Presented by

Robert S. Stern, M.D.

at theSeptember 10, 2003

meeting of the

Dermatologic and Ophthalmic Drugs Advisory Committee

Recurrence Rates in Primary Basal Cell Carcinoma According to

Treatment Modality

Jean C. Lee, Harvard Medical Student

Treatment Modalities for Basal Cell Carcinoma

Usually reserved for small (<2cm), well-defined tumors on low risk areas, performed with 4-5 mm margins

• Surgical Excision

• Cryosurgery

• Curettage and Electrodesiccation

• Mohs' Micrographic Surgery

Usually reserved for tumors < 1 cm on cosmetically less sensitive areasUsually for low risk

lesions on trunk or extremities

Reserved for high risk tumors, including:Size 5-10mm in H zone of face, >10 mm on rest of face, or > 20 mm on bodyTumors with no distinct margins High risk histology (morpheaform or infiltrative BCC)Persistently recurrent tumors

Predictors of BCC Recurrence• Size of tumor• Clinically indistinct margins• Location (embryonic fusion planes provide little

resistance to tumor growth)• Histologic type (morpheaform, micronodular,

sclerosing, or mixed type)• Perineural invasion• Recurrent tumor• Previously irradiated tumor• Skill of the operator

Defining Recurrence Rates

• Raw recurrence rate: total number of recurrences divided by the total number of tumors treated

• Strict recurrence rate: total number of patients with recurrence divided by number of treated patients observed for at least 5 years

• Life table cumulative 5 year recurrence rate: Adjusts recurrence rates for the number of patients lost to follow-up each year

BCC recurrence rates for Mohs’ Surgery

Study Comments No of Patients Cumm Recurr Rate (%) < 5 yr

Cumm Recurr Rate (%) 5yr

Julian and Bowers, 1997

1981-1995 145 0.7- 0.8

Mohs, et al, 1988 Ear 1032 1.3- 1.7

Mohs, 1986 Eyelid 1483 0.5- 0.6

Lindgren, et al 2000 Eyelid, medial canthus

Mean f/u 49 mos

64 5*

Roenigk et al, 1986 F/u 2-4 yrs 367** 1.4*

Robins, 1981 1483** 1.8*

Mohs, 1978 6187** 0.7*

Data from Thissen M et al. “A Systematic Review of Treatment Modalities for Primary Basal Cell Carcinomas”, Archives of Dermatology 1999;135(10):1177-1183.”

* Represents raw recurrence rate

**Represents total number of tumors, not number of patients

BCC recurrence rates for Surgical Excision

Study Comments No of Patients

Cumm Recurr Rate (%) < 5 yr

Cumm Recurr Rate (%) 5yr

Baur et al, 1977 443 8.0

Germann et al, 1992 272 3.2

Silverman et al, 1992 1955-1982 588 4.8

Werlinger et al, 2002 Private practice 90** 1.7

Van der Meer, 2001 Frozen section analysis

Mean f/u 59 mos

108 1.9*

Spraul et al, 2000 Periocular

Mean f/u 31.3 mos

141** 11.8* pos margins

2.3* neg margins

Rowe et al, 1989 Metanalysis (27) 5560** 2.8*

Rowe et al, 1989 Metanalysis (10) 2606** 10.1*

*Represents raw recurrence rate

**Represents total number of tumors, not number of patients

BCC recurrence rates for Cryosurgery

Study Comments No of Patients

Cumm Rate (%) < 5 yr

Cumm Rate (%) 5yr

Nordin et al, 1997 Nose, >10mm 61 1.6-2.0

Lindgren and Larko, 1997

Eyelid 214 0

Anders et al 1995 Eyelid 254 3.5

Fraunfelder et al, 1984 Eyelid (<=10mm)

Eyelid (> 10mm)

181

88

4.7

16.5

Kuflik and Gage, 1991 Single provider 628* 1.0

Rowe et al, 1989 Metanalysis (13) 2462** 3.7*

Rowe et al, 1989 Metanalysis (1) 269** 7.5*

* Represents raw recurrence rate

**Represents total number of tumors, not number of patients

BCC recurrence rates for Curettage and Electrodesiccation

Study Comments No of Patients

Cumm Recurr Rate (%) < 5 yr

Cumm Recurr Rate (%) 5yr

Kopf et al, 1977 1958-1962, trainees

1970

1962-1973, certified

597

91

210

18.8

9.6

5.7

Launis, 1993 356 6.2*

McDaniel, 1983 Curettage only 88 4.3- 8.5

Welinger et al, 2002 Private practice 102** 3.7

Nordin, 1999 Curettage-Cryosurg

External ear

39** 2.6

Nordin et al, 1997 Curettage-Cryosurg

Nose

50 2.0

Silverman et al, 1991 1955-1982, includes lesions > 10 mm

2258** 8.6 (low risk)

12.9 (med risk)

17.5 (high risk)

Rowe et al, 1989 Metanalysis (12) 3664** 4.7*

Rowe et al, 1989 Metanalysis (10) 3573** 7.7*

Dubin and Kopf, 1983 Trainees 758** 26.0

Summary• The range of recurrence rates appear to be similar for

most physical modalities, including surgical excision, cryosurgery, curettage and electrodesiccation, curettage and cryosurgery, and curettage alone.

• For follow-up period of 3-4 years, this rate falls between 3 to 5%

• For a follow-up period of 5 years or more, this rate is about double, approximately 5 to 12%

• Recurrence rates for tumors treated by Moh’s Micrographic Surgery appear to be lower at all points in time and averages between 1-2%.

Conclusions• The key predictors of tumor recurrence are size

and site of the lesion, histology of tumor, and skill of the operator

• All of the non-Mohs' modalities have roughly equal and excellent cure rates for BCC without high-risk prognostic factors

• There is an increased risk of BCC recurrence regardless of treatment modality with increasing time. This underscores the importance of long term follow-up for evaluating the effectiveness of a therapy.