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5%咪喹莫特乳膏治疗浅表性基底细胞癌后的复发率:欧洲一项为期5年的长期随访研究结论

Recurrence rate of superficial basal cell carcinoma following treatment with imiquimod 5% cream: conclusion of a 5-year long-term follow-up study in Europe.

作者信息

Gollnick Harald, Barona Carlos Guillén, Frank Ronald Gj, Ruzicka Thomas, Megahed Mosaad, Maus Joachim, Munzel Ullrich

机构信息

Clinic for Dermatology and Venereology, Otto von Guericke University of Magdeburg, Leipziger Str. 44, 39120 Magdeburg, Germany.

出版信息

Eur J Dermatol. 2008 Nov-Dec;18(6):677-82. doi: 10.1684/ejd.2008.0519. Epub 2008 Oct 27.

DOI:10.1684/ejd.2008.0519
PMID:18955210
Abstract

Imiquimod 5% cream is an immune response modifier approved for the treatment of superficial basal cell carcinoma (sBCC) once daily, 5 x per week for 6 weeks. This report reveals the final results of a 5-year follow-up study to evaluate the recurrence rate of sBCCs treated with imiquimod. As previously reported, 182 patients were enrolled in the study and 163 (89.6%) had no clinical evidence of their target sBCC at the 12-week post-treatment assessment; these 163 were followed for up to 5 years. During the follow-up period, 18 clinical recurrences occurred at the target tumour site, 8 and 10 of which occurred during the first 6 and 12 months of follow-up, respectively. The 5-year Kaplan-Meier and life-table estimates for sustained clinical clearance of those patients initially cleared were 84.5% and 86.9%, respectively, and 90.3% considering histology. The estimate of overall treatment success for all treated patients at the end of follow-up was 77.9% (80.9% considering histology). The data support clinical assessment of initial response as predictive of long-term outcome. Most of the recurrences occurred early, indicating that careful follow-up is important during the first year after treatment.

摘要

5%咪喹莫特乳膏是一种免疫反应调节剂,被批准用于治疗浅表性基底细胞癌(sBCC),每日一次,每周5次,共6周。本报告揭示了一项为期5年的随访研究的最终结果,以评估用咪喹莫特治疗的sBCC的复发率。如先前报道,182例患者入组该研究,163例(89.6%)在治疗后12周的评估中其目标sBCC无临床证据;这163例患者被随访长达5年。在随访期间,目标肿瘤部位发生了18例临床复发,其中8例和10例分别发生在随访的前6个月和12个月。最初清除的患者持续临床清除的5年Kaplan-Meier估计值和生命表估计值分别为84.5%和86.9%,考虑组织学则为90.3%。随访结束时所有接受治疗患者的总体治疗成功率估计为77.9%(考虑组织学为80.9%)。数据支持将初始反应的临床评估作为长期结果的预测指标。大多数复发发生在早期,这表明治疗后第一年的仔细随访很重要。

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