目的:对于有效的局部治疗基底细胞癌(BCC)的需求日益增长。通过改变皮肤屏障,烧蚀分数激光(AFL)增强协同化学治疗剂的皮肤摄取,顺铂,和5-氟尿嘧啶(5-FU)。在我们最近报道的临床试验中,AFL辅助的顺铂和5-FU的短期清除率为95%,在3个月时具有良好的美容效果。这项随访研究评估了持续的肿瘤清除,安全,和同一个病人队列中的宇宙,治疗后6个月和12个月观察。
方法:这项随访研究评估了低风险BCC中AFL辅助顺铂和5-FU。在我们为期3个月的初级试验中获得临床肿瘤清除的18/19患者中,全部纳入6个月随访.12个月时,由于一个6个月的残差,包括了17/19。在后续访问中,通过临床检查和光学相干断层扫描(OCT)评估治疗区域的复发肿瘤征象。组织学上确认残留肿瘤。在患者和医生的两次随访中评估美容结果。
结果:总体而言,6个月和12个月时肿瘤完全清除率分别为89%(17/19)和79%(15/19),分别。治疗后1年浅表BCC(sBCC)的清除率为100%(6/6),结节BCC(nBCC)的清除率为69%(9/13)。在复发性肿瘤中,67%(2/3)只接受过一次治疗,全部为结节亚型,位于头部和颈部区域。所有组织学证实的BCC复发均通过OCT鉴定。患者和评估人员对美容结果进行了类似的评级为“良好”或“优秀”(p=0.289和p=0.250)。治疗相关的局部皮肤反应轻微且可耐受,在研究结束时,两名患者持续出现红斑。在两次随访中通常都观察到色素沉着,而大多数患者在6个月(56%;10/18)至12个月(76%;13/17)之间出现疤痕。
结论:AFL辅助顺铂+5-FU双疗程代表了低风险sBCC可接受且安全的治疗策略,而单次治疗或nBCC的清除率似乎较差。这种强化的局部策略可能最适合于多发性病变的情况,或者在手术切除或家庭治疗的延长疗程具有挑战性的情况下。
OBJECTIVE: 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.
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).
CONCLUSIONS: 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.