Clinical TrialSurgical excision versus Mohs’ micrographic surgery for basal cell carcinoma of the face: A randomised clinical trial with 10 year follow-up☆
Introduction
Basal cell carcinoma (BCC) is the most common form of cancer among Caucasians worldwide. The incidence has increased with 5.5% per year over the past decades and is predicted to continue rising [1]. In the Netherlands, the lifetime risk of developing a BCC is one in every 5–6 persons [2]. The disease related mortality is very low due to the low rates of metastatic disease [3]. However, morbidity can be high due to local tissue destruction, especially since most tumours occur in functional areas such as the head and neck [4]. Although many therapeutic options are available today, standard surgical excision (SE) is still the most common form of treatment for BCCs [4]. Mohs’ micrographic surgery (MMS) is a specialised surgical technique and its use is increasing [5]. The main difference between both treatments is the method of histological margin examination. In standard SE, surgical margins are mostly examined on random vertical sections, the so-called bread loaf-technique. In MMS, the specimen is flattened and sliced horizontally. This offers the possibility to examine 100% of the resection margins, in contrast to the small percentage of margin control in SE. Therefore, MMS should theoretically lead to fewer recurrences with maximal sparing of surrounding healthy tissue [6].
We previously showed that, after a period of 5 years, treatment with MMS led to significantly fewer recurrences than SE in recurrent facial BCC [7]. However, consensus on treatment is difficult to reach since prospective randomised studies are rare [4]. Furthermore, most non-comparative studies only report 5 year recurrence rates, but there have been reports that recurrences may develop even later [7], [8], [9], [10], [11], [12], [13]. BCC located in the H-zone of the face, with positive excision margins in previous resections or with an aggressive histological growth pattern show higher recurrence rates [14], [15].
The goal of this study is to provide evidence on the long-term efficacy of MMS and SE in high risk facial BCC. In 1999, a randomised controlled trial was initiated and we previously reported the results after 2 and 5 years of follow-up [7], [16]. To our knowledge, this is the first randomised controlled trial on treatment of BCC which provides data that enable estimation of recurrence probability after a 10-year follow-up period.
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Material and methods
A prospective randomised controlled trial was started at the Maastricht University Medical Centre in 1999, comparing MMS with SE in facial BCC [7], [16]. The primary outcome of this trial was recurrence of tumour. Patient selection and techniques were described in the previous publications on this trial, but will be briefly described here [7], [16].
Primary basal-cell carcinomas
Between October 1999 and January 2001, 408 pBCCs in 374 patients were randomly assigned to treatment with SE or MMS (Fig. 1). 11 allocated patients were not treated. A total of 363 patients with 397 tumours were treated. Of the 374 randomised patients, 30 patients had two and two patients had three tumours. Treatment characteristics, nature and prevalence of complications were described previously [7], [16].
Baseline characteristics were comparable between the randomised groups (Table 1). The
Discussion
To our knowledge, this is the first prospective randomised study that compares SE and MMS for treatment of high risk primary and recurrent facial BCC with a long-term follow-up of 10 years. We observed substantial differences in estimated 10-year recurrence rates of 7.8% for pBCC and 9.6% for rBCC, favouring MMS. Our results show that, compared to SE, MMS is more effective in preventing recurrences for both high-risk pBCC and rBCC in the face.
Several prospective, non-randomised studies reported
Contributors
KM, NK-S, JO, PN, GK, PS, CD and MN took part in designing the protocol and literature search. NK-S, KM and EvL coordinated the study. NK-S, MR and EvL took part in the follow-up of patients. EvL and MR took part in data collection. All authors took part in writing of the report. NK-S, KM, EvL, JO and GK took part in enrolment of patients. EvL and PN were involved in the statistical analysis. All authors reviewed and approved the final version of the manuscript.
Conflict of interest statement
None declared.
Acknowledgements
We thank the patients who agreed to participate in this study. We thank all dermatologists, nurse practitioners, nursing staff and employees of the secretarial department of the participating hospitals. The study was financed by ‘the Netherlands Organization for Scientific Research ZonMW’, a governmental institution financing research to improve health care in the Netherlands.
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Funding: The study was financed by ‘the Netherlands Organization for Scientific Research ZonMW’. Clinical trial registration: This study is registered as an International Standard Randomised Controlled Trial (number ISRCTN65009900).
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Both authors contributed equally to the work.