Miller B H, Shavin J S, Cognetta A, Taylor R J, Salasche S, Korey A, Orenberg E K
Dermatology Service, University of Arizona Health Sciences Center, USA.
J Am Acad Dermatol. 1997 Jan;36(1):72-7. doi: 10.1016/s0190-9622(97)70328-1.
To develop a nonsurgical treatment alternative for basal cell carcinomas (BCCs), we evaluated intralesional sustained-release chemotherapy with 5-fluorouracil/epinephrine injectable gel (5-FU/epi gel).
To optimize the dose and treatment schedule, we compared the safety, tolerance, and efficacy of six treatment regimens of 5-FU/epi gel in patients with BCCs.
Two doses and four treatment schedules of 5-FU/epi gel were compared in an open-label, randomized study of 122 patients with biopsy-proven BCCs. One BCC per patient was treated for up to 4 to 6 weeks, then observed for 3 months at which time the tumor site was completely excised for histologic examination.
Overall, 91% of evaluable treated tumors (106 of 116) in all regimens had histologically confirmed complete tumor resolution. No clinically significant treatment-related systemic adverse events occurred. The best response rate, tolerance, and patient compliance with assigned dose were in patients receiving 0.5 ml of 5-FU/epi gel three times a week for 2 weeks. The complete response rate based on histologic assessment in this group was 100%.
Results demonstrate that treatment of BCC with 5-FU/epi gel is both safe and effective, may result in histologically confirmed complete response rates comparable to surgery, and provides a nonsurgical treatment alternative in selected patients.
为了开发一种非手术治疗基底细胞癌（BCC）的替代方法，我们评估了使用5-氟尿嘧啶/肾上腺素注射凝胶（5-FU/epi凝胶）进行瘤内缓释化疗。
为了优化剂量和治疗方案，我们比较了5-FU/epi凝胶的六种治疗方案在基底细胞癌患者中的安全性、耐受性和疗效。
在一项针对122例经活检证实为基底细胞癌患者的开放标签随机研究中，比较了5-FU/epi凝胶的两种剂量和四种治疗方案。每位患者的一个基底细胞癌接受长达4至6周的治疗，然后观察3个月，此时将肿瘤部位完全切除进行组织学检查。
总体而言，所有方案中91%的可评估治疗肿瘤（116例中的106例）在组织学上证实肿瘤完全消退。未发生临床上显著的与治疗相关的全身性不良事件。最佳反应率、耐受性和患者对指定剂量的依从性出现在每周接受3次0.5 ml 5-FU/epi凝胶治疗，持续2周的患者中。该组基于组织学评估的完全缓解率为100%。
结果表明，用5-FU/epi凝胶治疗基底细胞癌既安全又有效，可能导致组织学证实的完全缓解率与手术相当，并为选定患者提供了一种非手术治疗选择。
