Orit Markowitz, MD; Corinna Eleni Psomadakis, MBBS Copy

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ORIGINAL RESEARCHPatient-Driven Management UsingSame-Day Noninvasive Diagnosis andComplete Laser Treatment of BasalCell Carcinomas: A Pilot StudycopyOrit Markowitz, MD; Corinna Eleni Psomadakis, MBBS ovel imaging modalities such as reflectance confocalNmicroscopy and optical coherence tomography canbe used to diagnose, monitor treatment response,and confirm clearance of basal cell carcinoma. Leveraging new imaging technologies can enable astreamlined patient experience, with same-day diagnosis and management of skin cancer. For patients who do not desire surgical managementof nonmelanoma skin cancer, laser treatment withNd:YAG is a promising emerging therapeutic option.CUTIS D ono tPRACTICE POINTSexamination, and there is a considerate burden on dermatologists to diagnose these lesions, which is bothcostly and results in a long wait time to see a specialist.Furthermore, standard care requires patients to attendmultiple visits for the diagnosis and treatment of NMSC.In recent decades, diagnosing basal cell carcinoma(BCC) has been facilitated by the handheld dermatoscope.The advent of dermoscopy has led to increased sensitivity and specificity of the NMSC diagnosis (estimated at95%–99%) and has helped facilitate earlier diagnosis ofBCC and reduce unnecessary biopsy of benign lesions.2-5Dermoscopy also can be useful in monitoring responseto treatment.5 Lesions that are detected early tend to beeasier and less expensive to treat, a strong argument forthe use of early detection techniques.6-8More recently, in vivo reflectance confocal microscopy(RCM)(Vivascope 1500 [Caliber I.D.]) has become anacceptable means for confirming a BCC diagnosis, offering an alternative to tissue biopsy. Reflectance confocalmicroscopy can be reimbursed under Category I CurrentProcedural Terminology codes 96931 to 96936.9 Reflectanceconfocal microscopy is a noninvasive diagnostic techniquethat uses an 830-nm diode laser to enable visualization of a 0.5 0.5-mm patch of skin to a depth of 200 to300 μm, which corresponds roughly to the papillary dermis.Reflectance confocal microscopy has the advantage of providing real-time diagnosis, enabling same-day treatmentof BCC, and providing an efficient alternative to biopsy.Ultimately, these advantages are beneficial and timesaving for patients because biopsies can be painful; createThe increasing incidence of nonmelanoma skin cancer (NMSC)poses a serious public health concern. Standard care for basal cellcarcinoma (BCC) requires patients to attend multiple visits for diagnosis and treatment. This pilot study describes a model of care thataims to alleviate some of the demand placed both on the specialtyand on patients by utilizing a novel same-day approach to BCC management with noninvasive diagnosis, same-day treatment, and noninvasive imaging follow-up. This study evaluates the efficacy of the1064-nm Nd:YAG laser for treating BCC while leveraging noninvasiveimaging technology for diagnosis and confirmation of clearance.Cutis. 2019;104:345-348, 350-351.The increasing incidence of nonmelanoma skincancer (NMSC) is a serious public health concern.1Lesions often are identified on routine total-bodyFrom the Department of Dermatology, Icahn School of Medicine at Mount Sinai Medical Center, New York, New York; Department of Dermatology,SUNY Downstate Medical Center, Brooklyn; and Department of Dermatology, New York Harbor Healthcare System, Brooklyn.The authors report no conflict of interest.The eTable is available in the Appendix online at www.mdedge.com/dermatology.Correspondence: Orit Markowitz, MD, 5 E 98th St, New York, NY 10029 OL. 104 NO. 6I DECEMBER 2019 345Copyright Cutis 2019. No part of this publication may be reproduced, stored, or transmitted without the prior written permission of the Publisher.

PATIENT-DRIVEN MANAGEMENT OF BCCtcopyApart from Moskalik et al,24,25 these studies are limitedby a relatively short follow-up time to confirm tumorclearance. Prior studies utilizing the Nd:YAG laser to treatBCC are summarized in the eTable.This pilot study describes a model of care that aims toalleviate some of the demand placed both on the specialtyand on patients by utilizing a novel same-day approachto BCC management. We sought to evaluate management using noninvasive diagnosis with RCM; same-daylaser treatment; and follow-up examination with clinical, dermoscopic, and noninvasive imaging using OCT.This method focuses on patient-driven health care fromvarious perspectives. Patients are given real-time information about their diagnosis using RCM, leading toan increased level of information flow and immediatetransparency regarding their diagnosis and management options. Patients also are receiving tailored careby incorporating noninvasive imaging and same-daylaser treatment, allowing collaboration between patientand physician. Patients have more choices—to undergosurgical care; other at-home topical regimens; or lasermanagement with potentially fewer visits, immediateresults, a clearance rate similar to surgery, and improvedcosmetic outcome.Our study attempts to further evaluate the efficacyof the 1064-nm Nd:YAG laser in treating BCC whileleveraging noninvasive imaging technology. The objectivewas to perform a retrospective review of medical recordsof a subgroup of patients with BCC diagnosed by RCMwho were treated with the 1064-nm Nd:YAG laser andmonitored for clearance using OCT imaging, in additionto clinical and dermoscopic examination. Similar to priorlong-term Nd:YAG laser follow-up studies, we aimed todemonstrate the possibility of a minimally invasive BCCmanagement approach—in our protocol, utilizing imaging instead of biopsy to facilitate long-term follow-upand by offering a model for patient-driven care.CUTISDonoa delay in diagnosis; and require further follow-up visitsfor treatment, which may be of importance to patients whohave trouble attending multiple appointments.Optical coherence tomography (OCT) is anothernoninvasive imaging device that is useful in BCC management. It uses an infrared broadband light source tovisualize skin architecture to 2-mm deep with a 6 6-mmfield of view.10 Although OCT does not offer the samecellular clarity as RCM, it allows visualization of a greaterdepth of skin and a wider field of view, making it a usefultool both in marginating NMSCs prior to treatment andmonitoring response to treatment over time.11-16 Opticalcoherence tomography has demonstrated a high negativepredictive value (92.1%) for BCC, which makes it useful for ruling out residual tumor in lesions undergoingmanagement.17-19With all available options, BCC management benefitsfrom care that is tailored to the individual and the lesion,taking into account size and subtype because not everyavailable treatment is appropriate. Lasers, including solidstate, diode, dye, and gas types, are emerging as promising minimally invasive treatment modalities.20,21Nonablative laser therapy with a pulsed dye laser(PDL) and fractional laser is an example; the principalinvestigator (PI) of this study (O.M.) recently reporteda 95.70% clearance rate utilizing a PDL and fractionallaser protocol.22 The 1064-nm Nd:YAG laser also hasbeen used with PDL and as a stand-alone treatment.Jalian et al23 used PDL and the Nd:YAG laser on 13 BCClesions, with a 58% (7/12) clearance rate after 4 treatments; all nonresponders were taking an anticoagulant,which inhibited the laser’s mechanism of action, according to the researchers.Moskalik et al24 published a report of 3346 facial BCClesions treated with pulsed Nd and pulsed Nd:YAG lasers,and included follow-up for as long as 5 years, with a3.7% recurrence rate. Another report by Moskalik et al25recorded a recurrence rate of 2.2% to 3.1% for BCCs thatwere followed for at least 5 years.Ortiz et al26 reported use of the long-pulsed 1064-nmNd:YAG laser to treat 13 lesions with biopsy-confirmedBCC on the trunk and extremities, with a 92% (12/13)clearance rate based on histologic analysis 1 month afterlaser treatment. In an expanded study of 31 patientsby Ortiz et al,27 the histologic clearance rate was 90.3%(28/31)—also obtained after 1 month—after 1 Nd:YAGlaser treatment, also treating lesions on the trunk andextremities. A further retrospective review of Nd:YAGlaser treatment of BCC revealed a 100% clearance rate for16 lesions (including lesions on the face) that were monitored for at least 6 months (mean duration, 9 months;range, 6–15 months).28 Optical coherence tomographyimaging was used for one of the review’s lesions beforeand after treatment and suggested that the Nd:YAGlaser works by selectively destroying the vasculaturesupplying BCC tumors while preserving surroundinghealthy tissue.28346 I CUTIS MethodsStudy Design—Institutional review board approval wasreceived from Icahn School of Medicine at Mount SinaiProgram 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 witha 1064-nm Nd:YAG laser, as an alternative to surgery, atthe Mount Sinai Faculty Practice Associates betweenMarch 2018 and August 2018. Included in this pilot studyare 17 lesions in 16 patients.Inclusion Criteria—Patients were enrolled based onthe following criteria: BCCs diagnosed by clinical anddermoscopic examination followed by RCM imaging;treatment with the 1064-nm Nd:YAG laser, because ofpatients’ preference for this modality over surgery, superficial radiation therapy, topical regimens, and other lasertherapies that require more visits; eligibility by PI includedlimited clinical ulceration or bleeding (or both) and a safedistance from the eye when wearing an external eye shieldWWW.MDEDGE.COM/DERMATOLOGYCopyright Cutis 2019. No part of this publication may be reproduced, stored, or transmitted without the prior written permission of the Publisher.

PATIENT-DRIVEN MANAGEMENT OF BCCtcopyresidual disease or confirm clearance. All patients weregiven thorough information about the treatment, additional costs, treatment alternatives, potential adverseeffects, and complications.Clinical and dermoscopic images were obtained atevery visit using a commercially available point-and-shootdigital single-lens reflex camera for clinical photographs,with an attached DermLite DL3N (3Gen) dermatoscopefor all contact polarized dermoscopic photography.Laser treatment was carried out with the 1064-nmNd:YAG laser. Setting ranges were similar to previouslypublished studies that used the 1064-nm Nd:YAG laser totreat BCCs (spot sizes, 5–6 mm; fluences, 125–140 J/cm2;pulse durations, 7–10 milliseconds).26-28 The exact settingsand number of passes were tailored to the individuallesion based on skin type, anatomic location, extentof tumor involvement by depth (and margin on faciallesions), and posttreatment dermoscopic confirmation ofclearance; additionally, for facial lesions, OCT confirmation of clearance.Laser treatment was provided by the PI. Patients wereinstructed to apply a thick emollient (ie, formulation ofpetrolatum or 100% petrolatum) after treatment and untilthe area healed.All tumors received 1 to 3 treatments at an intervalof 1 to 2 months. The treatment end point was completeclearance, judged by absence of skin cancer clinically,dermoscopically, and on OCT scan. More specifically, thePI looked for vascular changes and echogenic changes onOCT consistent with tumor clearance as well as dermoscopic disappearance of recognized BCC features.Patients were asked to return for follow-up visits2 months after the final treatment to evaluate tumorclearance. They were asked to return subsequentlyevery 6 to 12 months for routine care and longterm follow-up.CUTISDono(ie, outside the orbital rim). The PI performed a detailedand thorough clinical and dermoscopic skin examination,enabling early detection of the BCCs. Basal cell carcinomaswere not included if they exhibited rolled borders, visibleulceration, or oozing growths that allowed for treatmentof less-advanced tumors. The PI utilized a clinical anddermoscopic color wheel algorithm to identify suspiciouslesions combined with RCM for diagnostic confirmation.29Two of 17 lesions that did not present as early lesionswere included in the study due to patient refusal of surgery or radiation. We consider more advanced tumors tobe exophytic, bleeding, crusting, nonhealing ulcerativegrowths. Patients who had received prior laser treatmentwith the PI’s PDL with fractional laser protocol with subsequent recurrence at the treatment site were included inthe study. Lesions receiving concurrent or prior nonsurgical therapy, such as a topical immunomodulator or oralhedgehog inhibitor, were excluded.Treatment Protocol—All patients attended the privateclinic at Mount Sinai Hospital of a pigmented lesionexpert (O.M.) for routine skin cancer screening. Patientswith lesions suspicious for BCC—based on clinical anddermoscopic features—were offered tissue biopsy orRCM. Following diagnosis with RCM, treatment optionswere discussed, and patients were offered laser treatmentwhen surgical options were declined. Topical treatmentoptions were not emphasized because they require weeksof application to be effective and have been studiedmainly in superficial BCC management.30,31Patients with early lesions were offered either thePDL with fractional laser or Nd:YAG protocol, with theirunderstanding that the Nd:YAG laser protocol wouldlikely involve fewer treatments but a higher likelihood ofresidual hyperpigmentation or potential scarring (or both)than the more gentle PDL with fractional laser treatment.All lesions on the face were premarginated using OCTby obtaining central scans and 4 additional scans—above,below, to the left, and to the right of the lesion—to ensuretargeted laser treatment with desirable cosmetic results.Facial premargination scans were mandatory; however,patients with lesions on the trunk or extremities wereoffered the option to have pretreatment margination asan out-of-pocket expense. We did not require premargination of lesions on the body because of their locationon less cosmetically critical areas. Most patients declinedthe optional scans.This can be considered analogous to the situation inwhich more insurers reimburse Mohs surgery for cosmetically challenging areas such as the head and neck,while limiting reimbursement for treatment of lesions onthe trunk and upper extremities to simple excision. Givencosmetic concerns on the head and neck compared to thebody, some patients found it acceptable to have slightlyincreased dyschromia over a broader treatment area ofnon–cosmetically critical locations on the body.Optical coherence tomography imaging was requiredfor all anatomic locations at follow-up visits to detectWWW.MDEDGE.COM/DERMATOLOGYResultsPatient Characteristics—A total of 16 patients (6 female,10 male) with 17 BCCs were included in this study.Mean age was 68 years (median, 71.5 years; range; 48–89years). Mean lesion size was 7.1 mm (median, 6 mm; range,3–15 mm). Eight lesions were on the face; 9 were onextrafacial sites. Two lesions had a history of laser treatment with the PI’s PDL with fractional laser treatmentprotocol and had locally recurred. Subtypes of lesionswere not elicited by RCM.Outcomes—Fourteen lesions (14/17 [82.4%]) required1 treatment to achieve clearance, as confirmed clinically,dermoscopically, and by OCT scanning. One lesion onthe back (1/17 [5.8%]) required 2 treatments (70 daysbetween treatments). Two lesions (2/17 [11.8%]) required3 treatments (time between treatments: 49 and 61 days[lesion 1]; 62 and 64 days [lesion 2]). Lesion 1 was on theface; lesion 2 was on the back. Mean time between lasttreatment and OCT clearance scan was 103 days (median,64 days; range, 48–371 days).VOL. 104 NO. 6I DECEMBER 2019 347Copyright Cutis 2019. No part of this publication may be reproduced, stored, or transmitted without the prior written permission of the Publisher.

PATIENT-DRIVEN MANAGEMENT OF BCCcopyimmunosuppressed patient requires a different treatmentapproach, broader treatment area, OCT premarginationregardless of anatomic location, or a greater numberof treatments.) Nevertheless, the 2 aforementionedpatients were offered treatment with the 1064-nmNd:YAG laser because they refused surgery, radiation,and other more aggressive modalities. The patients weregiven advanced warning of an increased possibility ofrecurrence or nonclearance.The lesion that required 2 treatments did not appearto be an aggressive subtype; however, it was considerably larger than most other treated lesions (1.5 cm)(Figure, E and F). In this patient, as with the others, weutilized milder (700–1000 J) fluence settings than thoseused in the Moskalik et al24 study; however, we wereoptimizing for patient comfort, overall downtime, andcosmetic outcomes.Clearance in this study was assessed by OCT scanning. Scans were obtained 2 months after the last treatment to avoid detecting inflammation and early scartissue. We opted not to perform biopsies to determineclearance, as done in prior studies, because we wereinvestigating a fully nonsurgical protocol and wantedto enable patients to avoid surgical intervention, as theyhad requested. Clinical and dermoscopic examinationsby a world expert in dermoscopy and OCT (O.M.) provided additional reassurance of lesion clearance.Limitations—The retrospective study design with alimited sample size was a main limitation of our study. Ourlimited data suggest that there is value in further investigation and prospective trials of minimally invasive skin cancer management with the pulsed 1064-nm Nd:YAG laser.Limitations or disadvantages of this nonablativelaser treatment include dyschromia and minimal scarring. Furthermore, at fluence settings utilized, treatmentcan be painful. Without use of a local anesthetic, treatment is limited to what patients can tolerate.The percentage of BCCs located on the body (53%)was higher in our study than in the general population, estimated in a study to be approximately 20%.33This percentage might have been an effect of the largerVivascope 1500 RCM probe, which made certain areasof the face difficult to access, therefore excluding certainfacial lesions encountered in our practice from the initialnoninvasive diagnosis.Most lesions in our study have not been followedlong-term; median noninvasive OCT follow-up was64 days; however, the longest follow-up from our data setis longer than 1 year posttreatment (371 days). We haveused OCT to establish clearance, which also will allow usto continue using imaging to monitor for changes thatmight indicate recurrence. Although OCT is not approvedby the US Food and Drug Administration as a validatedmeans of diagnosing and detecting BCC, numerous studies have suggested that this modality has high sensitivity(95.7%) and specificity (75.3%) for features of BCC asCUTISDonoOur study supports the notion that the 1064-nm Nd:YAGlaser is a viable option for treating BCC. All (100%)lesions cleared, most (82.4%) with a single treatment.Of course, for patients who required more than 1 treatment (17.6%), we cannot make an argument for fewerpatient visits because those patients had to return formultiple laser treatments, but they were able to avoidsurgery, as they had wanted. Overall, our diagnosticapproach utilizing RCM as opposed to traditional tissuebiopsy meant that patients’ skin cancers were diagnosedand treated the same day.A one-stop shop for diagnosis and treatment modelhas been reported by Kadouch et al32 as part of a randomized controlled trial in which patients were randomlyassigned to receive standard care for BCC—biopsy followed by surgical excision—or RCM diagnosis followed bysurgical excision. Their outcome was tumor-free marginsafter surgical treatment; the RCM approach was found tobe noninferior to standard care.32 Our retrospective studydiffers, of course, in its laser treatment approach; however,both studies investigated a potentially mor

Orit Markowitz, MD; Corinna Eleni Psomadakis, MBBS From the Department of Dermatology, Icahn School of Medicine at Mount Sinai Medical Center, New York, New York; Department of Dermatology, SUNY Downstate Medical Center, Brooklyn; and Department of Dermatology, New York Harbor Healthcare Syst

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