Surgical excision versus Mohs'
micrographic surgery for primary and recurrent basal-cell
carcinoma of the face: a prospective randomised controlled trial
with 5-years' follow-up
Dr Klara
Mosterd MD The Lancet
Oncology, Volume 9, Issue 12, Pages 1149 - 1156, December
2008
Background
Basal-cell carcinoma (BCC) is the
most common form of skin cancer and its incidence is
still rising worldwide. Surgery is the most
frequently used treatment for BCC, but large
randomised controlled trials with 5-year follow-up
to compare treatment modalities are rare. We did a
prospective randomised controlled trial to compare
the effectiveness of surgical excision with Mohs'
micrographic surgery (MMS) for the treatment of
primary and recurrent facial BCC.
Methods
Between Oct 5, 1999, and Feb 27,
2002, 408
primary BCCs (pBCCs) and
204
recurrent BCCs (rBCCs) in patients from seven
hospitals in the Netherlands were randomly assigned
to surgical excision or MMS. Randomisation and
allocation was done separately for both groups by a
computer-generated allocation scheme. Tumours had a
follow-up of 5 years. Analyses were done on an
intention-to-treat basis. The primary outcome was
recurrence of carcinoma, diagnosed clinically by
visual inspection with histological confirmation.
Secondary outcomes were determinants of failure and
cost-effectiveness.
Findings
Of the 397 pBCCs that were
treated, 127 pBCCs in 113 patients were lost to
follow-up.
Of the 11 recurrences that occurred in patients with
pBCC, seven (4·1%) occurred in patients treated with
surgical excision and four (2·5%) occurred in
patients treated with MMS. Of the 202 rBCCs that
were treated, 56 BCCs in 52 patients were lost to
follow-up. Two BCCs (2·4%) in two patients treated
with MMS recurred, versus ten BCCs (12·1%) in ten
patients treated with surgical excision. The
difference in the number of recurrences between
treatments was not significant for pBCC, but
significantly favoured MMS in rBCC. In pBCC,
Cox-regression analysis showed no significant
effects from risk factors measured in the study. In
rBCC, aggressive histological subtype was a
significant risk factor for recurrence in the
Cox-regression analysis. For pBCC, total treatment
costs were €1248 for MMS and €990 for surgical
excision, whereas for rBCC, treatment costs were
€1284 and €1043, respectively. Dividing the
difference in costs between MMS and surgical
excision by their difference in effectiveness leads
to an incremental cost-effectiveness ratio of
€23 454 for pBCC and €3171 for rBCC.
Interpretation
MMS is preferred over surgical
excision for the treatment of facial rBCC, on the
basis of significantly fewer recurrences after MMS
than after surgical excision. However, because there
was no significant difference in recurrence of pBCC
between treatment groups, treatment with surgical
excision is probably sufficient in most cases of
pBCC.
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