer patients with CAEs were included in this observational, cross-sectional study. Patient-reported outcomes instruments (FACT-G, DLQI and SKINDEX-16) were used. Results: Mean (SD) score in FACT-G was 65.3 (13.4), while in DLQI it was 8.4 (5) and in SKINDEX-16 it was 30.8 (16.9), showing a moderate impact on QoL. No significant differences in QOL indices according to the type of treatment (conventional chemotherapy vs targeted therapy) were observed Conclusions: CAEs had a moderate impact on QoL in cancer patients, evaluated with three different PRO instruments, but having more severe or two or more CAEs had a significant negative impact on QoL. No differences between conventional chemotherapy and targeted therapy were observed.

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“…The approved dosage of this HHI is 150 mg per day. Although this novel drug has been shown to be a safe and effective drug, usually increasing patients' health-related quality of life [5], some adverse events (AEs) during treatment, such as muscle spasms, dysgeusia, and alopecia, have been described [6]. In order to increase patients' compliance and adherence to treatment, many different schemes of dose reduction during treatment have been proposed [7,8].…”

Section: Introductionmentioning

confidence: 99%

Low-Dose Vismodegib as Maintenance Therapy After Locally Advanced Basal Cell Carcinoma Complete Remission: High Efficacy with Minimal Toxicity

Scalvenzi

Cappello

Costa

et al. 2020

Dermatol Ther (Heidelb)

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Introduction: Locally advanced basal cell carcinoma (laBCC) has always represented an uncommon, difficult-to-treat form of skin cancer, but approval of the Hedgehog inhibitor (HHI) vismodegib has provided an effective, well-tolerated therapy. While this drug has been shown to be a safe and effective during treatment, to date the effect of its prolonged use at a low dose after complete remission (CR) of laBCC has not been described. The aim of this study was to report our experience regarding the long-term efficacy of low-dose vismodegib as maintenance therapy in patients with CR of the disease during a 1-year follow-up period. Methods: An observational retrospective study was conducted at the Non-Melanoma Skin Cancer Unit of the University of Federico II (Naples). Patients who reported complete regression of their advanced BCC after vismodegib treatment were included in the study and subsequently separated into two groups. One group of patients continued with the ''drug

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Real-Life Effectiveness of Vismodegib in Patients with Metastatic and Advanced Basal Cell Carcinoma: Characterization of Adverse Events and Assessment of Health-Related Quality of Life using the Dermatology Life Quality Index (DLQI) Test

Cited by 26 publications

References 19 publications

Sonidegib: Safety and Efficacy in Treatment of Advanced Basal Cell Carcinoma

Sonidegib: Safety and Efficacy in Treatment of Advanced Basal Cell Carcinoma

Impact of cutaneous adverse events on the quality of life in patients receiving anticancer agents: Results from an observational, cross-sectional study

Low-Dose Vismodegib as Maintenance Therapy After Locally Advanced Basal Cell Carcinoma Complete Remission: High Efficacy with Minimal Toxicity

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