Publications by authors named "Marilena Di Napoli"

Article Synopsis
  • The IMDC score is crucial for predicting outcomes and guiding treatment in patients with metastatic renal cell carcinoma (mRCC), especially when starting therapy with nivolumab.
  • A multicenter study analyzed 492 mRCC patients to see how changes in IMDC categories affected their overall survival (OS) and progression-free survival (PFS) after starting nivolumab.
  • Results indicated that patients maintaining or improving their IMDC category had better survival outcomes compared to those whose condition worsened, highlighting the importance of IMDC monitoring in mRCC treatment.
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Endometrial cancer incidence and related mortality are on the rise due to aging demographics. This population often presents with unfavorable features, such as myometrial invasion, non-endometrioid histology, high-grade tumors, worse prognosis, etc. The role of age as an independent prognostic factor is still debated, and screening tools addressing frailty emerge as pivotal in guiding treatment decisions; however, they are still underutilized.

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Introduction: Rare genitourinary tumors are lacking of randomized and observational data. We aimed to describe the clinical characteristics and outcomes of patients with collecting duct carcinoma (CDC) through the Meet-URO 23/I-RARE database.

Materials And Methods: We performed a multicentric retrospective-prospective study within the Meet-URO network, enrolling patients from March 2021 (retrospectively up from 2011) until March 2023.

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Article Synopsis
  • The study aims to determine factors that predict sensitivity to nivolumab in patients with metastatic renal cell carcinoma (mRCC) by analyzing immune cell profiles, specifically peripheral blood NK cells and regulatory T-cells (Tregs).
  • A total of 57 mRCC patients and 62 healthy donors were analyzed for various immune cell characteristics over the first year of treatment, using statistical methods to identify key predictors.
  • Results indicated that KIR2DL2/DL3+ NK cells and Helios+ Tregs at pretreatment serve as important predictors of nivolumab response, with specific thresholds related to overall survival (OS) and progression-free survival (PFS) showing their potential significance in treatment outcomes.
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To define the prognostic significance of first-line TKI in mRCC patients receiving nivolumab. A total of 571 mRCC patients who received ≥second line nivolumab were included in this subanalysis. The correlation between prior TKI (sunitinib vs.

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Background: Immune-checkpoint inhibitors (ICIs) have significantly improved metastatic renal cell carcinoma (mRCC) prognosis, although their efficacy in patients with bone metastases (BMs) remains poorly understood. We investigated the prognostic role of natremia in pretreated RCC patients with BMs receiving immunotherapy.

Materials And Methods: This retrospective multicenter study included RCC patients with BMs receiving nivolumab as second-line therapy or beyond.

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Background: Although nivolumab prolongs overall survival (OS) in pretreated patients with metastatic renal cell carcinoma (mRCC), underlining clinical and biological features of long-term responses are still to be determined. This study aims to investigate clinical and pathological characteristics of mRCC patients who achieved long-term responses during nivolumab treatment.

Materials And Methods: A retrospective analysis was performed on mRCC patients receiving nivolumab as second or further therapy line between May 2016 and January 2019 in 34 Italian Oncology Centres.

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Article Synopsis
  • CXCR4 plays a significant role in regulating the trafficking of T regulatory cells (Tregs), and the new antagonist R54 was tested on Tregs from renal cell carcinoma (RCC) patients.
  • In the study, R54 was found to impair the function of peripheral blood Tregs, decreasing their frequency and secretion of inhibitory cytokines while increasing effector T cell secretion of IFN-γ.
  • The results suggest that targeting CXCR4 with R54 could effectively inhibit Treg activity in the tumor microenvironment of RCC by affecting key signaling pathways and Treg characteristics.
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Background: Peritoneal metastases (PM) have been reported in approximately 1% of patients with metastatic Renal Cell Carcinoma (mRCC). Outcome data are limited due to the rarity of this metastatic site. Therefore, the aim of our study is to describe renal cell carcinoma (RCC) patients with PM treated as per clinical practice.

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Introduction: Penile squamous cell carcinoma (PSCC) is a rare tumor with an aggressive behavior. The Meet-URO 23/I-RARE registry includes rare genitourinary malignancies. We extracted patients with PSCC to conduct a retrospective study aimed at assessing clinical outcomes and prognostic factors.

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Background: Immunotherapies exhibit peculiar cancer response patterns in contrast to chemotherapy and targeted therapy. Some patients experience disease response after initial progression or durable responses after treatment interruption. In clinical practice, immune checkpoint inhibitors may be continued after radiological progression if clinical benefit is observed.

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Article Synopsis
  • PARP inhibitors, specifically niraparib, are used in maintenance therapy for platinum-sensitive ovarian cancer, regardless of BRCA mutation status.
  • A study evaluated the real-world efficacy and safety of niraparib in patients with relapsed ovarian cancer, collecting clinical data from those who received the treatment.
  • Results showed a median progression-free survival of 9.1 months for BRCA wild-type patients and 10.3 months for BRCA mutated patients, indicating that niraparib is effective and well tolerated in clinical practice.
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Cervical cancer (CC) is the second most commonly diagnosed cancer and the third leading cause of cancer death among females. The options of treatment for recurrent/advanced CC are limited and patients experiencing recurrence after first line platinum-based chemotherapy have a poor prognosis. In this context, immune checkpoint inhibitors (ICI)s antagonizing PD-1 and programmed death-ligand 1 (PD-L1) have profoundly changed the treatment scenario and outcomes in CC in the first or subsequent lines both as monotherapies or in combination with chemotherapy or other ICIs.

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Background: As recommended in the European Society for Medical Oncology (ESMO) guidelines, assessment of health-related quality of life (HRQoL) should be a relevant endpoint in randomized controlled trials (RCTs) testing new anticancer therapies. However, previous publications by our group and others revealed a frequent underestimation and underreporting of HRQoL results in publication of RCTs in oncology. Herein, we systematically reviewed HRQoL reporting in RCTs testing new treatments in advanced prostate, kidney and urothelial cancers and published between 2010 and 2022.

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Importance: Low sodium levels have been associated with negative outcomes among patients with metastatic renal cell carcinoma (mRCC) receiving therapies other than immune checkpoint inhibitors (ICIs).

Objective: To investigate the role of natremia in patients with mRCC receiving nivolumab as a second-line or subsequent therapy.

Design, Setting, And Participants: In this retrospective cohort study, the clinical and biochemical data of patients with mRCC receiving nivolumab were collected from October 2015 to November 2019 as part of a multicenter Italian study.

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Article Synopsis
  • Immune-related liver injury (irLI) occurs more frequently in patients with hepatocellular carcinoma (HCC) treated with immune checkpoint inhibitors (ICIs) compared to those with other solid tumors, showing an incidence of 11.4% versus 2.6%.
  • Patients with HCC experienced irLI earlier (median of 1.4 months) than those with other cancers (median of 4.7 months), but had higher rates of irLI resolution (72.1% vs. 58.3%).
  • The study suggests that while irLI leads to improved overall survival in HCC patients with milder cases, it also results in lower need for corticosteroids, indicating a different response pattern compared to
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Background: The addition of neutrophil to lymphocyte ratio (NLR) and bone metastases to the IMDC classification provided by the Meet-URO score, resulted in higher prognostic accuracy in metastatic renal cell carcinoma (mRCC) patients receiving ≥2nd line nivolumab or cabozantinib in 2 retrospective analyses and 1st line nivolumab-ipilimumab in an expanded access programme. Prognostic estimates for older mRCC patients might be key for clinical decision-making.

Methods: The outcome of real-world older (≥70 years) mRCC patients treated with any line cabozantinib within the multicenter observational prospective ZEBRA (Meet-URO 9) study was analyzed according to the baseline Meet-URO score.

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The neutrophil-to-lymphocyte ratio (NLR) and systemic immune-inflammatory index (SII) have been reported as prognosticators in non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), and melanoma. This analysis of the INVIDIa-2 study on influenza vaccination in patients with cancer treated with immune checkpoint inhibitors (ICIs) assessed NLR and SII on overall survival (OS) by literature-reported (LR), receiver operating characteristic curve (ROC)-derived (ROC) cutoffs or as continuous variable (CV). NLR and SII with ROC cutoffs of <3.

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Background: The prospective multicentre observational INVIDIa-2 study investigated the clinical effectiveness of influenza vaccination in patients with advanced cancer receiving immune checkpoint inhibitors (ICI). In this secondary analysis of the original trial, we aimed to assess the outcomes of patients to immunotherapy based on vaccine administration.

Methods: The original study enrolled patients with advanced solid tumours receiving ICI at 82 Italian Oncology Units from Oct 1, 2019, to Jan 31, 2020.

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Article Synopsis
  • * Papillary and unclassified nccRCC subtypes show promising immunotherapy response rates of around 35%, while chromophobe cancers generally do not respond, and tumors with sarcomatoid features tend to respond well regardless of subtype.
  • * There is a need for larger clinical trials focusing on nccRCC to better assess tumor response rates and evaluate biomarkers like PD-L1, which may indicate better treatment outcomes.
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Background: Adding immunotherapy to first-line chemotherapy might improve outcomes for patients with advanced or recurrent endometrial cancer. We aimed to compare carboplatin and paclitaxel versus avelumab plus carboplatin and paclitaxel as first-line treatment with avelumab given concurrent to chemotherapy and as maintenance after the end of chemotherapy.

Methods: MITO END-3 is an open-label, randomised, controlled, phase 2 trial conducted at 31 cancer institutes, hospitals, and universities in Italy.

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Endometrial cancer (EC) is the most common gynecologic cancer in Europe and its prevalence is increasing. EC includes a biological and clinical heterogeneous group of tumors, usually classified as type I (endometrioid) or type II (non-endometrioid) based on the histopathological characteristics. In 2013, a new molecular classification was proposed by The Cancer Genome Atlas (TCGA) based on the comprehensive molecular profiling of EC.

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Non-clear cell renal cell carcinoma (nccRCC) represents a heterogeneous histological group which is 20-25% of those with renal cell carcinoma (RCC). Patients with nccRCC have limited therapeutic options due to their exclusion from phase III randomized trials. The aim of the present study was to investigate the effectiveness and tolerability of pembrolizumabaxitinib combination in chromophobe and papillary metastatic RCC (mRCC) patients enrolled in the I-RARE (Italian Registry on rAre genitor-uRinary nEoplasms) observational ongoing study (Meet-URO 23).

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Background: Platinum-based chemotherapy (PBCT) is the standard first-line treatment for advanced urothelial carcinoma (UC). Potential cross-sensitivity can be hypothesized between platinum drugs and poly-ADP ribose-polymerase (PARP) inhibitors.

Objective: To compare maintenance treatment with the PARP inhibitor niraparib plus best supportive care (BSC) versus BSC alone in patients with advanced UC without disease progression after first-line PBCT.

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Article Synopsis
  • The treatment choices for patients with metastatic renal cell carcinoma (mRCC) remain reliant on initial clinical and lab factors.
  • A study analyzing data from 422 mRCC patients on nivolumab found that changes in neutrophil, lymphocyte, and platelet counts, especially the neutrophil-to-lymphocyte ratio (NLR), correlate with disease progression.
  • Early variations in neutrophils and NLR were identified as significant independent predictors of overall and progression-free survival, potentially aiding in treatment decisions.
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