Results from the phase III Keynote-024 clinical trial established pembrolizumab monotherapy as the first-line standard of care for patients with metastatic NSCLC who have PD-L1 expression ≥ 50%, EGFR, and ALK wild-type tumors. However, given the differences between patients treated in routine clinical practice and those treated in a clinical trial, real-world data are needed to confirm the treatment benefit in standard practice. Given the lack of data on large cohorts of patients with long follow-ups, we designed an observational retrospective study of patients with metastatic NSCLC who were treated with pembrolizumab, starting from its reimbursement eligibility until December 2020. The primary endpoints were PFS and OS, determined using the Kaplan–Meier method. Response and safety were also evaluated. We followed 880 patients (median follow-up: 35.1 months) until February 2022. Median PFS and OS were 8.6 months (95% CI: 7.6–10.0) and 25.5 months (95% CI: 21.8–31.6), respectively. We also found that ECOG PS, PD-L1 expression, and habitual smoking were prognostic factors for PFS, while age, sex, ECOG PS, habitual smoking and histology had an impact on OS. Multivariable analysis confirms the prognostic role of PD-L1 for PFS and of ECOG for both PFS and OS. 39.9% of patients reported an adverse event, but only 6.3% of patients discontinued therapy due to toxicity. Our results suggest a long-term benefit of pembrolizumab in the first-line setting, as well as a safety profile consistent with the results of Keynote-024. Many collected variables appear to influence clinical outcome, but results from these exploratory unadjusted analyses should be interpreted with caution.

Introduction: Dose banding is an original approach that manages intravenous (IV) chemotherapy preparation by generating on a weekly basis a series of bags containing scaled dosages of the active agent. These predetermined, fixed dosage bags are intended to replace the traditional bags prepared daily that contain fully individualized dosages. Methods: Three different scenarios were examined: (1) the current method of daily preparation of individualized bags at the hospital pharmacy; (2) the weekly preparation at the hospital pharmacy of non-individualized bags containing discrete, predefined doses covering an adequate range of doses (dose banding); (3) the use of commercial ready-to-use bags based on the same approach of dose banding. The objective of this study was to compare these three different approaches in terms of cost per patient. We considered five cancer drugs (gemcitabine, oxaliplatin, paclitaxel, trastuzumab and 5-fluorouracil) that were suitable for the dose ranging approach. Appropriate dose bands for these five agents were identified. Costs were estimated for each of the three approaches. Results: A total of 13,490 fully individualized bags were studied, which corresponded to the real bags prepared at our institution for these five agents in 2018. Dose banding was predicted to determine savings ranging from €10,998 (−0.84%) for trastuzumab to €169,429.60 (−8.39%) for paclitaxel. Conclusion: The introduction of dose banding can determine economic savings along with other advantages, such as improved work conditions, management reorganization and containment of waste. The pharmaceutical industry can hopefully support these experiences by producing ready-to-use bags in predetermined dosages.

Objectives The effectiveness of omega-3 fatty acids (PUFAs) in cardiovascular diseases (CVD) remains a matter of debate. The aim of this work was to evaluate PUFAs in the reduction of cardiovascular mortality in primary and secondary prevention of CVD to determine if further original studies are needed or the available data can be considered conclusive. Methods A meta-analysis was performed according to a dichotomous endpoint followed by a trial-sequential analysis (TSA). Clinical data were identified through a PubMed search based on the following keywords: omega-3 fatty acids; cardiovascular disease; death; and cardiovascular risk. The clinical trials identified by this procedure were subjected to standard meta-analysis and TSA. Results and conclusions A total of 11 randomised studies for 100 609 patients were analysed. Our meta-analysis showed a statistically significant reduction in mortality due to cardiovascular issues (RR=0.937; 95% CI: 0.88 to 0.98; P=0.018). The TSA indicated that no further trials are needed to better evaluate the efficacy of PUFAs in preventing death related to CVD.

In patients with metastatic melanoma, ipilimumab has been shown to improve long-term survival. This observational multicenter study reports clinical outcomes of 418 patients treated with second-line ipilimumab from February 2013 to August 2014. Median overall survival (OS) was 6.43 months (95%CI: 5.45–7.42; n = 300), while median progression-free survival (PFS) was 3.7 months (95%CI: 3.23–4.17; n = 188). Demographic factors, such as sex or number of previous therapies did not affect OS. Survival was shorter in patients with ECOG > 0 (Eastern Cooperative Oncology Group, Performance Status) (p < 0.001), while a longer OS was found in patients who completed all four therapy cycles (p < 0.001). Adverse events of any grade were reported for 66% of patients (mainly cutaneous and gastrointestinal), but most were low grade and easily managed. Adverse events of grades 3–4 were observed in 13% of patients. This study confirmed the efficacy and safety of this treatment in real practice.

Immune-related adverse events (irAEs) constitute a challenge in the clinical management of solid tumors. This study aims to collect real-world data on the occurrence of immune-mediated diarrhea and colitis (IMDC) in advanced non-small cell lung cancer (aNSCLC) treated with immune checkpoint inhibitors (ICIs) and to assess the clinical impact of a multidisciplinary approach (MDA) on IMDC management. We retrospectively collected data on patients with aNSCLC consecutively treated with ICIs, either as single agent or in combination with chemotherapy, between September 2013 and July 2022. Among patients developing IMDC, we conducted blinded revision of colonic biopsies and evaluated the clinical impact of the introduction of MDA through predefined indicators. Among the 607 patients included, 84 (13.8%) experienced IMDC. Pathological review highlighted a high prevalence of microscopic colitis (28%), with a collagenous pattern linked to longer symptoms duration (P = .01). IMDC occurred more frequently in females (P = .05) and PD-L1 expressors (P = .014) and was correlated with longer progression-free survival (17.0 vs 5.8, P < .001) and overall survival (28.3 vs 9.5, P < .001). The introduction of MDA was associated with increased employment of diagnostical tools such as fecal calprotectin test (P < .001), colonoscopy (P < .001), and gastroenterological evaluation (P = .017) and a significant decrease in both grade 3 conversion rate (P = .046) and recurrence after rechallenge (P = .016). Hospitalization rate dropped from 17.2% to 3.8% (P: ns). These findings highlight the clinical relevance of IMDC and support the incorporation of a MDA to optimize the clinical management of this irAE to improve patient care. Prospective validation has been planned.

Purpose: Inappropriate use of antibiotics contributes to the increase in antimicrobial resistance with negative health safety implications. Global health organizations have promoted projects to improve proper and rational use of antibiotics. Recent studies show how antibiotics can also influence the efficacy of immune checkpoint inhibitors (ICIs) treatment in cancer patients. This work analyzes the impact of concomitant antibiotic therapy in patients affected by skin, lung, and kidney cancer, who started immunotherapy in 2020‐2021 at Veneto Institute of Oncology IRCCS. The aim of this study is to evaluate clinical outcomes, treatment efficacy, discontinuation causes, and occurrence of adverse drug reactions in cancer patients treated with ICIs. Methods: Data from the real‐world retrospective study were extracted from Territorial Pharmaceutical Care databases, medical records, and the AIFA registry. A descriptive analysis of the study population was performed, as well as of patient outcomes in terms of progression‐free survival (PFS) and overall survival (OS). Results: A total of 239 subjects affected by kidney (8%), lung (48%), and skin (44%) cancer were enrolled; of these, 50%, 32%, 9%, and 9% were treated with single‐agent nivolumab, pembrolizumab, atezolizumab, and cemiplimab, respectively. A total of 119 patients received concomitant antibiotic therapy. Median OS was 8.8 months (95% CI: 5.02–11.8) and 31.05 months (95% CI: 24.81–NA) in subjects with high and low antibiotic exposure, respectively. Multivariate subgroup analysis confirmed that high antibiotic exposure is an unfavorable factor also for median PFS. Conclusion: A prolonged exposure to antibiotics correlates with unfavorable outcomes in cancer patients undergoing concomitant immunotherapy. Thus, managing antibiotic exposure is fundamental for optimizing ICI treatment.