Publications by authors named "Luca Galli"
Background And Objective: Apalutamide (APA) is a treatment for metastatic castration-sensitive prostate cancer (mCSPC). In the ARON-3 study we investigated real-world experiences with APA treatment for mCSPC.
Methods: We retrospectively assessed real-world clinical outcomes for patients with mCSPC treated with APA in the ARON-3 study.
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.
Article Synopsis
- - Enfortumab vedotin (EV) is effective for patients with advanced urothelial carcinoma who have previously received platinum chemotherapy and immune therapy, despite lacking research on those treated with avelumab maintenance.
- - A study of 182 patients showed a median overall survival of 12.7 months and a progression-free survival of 7.9 months, with 39% achieving a positive response to EV after avelumab treatment.
- - The study confirms EV's effectiveness, suggesting it can be a viable option for patients previously treated with avelumab, with manageable side effects like grade ≥ 3 neuropathy and skin rash occurring in a minority of cases.
Article Synopsis
- - Metastatic renal cell carcinoma (mRCC) with sarcomatoid features (sRCC) is aggressive and has a poor prognosis; this study aimed to investigate its clinical features and outcomes compared to non-sarcomatoid patients.
- - The study analyzed data from 1362 mRCC patients, finding that the median overall survival for sRCC patients was 26.8 months, significantly lower than the 35.3 months for non-sRCC patients.
- - Both first-line treatment strategies, immunotherapy combined with immunotherapy (IO + IO) and immunotherapy with a tyrosine kinase inhibitor (IO + TKI), showed similar survival outcomes, confirming that
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.
The treatment landscape for metastatic renal cell carcinoma (mRCC) has undergone significant transformations in recent years. The introduction of novel combination therapies involving tyrosine kinase inhibitors (TKI) and immune checkpoint inhibitors has resulted in improved oncological outcomes compared to traditional TKI monotherapy. In this evolving paradigm, the pivotal role of the multidisciplinary tumor board is underscored, particularly in shaping the therapeutic trajectory for patients eligible for locoregional interventions like cytoreductive nephrectomy and metastasectomy.
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- The Meet-URO 18 study investigates metastatic renal cell carcinoma patients undergoing nivolumab treatment in two distinct groups based on their progression-free survival (PFS) times.
- The study utilizes detailed immunohistochemical analysis to assess various markers like T-lineage markers (CD3, CD4, CD8), macrophages (CD68), and PD-L1 expression in tumor samples from 113 patients, significantly expanding upon previous data.
- Results indicate that tumor tissue with lower CD4 and higher CD56 expression correlates with a more favorable antitumor response, suggesting the potential of CD56 as a biomarker for immunotherapy effectiveness.
Upper tract urothelial carcinoma (UTUC) accounts for the 5-10% of all urothelial carcinomas (UCs). In this analysis, we reported the real-world data from the ARON-2 study (NCT05290038) on the efficacy of pembrolizumab in patients with UTUC who recurred or progressed after platinum-based chemotherapy. Medical records of patients with metastatic UTUC treated with pembrolizumab as second-line therapy were reviewed from 34 institutions in 14 countries.
View Article and Find Full Text PDFBackground: Neutrophil-to-eosinophil ratio (NER) has been described to be associated with outcomes to immune checkpoint inhibitors (ICI) in several tumor types, but less is known about its role of in the response to avelumab in advanced urothelial cancer (aUC). Thus, we reported outcomes by NER of aUC patients treated with avelumab as maintenance after initial response to platinum-based chemotherapy and enrolled in the Maintenance with AVeLumAb ([MALVA] in advanced urothelial neoplasms in response to first-line chemotherapy: an observational retrospective study) study (Meet-URO 25).
Patients And Methods: Median NER at baseline and after 3 cycles of avelumab were calculated.
Prostate carcinoma (PC), the second most diagnosed cancer globally, saw approximately 1,414,000 new cases in 2020, with 17% being de novo metastatic. In these cases, the 5-year relative survival rate is 32%. Metastatic hormone-sensitive prostate cancer (mHSPC) includes those with metastatic disease at initial diagnosis or after initial therapy without long-term androgen deprivation therapy (ADT), eventually progressing to castration-resistant prostate cancer (CRPC).
View Article and Find Full Text PDFThe impact of tumor microenvironment (TME) in influencing clinical response to first-line immune checkpoint inhibitor (ICI)-based treatment in advanced renal cell carcinoma (RCC) is unclear. Immunohistochemistry (IHC) could identify biomarkers related to immune checkpoints and immune cell population. This study retrospectively characterized TME from 28 RCC patients who received first line ICI-based therapy through IHC assessment of selected markers and explored preliminary evidence about their possible correlation with treatment efficacy.
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- * The study involves detailed analysis of various immune markers in tumor samples, including T-cell markers (CD3, CD4, CD8), macrophage presence (CD68), and PD-L1 expression, now with an expanded sample size of 161 tumors from 113 patients.
- * Findings indicate that lower CD4 levels and higher CD8/CD4 ratios correlate with certain tumor characteristics, suggesting a specific T-cell subpopulation plays a role in anti-tumor response; CD56 might serve as a potential
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),
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.
View Article and Find Full Text PDFBackground And Objective: In comparison to chemotherapy, enfortumab vedotin (EV) prolonged overall survival in patients with previously treated advanced urothelial carcinoma in EV-301. The objective of the present study was to assess patient experiences of EV versus chemotherapy using patient-reported outcome (PRO) analysis of health-related quality of life (HRQoL).
Methods: For patients in the phase 3 EV-301 trial randomized to EV or chemotherapy we assessed responses to the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, weekly for the first 12 wk, and then every 12 wk until discontinuation.
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.
View Article and Find Full Text PDFBackground: 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.
Background: Although in metastatic renal cell carcinoma (mRCC) patients with intermediate and poor risk the benefit of combination strategies versus tyrosine kinase inhibitor (TKI) has been ascertained, in those with favorable risk data are ambiguous. Herein, we investigated the impact of number and type of metastatic site in patients with favorable risk to contribute to the best therapeutic choice.
Material And Methods: Multicenter data regarding patients with favorable risk mRCC carcinoma receiving first-line TKIs, sunitinib or pazopanib, were retrospectively collected.
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.
Background: Concomitant medications may potentially affect the outcome of cancer patients. In this sub-analysis of the ARON-2 real-world study (NCT05290038), we aimed to assess the impact of concomitant use of proton pump inhibitors (PPI), statins, or metformin on outcome of patients with metastatic urothelial cancer (mUC) receiving second-line pembrolizumab.
Methods: We collected data from the hospital medical records of patients with mUC treated with pembrolizumab as second-line therapy at 87 institutions from 22 countries.
Background/aim: We performed a multicenter retrospective observational study to investigate the impact of immune checkpoint inhibitors (ICIs) on the survival of patients with bone metastases (BMs) from renal cell cancer (RCC).
Patients And Methods: A total of 98 patients with metastatic RCC (mRCC) treated with ICIs were retrospectively enrolled. All patients received standard treatments with nivolumab alone or in combination with ipilimumab from December 2015 to March 2022.
Background: The upfront treatment of metastatic renal cell carcinoma (mRCC) has been revolutionized by the introduction of immune-based combinations. The role of cytoreductive nephrectomy (CN) in these patients is still debated. The ARON-1 study (NCT05287464) was designed to globally analyze real-world data of mRCC patients receiving first-line immuno-oncology combinations.
View Article and Find Full Text PDFBackground: Renal c carcinoma (RCC) is one of the most common urinary cancers worldwide, with a predicted increase in incidence in the coming years. Immunotherapy, as a single agent, in doublets, or in combination with anti-vascular endothelial growth factor receptor tyrosine kinase inhibitors (TKIs), has rapidly become a cornerstone of the RCC therapeutic scenario, but no head-to-head comparisons have been made. In this setting, real-world evidence emerges as a cornerstone to guide clinical decisions.
View Article and Find Full Text PDFImmune checkpoint inhibitor-based therapies represent the current standard of care in the first-line treatment of advanced renal cell carcinoma. Despite a clear benefit in survival outcomes, a considerable proportion of patients experience disease progression; prospective data about second-line therapy after first-line treatment with immune checkpoint inhibitors are limited to small phase II studies. As with other solid tumors (such as melanoma and non-small cell lung cancer), preliminary data about the clinical efficacy of rechallenge of immunotherapy (alone or in combination with other drugs) in renal cell carcinoma are beginning to emerge.
View Article and Find Full Text PDFBackground: Immuno-oncology combinations have achieved survival benefits in patients with metastatic renal cell carcinoma (mRCC).
Objective: The ARON-1 study (NCT05287464) was designed to globally collect real-world data on the use of immuno-combinations as first-line therapy for mRCC patients.
Patients And Methods: Patients aged ≥ 18 years with a cytologically and/or histologically confirmed diagnosis of mRCC treated with first-line immuno-combination therapies were retrospectively included from 47 International Institutions from 16 countries.