Mosterd Klara, Krekels Gertruud A M, Nieman Fred Hm, Ostertag Judith U, Essers Brigitte A B, Dirksen Carmen D, Steijlen Peter M, Vermeulen Anton, Neumann Ham, Kelleners-Smeets Nicole W J
Department of Dermatology, Maastricht University Medical Centre, Maastricht, Netherlands.
Lancet Oncol. 2008 Dec;9(12):1149-56. doi: 10.1016/S1470-2045(08)70260-2. Epub 2008 Nov 17.
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.
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. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN65009900.
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 (log-rank test chi(2) 0.718, p=0.397). 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 (log-rank test chi(2) 5.958, p=0.015). 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 euro1248 for MMS and euro990 for surgical excision, whereas for rBCC, treatment costs were euro1284 and euro1043, respectively. Dividing the difference in costs between MMS and surgical excision by their difference in effectiveness leads to an incremental cost-effectiveness ratio of euro23 454 for pBCC and euro3171 for rBCC.
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.
基底细胞癌（BCC）是最常见的皮肤癌形式，其在全球的发病率仍在上升。手术是治疗BCC最常用的方法，但很少有大型随机对照试验对治疗方式进行5年随访比较。我们进行了一项前瞻性随机对照试验，比较手术切除与莫氏显微外科手术（MMS）治疗原发性和复发性面部BCC的有效性。
1999年10月5日至2002年2月27日期间，荷兰七家医院的患者中，408例原发性BCC（pBCC）和204例复发性BCC（rBCC）被随机分配接受手术切除或MMS。两组分别通过计算机生成的分配方案进行随机化和分配。对肿瘤进行了5年随访。分析采用意向性分析。主要结局是癌复发，通过肉眼检查临床诊断并经组织学证实。次要结局是失败的决定因素和成本效益。本研究已注册为国际标准随机对照试验，编号为ISRCTN65009900。
在接受治疗的397例pBCC中，113例患者的127例pBCC失访。在pBCC患者发生的11例复发中，7例（4.1%）发生在接受手术切除的患者中，4例（2.5%）发生在接受MMS的患者中（对数秩检验χ² 0.718，p = 0.397）。在接受治疗的202例rBCC中，52例患者的56例BCC失访。接受MMS治疗的2例患者中有2例（2.4%）复发，而接受手术切除的10例患者中有10例（12.1%）复发（对数秩检验χ² 5.958，p = 0.015）。治疗之间复发数量的差异在pBCC中不显著，但在rBCC中显著有利于MMS。在pBCC中，Cox回归分析显示研究中测量的危险因素无显著影响。在rBCC中，侵袭性组织学亚型在Cox回归分析中是复发的显著危险因素。对于pBCC，MMS的总治疗成本为1248欧元，手术切除为990欧元，而对于rBCC，治疗成本分别为1284欧元和1043欧元。用MMS和手术切除之间的成本差异除以它们的有效性差异，得出pBCC的增量成本效益比为23454欧元，rBCC为3171欧元。
基于MMS后复发明显少于手术切除，对于面部rBCC的治疗，MMS优于手术切除。然而，由于治疗组之间pBCC的复发无显著差异，在大多数pBCC病例中，手术切除治疗可能就足够了。
