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  • 1
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    Online Resource
    BNT162b2 COVID-19 Vaccine Safety among Healthcare Workers of a Tertiary Hospital in Italy
    MDPI AG ; 2023
    In:  Vaccines Vol. 11, No. 2 ( 2023-02-17), p. 477-
    Details
    In: Vaccines, MDPI AG, Vol. 11, No. 2 ( 2023-02-17), p. 477-
    Abstract: Millions of people have died because of the COVID-19 pandemic. The vaccination campaign helped tackle the pandemic and saved millions of lives. In a retrospective pharmacovigilance study, we explored the safety of the BNT162b2 (Comirnaty) vaccine among healthcare workers (HCWs) in a large Italian teaching hospital, and 2428 Adverse Events Reports (AERs) filed by HCWs after the administration of the first dose of vaccine were collected and analyzed, reporting the results quantitively and comparing them to the vaccine Summary of Product Characteristics (SPC). Spearman’s correlation coefficients were computed to investigate the correlation among reported adverse effects, and recurrent clusters of symptoms were investigated through the Principal Component Analysis (PCA) and k-means Cluster Analysis. The BNT162b2 vaccine’s safety profile was favorable, with predominant reports of early onset, mild, non-serious and short-term resolved symptoms. We observed higher than the expected frequency for various non-serious undesirable effects, especially among those listed and classified as less common in the SPC. Furthermore, we identified three clusters of adverse effects that were frequently reported together, defined by the presence/absence of fatigue, malaise, localized pain, chills, pyrexia, insomnia, nausea and injection site pain. Post-marketing pharmacovigilance activities, together with targeted public health interventions, can be valuable tools to promote vaccination and improve the control of the spread of the pandemic, especially in sensitive settings and populations such as hospitals and healthcare professionals.
    Type of Medium: Online Resource
    ISSN: 2076-393X
    URL: Article
    DOI: 10.3390/vaccines11020477
    Language: English
    Publisher: MDPI AG
    Publication Date: 2023
    detail.hit.zdb_id: 2703319-3
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  • 2
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    Maintenance strategies after anti–EGFR-based induction in RAS wild-type (wt) metastatic colorectal cancer (mCRC): A systematic review and Bayesian network meta-analysis.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 4_suppl ( 2023-02-01), p. 148-148
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 4_suppl ( 2023-02-01), p. 148-148
    Abstract: 148 Background: In RAS wt mCRC the use of maintenance therapy after induction with fluoropyrimidine (FP)-based cytotoxic therapy (CT) plus anti-EGFR agents is controversial. Herein, we conducted a systematic review and network meta-analysis to compare different maintenance strategies. Methods: PubMed, CENTRAL, Embase and oncological meeting websites were screened to identify eligible studies. Phase II-III randomized trials which enrolled patients with previously untreated RAS wt mCRC, who switched to a maintenance strategy after an induction of CT combined with an anti-EGFR agent were included. Maintenance strategies considered were: observation, single agent anti-EGFR or FP, FP + anti-EGFR, doublet CT + anti-EGFR. Outcomes were progression-free survival (PFS), overall survival (OS) and safety (grade 3-4 adverse events). Subgroup analyses were performed in BRAF wt patients and left sided tumors. The meta-analysis was conducted using a random-effects model. A Markov Chain Monte Carlo simulation was used to estimate the posterior distributions. Strategies were ranked using the surface under the cumulative ranking (SUCRA) probabilities. Risk of bias was assessed with Cochrane Risk of Bias Tool. Results: Overall, 4207 records were screened and 10 trials were included in the analysis. Cumulative risk of bias was low-moderate. Maintenance therapy with FP + anti-EGFR (HR 0.56, 95% CrI 0.36-0.88) and doublet CT + anti-EGFR (HR 0.68, 95% CrI 0.46-1.01), showed the greatest PFS benefit compared to observation. On SUCRA analysis, FU + anti-EGFR had the highest likelihood of improving PFS (96.3%), compared to doublet CT + anti-EGFR (73.5%) or EGFR monotherapy (48.0%). In terms of OS, compared to observation, maintenance therapy with doublet CT + anti-EGFR (HR 0.51, 95% CrI 0.19-1.28), FU + anti-EGFR (HR 0.59, 95% CrI 0.19-1.68) or anti-EGFR monotherapy (HR 0.56, 95% CrI 0.24-1.34) yielded similar results. On SUCRA analysis probabilities were 78.3% with doublet CT + anti-EGFR, 64.5% with FP + anti-EGFR and 63.4% with anti-EGFR monotherapy. FP + anti-EGFR confirmed to be the best option in terms of PFS in BRAF wt patients (SUCRA: 96.3%) and left sided tumors (SUCRA: 89.6%). OS results in BRAF wt patients were consistent with the primary analysis. In left sided tumors, the OS benefit of adding CT seems limited compared to EGFR monotherapy. The addition of CT to anti-EGFR agents resulted in an increase of toxicity while FP monotherapy plus anti-EGFR showed a favourable safety profile compared to doublet CT + anti-EGFR. Conclusions: FP + anti-EGFR should be considered the best maintenance option in RAS wt mCRC in terms of PFS. Taking into account the similar OS performance of the different strategies, EGFR monotherapy could be considered, especially in left-sided tumors. Doublet CT + anti-EGFR, despite being effective, is limited by toxicities.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.4_suppl.148
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 3
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    Re: Thomas Powles, Zoe June Assaf, Viraj Degaonkar, et al. Updated Overall Survival by Circulating Tumor DNA Status from the Phase 3 IMvigor010 Trial: Adjuvant Atezolizumab Versus Observation in Muscle-invasive Urothelial Carcinoma. Eur Urol 2024;85:114–22
    Elsevier BV ; 2024
    In:  European Urology ( 2024-4)
    Details
    In: European Urology, Elsevier BV, ( 2024-4)
    Type of Medium: Online Resource
    ISSN: 0302-2838
    URL: Article
    DOI: 10.1016/j.eururo.2024.03.040
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2024
    detail.hit.zdb_id: 1482253-2
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  • 4
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    2023 ASCO Genitourinary Cancers Symposium: a focus on urothelial carcinoma
    Informa UK Limited ; 2023
    In:  Expert Review of Anticancer Therapy
    Details
    In: Expert Review of Anticancer Therapy, Informa UK Limited
    Type of Medium: Online Resource
    ISSN: 1473-7140 , 1744-8328
    URL: Article
    DOI: 10.1080/14737140.2023.2265570
    Language: English
    Publisher: Informa UK Limited
    Publication Date: 2023
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  • 5
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    Knowledge and beliefs about vaccination in pregnant women before and during the COVID-19 pandemic
    Frontiers Media SA ; 2022
    In:  Frontiers in Public Health Vol. 10 ( 2022-8-4)
    Details
    In: Frontiers in Public Health, Frontiers Media SA, Vol. 10 ( 2022-8-4)
    Abstract: Vaccine hesitancy threatens the health of populations and challenges Public Health professionals. Strategies to reduce it aim to improve people's risk perception about vaccine-preventable diseases, fill knowledge gaps about vaccines and increase trust in healthcare providers. During pregnancy, educational interventions can provide a proper knowledge about safety and efficacy of maternal and childhood vaccinations. Fighting hesitancy and clarifying doubts is fundamental during the COVID-19 pandemic, which may have affected people's knowledge and beliefs toward vaccination. This study aimed at assessing if the advent of the pandemic was associated with changes in pregnant women's knowledge and beliefs toward vaccination, and trust in healthcare services. Methods A repeated cross-sectional study was conducted through self-reported questionnaires in a Roman teaching hospital, where educational classes about vaccinations are routinely held as part of a birthing preparation course. Data were collected on a sample of pregnant women before and during the pandemic. Free-of-charge flu vaccinations were offered to all course participants and adherence to flu vaccination was assessed. Results The proportion of pregnant women reporting that vaccines have mild side effects and that are sufficiently tested increased from 78.6 to 92.0% ( p = 0.001) and from 79.4 to 93.2% ( p = 0.001), respectively. There was a reduction from 33.0 to 23.3% ( p = 0.065) in the proportion of those declaring that healthcare workers (HCWs) give information only on the benefits and not on the risks of vaccines, and a reduction from 27.3 to 12.1% ( p = 0.001) in those reporting that vaccines are an imposition and not a free choice of mothers. Trust in National Health Service (NHS) operators slightly decreased. Among participants, the monthly flu vaccination adherence ranged from 50.0% in November to 29.2% January for 2019–20 flu season, and from 56.3% in September to 14.5% in January for 2020–21 flu season, showing a higher vaccination acceptance in the earlier months of 2020-21 flu season. Conclusions The pandemic may have positively affected pregnant women's knowledge and opinions about vaccinations and trust in HCWs, despite a possible negative impact on their perceptions about NHS operators. This should inspire Public Health professionals to rethink their role as health communicators.
    Type of Medium: Online Resource
    ISSN: 2296-2565
    URL: Article
    DOI: 10.3389/fpubh.2022.903557
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2022
    detail.hit.zdb_id: 2711781-9
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  • 6
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    Theranostics revolution in prostate cancer: Basics, clinical applications, open issues and future perspectives
    Elsevier BV ; 2024
    In:  Cancer Treatment Reviews Vol. 124 ( 2024-03), p. 102698-
    Details
    In: Cancer Treatment Reviews, Elsevier BV, Vol. 124 ( 2024-03), p. 102698-
    Type of Medium: Online Resource
    ISSN: 0305-7372
    URL: Article
    DOI: 10.1016/j.ctrv.2024.102698
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2024
    detail.hit.zdb_id: 2002084-3
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  • 7
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    The impact of second-line treatment after fist-line cisplatin plus gemcitabine in advanced biliary tract cancers: A mono-institutional retrospective study.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. e16180-e16180
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. e16180-e16180
    Abstract: e16180 Background: The prognosis of advanced biliary tract cancers (ABTCs) is poor with a 5 year overall survival (OS) lower than 20%. The standard of care first-line chemotherapy is the combination of cisplatin plus gemcitabine. The efficacy of second-line treatment is supported by few evidence and only one randomized phase III clinical trial is reported. The ABC-06 trial showed a minimal improvement in overall survival with FOLFOX compared to active symptoms control (ASC). Herein, we provide a retrospective analysis of patients treated with second-line treatment at our Institution investigating the impact of treatment regimen and possible prognostic or predictive factors. Methods: ABTCs patients receiving second-line treatment following a first-line chemotherapy with cisplatin plus gemcitabine were included in the analysis. The following variables were collected: gender; age ( 〈 65 years vs ≥ 65 years); baseline ECOG PS (0-1 vs ≥2); second-line regimen (FOLFIRI vs FOLFOX); comorbidities (yes vs no); number of comorbidities (0-1 vs ≥ 2); number of metastatic sites (1 vs ≥2). Univariate and multivariate analysis for progression free survival (PFS) and OS were performed. Results: Fifty-one patients affected with ABTCs receiving second-line treatment between January 2016 and May 2021 were included in the analysis. The median age was 70 years (38-82), 39% (20) were males, 70% (36) were aged ≥ 65 years, ECOG PS was 0-1 in 86% (44) of patients; 39% (20) had ≥2 comorbidities; 60% (31) had ≥ 2 metastatic sites. Second-line regimen included FOLFIRI (28; 55%), FOLFOX (15; 29%), capecitabine (2; 4%) and experimental drugs (6; 12%). The overall population median PFS and OS at second-line were 3.5 months (median follow-up 11.4 months) and 8.8 months (median follow-up 22.6 months), respectively. Two patients (4%) achieved a partial response and the disease control rate was 39%. At the univariate and multivariate analysis, no variable was associated with PFS. At the univariate analysis, second-line regimen FOLFIRI (p = 0.03) and single metastatic site (p = 0.06) were associated with improved OS; at the multivariate analysis only the second-line regimen was confirmed associated with OS (p = 0.02). In particular, out of 43 evaluable patients, the median OS according to treatment (FOLFIRI vs FOLFOX) was 11.3 months versus 5.4 months (p = 0.019, HR 0.46, 95% CI: 0.18-0.88). Conclusions: Despite the retrospective analysis and the limited sample size, we confirm the importance of second-line chemotherapy in ABTCs patients, when feasible. Our results show that the second-line FOLFIRI regimen after a platinum-containing fist-line, was independently associated with improved OS. Given that the ABC-06 trial compared FOLFOX to ASC, a randomized trial of FOLFOX vs FOLFIRI as second-line would provide further information in this setting.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.e16180
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 8
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    DNA damage repair (DDR) germline mutations (GMs) in pancreatic ductal adenocarcinoma (PDAC): A mono-institutional retrospective study.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 10587-10587
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 10587-10587
    Abstract: 10587 Background: GMs in DDR genes, in particular BRCA1/2, are associated with increased risk of cancer, including PDAC. Their identification is crucial for the clinical relevance, the best treatment choice, and the family implications in cancer prevention. However, there are few data regarding the epidemiology and the prognostic role of DDR GMs in PDAC patients (pts). The aim of our study is to determine the prevalence of DDR GMs, their correlation with clinicopathological features and their prognostic role. Methods: Unselected PDCA pts, assessed by BRCA1/2 GM analysis or multigenic panel at our Institution, were retrospectively analyzed. We divided the overall population into three groups based on GMs: pts with pathogenic variants (PVs), pts with variants of uncertain significance (VUS) and pts with no alterations. Clinicopathologic characteristics and treatment data were collected. The incidence of DDR GMs variants and their association with overall survival (OS) were evaluated. Univariate and multivariate analyses for OS were performed. Results: From September 2019 to August 2021, 200 PDAC pts were tested for DDR GMs: all pts were evaluated for BRCA 1/2; 140 pts were tested for further DDR GMs by a multigenic panel. Twenty-five pts (12.5%) had PVs, 45 (22.5%) pts had VUS and 130 (65%) pts had no GMs. BRCA 1-2 PVs were found in 10 pts (5%). Out of 91 pts with metastatic disease, the rate of PVs BRCA1/2 was 8.8%. Among 140 pts tested with multigenic panel, further PVs included: 7 (5%) ATM, 5 (3.6%) MUTYH, 1 (0.7%) TP53, 1 (0.7%) BARD1, and 1 (0.7%) MSH6. The most frequent VUS were: CHECK2 (5%), APC (3.6%), ATM (3.6%) and BRCA2 (3.6%). Regarding cancer family history, a statistically significant difference was reported between the 3 group (76% in PV pts, 82% in VUS pts and 60% in pts with no GMs; p 0.01). No difference was found concerning age (p 0.69), stage at diagnosis (p 0.31) and platinum-exposure (p 0.27). Out of 189 evaluable pts, median OS was 23 months. A significant difference in OS was observed in the 3 groups (30 months in PVs pts, 14 months in VUS pts and 24 months in pts with no GMs, p 0.0006). No factor, including the presence or the type of GMs, age, stage and family history, was significantly associated with OS at the multivariate analysis. Conclusions: In our study, we observed a high incidence of DDR GMs PV (12.5%), beyond BRCA 1/2, regardless of age, stage and family history. Despite retrospective nature of our analysis, small population, and single-institution evaluation, our findings confirm the importance of genetic testing for BRCA1/2 and, where available, of a multigenic test in all PDAC pts, due to the therapeutic implications and cancer risk prevention in patients relatives. The prognostic role of DDR GMs and the impact of VUS remain unclear.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.10587
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 9
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    Management of Early-onset Metastatic Colorectal Cancer (ERMIONE): A single institution analysis.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 3593-3593
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 3593-3593
    Abstract: 3593 Background: Despite rising incidence and mortality reported worldwide for CRC diagnosed in pts aged 〈 50 yrs, currently early onset metastatic CRC (EOmCRC) are treated as their older counterparts. We aimed to investigate how this specific subgroup is treated in real world. Methods: This an observational, retrospective, monocentric study aiming to describe features, management and prognosis of EOmCRC. Pts with EOmCRC treated at our Institution between Apr2002 and Dec2022 were included. Applying a descriptive method, counts and percentages were reported for categorical variables, while median and range for continuous variables. PFS and OS were estimated with the Kaplan-Meier method. A multivariate Cox regression analysis was performed. Results: 172 pts were included, of those 60.5% were female and 66% had an ECOG PS of 0. Median age at diagnosis was 43 yrs (range 12-49 yrs). Metastatic disease was mainly synchronous (72.1%), while only 12.2% and 15.7% were stage II and III at diagnosis and developed metachronous metastases. Primary tumor was left-sided in 70.1%. Metastatic site was most frequently liver (67.4%), followed by peritoneum (41.3%), lungs (33.7%), ovary (23.2%) and bones (9.9%). Disease was mostly widespread, while only 30.2% had a single metastatic site. MMR status was available for 87.2% of pts, being proficient in 90% and deficient in 10%. RAS/BRAF status was available for 95.3% of cases, of those 47.5% was RAS/BRAF wt, 48.2% was RAS mt and 4.3% was BRAF mt. 42.4% of cases had a family history positive for cancer. Germline pathogenic or likely pathogenic variants were identified in 6.4% of cases, of those 63.6% involved MMR genes and 18.2% involved HRD genes. Median number of lines of treatment received was 2 (range 1–6). Most frequent first line regimen was a doublet CT (69.8%), followed by a triplet CT (23.8%) and immunotherapy (4.1%), CT regimens were associated to bevacizumab in 45.3% of cases and to antiEGFRs in 29.1% of cases. Throughout the whole continuum of care 8.7% of pts received immunotherapy and 21.5% received treatment within a clinical trial. 70.3% of pts received surgery and/or local ablative treatments (LATs) with radical intent (52.9% surgery, 12.2 both, 4.6% LATs). At a median FU of 38.6 m, mPFS for first line was 13.5 m (95%CI 12.1-15.0 m) and mOS was 41.5 m (95%CI 33.9 - 44.1 m). Median OS was significantly longer for pts who received surgery and/or LATs compared to those who did not (43.4 vs 23.6 m, p 〈 .0001). At multivariate analysis, besides surgery and/or LATs (p= .0007), BRAF status (p= .0165) and ECOG PS (p= .0209) independently correlated with OS. Conclusions: We confirmed that EOmCRC is more frequently diagnosed as synchronous disease, due to delayed diagnosis. Despite the small population and the retrospective nature, we showed that combining surgery and/or LATs to systemic therapy is associated with increased OS in EOmCRC. These evidence warrant further validation in prospective setting.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.3593
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 10
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    Adjuvant therapy (AT) in patients (pts) with radically resected ampullary adenocarcinoma (AA): A monocentric retrospective analysis.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. e16142-e16142
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. e16142-e16142
    Abstract: e16142 Background: Ampullary adenocarcinoma (AA) is a rare tumor. Radical surgery is the only curative treatment for localized AA. The role of AT is not clearly defined and previous evidence in literature is poor and controversial. Hence, we retrospectively analyzed radically resected AA pts at our Institution, investigating the impact of AT on survival and the role of possible prognostic and/or predictive factors. Methods: Radically resected AA pts were retrospectively included in the analysis, divided into two groups: pts receiving AT and pts undergoing only postoperative observation (PO). The following variables were collected: gender; age (≤ 65 vs 〉 65 years); baseline ECOG PS (0 vs ³ 1); histologic subtype (pancreatobiliary vs intestinal); tumor stage (T1-2 vs T3-4); nodal status (N0 vs N+), margin status (R0 vs R+); radiotherapy (yes vs no), AT regimen [Gemcitabine (GMZ)-based vs fluoropyrimidine (FP)-based treatment)]. The objective of the analysis was to evaluate the impact of AT on overall survival (OS). Univariate and multivariate analyses were performed. Results: From 2007 to 2021, a total of 69 pts with radically resected AA were identified: 41 (59%) pts received AT, 28 (41%) PO. The median age was 65 years (41-81), 42 (61%) were males, ECOG PS was ³ 1 in 45 (65%) pts. Tumor characteristics were: 31 (45%) pancreatobiliary, 26 (38%) intestinal, 9 (13%) mixed subtype and 3 (4%) not available; 41 (59%) pts had T3-T4 stage tumor; 34 (49%) were N+. Out of 41 pts receiving AT, 27 (66%) pts were treated with FP-based AT, 14 (34%) with GMZ-based AT; 16 (23%) pts received also RT. In the overall population, median OS was 59.8 months. At the univariate analysis, there was a statistically significant association of T status with OS (p 0.03), confirmed at multivariate analysis (p 0.03). Further variables (ECOG PS, AT, nodal status and histologic subtype) were not associated with survival. Among the 41 pts receiving AT, median OS was 58.7 months. At the univariate analysis, AT regimen was significantly associated with OS (p 0.02), and it was confirmed at the multivariate analysis. In particular, median OS was 59.8 and 28.3 months in pts receiving FP- and GMZ-based AT, respectively [HR 0.26, (95% CI: 0.09-0.78), p = 0.001] . Conclusions: Among pts with radically resected AA, AT, compared with PO, was not associated with a significant survival benefit. However, among pts receiving AT, FP-based regimen seems to significantly improve OS in comparison to GMZ-based regimen, independently of histologic subtype. Our findings, from a retrospective and limited case series, add to controversial literature data and miss to clarify the real impact of AT in radically resected AA pts. A randomized trial of AT vs PO would provide further information in this setting.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.e16142
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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