Publications by authors named "Procopio G"

Background: "Patient Voices" is a software developed to promote the systematic collection of electronic patient-reported outcome measures (ePROMs) in routine oncology clinical practice.

Objective: This study aimed to assess compliance with and feasibility of the Patient Voices ePROM system and analyze patient-related barriers in an Italian comprehensive cancer center.

Methods: Consecutive patients with cancer attending 3 outpatient clinics and 3 inpatient wards were screened for eligibility (adults, native speakers, and being able to fill in the ePROMs) and enrolled in a quantitative and qualitative multimethod study.

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Background: There is a lack of published data on real-world cabozantinib use in patients with advanced renal cell carcinoma after prior vascular endothelial growth factor (VEGF)-targeted therapy.

Methods: CASSIOPE was a real-world, prospective, multicenter, non-interventional postauthorization safety study of cabozantinib in adult patients with advanced renal cell carcinoma in Europe following prior VEGF-targeted treatment (NCT03419572). Endpoints included cabozantinib utilization (dose modifications due to adverse events [AEs; primary endpoint], dose, dose modifications, and treatment duration), safety, effectiveness (progression-free survival [PFS], overall survival [OS], best overall response [BOR]), and healthcare resource utilization.

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  • 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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PROpel (NCT03732820) was a positive phase 3 trial that demonstrated a clinically significant improvement in radiographic progression-free survival with olaparib plus abiraterone versus placebo plus abiraterone in first-line metastatic castration-resistant prostate cancer. For a subset of PROpel patients, steady-state concentrations of olaparib, abiraterone, and Δ-abiraterone were measured in blood samples collected before and at several time points after dose administration. The pharmacokinetics (PK) for each drug and metabolite were evaluated to determine whether any clinically relevant drug-drug interactions between olaparib and abiraterone occurred.

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  • The study focuses on the effectiveness and safety of second-line treatment options (docetaxel vs. alternative ARSI) for patients aged 75 and older who have metastatic castration-resistant prostate cancer (mCRPC) after failing first-line androgen receptor signaling inhibitors (ARSIs).
  • Researchers analyzed a group of 122 elderly patients, finding no significant differences in overall survival or progression-free survival when comparing those who received docetaxel to those who received an alternative ARSI.
  • The results suggest that both treatment options are similar for elderly patients, providing useful insights despite the limitations of a small and retrospective study design.
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The definition of "non-metastatic hormone-sensitive prostate cancer" (nmHSPC) can be applied to patients with prostate cancer (PC) who are androgen-deprivation therapy-naïve and without evidence of metastatic disease. This definition includes heterogeneous situations; however, PC patients at high risk of metastatic spread - and who have not started a hormonal treatment - constitute a unique category with unmet clinical needs. This narrative review critically discusses the advances that characterize the rapidly evolving diagnostic and therapeutic scenario in the nmHSPC setting.

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  • The clinical trial PROpel investigated the combination of olaparib and abiraterone for treating first-line metastatic castration-resistant prostate cancer (mCRPC) and found it improved progression-free survival (rPFS) compared to a placebo with abiraterone.
  • In post hoc analyses, asymptomatic/mildly symptomatic patients experienced a significant rPFS benefit (27.6 months vs. 19.1 months) with the treatment, whereas symptomatic patients showed no meaningful improvement (14.1 vs. 13.8 months).
  • The study concluded that olaparib plus abiraterone demonstrates efficacy in asymptomatic/mildly symptomatic mCRPC patients, while results for symptomatic
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Genitourinary cancers present significant challenges to oncologists, necessitating innovative approaches for improved patient outcomes. The 'Controversies in Genitourinary Cancers' congress, held in January 2024, convened international experts to address the complexities of prostate, bladder, renal and rare genitourinary cancers. Sessions explored current trends, novel treatments, and unmet needs, emphasizing collaborative efforts to advance knowledge and patient care.

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  • Managing metastatic castration-resistant prostate cancer (mCRPC) in men aged 75 and older is difficult due to limited research, but common first-line treatments include abiraterone acetate plus prednisone (AA) and enzalutamide (Enza).
  • A study analyzed 337 patients aged 75+ who started AA or Enza and found no significant differences in survival rates or adverse effects between those who previously used docetaxel (D) and those who only received androgen deprivation therapy (ADT).
  • The results imply that elderly men with mCRPC can expect similar outcomes and side effect profiles from AA or Enza, irrespective of prior D treatment, though the study's retrospective nature
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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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  • * Methods: Researchers analyzed data from 94 patients treated at 29 institutions, assessing various factors like type of therapy, timing of recurrence, and patient risk categories, while also monitoring treatment-related side effects.
  • * Key Findings: The study revealed an 18-month PFS rate of 45% and overall survival (OS) rate of 85%, with common treatment-related side effects including skin toxicity and fatigue; it did have limitations due to patient selection.
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Background: Metastatic Pheochromocytomas and paragangliomas (PPGLs) are rare neuroendocrine tumors characterized by high morbidity and limited systemic treatment options, mainly based on radiometabolic treatments or chemotherapy. Based on the preclinical rationale that PGGLs carcinogenesis relies on angiogenesis, treatment with tyrosine kinase inhibitors (TKI) may represent another viable therapeutic option.

Methods: We conducted a prospective phase II study in patients with metastatic or unresectable PGGLs.

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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
  • There are various first-line treatment options for metastatic renal cell carcinoma (mRCC), with immuno-combination therapies being the standard for all patients, while TKI monotherapy is suitable for some individuals.
  • The REGAL study is a multi-center observational research project that will analyze both current and past systemic therapy data in mRCC patients to identify factors that might influence treatment decisions.
  • The study also aims to compare the effectiveness and safety of different treatments and to evaluate a new prognostic tool called the Meet-URO score against the established IMDC score.
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Background: Prostate cancer (PCa) treatments are associated with a detrimental impact on bone health (BH) and body composition. However, the evidence on these issues is limited and contradictory. This consensus, based on the Delphi method, provides further guidance on BH management in PCa.

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The purpose of this European Society for Radiotherapy and Oncology (ESTRO) project, endorsed by the European Association of Urology, is to explore expert opinion on the management of patients with oligometastatic and oligoprogressive renal cell carcinoma by means of stereotactic ablative radiotherapy (SABR) on extracranial metastases, with the aim of developing consensus recommendations for patient selection, treatment doses, and concurrent systemic therapy. A questionnaire on SABR in oligometastatic renal cell carcinoma was prepared by a core group and reviewed by a panel of ten prominent experts in the field. The Delphi consensus methodology was applied, sending three rounds of questionnaires to clinicians identified as key opinion leaders in the field.

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Article Synopsis
  • - The ARON-2 study investigated the real-world effectiveness of pembrolizumab, an immune checkpoint inhibitor, in patients with advanced urothelial carcinoma who had progression after platinum-based chemotherapy, utilizing data from 836 patients across 88 institutions in 23 countries.
  • - Results showed median overall survival (OS) of 10.5 months and overall response rate (ORR) of 31%; those who progressed after initial chemotherapy (cohort A) had lower OS (9.1 months) compared to those who recurred within a year post-chemotherapy (cohort B) with 14.6 months OS.
  • - Multivariate analysis identified several prognostic factors affecting OS and progression-free survival (PFS),
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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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Clear cell renal carcinoma (ccRCC) can occur in young people and could be associated with an aggressive behavior. While for the first-line treatment in metastatic disease, there is an agreement to rely on an immunotherapy (IO)-based combination regimen, no standard second-line regimens exist. Generally, tyrosine kinase inhibitors (TKIs) are employed, even in sequence, although no trials have demonstrated yet the best succession.

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  • * In a trial involving 79 patients, 38% had their axitinib treatment stopped after achieving tumor response, with 72% showing no disease progression eight weeks later; the median progression-free survival was 24 months.
  • * The study suggests that withdrawing VEGFR-TKI can reduce side effects while maintaining ICI treatment, indicating a potential new approach for managing mRCC, though it lacked a comparative control group.
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Importance: Immune checkpoint inhibitors (ICIs) have broadened the metastatic urothelial carcinoma (mUC) therapeutic scenario. The association of programmed death ligand 1 (PD-L1) with response and survival in patients treated with ICIs is still controversial.

Objectives: To evaluate the association of PD-L1 with response rate and overall survival among patients with mUC treated with ICIs.

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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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Background: Currently, several therapies are available for metastatic castration-resistant prostate cancer (mCRPC) but no specific clinical factors to personalize treatment. We first sought the prognostic value of duration on androgen-deprivation therapy (ADT) for hormone-sensitive prostate cancer (HSPC) in patients receiving androgen-receptor-signaling inhibitors (ARSI) for mCRPC.

Methods: A multicenter cohort of mCRPC patients who started ARSI between July 2011 and October 2021 was identified.

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