Basal Cell Carcinoma: Drug Therapy

Therapeutic targets

  • Healing
  • Improvement of prognosis
  • Palliative

Therapy recommendations

  • First-line therapy is complete surgical removal of the tumor
  • Local therapy (topical therapy) for superficial basal cell carcinoma or basal cell nevus syndrome using immunomodulators (5% imiquimod cream) or cytostatics (5% 5-FU [5-fluorouracil] cream).
  • Systemic therapy: hedgehog signal transduction pathway inhibitors: vismodegib, sonidegib; indications: Patients with symptomatic, metastatic, or locally advanced basal cell carcinoma for whom surgery or radiotherapy is not appropriate.
  • Note: due to teratogenicity risk:
    • In women of childbearing age, pregnancy tests must be performed within seven days before starting treatment and monthly during treatment.
    • Women of childbearing age must use two recommended methods of pregnancy prevention during treatment and for 20 months after treatment ends, unless they abstain from sexual intercourse.
    • Male patients must use a condom (with spermicide if necessary) during treatment and for six months after the end of therapy when having sexual intercourse with women.
  • See also under “Further therapy” (e.g., photodynamic therapy (PDT), indications: thin basal cell carcinoma (BCC); superficial multicentric BCC).

Further notes

  • In patients with basal cell carcinomas in low-risk localizations, a therapy trial with topical imiquimod can be performed first, if necessary (5% imiquimod cream 1 x daily for six weeks for superficial tumors/twelve weeks for nodular tumors). Only in case of recurrence, surgical treatment with histological control of complete resection in healthy tissue is then performed. This approach resulted in the following 5-year success rates: neither early treatment failure nor later recurrence, had 82.5% and 97.7%, respectively. Note: Most cases of imiquimod failure occurred in the first year of this.

Agents (main indication)

Topical agents

Immunomodulator

  • Mode of action of imiquimod: binds to Toll-like receptors 7 and 8 on dendritic cells and macrophages; indirectly antiviral and antitumor by modulating immune response.
  • Low absorption, rapid elimination
  • Indications: small superficial basal cell carcinoma; basal cell nevus syndrome.
  • Dosing Instructions: Local (topical) therapy should be performed with a cream (5% imiquimod) five days/week for a total of six weeks (wash off with soap after exposure time of at least 8 h).
  • Contraindications: therapy on risk localizations such as ears, eyelids, nose, hands and feet and anogenital region.
  • Side effects: local reactions, myalgia (muscle pain), flu-like symptoms.

Cytostatics

  • Mode of action of 5-fluorouracil: pyrimidine antagonist; tumor cell proliferation-inhibiting and apoptosis-inducing.
  • Indications: superficial basal cell carcinomas that are.
    • Were not successfully treatable surgically or radiologically.
    • Are not treatable due to localization or multiplicity
  • Dosing Instructions: Local therapy should be administered with a cream/ointment (1-5% 5-fluorouracil) twice daily for 3 to12 weeks until a flat ulceration develops.
  • Side effects: local reactions, stomatitis (inflammation of the oral mucosa); ulceration in the GI tract (ulceration of the gastrointestinal tract), bone marrow depression (bone marrow inhibition with with suspension of hematopoiesis) as chronic toxicity.

Effectiveness of topical therapies for superficial basal cell carcinoma (BCC).

Complete healings for the nonoperative therapies of superficial BCC.

  • Imiquimod 83%
  • 5-fluorouracil 80 %
  • MAL-PDT 73 %

Other therapy options

  • Advanced basal cell carcinoma (locally advanced lesions or metastatic forms not suitable for surgery or radiatio (radiotherapy)):
  • Interferon therapy is currently being tested in basal cell carcinoma.
  • No detailed information on agents and dosages is provided here, as therapy regimens are constantly being modified.