A Retrospective Study of Cemiplimab Effectiveness in Elderly Patients with Squamous Cell Carcinoma of the Skin: Insights from a Real-Life Scenario.

INTRODUCTION: This retrospective study investigates the efficacy of cemiplimab, a monoclonal antibody targeting the PD-1 receptor, in treating squamous cell carcinoma (SCC) of the skin. METHODS: The study analyzes data from 50 patients with SCC, focusing on various clinical parameters, including patient demographics, tumor characteristics, treatment history, disease status at the beginning of therapy, and survival outcomes. RESULTS: Of the patients who received at least one cycle of cemiplimab, 42% showed a clinical response. Adverse reactions were generally low, with the safety profile deemed excellent. During a median follow-up of 9.6 months, 17 patients experienced progression or death. Among these, 15 patients had died at the time of the analysis. The median progression-free survival (PFS) for the entire cohort was approximately 20.8 months, while median overall survival (OS) was not reached. Univariate Cox regression analysis for PFS showed that tumors in the arms and legs were associated with higher progression risk, while age above 65 years was not statistically significant. Distant metastasis exhibited a trend towards improved PFS. In terms of OS, distant metastasis was a significant predictor of reduced survival, while age above 65 years was not statistically significant. In a multivariate model, only the absence of distant metastasis remained significant, with an adjusted odds ratio (OR) of 12.3 (95% confidence interval 1.3-112.1). CONCLUSION: These findings provide valuable insights into the real-world effectiveness of cemiplimab in SCC management.

MRI-Derived Apparent Diffusion Coefficient of Peri-Prostatic Adipose Tissue Is a Potential Determinant of Prostate Cancer Aggressiveness in Preoperative Setting: A Preliminary Report.

Background: The aim of this study was to test the association between periprostatic adipose tissue (PPAT)­apparent diffusion coefficient (ADC) value recorded at multiparametric magnetic resonance imaging (mpMRI) and determinants of prostate cancer (PCa) aggressiveness in the preoperative setting. Methods: Data from 219 consecutive patients undergoing prostate biopsy (PBx) for suspicion of PCa, between January 2020 and June 2022, at our institution were retrospectively evaluated. Only patients who had mpMRI performed before PBx were included. The distribution of demographics and clinical features among PPAT-ADC values up to vs. above the median was studied using both parametric and non-parametric tests, according to variables. Linear and logistic regression models tested the association between PPAT-ADC values and determinants of PCa aggressiveness and the presence of intermediate-high risk PCa, respectively. Results: Of 132 included patients, 76 (58%) had PCa. Median PPAT-ADC was 876 (interquartile range: 654 − 1112) × 10−6 mm2/s. Patients with PPAT-ADC up to the median had a higher rate of PIRADS (Prostate Imaging­Reporting and Data System) 5 lesions (41% vs. 23%, p = 0.032), a higher percentage of PBx positive cores (25% vs. 6%, p = 0.049) and more frequently harbored ISUP (International Society of Urological Pathology) > 1 PCa (50% vs. 28%, p = 0.048). At univariable linear regression analyses, prostate-specific antigen (PSA), PSA density, PIRADS 5, and percentage of PBx positive cores were associated with lower PPAT-ADC values. PPAT-ADC up to the median was an independent predictor for intermediate-high risk PCa (odds ratio: 3.24, 95%CI: 1.17−9.46, p = 0.026) after adjustment for age and body mass index. Conclusions: Lower PPAT-ADC values may be associated with higher biopsy ISUP grade group PCa and a higher percentage of PBx-positive cores. Higher-level studies are needed to confirm these preliminary results.

Management of HER2-Positive Early Breast Cancer in Italy: A Maze Presenting Opportunities and Challenges.

The management of human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer (BC) has changed in recent years thanks to the introduction of anti-HER2 agents in clinical practice as standard of care in the neoadjuvant setting. In this scenario, we probed the issue of which HER2-positive BC patients are eligible for neoadjuvant or for adjuvant treatment, since these therapeutic strategies seem to be mutually exclusive in clinical practice according to an Italian drug surveillance system. We reviewed both alternatives to establish which is more suitable, considering the anti-HER2 drugs available in Italy. Randomized clinical trials demonstrated a similar clinical benefit for chemotherapy administered as neoadjuvant therapy or adjuvant therapy. A meta-analysis, including 11,955 patients treated with neoadjuvant therapy, demonstrated an improvement in event-free survival (EFS) and overall survival (OS). Moreover, the recent APHINITY trial, analyzed at 6 years follow-up, demonstrated the superiority of the combination pertuzumab-trastuzumab versus trastuzumab-placebo in previously untreated patients. A greater benefit was found in patients with positive lymph nodes treated in the adjuvant setting. Our analysis underlines the need for a therapeutic decision-making algorithm, which is still unavailable, to support clinicians in identifying patients suitable for neoadjuvant or adjuvant therapy. Further prospective clinical trials should be performed in collaboration with other Italian Breast Cancer Centers to establish the best strategy to be adopted in early HER2+ BC.