Managing adverse effects by dose reduction during routine treatment of locally advanced basal cell carcinoma with the hedgehog inhibitor vismodegib: a single centre experience

Woltsche, Nora; Pichler, Nadir Antônio; Wolf, Ingrid; Meo, Nicola di; Zalaudek, Iris

doi:10.1111/jdv.15367

Cited by 27 publications

(25 citation statements)

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“…Furthermore, 11 out of 35 (31%) patients that reported a complete remission of the disease after 6 months of vismodegib treatment reported BCC recurrence. These data highlight the importance of continuous follow-up and perhaps different regimens of treatment, such as an alternate dose regimen to maintain disease control and reduce the adverse events as previously described in the literature [12]. In recent years, different dose reduction strategies during routine treatment have been proposed as a means to reduce the severity of adverse events and achieve the optimum duration of vismodegib treatment.…”

Section: Discussionmentioning

confidence: 74%

Long-Term Efficacy of Vismodegib After its Withdrawal and Patients’ Health-Related Quality of Life Using the Dermatology Life Quality Index (DLQI)

Villani

Megna

Fabbrocini

et al. 2019

Dermatol Ther (Heidelb)

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IntroductionAlthough non-melanoma skin cancers (NMSCs) are associated with a very low mortality risk, they have been reported to have a major impact on patients’ health-related quality of life (HRQoL). Vismodegib is a therapy for patients who are affected by locally advanced basal cell carcinoma (BCC) or metastatic BCC who are ineligible for surgery and/or radiotherapy. The aim of the present clinical study was to assess the long-term efficacy of vismodegib after its withdrawal by evaluating the recurrence rate of advanced BCC, assessing also patients’ HRQoL after 3 and 6 months from drug withdrawal.MethodsA retrospective study was performed to analyze patients with advanced and/or multiple BCCs that had been treated with vismodegib (150 mg daily) at the Non-Melanoma Skin Cancer Unit of the University of Naples Federico II (Italy) and had obtained a complete regression in 6 months. At the end of the 6-month treatment cycle, patients that reported total remission of the skin tumor were visited monthly in order to assess their therapeutic response. Moreover, to assess the specific impact of vismodegib on HRQoL, DLQI was administered before vismodegib treatment (baseline), at the end of the therapy cycle (6 months), as well as after 3 and 6 months from vismodegib discontinuation.ResultsThirty-five patients (27 male, 8 female), with a complete regression of their advanced BCC after vismodegib treatment, were included in the study. The duration of treatment for all patients was 6 months as set by study inclusion criteria. A BCC recurrence rate of 31% (11/35) was reported after a 6-month follow-up. The average reported Dermatology Life Quality Index (DLQI) score increased from a value of 0 at the end of the 6-month vismodegib treatment to a mean value of 2.4 after 3 months from drug withdrawal and 3.6 after 6 months from treatment discontinuation.ConclusionThe results of this exploratory analysis of vismodegib withdrawal are consistent with a substantial link between treatment response and patients’ HRQoL. Furthermore, 11 out of 35 (31%) patients that reported a complete remission of the disease after 6 months of vismodegib treatment reported BCC recurrence. These data highlight the importance of continuous follow-up and perhaps different regimens of treatment, such as an alternate dose regimen to maintain disease control and reduce the adverse events as previously described in the literature.

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Section: Discussionmentioning

confidence: 74%

Long-Term Efficacy of Vismodegib After its Withdrawal and Patients’ Health-Related Quality of Life Using the Dermatology Life Quality Index (DLQI)

Villani

Megna

Fabbrocini

et al. 2019

Dermatol Ther (Heidelb)

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“…In recent years, different dose reduction strategies during routine treatment have been proposed as a means to reduce AE severity and achieve the optimum duration of vismodegib treatment. Transitioning from a continuous to an intermittent regimen could be a way to avoid dropouts [9,10]. NMSC also has an appreciable impact on patient QOL, especially for the locally advanced and the metastasizing forms of BCC, due to the symptomatology involved and the potential for physical disfigurement, which usually compromises the psychological state of the patient [11].…”

Section: Discussionmentioning

confidence: 99%

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

Fabbrocini

Cappello

et al. 2019

Dermatol Ther (Heidelb)

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Introduction: Non-melanoma skin cancer (NMSC) is the most common type of human tumor, with an estimated five million new cases each year. NMSC has been described as having a major impact on the health-related quality of life of the patient. Vismodegib is a hedgehog pathway inhibitor therapy for patients who are affected by locally advanced basal cell carcinoma (laBCC) and metastatic basal cell carcinoma and are ineligible for surgery and/or radiotherapy. The objective of this study was to assess treatment-emergent adverse events reported by patients with advanced BCC who were undergoing hedgehog pathway inhibitor therapy with vismodegib, and to quantify their health-related quality of life using the Dermatology Life Quality Index (DLQI) questionnaire.

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“…More recently, dose reduction has been considered an alternative in the management of drug toxicities from Hh inhibitors [116].…”

Section: How To Manage the Adverse Events From Hh Inhibitors?mentioning

confidence: 99%

Diagnosis and treatment of basal cell carcinoma: European consensus–based interdisciplinary guidelines

Peris

Fargnoli

Garbe³

et al. 2019

European Journal of Cancer

451

574

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Terms of useThis work is brought to you by the University of Southern Denmark through the SDU Research Portal. Unless otherwise specified it has been shared according to the terms for self-archiving. If no other license is stated, these terms apply:• You may download this work for personal use only. • You may not further distribute the material or use it for any profit-making activity or commercial gain • You may freely distribute the URL identifying this open access version DIAGNOSIS AND TREATMENT OF BASAL CELL CARCINOMA: EUROPEAN CONSENSUS-BASED INTERDISCIPLINARY GUIDELINES On behalf of the European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC)

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Managing adverse effects by dose reduction during routine treatment of locally advanced basal cell carcinoma with the hedgehog inhibitor vismodegib: a single centre experience

Abstract: Linked article: This article is commented on by M. Scalvenzi et al., pp. e146–e147 in this issue. To view this article visit https://doi.org/10.1111/jdv.15469.

Cited by 27 publications

References 10 publications

Long-Term Efficacy of Vismodegib After its Withdrawal and Patients’ Health-Related Quality of Life Using the Dermatology Life Quality Index (DLQI)

Long-Term Efficacy of Vismodegib After its Withdrawal and Patients’ Health-Related Quality of Life Using the Dermatology Life Quality Index (DLQI)

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

Diagnosis and treatment of basal cell carcinoma: European consensus–based interdisciplinary guidelines

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