Analyses of Basal and Squamous Cell Carcinoma Reported As an Adverse Drug Reaction and Comparison with Cases from the Cancer Registry from Germany

Overview

Journal Drugs R D

Specialty Pharmacology

Date 2022 Nov 19

PMID 36401718

Authors

Diana Dubrall

Bernhardt Sachs

Klaus Kraywinkel

Maike Schulz

Matthias Schmid

Wilma Fischer-Barth

Jens Bate

Affiliations

Soon will be listed here.

Abstract

Introduction: In Germany, incidence rates of basal cell (BCC) and squamous cell carcinoma (SCC) rose significantly from 1998 to 2010. Ultraviolet (UV) light exposure, immunosuppressants and drugs with photosensitising potential are known to increase the risk to develop BCC and SCC. The aim of our study was to analyse the adverse drug reaction (ADR) reports from Germany referring to BCC and SCC and to compare them to BCC and SCC occurring in the general population.

Methods: We analysed all validated spontaneous ADR reports referring to BCC (n = 191) and SCC (n = 75) from Germany contained in the European ADR database EudraVigilance prior to 6 March 2019. These reports were compared to 1,267,210 BCC and 476,903 SCC cases from the German Centre for Cancer Registry Data recorded from 2006 to 2018.

Results: The number of BCC and SCC reports as well as the BCC and SCC incidences in the registry increased in the analysed time period. Patients with drug-associated BCC (60 years) and SCC (64 years) were younger than patients with BCC (72 years) and SCC (76 years) in the registry. In 57.1 and 60.0% of BCC and SCC reports immunosuppressants were reported as suspected. The reported suspected drug was assumed to possess a photosensitising potential in 41.9 and 44.0% of BCC and SCC reports.

Conclusions: In Germany, drug-associated BCC and SCC occurred at a younger age than in the general population. The results underline the necessity for skin cancer screening of patients treated with immunosuppressants or with drugs with photosensitising potential.

References

Dubrall D, Just K, Schmid M, Stingl J, Sachs B . Adverse drug reactions in older adults: a retrospective comparative analysis of spontaneous reports to the German Federal Institute for Drugs and Medical Devices. BMC Pharmacol Toxicol. 2020; 21(1):25. PMC: 7092423. DOI: 10.1186/s40360-020-0392-9. View

Kingwell E, Bajdik C, Phillips N, Zhu F, Oger J, Hashimoto S . Cancer risk in multiple sclerosis: findings from British Columbia, Canada. Brain. 2012; 135(Pt 10):2973-9. DOI: 10.1093/brain/aws148. View

Hoer A, Schiffhorst G, Zimmermann A, Fischaleck J, Gehrmann L, Ahrens H . Multiple sclerosis in Germany: data analysis of administrative prevalence and healthcare delivery in the statutory health system. BMC Health Serv Res. 2014; 14:381. PMC: 4169838. DOI: 10.1186/1472-6963-14-381. View

Didona D, Paolino G, Bottoni U, Cantisani C . Non Melanoma Skin Cancer Pathogenesis Overview. Biomedicines. 2018; 6(1). PMC: 5874663. DOI: 10.3390/biomedicines6010006. View

Eisemann N, Waldmann A, Geller A, Weinstock M, Volkmer B, Greinert R . Non-melanoma skin cancer incidence and impact of skin cancer screening on incidence. J Invest Dermatol. 2013; 134(1):43-50. DOI: 10.1038/jid.2013.304. View

Ciazynska M, Kaminska-Winciorek G, Lange D, Lewandowski B, Reich A, Slawinska M . The incidence and clinical analysis of non-melanoma skin cancer. Sci Rep. 2021; 11(1):4337. PMC: 7900109. DOI: 10.1038/s41598-021-83502-8. View

Madan V, Lear J, Szeimies R . Non-melanoma skin cancer. Lancet. 2010; 375(9715):673-85. DOI: 10.1016/S0140-6736(09)61196-X. View

Flohil S, Seubring I, van Rossum M, Coebergh J, de Vries E, Nijsten T . Trends in Basal cell carcinoma incidence rates: a 37-year Dutch observational study. J Invest Dermatol. 2012; 133(4):913-8. DOI: 10.1038/jid.2012.431. View

Karagas M, Stukel T, Umland V, Tsoukas M, Mott L, Sorensen H . Reported use of photosensitizing medications and basal cell and squamous cell carcinoma of the skin: results of a population-based case-control study. J Invest Dermatol. 2007; 127(12):2901-3. DOI: 10.1038/sj.jid.5700934. View

10.

Pariente A, Gregoire F, Fourrier-Reglat A, Haramburu F, Moore N . Impact of safety alerts on measures of disproportionality in spontaneous reporting databases: the notoriety bias. Drug Saf. 2007; 30(10):891-8. DOI: 10.2165/00002018-200730100-00007. View

11.

Rudolph C, Schnoor M, Eisemann N, Katalinic A . Incidence trends of nonmelanoma skin cancer in Germany from 1998 to 2010. J Dtsch Dermatol Ges. 2015; 13(8):788-97. DOI: 10.1111/ddg.12690. View

12.

Bergvall T, Noren G, Lindquist M . vigiGrade: a tool to identify well-documented individual case reports and highlight systematic data quality issues. Drug Saf. 2013; 37(1):65-77. PMC: 6447519. DOI: 10.1007/s40264-013-0131-x. View

13.

Chlebicka I, Jastrzab B, Stefaniak A, Szepietowski J . Basal cell carcinoma secondary to trauma: A 3-year experience of the single center. Adv Clin Exp Med. 2021; 30(1):83-86. DOI: 10.17219/acem/130593. View

14.

Leiter U, Garbe C . Epidemiology of melanoma and nonmelanoma skin cancer--the role of sunlight. Adv Exp Med Biol. 2008; 624:89-103. DOI: 10.1007/978-0-387-77574-6_8. View

15.

John S, Trakatelli M, Gehring R, Finlay K, Fionda C, Wittlich M . CONSENSUS REPORT: Recognizing non-melanoma skin cancer, including actinic keratosis, as an occupational disease - A Call to Action. J Eur Acad Dermatol Venereol. 2016; 30 Suppl 3:38-45. DOI: 10.1111/jdv.13608. View

16.

Hollestein L, de Vries E, Nijsten T . Trends of cutaneous squamous cell carcinoma in the Netherlands: increased incidence rates, but stable relative survival and mortality 1989-2008. Eur J Cancer. 2012; 48(13):2046-53. DOI: 10.1016/j.ejca.2012.01.003. View

17.

Dubrall D, Schmid M, Alesik E, Paeschke N, Stingl J, Sachs B . Frequent Adverse Drug Reactions, and Medication Groups under Suspicion. Dtsch Arztebl Int. 2018; 115(23):393-400. PMC: 6041966. DOI: 10.3238/arztebl.2018.0393. View

18.

Ciazynska M, Pabianek M, Slawinska M, Reich A, Lewandowski B, Szczepaniak K . Risk Factors and Clinicopathological Features for Developing a Subsequent Primary Cutaneous Squamous and Basal Cell Carcinomas. Cancers (Basel). 2022; 14(13). PMC: 9264931. DOI: 10.3390/cancers14133069. View

19.

Pedersen S, Gaist D, Schmidt S, Holmich L, Friis S, Pottegard A . Hydrochlorothiazide use and risk of nonmelanoma skin cancer: A nationwide case-control study from Denmark. J Am Acad Dermatol. 2017; 78(4):673-681.e9. DOI: 10.1016/j.jaad.2017.11.042. View

20.

Muzic J, Schmitt A, Wright A, Alniemi D, Zubair A, Olazagasti Lourido J . Incidence and Trends of Basal Cell Carcinoma and Cutaneous Squamous Cell Carcinoma: A Population-Based Study in Olmsted County, Minnesota, 2000 to 2010. Mayo Clin Proc. 2017; 92(6):890-898. PMC: 5535132. DOI: 10.1016/j.mayocp.2017.02.015. View