Department of Dermatology, Maastricht University Medical Centre+, Maastricht, Netherlands; GROW-School for Oncology and Reproduction, Maastricht University, Maastricht, Netherlands.
Department of Epidemiology, Maastricht University, Maastricht, Netherlands.
Lancet Oncol. 2022 Aug;23(8):1087-1096. doi: 10.1016/S1470-2045(22)00347-3. Epub 2022 Jul 11.
Punch biopsy is the gold standard for diagnosis and subtyping of basal cell carcinoma. The aim of this study was to assess whether use of optical coherence tomography (OCT), a non-invasive imaging tool, might avoid the need for biopsy.
In a multicentre, randomised, non-inferiority trial, patients (aged ≥18 years) with an indication for biopsy of a suspected basal cell carcinoma outside the H-zone (high-risk zone) of the face were randomly assigned (1:1) to receive either OCT or punch biopsy (regular care) via a web-based randomisation system. Patients were enrolled from three participating centres in the Netherlands: Maastricht University Medical Centre+, Catharina Hospital Eindhoven, and Zuyderland Medical Centre Heerlen. Stratification factors for randomisation were participating centre and the grade of clinical basal cell carcinoma suspicion (high vs low). The primary endpoint was the proportion of patients free from a recurrent or residual lesion (malignant or premalignant) 12 months after treatment. Modified intention-to-treat and per-protocol analyses were conducted, with a predefined non-inferiority margin of -10%. This trial is registered with ClinicalTrials.gov number, NCT03848078, and is complete.
Between Feb 25, 2019, and Sept 2, 2020, 598 patients were enrolled and randomly assigned to either the regular care group (n=299) or the OCT group (n=299). Data on the primary endpoint were available in 553 patients (n=268 in the regular care group, n=285 in the OCT group). After median follow-up of 12·7 months (IQR 11·2-14·1) in the OCT group and 12·6 months (10·8-14·3) in the regular care group, 253 (94%) of 268 patients in the OCT group and 266 (93%) of 285 patients in the regular care group were free from recurrent or residual lesions (malignant or pre-malignant) 12 months after treatment. According to our modified intention-to-treat analysis, the absolute difference (OCT vs regular care) was 1·07% (95% CI -2·93 to 5·06; one-sided p=0·30), with the lower limit of the 95% CI not exceeding the predefined non-inferiority margin of -10%. Per-protocol analyses led to proportions free from a residual or recurrent lesion (premalignant or malignant) of 95% (250 of 263) in the OCT group and 94% (262 of 278) in the regular care group, and an absolute difference of 0·81% (95% CI -2·98 to 4·60; one-sided p=0·34).
OCT-guided diagnosis and treatment of basal cell carcinoma is non-inferior to regular care punch biopsy. Implementation of OCT for diagnosis of basal cell carcinoma could reduce the number of consultations and invasive procedures.
The Netherlands Organization for Health Research and Development and Maurits en Anna de Kock Stichting.
打孔活检是诊断和细分基底细胞癌的金标准。本研究旨在评估是否可以使用光学相干断层扫描（OCT）这一非侵入性成像工具来避免活检的需要。
在一项多中心、随机、非劣效性试验中，有疑似基底细胞癌（面部 H 区[高危区]以外）活检指征的患者（年龄≥18 岁），通过基于网络的随机系统以 1:1 的比例随机分配接受 OCT 或打孔活检（常规护理）。患者来自荷兰的三个参与中心：马斯特里赫特大学医学中心+、埃因霍温 Catharina 医院和海尔伦 Zuyderland 医疗中心。随机因素为参与中心和临床基底细胞癌怀疑程度（高 vs 低）。主要终点是治疗后 12 个月无复发性或残留病变（恶性或癌前病变）的患者比例。进行了改良意向治疗和方案分析，预设的非劣效性边界为-10%。该试验在 ClinicalTrials.gov 注册，编号为 NCT03848078，现已完成。
2019 年 2 月 25 日至 2020 年 9 月 2 日期间，共纳入 598 名患者并随机分为常规护理组（n=299）或 OCT 组（n=299）。553 名患者（常规护理组 n=268，OCT 组 n=285）有主要终点数据。在 OCT 组的中位随访 12.7 个月（IQR 11.2-14.1）和常规护理组的 12.6 个月（10.8-14.3）后，OCT 组 268 名患者中有 253 名（94%）和常规护理组 285 名患者中有 266 名（93%）无复发性或残留病变（恶性或癌前病变）。根据我们的改良意向治疗分析，OCT 与常规护理之间的绝对差异为 1.07%（95%CI-2.93 至 5.06；单侧 p=0.30），95%CI 的下限未超过预设的非劣效性边界-10%。方案分析得出，OCT 组有 250 名（95%）患者无残留或复发性病变（癌前或恶性），常规护理组有 262 名（94%）患者无残留或复发性病变，绝对差异为 0.81%（95%CI-2.98 至 4.60；单侧 p=0.34）。
OCT 引导的基底细胞癌诊断和治疗与常规护理打孔活检一样有效。OCT 用于基底细胞癌的诊断可能会减少就诊和侵入性操作的次数。
荷兰健康研究与发展组织和 Maurits en Anna de Kock 基金会。
