Background: Novel SARS-CoV-2 infection has been a severe health problem in Italy since the beginning of March 2020, with around 227,000 confirmed cases on May 18th, 2020. The north-western part of Tuscany has been one of the areas with the highest incidence (342/100,000 inhabitants) and the highest lethality rate (31,2/ 100,000 inhabitants). The lethality rate was higher in men than women (12.6% vs. 7.4%). People aged 70-79 represented half of this population and the deaths in this subgroup represented 15.9% of all SARS-CoV-2-related deaths. Cancer patients are known to be at higher risk of incidence and complications from SARS-CoV-2. We aimed at analyzing the incidence and the lethality of Sars-CoV-2 in our prostate cancer (PC) patients (pts), in whom hormonal therapy seems to be protective from the first evidences published in the literature. Methods:We reviewed all the clinical files of PC pts'visits performed from March 1st to April 30th, 2020 in the University Hospital of Pisa. We analyzed the demographic characteristics, the comorbidities, the type of hormonal therapy pts received, the incidence of SARS-CoV-2 and the related lethality rate.
We reported the preoperative radio-guided localization of 4 peritoneal metastatic nodules in the case of a 45-year-old woman with uterine leiomyosarcoma. Three lines of chemotherapy were tried, but cardiotoxicity occurred. Within the context of so-called GOSTT (guided intraoperative scintigraphic tumor targeting), preoperative radio-guided localization of peritoneal metastases enabled their subsequent radio-guided excisional biopsy. SPECT/CT allowed for anatomical localization of the hot lesions and generated a 3-dimensional volume-rendering roadmap, facilitating a surgical approach.
Background: Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. Multinational, placebo-controlled, observer-blinded trials were conducted since the beginning of pandemic because safe and effective vaccines were needed urgently. In most trials of COVID-19 vaccines patients affected by malignancies or on treatment with immunosuppressive drugs were excluded. Patients and methods: A retrospective monocentric study was conducted at Medical Oncological Unit of Santa Chiara Hospital (Pisa, Italy) in this subset of population to investigate safety and tolerability of COVID-19 vaccines; 377 patients with solid tumor on treatment were enrolled. Vaccine-related adverse events were recorded using a face-to-face questionnaire including a toxicity grading scale. Most of the patients (94%) received mRNA vaccine as indicated by Italian health ministry guidelines. Mean age was 66 years (range 27–87), 62% of the patients were older than 65 years and 68% had at least one additional comorbidity. The majority (86%) of patients were in a metastatic setting and 29% received immunotherapy-based treatment. For statistical analysis, multivariate binary logistic regression models were performed and linear regression models were applied. Results: Adverse events were mild and transient and ended in a few days without any sequelae. No severe or uncommon adverse events were recorded. In multivariate analysis, we found that the female sex was associated with a greater risk of more severe and longer lasting adverse events, and a higher risk of adverse events was found for patients treated with immunotherapy. Conclusions: Our results demonstrate that COVID-19 vaccines were safe and well-tolerated in this population of patients being treated for solid tumors.
BackgroundBRAF and MEK inhibitors target therapies (TT) and AntiPD1 immunotherapies (IT) are available first-line treatments for BRAF v600 mutant metastatic melanoma patients. ECOG PS (E), baseline LDH (L), and baseline number of metastatic sites (N) are well-known clinical prognostic markers that identify different prognostic categories of patients. Direct comparison between first-line TT and IT in different prognostic categories could help in first line treatment decision.MethodsThis is a retrospective analysis conducted in 14 Italian centers on about 454 metastatic melanoma patients, divided in 3 groups: group A—patients with E = 0, L within normal range, and N less than 3; group B—patients not included in group A or C; group C—patients with E > 0, L over the normal range, and N more than 3. For each prognostic group, we compared TT and IT in terms of progression free survival (PFS), overall survival (OS), and disease control rate (DCR).ResultsIn group A, results in 140 TT and 36 IT-treated patients were, respectively, median PFS 35.5 vs 11.6 months (HR (95% CI) 1.949 (1.180–3.217) p value 0.009); median OS not reached vs 55 months (HR (95% CI) 1.195 (0.602–2.373) p value 0.610); DCR 99% vs 75% p value <0.001). In group B, results in 196 TT and 38 IT-treated patients were, respectively, median PFS 11.5 vs 5 months (HR 1.535 (1.036–2.275) p value 0.033); median OS 19 vs 20 months (HR 0.886 (0.546–1.437) p value 0.623); DCR 85% vs 47% p value <0.001). In group C, results in 41 TT and 3 IT-treated patients were, respectively, median PFS 6.4 vs 1.8 months (HR 4.860 (1.399–16) p value 0.013); median OS 9 vs 5 months (HR 3.443 (0.991–11.9) p value 0.052); DCR 66% vs 33% p value 0.612).ConclusionsIn good prognosis, group A—TT showed statistically significant better PFS than IT, also in a long-term period, suggesting that TT can be a good first line option for this patient category. It is only in group B that we observed a crossing of the survival curves after the 3rd year of observation in favor of IT. Few patients were enrolled in group C, so few conclusions can be made on it.
Background: Immune checkpoint inhibitors (ICIs) represent the standard therapy for malignant melanoma. However, a number of patients do not respond to ICIs and biomarker development remains challenging. Methods: This single cohort observational study investigates the association between mRNA levels of programmed cell death-1 (PD-1) ligand 1 (PD-L1), interferon-gamma (IFN-γ), and transforming growth factor-β (TGF-β) in circulating extracellular vesicles (EVs) in 30 patients with metastatic melanoma treated with first line anti-PD-1 antibodies. Blood samples were collected at baseline and RNA extracted from EVs. The RNA levels of PD-L1, IFN-γ, and TGF-β were analysed by digital droplet PCR (ddPCR). A biomarker-radiomic analysis was performed in a subset of patients.Results: Patients with high TGF-β expression (cut-off fractional abundance [FA] >0.19) at baseline had longer median progression-free survival (8.4 vs 1.8 months; p=0.006) and overall survival (17.9 vs 2.63 months; p=0.0009). Moreover, radiomic analysis demonstrated that patients with high TGF-β expression at baseline had smaller lesions (2.41 ± 3.27 ml vs 42.79 ± 101.08 ml, p<0.001) and higher dissimilarity (12.01 ± 28.23 vs 5.65 ± 8.4; p=0.018).Conclusions: These results provide evidence that high TGF-β expression in extracellular vesicles at baseline is associated with a better response to immunotherapy. Further investigation on a larger patient population is needed to validate the predictive power of this potential biomarker of response to ICIs.
Background: PARP-inhibitors target pathogenic BRCA mutations and homologous recombination deficiency, representing a novel therapeutic approach in patients with this specific alteration, offering longer survival. However, their use in clinical practice has revealed a number of important cardiovascular side effects which can decrease patients' quality of life. This has been little researched, and the information we have is scarce. Methods:We conducted an observational retropective study selecting patients treated with PARP-inhibitors between 2018 and 2021 in our institution, and analyzed their cardiovascular risk factors (CVRF). The aim of this study was to assess the incidence of cardiovascular events in this population.Results: A total of 44 patients were analyzed. Data regarding demographic characteristics, CVRF and oncological information are shown in the table. When we analyzed cardiovascular events the results were as follows: the most frequent events were hypertension (20.5%) and palpitations (18.6%), most of them requiring cardiologic assessment and treatment with beta-blockers (16.3%) or antihypertensive drugs. 9.3% of the patients presented an ECG alteration and only 4.6% echocardiographic abnormalities. Two patients required hospital admission, because of an acute coronary síndrome and a pulmonary embolism. There were no congestive heart failure episodes related to PARP-inhibitors treatment. No patient had to stop treatment due to cardiotoxicity and there were no deaths related with cardiological events. 25% of the patients were referred to the cardiologist in order to optimize treatment and continued periodic reviews.Conclusions: Almost half of the patients in our study experienced some kind of cardiac event. Prospective studies with cardiovascular comprehensive follow-up protocols are needed. Due to the increased use of these drugs, it's important to highlight the role of the cardiologist in order to optimize treatment, improve patients' symptoms and carry out a multidisciplinary approach.
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