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CORRESPONDENCE |
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| Year : 2022 | Volume
: 67
| Issue : 6 | Page : 796-797 |
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| Real world data on efficacy and safety of vismodegib in Greek patients with advanced, multiple and metastatic basal cell carcinoma |
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Dimitrios Sgouros1, Georgia Pappa1, Anna Syrmali1, Konstantinos Theodoropoulos1, Sofia Theotokoglou1, Evangelia Bozi1, Vasileia Damaskou2, Ioannis G Panayiotides2, Alexandros C Katoulis1
1 From the 2nd Department of Dermatology and Venereology, National and Kapodistrian University of Athens, Medical School, “Attikon” General University Hospital, Athens, Greece
2 Department of Pathology, National and Kapodistrian University of Athens, Medical School, “Attikon” General University Hospital, Athens, Greece
| Date of Web Publication | 23-Feb-2023 |
Correspondence Address:
Georgia Pappa
From the 2nd Department of Dermatology and Venereology, National and Kapodistrian University of Athens, Medical School, “Attikon” General University Hospital, Athens
Greece
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/ijd.ijd_354_22
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How to cite this article:
Sgouros D, Pappa G, Syrmali A, Theodoropoulos K, Theotokoglou S, Bozi E, Damaskou V, Panayiotides IG, Katoulis AC. Real world data on efficacy and safety of vismodegib in Greek patients with advanced, multiple and metastatic basal cell carcinoma. Indian J Dermatol 2022;67:796-7 |
How to cite this URL:
Sgouros D, Pappa G, Syrmali A, Theodoropoulos K, Theotokoglou S, Bozi E, Damaskou V, Panayiotides IG, Katoulis AC. Real world data on efficacy and safety of vismodegib in Greek patients with advanced, multiple and metastatic basal cell carcinoma. Indian J Dermatol [serial online] 2022 [cited 2023 Mar 23];67:796-7. Available from: https://www.e-ijd.org/text.asp?2022/67/6/796/370293 |
Sir,
Basal cell carcinoma (BCC) is the most common cutaneous neoplasm in Caucasians.[1] As alterations in the hedgehog signalling pathway play a crucial pathophysiological role, vismodegib has emerged as an effective alternative therapeutic modality for advanced, metastatic and recurrent BCC, not amenable to surgery or radiotherapy.[1]
We present our experience, regarding the efficacy and safety of vismodegib, in a real-world clinical setting. This retrospective, non-blinded study included patients with locally advanced (la) BCC, multiple BCCs and Gorlin-Goltz syndrome (G-G), treated with oral vismodegib 150 mg daily, during a three-year period (2015–2017). Treatment was administered until clearance, disease progression, intolerable/unacceptable toxicity or withdrawal. Patients were followed for up to two years. Baseline characteristics, efficacy data and treatment-related adverse events (AEs) were recorded.
Fourteen patients were included: ten males (71,43%) and four females, with a median age of 77 (range 46–93) years. Six had laBCC, four multiple BCCs and four G-G. Most laBCCs (66.66%) were located in the face H-mask. The median duration of vismodegib exposure was 7.5 (range 4–11) months for the laBCC group, six (range 4–8) for the multiple BCCs and eight (range 3–11) for the G-G. At six months, the overall response rate was 100%. Five patients (35.71%) achieved complete response (clinical disappearance of all lesions): two with laBCC [Figure 1]a and [Figure 1]b and three with multiple BCCs; nine patients (64.28%) achieved partial response (≥30% surface reduction of target lesions): four with laBCC, one with multiple BCCs and four with G-G. | Figure 1: (a) Locally advanced basal cell carcinoma in the left cheek of a 61-year-old male patient. (b) Lesion after ten months of treatment with vismodegib
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AEs were observed in all patients, being the main reason for treatment discontinuation in nine, and the sole reason in two. Reported AEs were consistent with the safety profile of vismodegib,[1] the most common being dysgeusia, muscle cramps and alopecia. All AEs were grade 1/2. The median time to onset was three months for all groups. Less frequently reported AEs were weight loss, aberrant SCC development and hepatotoxicity, in one patient each. Hepatotoxicity occurred in a 77-year-old female with G-G, also treated with tamoxifen for metastatic breast cancer.
Interestingly, of the eight patients deemed eligible for a second course of vismodegib, six declined readministration because of AEs during the first course. Only one patient received vismodegib for another six months.
During follow-up, five patients remained disease-free; seven recurred; two died, both with laBCC. No deaths were suspected to be related with the drug (≥12 months off vismodegib). Our results are summarized in [Table 1]. | Table 1: Clinical characteristics, therapeutic outcomes, adverse events and recurrence rate of patients (n=14) with BCC treated with vismodegib
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In our cohort, clinical response rates were higher than those of premarket clinical trials, albeit the duration of drug exposure was shorter.[2],[3] They were also superior compared to previous reports, which, however, included a larger number of patients.[4],[5] Similar to the previous experience, the majority of patients discontinued treatment or refused re-treatment due to AEs.[4],[5] Our study limitations include the retrospective design and the small sample size. Despite the short-term efficacy of vismodegib, the AEs undermine its effective use for long-term control of advanced, multiple and metastatic BCCs. Main challenge for the future is the development of strategies to increase drug tolerability and patients' compliance.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
 References | |  |
| 1. | Peris K, Fargnoli MC, Garbe C, Kaufmann R, Bastholt L, Seguin NB, et al.; European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC). Diagnosis and treatment of basal cell carcinoma: European consensus-based interdisciplinary guidelines. Eur J Cancer 2019;118:10-34.  |
| 2. | Basset-Seguin N, Hauschild A, Grob JJ, Kunstfeld R, Dréno B, Mortier L, et al. Vismodegib in patients with advanced basal cell carcinoma (STEVIE): A pre-planned interim analysis of an international, open-label trial. Lancet Oncol 2015;16:729-36. |
| 3. | Sekulic A, Migden MR, Basset-Seguin N, Garbe C, Gesierich A, Lao CD, et al. Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: Final update of the pivotal ERIVANCE BCC study. BMC Cancer 2017;17:332. |
| 4. | Cozzani R, Del Aguila R, Carrizo M, Sanchez S, Gonzalez A; ML29740 Investigators. Efficacy and safety profile of vismodegib in a real-world setting cohort of patients with advanced basal cell carcinoma in Argentina. Int J Dermatol 2020;59:627-32. |
| 5. | Scalvenzi M, Villani A, Costa C, Cappello M. Efficacy and safety of vismodegib in patients with basal cell carcinoma: An Italian Center experience. Dermatol Ther 2019;32:e12971. |
[Figure 1]
[Table 1] |
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