Methods
Study Design
Institutional review board approval was received from Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects (New York, New York). We performed a retrospective review of medical records of patients diagnosed by RCM and treated with a 1064-nm Nd:YAG laser, as an alternative to surgery, at the Mount Sinai Faculty Practice Associates between March 2018 and August 2018. Included in this pilot study are 17 lesions in 16 patients.
Inclusion Criteria
Patients were enrolled based on the following criteria: BCCs diagnosed by clinical and dermoscopic examination followed by RCM imaging; treatment with the 1064-nm Nd:YAG laser, because of patients’ preference for this modality over surgery, superficial radiation therapy, topical regimens, and other laser therapies that require more visits; eligibility by PI included limited clinical ulceration or bleeding (or both) and a safe distance from the eye when wearing an external eye shield (ie, outside the orbital rim). The PI performed a detailed and thorough clinical and dermoscopic skin examination, enabling early detection of the BCCs. Basal cell carcinomas were not included if they exhibited rolled borders, visible ulceration, or oozing growths that allowed for treatment of less-advanced tumors. The PI utilized a clinical and dermoscopic color wheel algorithm to identify suspicious lesions combined with RCM for diagnostic confirmation.29
Two of 17 lesions that did not present as early lesions were included in the study due to patient refusal of surgery or radiation. We consider more advanced tumors to be exophytic, bleeding, crusting, nonhealing ulcerative growths. Patients who had received prior laser treatment with the PI’s PDL with fractional laser protocol with subsequent recurrence at the treatment site were included in the study. Lesions receiving concurrent or prior nonsurgical therapy, such as a topical immunomodulator or oral hedgehog inhibitor, were excluded.
Treatment Protocol
All patients attended the private clinic at Mount Sinai Hospital of a pigmented lesion expert (O.M.) for routine skin cancer screening. Patients with lesions suspicious for BCC—based on clinical and dermoscopic features—were offered tissue biopsy or RCM. Following diagnosis with RCM, treatment options were discussed, and patients were offered laser treatment when surgical options were declined. Topical treatment options were not emphasized because they require weeks of application to be effective and have been studied mainly in superficial BCC management.30,31
Patients with early lesions were offered either the PDL with fractional laser or Nd:YAG protocol, with their understanding that the Nd:YAG laser protocol would likely involve fewer treatments but a higher likelihood of residual hyperpigmentation or potential scarring (or both) than the more gentle PDL with fractional laser treatment.
All lesions on the face were premarginated using OCT by obtaining central scans and 4 additional scans—above, below, to the left, and to the right of the lesion—to ensure targeted laser treatment with desirable cosmetic results. Facial premargination scans were mandatory; however, patients with lesions on the trunk or extremities were offered the option to have pretreatment margination as an out-of-pocket expense. We did not require premargination of lesions on the body because of their location on less cosmetically critical areas. Most patients declined the optional scans.
This can be considered analogous to the situation in which more insurers reimburse Mohs surgery for cosmetically challenging areas such as the head and neck, while limiting reimbursement for treatment of lesions on the trunk and upper extremities to simple excision. Given cosmetic concerns on the head and neck compared to the body, some patients found it acceptable to have slightly increased dyschromia over a broader treatment area of non–cosmetically critical locations on the body.
Optical coherence tomography imaging was required for all anatomic locations at follow-up visits to detect residual disease or confirm clearance. All patients were given thorough information about the treatment, additional costs, treatment alternatives, potential adverse effects, and complications.
Clinical and dermoscopic images were obtained at every visit using a commercially available point-and-shoot digital single-lens reflex camera for clinical photographs, with an attached DermLite DL3N (3Gen) dermatoscope for all contact polarized dermoscopic photography.
Laser treatment was carried out with the 1064-nm Nd:YAG laser. Setting ranges were similar to previously published studies that used the 1064-nm Nd:YAG laser to treat BCCs (spot sizes, 5–6 mm; fluences, 125–140 J/cm2; pulse durations, 7–10 milliseconds).26-28 The exact settings and number of passes were tailored to the individual lesion based on skin type, anatomic location, extent of tumor involvement by depth (and margin on facial lesions), and posttreatment dermoscopic confirmation of clearance; additionally, for facial lesions, OCT confirmation of clearance.
Laser treatment was provided by the PI. Patients were instructed to apply a thick emollient (ie, formulation of petrolatum or 100% petrolatum) after treatment and until the area healed.
All tumors received 1 to 3 treatments at an interval of 1 to 2 months. The treatment end point was complete clearance, judged by absence of skin cancer clinically, dermoscopically, and on OCT scan. More specifically, the PI looked for vascular changes and echogenic changes on OCT consistent with tumor clearance as well as dermoscopic disappearance of recognized BCC features.
Patients were asked to return for follow-up visits 2 months after the final treatment to evaluate tumor clearance. They were asked to return subsequently every 6 to 12 months for routine care and long-term follow-up.