Current Clinical Trials

The traditional methods of treatment involve the use of cryosurgery, radiation therapy, electrodesiccation and curettage, and simple excision. Each of these methods is useful in specific clinical situations.[1] Depending on case selection, these methods have cure rates ranging from 85% to 95%.

Mohs micrographic surgery has the highest 5-year cure rates for surgical treatment of both primary (96%) and recurrent (90%) tumors. This method uses microscopic control to evaluate the extent of tumor invasion.

Treatment options:

1. Mohs micrographic surgery.[2,3] Although this method is complicated and requires special training, it has the highest cure rate of all surgical treatments because the tumor is microscopically delineated until it is completely removed. While other treatment methods for recurrent basal cell carcinoma have failure rates of about 50%, cure rates have been reported at 96% when treated by Mohs micrographic surgery. In addition, its use is indicated for the treatment of primary basal cell carcinomas when they occur at sites known to have a high initial-treatment failure rate with traditional methods (e.g., periorbital area, nasolabial fold, nose-cheek angle, posterior cheek sulcus, pinna, ear canal, forehead, scalp, or tumors arising in a scar). Mohs micrographic surgery is also indicated for:
   • Tumors with poorly defined clinical borders.
   • Tumors with diameters more than 2 cm.
   • Tumors with histopathologic features showing morpheaform or sclerotic patterns.
   • Tumors arising in regions where maximum preservation of uninvolved tissue is desirable such as the eyelid, nose, finger, and genitalia.



2. Simple excision with frozen or permanent sectioning for margin evaluation. This traditional surgical treatment usually relies on surgical margins ranging from 3 mm to 10 mm, depending on the diameter of the tumor.[4]

   Tumor recurrence is not uncommon because only a small fraction of the total tumor margin is examined pathologically. Recurrence rate for primary tumors more than 1.5 cm in diameter is at least 12% within 5 years; if the primary tumor measures more than 3 cm, the 5-year recurrence rate is 23.1%. Primary tumors of the ears, eyes, scalp, and nose have recurrence rates ranging from 12.9% to 25%.




3. Electrodesiccation and curettage. This method is the most widely employed method for removing primary basal cell carcinomas. Although it is a quick method for destroying the tumor, adequacy of treatment cannot be assessed immediately since the surgeon cannot visually detect the depth of microscopic tumor invasion.

   Tumors with diameters ranging from 2 mm to 5 mm have a 15% recurrence rate after treatment with electrodesiccation and curettage. When tumors more than 3 cm are treated with electrodesiccation and curettage, a 50% recurrence rate should be expected within 5 years.




4. Cryosurgery. Cryosurgery may be considered for patients with small, clinically well-defined primary tumors. It is especially useful for debilitated patients with medical conditions that preclude other types of surgery.

   Absolute contraindications for cryosurgery include abnormal cold tolerance, cryoglobulinemia, cryofibrinogenemia, Raynaud disease (only for treatment of lesions on hands and feet), and platelet deficiency disorders. Morphea or sclerosing basal cell carcinoma should not be treated by cryosurgery. Relative contraindications to cryosurgery include tumors of the scalp, ala nasi, nasolabial fold, tragus, postauricular sulcus, free eyelid margin, upper lip vermillion border, and lower legs. Caution should also be used before treating nodular ulcerative neoplasia more than 3 cm, carcinomas fixed to the underlying bone or cartilage, tumors situated on the lateral margins of the fingers and at the ulnar fossa of the elbow, or recurrent carcinomas following surgical excision. Significant morbidity is associated with the use of cryosurgery.

   Edema is common following treatment, especially around the periorbital region, temple, and forehead. Treated tumors usually exude necrotic material after which an eschar forms and persists for about 4 weeks. Permanent pigment loss at the treatment site is unavoidable. Atrophy and hypertrophic scarring have been reported as well as instances of motor and sensory neuropathy.




5. Radiation therapy. Radiation therapy is a logical treatment choice, particularly for patients with primary lesions requiring difficult or extensive surgery (e.g., eyelids, nose, or ears).[5] Radiation therapy eliminates the need for skin grafting when surgery would result in an extensive defect. Cosmetic results are generally good to excellent with a small amount of hypopigmentation or telangiectasia in the treatment port. Radiation therapy can also be used for lesions that recur after a primary surgical approach.[6]

   Radiation therapy is contraindicated for patients with xeroderma pigmentosum, epidermodysplasia verruciformis, or the basal cell nevus syndrome because it may induce more tumors in the treatment area.




6. Carbon dioxide laser. This method is most frequently applied to the superficial type of basal cell carcinoma. It may be considered when a bleeding diathesis is present, since bleeding is unusual when this laser is used.



7. Topical fluorouracil (5-FU). This method may be helpful in the management of selected patients with superficial basal cell carcinomas. Careful and prolonged follow-up is required, since deep follicular portions of the tumor may escape treatment and result in future tumor recurrence.[7]



8. Interferon alpha. Several early studies have shown variable responses of basal cell carcinoma to intralesional interferon alpha.[8,9] Further reports are awaited until this treatment may be recommended for routine clinical practice.



9. Photodynamic therapy.[10] Photodynamic therapy with photosensitizers may be effective treatment for patients with superficial epithelial skin tumors.[11]

Follow-up:

• Following treatment for basal cell carcinoma, patients should be clinically examined every 6 months for 5 years.[12] Thereafter, patients should be examined for recurrent tumors or new primary tumors at yearly intervals. Of the patients who develop a basal cell carcinoma, 36% will develop a second primary basal cell carcinoma within the next 5 years. Early diagnosis and treatment of recurrent basal cell carcinomas or another primary basal cell carcinoma is desirable since the treatment of the disease in its earliest stages results in less patient morbidity.

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with basal cell carcinoma of the skin. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References

1. Preston DS, Stern RS: Nonmelanoma cancers of the skin. N Engl J Med 327 (23): 1649-62, 1992.  [PUBMED Abstract]
   
   
2. Malhotra R, Huilgol SC, Huynh NT, et al.: The Australian Mohs database, part II: periocular basal cell carcinoma outcome at 5-year follow-up. Ophthalmology 111 (4): 631-6, 2004.  [PUBMED Abstract]
   
   
3. Thomas RM, Amonette RA: Mohs micrographic surgery. Am Fam Physician 37 (3): 135-42, 1988.  [PUBMED Abstract]
   
   
4. Abide JM, Nahai F, Bennett RG: The meaning of surgical margins. Plast Reconstr Surg 73 (3): 492-7, 1984.  [PUBMED Abstract]
   
   
5. Caccialanza M, Piccinno R, Moretti D, et al.: Radiotherapy of carcinomas of the skin overlying the cartilage of the nose: results in 405 lesions. Eur J Dermatol 13 (5): 462-5, 2003 Sep-Oct.  [PUBMED Abstract]
   
   
6. Lovett RD, Perez CA, Shapiro SJ, et al.: External irradiation of epithelial skin cancer. Int J Radiat Oncol Biol Phys 19 (2): 235-42, 1990.  [PUBMED Abstract]
   
   
7. Dabski K, Helm F: Topical chemotherapy. In: Schwartz RA: Skin Cancer: Recognition and Management. New York, NY: Springer-Verlag, 1988, pp 378-389. 
   
   
8. Greenway HT, Cornell RC, Tanner DJ, et al.: Treatment of basal cell carcinoma with intralesional interferon. J Am Acad Dermatol 15 (3): 437-43, 1986.  [PUBMED Abstract]
   
   
9. Padovan I, Brodarec I, Ikić D, et al.: Effect of interferon in therapy of skin and head and neck tumors. J Cancer Res Clin Oncol 100 (3): 295-310, 1981.  [PUBMED Abstract]
   
   
10. Wilson BD, Mang TS, Stoll H, et al.: Photodynamic therapy for the treatment of basal cell carcinoma. Arch Dermatol 128 (12): 1597-601, 1992.  [PUBMED Abstract]
    
    
11. Wolf P, Rieger E, Kerl H: Topical photodynamic therapy with endogenous porphyrins after application of 5-aminolevulinic acid. An alternative treatment modality for solar keratoses, superficial squamous cell carcinomas, and basal cell carcinomas? J Am Acad Dermatol 28 (1): 17-21, 1993.  [PUBMED Abstract]
    
    
12. Rowe DE, Carroll RJ, Day CL Jr: Long-term recurrence rates in previously untreated (primary) basal cell carcinoma: implications for patient follow-up. J Dermatol Surg Oncol 15 (3): 315-28, 1989.  [PUBMED Abstract]
    
    

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