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Han J, Nosrati NN, Soleimani T, Munshi IA, Flores RL, Tholpady SS. Analysis of Cases in Which a Biopsy Specimen Is Positive and an Excised Lesion Is Negative for Nonmelanoma Skin Cancer. JAMA Surg. 2016;151(5):486–488. doi:10.1001/jamasurg.2015.4449
Nonmelanoma skin cancers (NMSCs), including squamous cell carcinoma (SCC) and basal cell carcinoma (BCC), are the most common types of cancer with the fastest-growing treatment costs in the United States.1 Standard treatment requires biopsy for histologic confirmation, followed by excision. Oftentimes, no residual carcinoma is detected, implying spontaneous clearance at rates reported to vary from 24% to 76%.2-5 These types of lesions have been investigated by others2-5 and are not fully understood. Our study aims to determine the lesion and patient characteristics that would most strongly predict a histologically negative result for an excised lesion after a biopsy specimen had positive margins.
Our retrospective database study was approved by the institutional review board of the Richard L. Roudebush Veterans Affairs Medical Center in Indianapolis, Indiana; informed consent was not obtained because the data were deidentified. Our study was conducted using the International Classification of Diseases, Ninth Revision codes for NMSCs and the Current Procedural Terminology codes for both biopsy and excision of lesions treated at the Richard L. Roudebush Veterans Affairs Medical Center during the period from 2003 to 2013. Data were collected for primary NMSCs that had a positive-margin biopsy followed by lesion excision. Lesions that underwent concurrent dermatologic treatment were excluded from our study. Patients with more than 20 lesions in a lifetime were also excluded. Bivariate analysis was performed to identify the parameters that significantly contributed to the negative results regarding the excised lesions. Analysis was performed using SAS (SAS Institute Inc). P = .05 was considered statistically significant.
The inclusion and exclusion criteria described in the Methods section yielded a total of 1867 lesions from 1299 patients who were mostly white (92%), male (99%), and between the ages of 50 and 90 years (97%) (mean age, 72 years). The rate of excised lesions that tested negative was 58% in cases of SCC and 23% in cases of BCC. Parameters significantly associated with negative results after excision were type of cancer (SCC or BCC), histologic appearance of scar or ulcer after excision, clinical appearance of scar after biopsy but before excision, prebiopsy ulceration, type of biopsy (punch or shave), and simplified anatomic site (head and neck or trunk and limb). Their P values and odds ratios are listed in the Table. Odds ratios for lesions subdivided by SCC and BCC are also listed. Clinically important associations included the histologic finding of a scar after excision, clinical appearance of a scar after biopsy but before excision, histologic ulceration on the excised lesion, clinical or histologic ulceration on the biopsy specimen, and location in the head and neck.
Our study included data collected from a very large Veterans Affairs Medical Center data set; variables not likely to be important with regard to excised lesions that were negative for residual cancer include age, diabetes, immunosuppression, Vietnam service, Agent Orange exposure, nicotine use, and number of days between biopsy and excision. The most significant pre-excisional factor was NMSC type, for which cases of SCC had a higher rate of excised lesions that were negative than did cases of BCC. The literature suggests that the biopsy-induced wound-healing process is a major cause of these negative findings after excision4-6 and is consistent with the results of our study. The clinical appearance of just a scar was predictive, with odds ratios for a negative finding after excision of 4.6 for cases of SCC and 1.9 for cases of BCC. Historically, the mean (SD) recurrence rate for surgical excision with a 4-mm margin has been reported at 1.6% (1.8%).7
The 2 major limitations of our study are its veteran population (mostly white male patients), which limits generalization to all populations, and our inability to verify total lack of NMSC in excision specimens via pathology. Although lesions are “breadloafed,” not every part of the section is viewed. A logistic regression analysis would help identify additional relationships, as well as confounders, among the variables and may be useful in creating a prediction model for negative findings after excision that can be used to make cost-cutting decisions in the clinic. Such a model would allow patients with a high likelihood of a negative finding after excision and with a limited lifespan to be treated conservatively because the chance of the NMSC causing significant morbidity would be minimal. Currently, no long-term outcome data exist, and so further studies are being conducted. Patients with a high probability of negative findings after excision are randomly assigned to 1 of 2 different treatment groups: conservative therapy or surgical excision. The patients would then be closely monitored yearly for recurrence to determine the utility of prediction and of conservative therapy.
Corresponding Author: Sunil S. Tholpady, MD, PhD, Department of Surgery, Richard L. Roudebush Veterans Affairs Medical Center, 705 Riley Hospital Dr, RI 2514, Indianapolis, IN 46202 (firstname.lastname@example.org).
Published Online: December 30, 2015. doi:10.1001/jamasurg.2015.4449.
Author Contributions: Drs Tholpady and Nosrati had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Han, Nosrati, Flores, Tholpady.
Acquisition, analysis, or interpretation of data: Han, Nosrati, Soleimani, Munshi, Tholpady.
Drafting of the manuscript: Han, Nosrati, Soleimani, Tholpady.
Critical revision of the manuscript for important intellectual content: Han, Nosrati, Munshi, Flores, Tholpady.
Statistical analysis: Han, Soleimani, Tholpady.
Administrative, technical, or material support: Munshi, Flores, Tholpady.
Study supervision: Munshi, Tholpady.
Conflict of Interest Disclosures: None reported.
Previous Presentation: This paper was presented at the 39th Annual Meeting of the Association of VA Surgeons; May 3, 2015; Miami Beach, Florida.