Summary
Background
Even though progress has been made, the detection of melanoma still poses a challenge. In light of this situation, the Nevisense electrical impedance spectroscopy (EIS) system ...(SciBase AB, Stockholm, Sweden) was designed and shown to have the potential to be used as an adjunct diagnostic tool for melanoma detection.
Objectives
To assess the effectiveness and safety of the Nevisense system in the distinction of benign lesions of the skin from melanoma with electrical impedance spectroscopy.
Methods
This multicentre, prospective, and blinded clinical study was conducted at five American and 17 European investigational sites. All eligible skin lesions in the study were examined with the EIS‐based Nevisense system, photographed, removed by excisional biopsy and subjected to histopathological evaluation. A postprocedure clinical follow‐up was conducted at 7 ± 3 days from the initial measurement. A total of 1951 patients with 2416 lesions were enrolled into the study; 1943 lesions were eligible and evaluable for the primary efficacy end point, including 265 melanomas – 112 in situ and 153 invasive melanomas with a median Breslow thickness of 0·57 mm 48 basal cell carcinomas (BCCs) and seven squamous cell carcinomas (SCCs).
Results
The observed sensitivity of Nevisense was 96·6% (256 of 265 melanomas) with an exact one‐sided 95% lower confidence bound estimated at 94·2% and an observed specificity of 34·4%, and an exact two‐sided 95% confidence bound estimated at 32·0–36·9%. The positive and negative predictive values of Nevisense were 21·1% and 98·2%, respectively. The observed sensitivity for nonmelanoma skin cancer was 100% (55 of 48 BCCs and seven SCCs) with an exact two‐sided 95% confidence bound estimated at 93·5–100·0%.
Conclusions
Nevisense is an accurate and safe device to support clinicians in the detection of cutaneous melanoma.
What's already known about this topic?
Although progress has been made in the detection of melanoma it still poses a challenge.
Electrical impedance spectroscopy (EIS) may potentially be used as a diagnostic aid for the detection of melanoma.
What does this study add?
In the largest international prospective study of its kind in melanoma detection, the EIS system Nevisense was shown to be both accurate and safe in the lesion cohort studied.
In the absence of a perfect gold standard, the accuracy of a device should be compared with the consensus diagnosis from multiple experts.
Background
There are several clinical and histological classification systems for grading actinic keratosis (AK) lesions. The Olsen clinical classification scheme grades AK lesions according to their ...thickness and degree of hyperkeratosis (grades 1–3). The Roewert‐Huber histological classification system grades AK lesions based on the extent of epidermal atypical keratinocytes (AK I–III).
Objective
The aim of this study was to determine whether there is a correlation between these clinical and histological AK classification schemes.
Methods
One AK lesion from patients in three pivotal clinical studies and routine practice was assessed clinically and histologically. A match in grading was defined as Olsen grade 1 being classified histologically as AK I, Olsen grade 2 as AK II and Olsen grade 3 as AK III.
Results
Of the 892 lesions included, 29.0% were classified as Olsen grade 1, 59.6% as Olsen grade 2 and 11.3% as Olsen grade 3; 19.2% were histologically classified as AK I, 69.6% as AK II and 11.2% as AK III. Only 480 lesions (53.8%) had a matching clinical and histological classification. Of these matches, most were ‘Olsen grade 2 = AK II’ (83.1%). The Spearman's rank correlation coefficient for clinical and histological classification was r = 0.0499 (P = 0.137).
Conclusions
Clinical classification of AK lesions using the system of Olsen does not accurately match histological classification of the same lesions using the system of Roewert‐Huber. Consequently, it is not possible to draw conclusions about the histology of AK lesions from their clinical appearance. This finding reinforces the need to treat all AK lesions as well as field cancerization.
Summary
Background
The diagnostic criteria for basal cell carcinoma (BCC) using optical coherence tomography (OCT) have been described previously, but the clinical value of these findings remains ...unknown.
Objectives
To investigate the diagnostic value of OCT for BCC in a typical clinical setting. The primary efficacy end point was a diagnosis of BCC for each lesion. Secondary end points were the diagnosis of other possible conditions.
Methods
This was an observational, prospective, multicentre study in which consecutive patients with nonpigmented pink lesions suspicious for BCC underwent clinical assessment, dermoscopy and OCT, with the diagnosis recorded at each stage. Once all diagnoses had been recorded, the histological results were disclosed. In total 164 patients with 256 lesions were recruited. Histology was missing for 21 lesions, leaving 235 lesions in 155 patients for analysis.
Results
Sixty per cent of lesions (141 of 235) were identified as BCC by histology. A slight increase of sensitivity was noted following OCT, which did not reach statistical significance. The specificity increased significantly from 28·6% by clinical assessment to 54·3% using dermoscopy and to 75·3% with the addition of OCT (P < 0·001). The positive predictive value for the diagnosis of BCC using OCT was 85·2% 95% confidence interval (CI) 78·6–90·4, and the negative predictive value was 92·1% (95% CI 83·6–97·0). The accuracy of diagnosis for all lesions increased from 65·8% with clinical evaluation to 76·2% following additional dermoscopy and to 87·4% with the addition of OCT.
Conclusions
OCT significantly improved the diagnostic specificity for BCC compared with clinical assessment and dermoscopy alone.
What's already known about this topic?
The diagnostic criteria of basal cell carcinoma (BCC) by optical coherence tomography (OCT) have previously been defined.
Recent studies have also described the OCT criteria of actinic keratoses.
What does this study add?
The results of this study support the additional diagnostic value of OCT for the diagnosis of pink patches.
The diagnostic specificity for BCC may be increased by the use of OCT.
Summary
Background
In addition to the extent of atypical keratinocytes throughout the epidermis, actinic keratoses (AKs) are histologically characterized by downward‐directed basal‐layer expansion. ...It is not known whether this growth pattern correlates with the risk of developing invasive squamous cell carcinoma (iSCC).
Objectives
To characterize the prevalence of downward‐directed basal‐layer expansion of AKs adjacent to iSCC.
Methods
The epidermis overlying and adjacent to iSCCs was assessed histologically. We determined the histological grade (AK I–III), basal growth pattern (PRO I–III) and accompanying parameters such as adnexal involvement.
Results
Among 307 lesions, 52·4% of AKs were histologically classified as AK grade I, 38·1% as AK II and 6·8% as AK III (χ2‐test, P < 0·001). Only 2·6% of adjacent epidermal samples did not show any atypical keratinocytes. The epidermis adjacent to iSCCs was classified as having a PRO I basal growth pattern in 25·7%, PRO II in 31·9% and PROIII in 39·4% of cases. Only 2·9% of AKs showed no basal growth (χ2‐test, P < 0·001). In total 118 AKs (48·8%) showed extension into adnexal structures. These AKs were graded as PRO I in 18·6% of cases, PRO II in 30·5% and PRO III in 50·8%. The epidermis above iSCCs could be assessed only for upwards‐directed growth and showed no significant differences in the three AK grades (P = 0·42).
Conclusions
Basal proliferative AKs, as well as atypical keratinocytes restricted to the lower third of the epidermis, are most commonly seen adjacent to iSCC, with less evidence for full‐thickness epidermal dysplasia. Our study supports the important role of dysplastic keratinocytes in the epidermal basal layer and their potential association with iSCC.
What's already known about this topic?
Actinic keratosis (AK) can progress into invasive squamous cell carcinoma (iSCC).
The established histological classification of AKs lacks predictive properties to determine progression risk.
A recently proposed classification scheme has reported on the histological changes in the epidermis, particularly the downward‐directed proliferation of atypical keratinocytes at the basal layer
What does this study add?
iSCCs are associated with basal proliferation of AKs.
In our study, AK grade I is confirmed to be the dominant AK grade adjacent to iSCC.
iSCCs are more commonly associated with marked basal proliferation and with adnexal involvement, along with atypical keratinocytes restricted to the lower third of the epidermis (AK grade I).
Linked Editorial: Welzel. Br J Dermatol 2019; 180:699–700.
Respond to this article
Background
Actinic keratosis (AK) is an early in situ epidermal cancer which can progress to invasive squamous cell carcinoma (SCC). Imiquimod 5% cream (IMIQ) and diclofenac 3% gel (DIC) are ...frequently used to treat AK; however, their long‐term effects following repeated treatment cycles have never been compared.
Objective
To compare IMIQ and DIC in the treatment of AK with respect to the risk of change to grade III AK or invasive SCC, after 3 years.
Methods
Data were pooled from two randomized, active‐controlled, open‐label, multicentre, multinational, phase IV studies (Clinicaltrials.gov NCT00777127/NCT01453179), with two parallel groups. Studies were conducted between 2008 and 2015 and were almost identical in design. Patients eligible for inclusion were immunocompetent adults with 5–10 visible AK lesions on the face/scalp and grade I/II AK. The primary endpoint was inhibition of histological change to grade III AK or invasive SCC in the study treatment area, observed until month 36. Patients applied either IMIQ or DIC for a maximum of six treatment cycles.
Results
In total, 479 patients (IMIQ 242; DIC 237) were included in the full analysis set. Histological change to grade III AK or invasive SCC was observed until month 36 in 13 (5.4%) patients treated with IMIQ, compared with 26 (11.0%) patients treated with DIC (absolute risk difference –5.6% 95% confidence interval –10.7%, –0.7%). Time to histological change was greater in the IMIQ group than the DIC group (P = 0.0266). Frequency of progression to invasive SCC was lower with IMIQ than with DIC at all time points. Initial clearance rate was higher in the IMIQ group compared with the DIC group, while recurrence rate was lower. Both treatments were well tolerated.
Conclusions
Over 3 years, IMIQ was superior to DIC in clearing AK lesions and preventing histological change to grade III AK or invasive SCC and recurrence.
Background
Treatment for both facial and truncal acne has not sufficiently been studied.
Objectives
To evaluate the long‐term safety and efficacy of trifarotene in both facial and truncal acne.
...Methods
In a multicentre, open‐label, 52‐week study, patients with moderate facial and truncal acne received trifarotene 50 μg/g cream (trifarotene). Assessments included local tolerability, safety, investigator and physician's global assessments (IGA, PGA) and quality of life (QOL). A validated QOL questionnaire was completed by the patient at Baseline, Week 12, 26 and 52/ET.
Results
Of 453 patients enrolled, 342 (75.5%) completed the study. Trifarotene‐related treatment‐emergent adverse events (TEAEs) were reported in 12.6% of patients, and none was serious. Most related TEAEs were cutaneous and occurred during the first 3 months. Signs and symptoms of local tolerability were mostly mild or moderate and severe signs, and symptoms were reported for 2.2% to 7.1% of patients for the face and 2.5% to 5.4% for the trunk. Local irritation increased during the first week of treatment on the face and up to Weeks 2 to 4 on the trunk with both decreasing thereafter.
At Week 12, IGA and PGA success rates were 26.6% and 38.6%, respectively. Success rates increased to 65.1% and 66.9%, respectively at Week 52. Overall success (both IGA and PGA success in the same patient) was 57.9% at Week 52.
At Week 52 visit, 92/171 (53.8%) patients who had completed their assessments had scores from 0 to 1 (i.e. no effect of acne on their QOL) vs. 47/208 (22.6%) patients at Baseline visit.
Conclusion
In this 52‐week study, trifarotene was safe, well tolerated and effective in moderate facial and truncal acne.
Background
Actinic keratoses (AKs) are commonly diagnosed clinically. Actinic keratosis area and severity index (AKASI) is a new easy‐to‐use tool to assess the severity of AKs on the head.
Objectives
...To determine the association between chronically UV‐induced tumours such as basal cell carcinomas (BCC) or squamous cell carcinomas (SCC) and AKASI.
Methods
We performed a retrospective analysis of patients who had undergone oncological surgery due to UV‐induced tumours and who were assessed for AKASI and Physician's global assessment (PGA) prior to surgery. Statistical analysis was performed to evaluate correlation between AKASI, PGA and invasive carcinomas.
Results
Of the 210 patients included, 26 patients had histologically diagnosed SCCs and presented with a median (range) AKASI of 6.9 (0–13.0) and PGA of 2 (0–4). In contrast, the 82 patients with BCCs showed a median (range) AKASI of 3.3 (0–15.2) and PGA of 1 (0–4). The Mann–Whitney U‐test showed significant differences (P = 0.0018) between AKASI of patients with SCC and BCC. In addition, we found a significantly higher AKASI in patients with SCC compared to patients with non‐invasive lesions like AK and Bowen disease (BD) (P = 0.0275). Spearman's coefficient of rank correlation between AKASI and PGA indicates that these measures of AK severity were strongly correlated (P < 0.0001; r = 0.90; 95% CI 0.865–0.920).
Conclusions
Patients with SCC show significantly higher AKASI than patients with BCC or patients without invasive tumours. Hence, AKASI may be used to stratify risk for developing invasive SCC.
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