INTRODUCTION
Skin cancer is one of the most common malignancies worldwide and prevalence rates continue to rise each year.1 From 2007 to 2011, the United States spent an annual average of $8.1 billion treating melanoma and non-melanoma skin cancers (NMSC).2 For treatment, there are a spectrum of options from surgical to medical management of NMSCs. Various factors are taken into consideration such as type of malignancy, anatomic location, size, and depth.3 Within the past 10 years, medical management of NMSCs has expanded with a handful of drugs approved by the US Food and Drug Administration (FDA) for treating basal cell carcinomas (BCCs), squamous cell carcinomas (SCCs), and Merkel cell carcinomas (MCCs).
Historically, immunotherapy research was largely focused on treating cutaneous melanoma.4 With NMSCs accounting for a significant portion of cutaneous oncology cases, there has been a shift in interest toward studying immunologic therapies for difficult to treat NMSCs. These immune checkpoint inhibitors include cemiplimab, pembrolizumab, retifanlimab, and avelumab which specifically target programmed cell death protein 1 (PD-1) preventing normal T-cell functioning, which can be upregulated in certain tumors.4 Sonidegib and vismodegib are similar checkpoint inhibitors but work on obstructing the Hedgehog (Hh) signaling pathway hindering tumor cell growth and survival.5 Older treatment options are imiquimod and topical fluorouracil, which work through activating cytotoxic T cells to destroy tumor cells and inhibiting DNA synthesis, respectively.6
These medications have expanded treatment options for NMSC patients; however, potential side effects need to be taken into consideration. Although fatal immune checkpoint inhibitor associated adverse events are reported to be low at 0.3-1.3%, naturally there is an increased risk for infections as these agents dampen immunologic defenses.7 Other side effects can include fatigue, pruritus, rashes, and diarrhea.8 While medications are required to include a package insert documenting side effects, the list can be daunting.9 Given that fear and anxiety over side effects are among the many causes of medication noncompliance in patients, accurately characterizing experiences of side-effect profiles is useful.10 The FDA Adverse Events Reporting System (FAERS) is a publicly available database that documents all reported adverse events experienced by patients on medications. Thus, the goal of this paper was to capture real-world adverse events and side effects experienced by patients taking FDA-approved NMSC treatments using the FAERS.
Historically, immunotherapy research was largely focused on treating cutaneous melanoma.4 With NMSCs accounting for a significant portion of cutaneous oncology cases, there has been a shift in interest toward studying immunologic therapies for difficult to treat NMSCs. These immune checkpoint inhibitors include cemiplimab, pembrolizumab, retifanlimab, and avelumab which specifically target programmed cell death protein 1 (PD-1) preventing normal T-cell functioning, which can be upregulated in certain tumors.4 Sonidegib and vismodegib are similar checkpoint inhibitors but work on obstructing the Hedgehog (Hh) signaling pathway hindering tumor cell growth and survival.5 Older treatment options are imiquimod and topical fluorouracil, which work through activating cytotoxic T cells to destroy tumor cells and inhibiting DNA synthesis, respectively.6
These medications have expanded treatment options for NMSC patients; however, potential side effects need to be taken into consideration. Although fatal immune checkpoint inhibitor associated adverse events are reported to be low at 0.3-1.3%, naturally there is an increased risk for infections as these agents dampen immunologic defenses.7 Other side effects can include fatigue, pruritus, rashes, and diarrhea.8 While medications are required to include a package insert documenting side effects, the list can be daunting.9 Given that fear and anxiety over side effects are among the many causes of medication noncompliance in patients, accurately characterizing experiences of side-effect profiles is useful.10 The FDA Adverse Events Reporting System (FAERS) is a publicly available database that documents all reported adverse events experienced by patients on medications. Thus, the goal of this paper was to capture real-world adverse events and side effects experienced by patients taking FDA-approved NMSC treatments using the FAERS.
