Real world data of cemiplimab in locally advanced and metastatic cutaneous squamous cell carcinoma.

BACKGROUND: Cutaneous squamous cell carcinoma (cSCC) has an overall favourable outcome, except for patients with an advanced stage disease. The programmed death protein-1 (PD-1) inhibitor cemiplimab has been approved for use in advanced cSCC. We report clinical outcomes from the named patient programme-compassionate use of cemiplimab for patients with advanced cSCC in Italy. METHODS: This is a retrospective, observational, multicentre study. We analysed medical records of patients with advanced cSCC treated with cemiplimab between May 2019 and February 2020 in 17 referral Italian centres. We assessed the safety profile according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v 5.0), the clinical activity in terms of response rate, clinical benefit and duration of response and baseline clinical-pathologic characteristics associated with response. RESULTS: 131 patients were included, with a median age of 79 years. Of them, 9.2% had a concurrent chronic lymphoproliferative disease and 8.5% a concomitant autoimmune disease. Some 42.7% of the total patients had at least one treatment-related adverse events (AEs); out of above, 9.2% had grade 3-4 adverse events, and there were two fatal adverse events. The overall response rate (ORR) was 58%, and the disease control rate (DCR) was 71.7%. Cutaneous squamous cell carcinomas (cSCCs) arising on the head and neck area (p = 0.007) and haemoglobin values in normal range (p = 0.034) were significantly associated with a better response, while cSCCs on the genitalia (p = 0.041), treatment with any systemic antibiotic within 1 month of cemiplimab initiation (p = 0.012), performance status ≥1 (p = 0.012), chronic corticosteroids therapy (p = 0.038), previous radiation therapy to lymph nodes (p = 0.052) and previous chemotherapy (p = 0.0020) were significantly associated with a worse response. CONCLUSIONS: Our real-world study showed safety and effectiveness results comparable to those obtained in clinical trials. We identified some clinical and biochemical factors potentially associated with response to cemiplimab.

Absence of PCR-detectable human papilloma virus in erythroplasia of Queyrat using a comparative control group.

OBJECTIVES: High-risk human papillomavirus (HPV) types have been linked with genital carcinomas. However, the exact relation between HPV and erythroplasia of Queyrat (EQ), for example, in-situ carcinoma of the glans and prepuce, is still unclear. The aim of this study was to detect the presence of lesional HPV-DNA in patients with EQ. METHODS: Paraffin-embedded biopsies were obtained from the glans or inner foreskin of 11 adult uncircumcised patients (mean age 67.7 years; range 57-79) with EQ. An equal number of randomly selected uncircumcised healthy control patients underwent a single brush cytology smear of the penile mucosa. Biopsy specimens and brushings were then assayed by a highly sensitive two-step nested PCR technique based on MY11/MY09 consensus primers and general GP5+/GP6+ PCR primers, followed by cycle sequencing. Statistical evaluation was performed using conditional logistic regression analysis. RESULTS: None of the EQ or control samples proved to be positive for the presence of HPV-DNA. CONCLUSIONS: The findings do not support the hypothesis that there is a considerable risk of EQ development in patients with HPV infection. The prevalence of HPV infection in patients with EQ has rarely been investigated and available data are relatively scant and controversial. Therefore, the relation between HPV infection and the risk of progression of EQ into squamous cell carcinoma remains a matter of debate, and further investigations are needed in order to confirm the role of HPV in delineating this risk.

Penile lichen sclerosus: Correlation between histopathologic features and risk of cancer.

The relationship between penile lichen sclerosus (LS) and cancer development has not been clearly assessed so far. In order to define these histological features of LS that may indicate or precede a malignant degeneration, 104 biopsy specimens from 86 patients with LS of the glans (90.5%) and from 9 patients with a penile malignancy (7 squamous cell carcinomas, 1 in situ carcinoma, and 1 verrucous carcinoma) arising on LS (9.5%) were reviewed. Three different histopathologic LS patterns were identified: pattern 1 with a prominent lichenoid inflammatory infiltrate in the dermis (9%), pattern 2 characterized by a band-like infiltrate separated from the epidermis by a band of dermal sclerosis (44%), and pattern 3 showing prominent sclerosis with minimal or absent inflammatory infiltrate (9%). These patterns have previously been described in vulvar LS, and have been considered typical of early, mature, and late LS, respectively. In our study, we also found a fourth pattern in 38% of cases, with overlapping features between the first and third pattern, occasionally showing areas of epidermal thickening, with loss of the normal keratinocyte cytoarchitectural differentiation, mitoses and apoptotic cells. In our opinion, the histological features observed in this last pattern may be interpreted as areas of disease reactivation within a chronic stage. Furthermore, 7 out of 9 cases of penile cancer from our series (78%) were associated with this pattern, suggesting that it may correlate with a malignant degeneration.

Successful treatment and management of large superficial basal cell carcinomas with topical imiquimod 5% cream: a case series and review.

Basal cell carcinoma (BCC) is the most common non-melanoma skin cancer in the Caucasian population and its incidence is increasing worldwide. Although surgical procedures show a high cure rate with acceptable morbidity, non-surgical, pharmacotherapeutic approaches have been regarded as appropriate alternatives, and/or first-line treatments, in selected cases. Imiquimod (IQ) is a synthetic imidazoquinoline amine that locally enhances, through cytokine induction, both innate and acquired immune pathways, resulting in immunomodulating, antiviral and antitumor effects. Topical IQ 5% cream is approved by the FDA and the European Union for the treatment of small superficial BCCs (<2.0 cm); however, published data highlight the possibility of successful outcomes in larger lesions. We report three patients, each one presenting with a large BCC and successfully treated with IQ 5% cream. Although our cases and those from the literature do not rise to the level of evidence, IQ may be a reliable, efficacious and safe non-surgical option for selected cases of large superficial BCCs. Histological examination should occur at baseline and at the end of treatment along with clinical and dermatoscopic examination at least monthly during the course of the treatment and every 6 months for 2 years following the treatment.