Comparative Analysis of Nipple Reconstruction Techniques: Five Flap vs. C-V Flap.

Background: Nipple-areola complex reconstruction represents the final phase in the comprehensive post-mastectomy treatment regimen. Despite the diversity of approaches available, there is currently no universally accepted benchmark technique for this critical aspect of breast reconstruction. In this study, we conducted a comparative assessment of two prominent techniques, the five Flap and C-V Flap. Materials and Methods: Between November 2016 and April 2023, we recruited 100 female patients who had undergone unilateral post-oncological mastectomy and divided them into two groups: Group A comprising 50 patients who underwent the 5-Flap technique, whereas Group B comprising the remaining 50 underwent the C-V Flap technique. Over a 6-month observation period, we assessed nipple projection loss and evaluated overall satisfaction through self-reporting by patients and independent assessments by a medical observer. Results: In our study, none of the reconstructed nipples in Group A (5 Flap) experienced either total or partial necrosis, contrasting with Group B (C-V Flap) which encountered a 10% incidence of partial necrosis and 4% incidence of total necrosis. Furthermore, the average nipple projection loss in Group B was substantial, measuring a 30% reduction from the initial projection at the 1-year mark, whereas Group A demonstrated a significantly lower 13% reduction. Notably, despite these variations in outcomes, both groups reported an equal and high level of satisfaction, with patients and external observers providing an average satisfaction score of 8.0 and 9.0, respectively. Conclusion: The five-flap technique represents a safe and effective approach for patients undergoing nipple reconstruction.

Immune Checkpoint Inhibitors and Scleroderma: Data from the European Pharmacovigilance Database.

BACKGROUND: Immune checkpoint inhibitors (ICIs) can be commonly associated with the occurrence of immune-related adverse drug reactions (irADRs), which can involve any tissue and organ. ICI-induced skin toxicities are common irADRs and they can be a consequence of a rheumatologic ADR, such as in the case of scleroderma. A recent literature review reported that scleroderma and scleroderma mimics represent a group of disorders with significant morbidity that have been described during ICIs' use. OBJECTIVE AND METHODS: Considering the clinical significance of scleroderma cases, the present study aimed to analyze the occurrence of these events in patients receiving ICIs by describing data from individual case safety reports (ICSRs) retrieved from the European spontaneous reporting system, EudraVigilance (EV). RESULTS: Until February 2023, 70 ICSRs with at least one ICI as the suspected drug and at least one preferred term (PT) related to scleroderma cases were retrieved from the EV. Pembrolizumab was reported as suspected in 41 ICSRs, nivolumab in 25 ICSRs, ipilimumab in 8 ICSRs and atezolizumab in 3 ICSRs. Patients who experienced scleroderma cases were adults, and no differences were found in terms of sex distribution. Scleroderma cases were mainly classified as serious, while the outcome was mainly reported as favorable. The most reported PTs were scleroderma and morphea. CONCLUSIONS: Considering the seriousness of ICI-induced scleroderma cases and the recent marketing authorization of some ICIs, we believe that further high-quality clinical studies should be conducted on this topic to better estimate the impact of these events in patients with cancer.

Skin Toxicities Associated with Botulin Toxin Injection for Aesthetic Procedures: Data from the European Spontaneous Reporting System.

Botulinum toxin is a protein deriving from the bacteria Clostridium botulinum and it is widely used for the treatment of a variety of muscle hyperactivity syndromes and for cosmetic indications. Having a long-lasting effect, Botulinum toxin type A (BTA) is one of the most botulin toxin products used. Even if BTA has shown benefits in reducing the vertical lines between the eyebrows, Adverse Drug Reactions (ADRs) have been experienced as well, of which the most common ones are headache and drooping eyelids. In addition, since other local and systemic risks have been identified, a non-interventional post-authorization safety study (PASS) has been started. The aim of the present study was to report cases of skin toxicity associated with this drug, considering Individual Case Safety Reports (ICSRs) existing on the Eudravigilance website. Among 1464 ICSRs sent to the EV database, 718 ICSRs, including 5154 PTs, reported BTA as a suspected drug associated with cutaneous toxicity. The majority of patients experiencing BTA-induced skin toxicity were female (92.1%) belonging mostly to the age group of 18-64 years. The most serious criteria, when reported, were "Other Medically Important Condition" and "Caused/prolonged hospitalization", although the outcome was mainly reported as "Unknown". The most reported PTs, related to skin disorders, were: "Erythema", "Rash", "Pruritus", "Urticaria", "Swelling face", "Brow ptosis", "Eyelid ptosis", "Injection site pain", and "Angioedema". Considering that in most ICSRs, ADRs related to skin disorders were symptoms of hypersensitivity reactions which in some conditions could be life-threatening, further studies are required to better define the safety profile of BTA used for aesthetic procedures.