Department of Skin and Venereal Diseases, Medical School, University of Ioannina, GR-45110 Ioannina, Greece.
Acta Derm Venereol. 2014 Jan;94(1):38-44. doi: 10.2340/00015555-1609.
Cryosurgery and topical imiquimod are established mono-therapies for superficial basal cell carcinoma (BCC) but are often insufficient for thicker BCCs. We present here a phase III, prospective, interventional, single-arm (cases only) study (trial registration: NCT01212562) to evaluate the feasibility and efficacy of cryosurgery (liquid nitrogen, open spray, 2 × 15 s; day 14) during 5 weeks' imiquimod ("immunocryosurgery") for primary, non-superficial BCC, ≤ 2 cm in diameter. Ninety-one consecutive patients with 134 basal cell carcinoma were evaluated. A total of 83 patients (124 tumours) started treatment, and 79 patients (119 tumours) completed at least one cycle of immunocryosurgery (feasibility: 95.2%; follow-up: 18-60 months). The efficacy after one treatment cycle was 95 ± 2% stable complete remissions (116/119 tumours cleared, 3/116 tumours relapsed: 6 treat-ment "failures"). Neither tumour size (p = 0.865) nor localization (p = 0.233) predicted outcome. Repeat immunocryosurgery controlled 5/6 treatment failures (overall efficacy: 99%). Lack of a conventionally treated control group is a limitation of this study. However, the results show a high therapeutic efficacy of immunocryosurgery in a large series of primary non-superficial BCC.
冷冻疗法和局部咪喹莫特已被确立为治疗浅表基底细胞癌 (BCC) 的单一疗法，但对于较厚的 BCC 往往不够有效。我们在此报告了一项 III 期前瞻性干预性单臂（仅病例）研究（试验注册：NCT01212562），以评估冷冻疗法（液氮，开放式喷雾，2×15 秒；第 14 天）在 5 周内咪喹莫特（“免疫冷冻疗法”）治疗原发性、非浅表性 BCC（直径≤2cm）的可行性和疗效。91 例连续患者的 134 例基底细胞癌得到了评估。共有 83 例患者（124 个肿瘤）开始治疗，79 例患者（119 个肿瘤）至少完成了一个周期的免疫冷冻疗法（可行性：95.2%；随访：18-60 个月）。一个治疗周期后的疗效为 95±2%的稳定完全缓解（116/119 个肿瘤清除，3/116 个肿瘤复发：6 个治疗“失败”）。肿瘤大小（p=0.865）和定位（p=0.233）均不能预测结果。重复免疫冷冻疗法控制了 5/6 个治疗失败（总疗效：99%）。缺乏常规治疗对照组是本研究的一个局限性。然而，结果显示免疫冷冻疗法在一大系列原发性非浅表性 BCC 中具有很高的治疗疗效。
