Biopsy outperforms reflectance confocal microscopy in diagnosing and subtyping basal cell carcinoma: results and experiences from a randomized controlled multicentre trial*

Abstract

Summary Background Reflectance confocal microscopy (RCM) is a noninvasive method for skin assessment, allowing entire lesion evaluation up to the papillary dermis. RCM is a potentially attractive alternative to punch biopsy (PB) in basal cell carcinoma (BCC). Objectives To determine the diagnostic accuracy of RCM vs. PB in diagnosing and subtyping BCC, and to study patient satisfaction and preferences. Methods Patients with a clinically suspected primary BCC were randomized between RCM and biopsy. Conventional surgical excision or follow‐up were used as reference. Sensitivity and specificity for BCC diagnosis and subtyping were calculated for both methods. BCC subtype was stratified based on clinical relevance: aggressive (infiltrative/micronodular) vs. nonaggressive (superficial/nodular) histopathological subtype and superficial vs. nonsuperficial BCC. Data on patient satisfaction and preferences were collected using a questionnaire and a contingent valuation method. Results Sensitivity for BCC diagnosis was high and similar for both methods (RCM 99·0% vs. biopsy 99·0%; P = 1·0). Specificity for BCC diagnosis was lower for RCM (59·1% vs. 100·0%; P < 0·001). Sensitivity for aggressive BCC subtypes was lower for RCM (33·3% vs. 77·3%; P = 0·003). Sensitivity for nonsuperficial BCC was not significantly different (RCM 88·9% vs. biopsy 91·0%; P = 0·724). Patient satisfaction and preferences were good and highly comparable for both methods. Conclusions Biopsy outperforms RCM in diagnosing and subtyping clinically suspected primary BCC. This outcome does not support routine clinical implementation of RCM, as a replacement for PBs in this patient group.

Lost in translation: true clinical impact of reflectance confocal microscopy overlooked in ‘Biopsy outperforms reflectance confocal microscopy in diagnosing and subtyping basal cell carcinoma: results and experiences from a randomized controlled multicentre trial’: reply from authors

“…Lost in translation: true clinical impact of reflectance confocal microscopy overlooked in 'Biopsy outperforms reflectance confocal microscopy in diagnosing and subtyping basal cell carcinoma: results and experiences from a randomized controlled multicentre trial': reply from authors DEAR EDITOR, Firstly, we would like to thank M. Gill and colleagues for their interest shown in our study. 1,2 We agree on the importance of determining the place of reflectance confocal microscopy (RCM) as a diagnostic tool in real-world clinical practice, which is why we originally initiated our study. We chose to include patients with clinically suspected primary basal cell carcinoma (BCC), in which dermatoscopic evaluation was usually performed as well, as part of the daily clinical practice examination (as also mentioned by the authors as the current standard of many worldwide).…”

“…Dear Editor , Firstly, we would like to thank M. Gill and colleagues for their interest shown in our study 1,2 . We agree on the importance of determining the place of reflectance confocal microscopy (RCM) as a diagnostic tool in real‐world clinical practice, which is why we originally initiated our study.…”

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Lost in translation: true clinical impact of reflectance confocal microscopy overlooked in ‘Biopsy outperforms reflectance confocal microscopy in diagnosing and subtyping basal cell carcinoma: results and experiences from a randomized controlled multicentre trial’

“…Dear Editor , In ‘Biopsy outperforms reflectance confocal microscopy in diagnosing and subtyping basal cell carcinoma: results and experiences from a randomized controlled multicentre trial’, the authors found that reflectance confocal microscopy (RCM) identifies basal cell carcinoma (BCC) with 99% sensitivity and, impressively, distinguishes superficial BCCs from more aggressive BCCs with 88·9% sensitivity compared with punch biopsy (PB) at 91%, 1 a difference without statistical significance. RCM’s imaging depth is limited to ~ 0·2 mm, but its advantage is comprehensive lateral sampling; PBs provide deep sampling, but demonstrate 18% discordance with wide excisions due to lateral sampling error 2 .…”