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激光辅助联合化疗的疗效和安全性:5-氟尿嘧啶和顺铂治疗基底细胞癌的随访研究。

Efficacy and safety of laser-assisted combination chemotherapy: A follow-up study of treatment with 5-fluorouracil and cisplatin for basal cell carcinoma.

机构信息

Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.

出版信息

Lasers Surg Med. 2022 Jan;54(1):113-120. doi: 10.1002/lsm.23497. Epub 2021 Dec 5.

Abstract

BACKGROUND AND OBJECTIVES

There is a growing need for effective topical treatments for basal cell carcinoma (BCC). By altering the skin barrier, ablative fractional lasers (AFLs) enhance cutaneous uptake of the synergistic chemotherapeutic agents, cisplatin, and 5-fluorouracil (5-FU). In our recently reported clinical trial, AFL-assisted delivery of cisplatin and 5-FU showed favorable short-term clearance rates of 95% with good cosmetic results at 3 months. This follow-up study assessed sustained tumor clearance, safety, and cosmesis in the same patient cohort, observed 6- and 12-months posttreatment.

MATERIALS AND METHODS

This follow-up study assessed AFL-assisted cisplatin and 5-FU in low-risk BCC. Among the 18/19 patients who achieved clinical tumor clearance in our 3-months primary trial, all were included for a 6-months follow-up. At 12 months, 17/19 were included due to one 6-month residual. During follow-up visits, treated areas were evaluated for signs of recurrent tumour by clinical inspection and optical coherence tomography (OCT). Residual tumors were confirmed histologically. Cosmetic outcome was evaluated at both follow-up visits by patients and physicians.

RESULTS

Overall, complete tumor clearance was 89% (17/19) and 79% (15/19) at 6 and 12 months, respectively. Clearance rate for superficial BCCs (sBCCs) 1 year after treatment was 100% (6/6) and lower for nodular BCC (nBCC) at 69% (9/13). Among recurrent tumors, 67% (2/3) had received only a single treatment and all were of the nodular subtype, situated in the head and neck area. All histologically confirmed BCC recurrences were identified by OCT. Cosmetic outcomes were similarly rated "good" or "excellent" by patients and evaluators (p = 0.289 and p = 0.250). Treatment-related local skin reactions were mild and tolerable, consisting of persisting erythema in two patients at the end of the study. Dyspigmentation was commonly observed at both follow-up visits, while the appearance of scarring resolved in the majority of patients between 6 months (56%; 10/18) and 12 months (76%; 13/17).

CONCLUSION

AFL-assisted cisplatin + 5-FU in double sessions represents an acceptable and safe treatment strategy for low-risk sBCC, while clearance rates following single treatment or for nBCC seem inferior. This intensified topical strategy may be best suited to cases of multiple lesions or in instances where surgical excision or extended courses of at-home therapy is challenging.

摘要

背景与目的

对于基底细胞癌(BCC),人们越来越需要有效的局部治疗方法。光消融性微剥脱点阵激光(AFL)通过改变皮肤屏障,增强协同化疗药物顺铂和 5-氟尿嘧啶(5-FU)的皮肤摄取。在我们最近报告的临床试验中,AFL 辅助递送顺铂和 5-FU 在 3 个月时显示出 95%的良好短期清除率和良好的美容效果。本随访研究评估了同一患者队列在治疗后 6 个月和 12 个月的持续肿瘤清除率、安全性和美容效果。

材料与方法

本随访研究评估了 AFL 辅助顺铂和 5-FU 治疗低危 BCC。在我们的 3 个月主要试验中,18/19 例达到临床肿瘤清除的患者均被纳入 6 个月的随访。在 12 个月时,由于 1 例 6 个月时仍有残留,17/19 例患者被纳入。在随访期间,通过临床检查和光学相干断层扫描(OCT)评估治疗区域是否有肿瘤复发的迹象。残留肿瘤通过组织学确认。在两次随访时,由患者和医生评估美容效果。

结果

总的来说,17/19 例患者在治疗后 6 个月和 12 个月时的完全肿瘤清除率分别为 89%和 79%。治疗后 1 年,浅表性 BCC(sBCC)的清除率为 100%(6/6),结节性 BCC(nBCC)的清除率较低,为 69%(9/13)。在复发性肿瘤中,67%(2/3)仅接受了一次治疗,且均为结节型,位于头颈部。所有经组织学证实的 BCC 复发均通过 OCT 检测到。患者和评估者同样将美容效果评为“好”或“优”(p=0.289 和 p=0.250)。与治疗相关的局部皮肤反应轻微且可耐受,2 例患者在研究结束时仍有持续红斑。在两次随访时均常见色素沉着异常,而大多数患者的疤痕外观在 6 个月(56%;10/18)和 12 个月(76%;13/17)时得到改善。

结论

AFL 辅助两次给予顺铂+5-FU 是一种安全且可接受的治疗低危 sBCC 的方法,而单次治疗或 nBCC 的清除率似乎较低。这种强化的局部治疗策略可能最适合多发性病变或手术切除或家庭治疗延长疗程有困难的情况。

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