Surgery Versus Combined Treatment With Curettage and Imiquimod for Nodular Basal Cell Carcinoma
Status:
Active, not recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Basal cell carcinoma (BCC) is a slow-growing, locally invasive malignant epidermal skin
tumour. It is the most common malignant disease in Caucasians, representing approximately 80%
of all cases of skin cancer and is therefore an important health problem. In the Netherlands
incidence rates are 165 for men and 157 for women per 100.000 person-years, and these rates
are rising with 3-10% every year.
A simplified histological classification of BCCs includes the following three subtypes:
nodular, superficial and infiltrative variants, with the nodular variant being the most
frequent type. Although a characteristic feature of BCCs is their low risk to metastasize, if
untreated they may be locally invasive and may induce considerable functional and cosmetic
morbidity.
The gold standard treatment of all histological BCC subtypes is surgical excision (SE), but
not all patients are eligible for surgery. In patients with multiple BCCs and older patients,
surgery may lead to significant morbidity, and in some cases, it may result in disfiguring
scarring. For these reasons and to reduce workload and costs in the healthcare system, there
is a growing demand for alternative, non-invasive, treatments. An advantage of non-invasive
treatment options is that they can be performed by other healthcare professionals, such as
general practitioners and specialized nurses. For treatment of superficial BCCs (sBCC)
non-invasive treatments, such as topical imiquimod (IMQ), 5-fluorouracil (5-FU) or
photodynamic therapy (PDT) are already commonly used. Our group investigated the efficacy of
those three therapies and found that after 3 years, BCCs treated with IMQ had a significant
lower risk of recurrence, compared to the other therapies.
A recent study suggests that IMQ, besides being an immune-response modifier, also directly
inhibits sonic hedgehog (SHH) signalling, the most important pathway active in BCCs. This
targeted effect of IMQ very likely explains the superior therapeutic effect. Treatment of
nodular BCC (nBCC) with IMQ has been investigated. Without prior curettage, high efficacy
rates were found, although efficacy was still slightly inferior to SE.
The investigators hypothesize that the effectiveness of IMQ following prior curettage will
not be inferior to SE and that the benefits will be a higher patient satisfaction and lower
healthcare costs. A recently published discreet choice experiment showed that patients
preferred IMQ to surgery regardless of previous experience of BCC symptoms and treatment.