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.

Purpose: To address the safety and feasibility of adjuvant single-dose upper urinary tract instillation of mitomycin (ASDM) immediately after therapeutic ureteroscopy for upper tract urothelial carcinoma (UTUC) and to compare urothelial (ipsilateral or bladder) recurrence rates in the ASDM group and controls. Materials and Methods: Between April 2015 and August 2018, 52 patients affected by UTUC were treated by endoscopic ablation, of whom 26 were selected for ASDM. Clinical and perioperative data and 30-day complications were recorded. Urothelial recurrence-free survival (URFS) was evaluated with second-look ureteroscopy (URS) and CT scan/URS every 6 months. Results: ASDM was administered through a Single-J (19/25, 76%) or a Double-J (6/25, 24%) in 25/26 (96%) patients. Median follow-up was 18 months (IQR 10-29). The urothelial recurrence rate was 23.5% and 55.5% in the ASDM group and controls, respectively (p = 0.086). Mean URFS was 28.8 months in the ASDM group vs 18.8 months in controls (log-rank p = 0.067). On multivariate Cox regression, ASDM was associated with a 7.7-fold lower risk of urothelial recurrence (HR = 0.13; 95% CI 0.03-0.65; p = 0.01). Clavien grade ≤II complications occurred in 32% (8/25) and 30.7% (8/26) of the ASDM and control group, respectively (p = 0.9). Two Clavien III complications occurred in the ASDM group: bladder hematuria after concomitant transurethral resection of bladder and obstructive kidney failure in a single-kidney patient. Conclusions: ASDM was well tolerated after therapeutic URS. It appears to reduce the risk of urothelial recurrence in patients affected by low-grade UTUC without bladder tumor. Therefore, its use should be evaluated.