Publications by authors named "Oudard S"

Background: Immunotherapies targeting PD-1 and CTLA-4 are key components of the treatment of metastatic clear cell renal cell carcinoma (mccRCC). However, they have distinct safety profiles and resistance to treatment can occur. We assess soluble TIM-3 (sTIM-3) in the plasma of mccRCC patients as a potential theranostic biomarker, as well as its source and biological significance.

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Background: Endogenous retrovirus (ERV) elements are genomic footprints of ancestral retroviral infections within the human genome. While the dysregulation of ERV transcription has been linked to immune cell infiltration in various cancers, its relationship with immune checkpoint inhibitor (ICI) response in solid tumors, particularly metastatic clear-cell renal cell carcinoma (ccRCC), remains inadequately explored.

Methods: This study analyzed patients with metastatic ccRCC from two prospective clinical trials, encompassing 181 patients receiving nivolumab in the CheckMate trials (-009 to -010 and -025) and 48 patients treated with the ipilimumab-nivolumab combination in the BIONIKK trial.

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Introduction: KEYNOTE-361 evaluated first-line pembrolizumab with and without platinum-based chemotherapy versus chemotherapy alone in advanced or metastatic urothelial carcinoma. The primary end points of progression-free survival (PFS) or overall survival (OS) were not met. Exploratory analysis of efficacy by platinum agent (cisplatin or carboplatin) is reported.

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Introduction: LIPI has been strongly correlated with immunotherapy (IT) outcomes in advanced NSCLC. Limited data is available for upfront chemotherapy (CT) + IT combinations. We aimed to study its prognostic value in 1st-line CT +/- IT +/- antiangiogenics.

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Background: Oncological systemic treatments such as cytotoxic chemotherapy, radiation therapy or treatment with biological response modifiers can alter the quality of life (QoL) of cancer patients.The aim of this study is to assess the effects of cardiologic magnetic and optical stimulation (CMOS) on QoL in patients with advanced cancer receiving systemic treatment. For this purpose, we designed a non-invasive device that can reproduce and dynamically modulate stimulations of the same nature as the biological electromagnetic emissions specific to the body (cardiac).

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Purpose: The three-arm, phase III KEYNOTE-361 study did not meet its dual primary endpoints of progression-free survival (PFS) or overall survival (OS) with first-line pembrolizumab plus chemotherapy versus chemotherapy in advanced urothelial carcinoma. This prespecified exploratory analysis assessed the association of tumor mutational burden (TMB) and PD-L1 combined positive score (CPS) with clinical outcomes.

Patients And Methods: TMB and PD-L1 CPS were determined via whole-exome sequencing and PD-L1 IHC 22C3 pharmDx, respectively.

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Article Synopsis
  • In 2022, nivolumab was approved for high-risk patients with localized invasive muscle urothelial carcinoma after surgery, prompting a study to explore its real-world use.
  • Conducted at two hospitals from July 2022 to January 2024, the study included 200 patients; 70 were deemed high-risk, but nearly half did not receive treatment due to various reasons.
  • The outcomes showed a median disease-free survival of 11.34 months for treated patients, and while nivolumab was well-tolerated, 25% discontinued it due to side effects, with findings supporting prior research on its effectiveness.
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  • - The LITESPARK-004 study is testing the hypoxia-inducible factor-2α inhibitor, belzutifan, for its effectiveness in treating tumors associated with von Hippel-Lindau disease, specifically focusing on patients with central nervous system (CNS) haemangioblastomas after additional follow-up.
  • - A total of 61 patients, with a majority having CNS haemangioblastomas, were enrolled in this phase 2 study across multiple cancer centers in four countries, and they received oral belzutifan until there were unacceptable side effects or disease progression.
  • - The study assesses the antitumor activity by evaluating patient responses using two different methods based on tumor measurements and is ongoing, with results still being
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Castration-resistant metastatic prostate cancer remains lethal and a therapeutic challenge. Current strategies are geared towards the personalization of treatments based on the identification of relevant molecular targets, including genomic alterations involved in tumoral processes. Among these novel targeted therapies, poly-ADP-ribose polymerase inhibitors (PARPi), by blocking the action of enzymes involved in deoxyribonucleic acid (DNA) repair, induce the destruction of cells carrying defects in homologous recombination repair, often associated with alterations in genes involved in this mechanism.

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What Is This Summary About?: This is a summary of a paper that describes the results of the SPARTAN and TITAN studies, which looked at whether a treatment called apalutamide can help treat individuals with advanced prostate cancer.The SPARTAN study included 1207 participants with nonmetastatic castration-resistant prostate cancer (or nmCRPC). The TITAN study included 1052 participants with metastatic castration-sensitive prostate cancer (or mCSPC).

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Article Synopsis
  • The CABASTY study investigated the effects of biweekly administration of a lower dose of cabazitaxel on pain and quality of life for older men with metastatic castration-resistant prostate cancer (mCRPC).
  • In a trial involving 196 patients, researchers compared biweekly dosing (16 mg/m) to a standard triweekly dosing (25 mg/m) regarding pain progression and health-related quality of life (HRQoL).
  • Results showed no significant differences in pain progression or HRQoL between treatment groups, but the biweekly group experienced a delayed onset of some adverse events, suggesting it could be a safer option for older patients.
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Background And Objective: Trough abiraterone concentration (ABI C) of 8.4 ng/mL has been identified as an appropriate efficacy threshold in patients treated for metastatic castration-resistant prostate cancer (mCRPC). The aim of the phase II OPTIMABI study was to evaluate the efficacy of pharmacokinetics (PK)-guided dose escalation of abiraterone acetate (AA) in underexposed patients with mCRPC with early tumour progression.

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Radiotherapy (RT) for high-risk localized prostate cancer (HRLPC) can be controversial in the context of increasing detection of suspicious lymph nodes via advanced imaging techniques. The EORTC 22683 trial initially established RT with androgen deprivation therapy (ADT) as the standard of care for HRLPC, but many patients remain uncured. GETUG-AFU-12 showed that addition of docetaxel and estramustine to ADT improved relapse-free survival but not overall survival.

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Background: Immune checkpoint inhibitors (ICIs) can induce cardiovascular toxicities.

Objectives: To prospectively assess the incidence of major cardiovascular events (MACE) on ICIs in solid cancer patients: myocarditis, pericarditis, acute coronary syndrome, heart failure, high-degree conduction abnormalities or sustained ventricular arrhythmias, or cardiovascular death at 6 weeks (early MACE), including asymptomatic clinical changes by an independent adjudication committee using current recommended diagnostic criteria. The secondary objective was the incidence of the above-mentioned events adding atrial fibrillation (AF) at 6 months (late MACE).

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Introduction: Papillary renal cell carcinoma (pRCC) is a rare and aggressive cancer with no specifically established therapeutic strategy in the metastatic setting. Combinations of tyrosine kinase and immune checkpoint inhibitors (ICI) are a promising option. We aimed to study the immune landscape of metastatic pRCC, and its interactions with angiogenesis pathways, to search for potential therapeutic targets.

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  • The study examines the Lung Immune Prognostic Index (LIPI) to see if it can predict survival in patients with metastatic renal cell carcinoma (mRCC).
  • LIPI categorizes patients into groups based on specific blood markers, and results show that those with a better LIPI score have significantly longer overall and progression-free survival.
  • The findings indicate that LIPI can be a useful prognostic tool for mRCC patients regardless of the type of treatment they receive, whether it’s immune checkpoint inhibitors or antiangiogenic therapy.
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Background: Adjuvant pembrolizumab therapy after surgery for renal-cell carcinoma was approved on the basis of a significant improvement in disease-free survival in the KEYNOTE-564 trial. Whether the results regarding overall survival from the third prespecified interim analysis of the trial would also favor pembrolizumab was uncertain.

Methods: In this phase 3, double-blind, placebo-controlled trial, we randomly assigned (in a 1:1 ratio) participants with clear-cell renal-cell carcinoma who had an increased risk of recurrence after surgery to receive pembrolizumab (at a dose of 200 mg) or placebo every 3 weeks for up to 17 cycles (approximately 1 year) or until recurrence, the occurrence of unacceptable toxic effects, or withdrawal of consent.

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In the phase 3 CLEAR trial, lenvatinib plus pembrolizumab (L + P) showed superior efficacy versus sunitinib in treatment-naïve patients with advanced renal cell carcinoma (aRCC). The combination treatment was associated with a robust objective response rate of 71%. Here we report tumor responses for patients in the L + P arm in CLEAR, with median follow-up of ∼4 yr at the final prespecified overall survival (OS) analysis.

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  • Abemaciclib, a CDK4/6 inhibitor, has shown promise in treating metastatic castration-resistant prostate cancer (mCRPC), potentially shifting treatment approaches similar to its use in breast cancer.
  • In a study involving 44 patients with mCRPC who had previously undergone multiple treatments, the primary goal was to report the objective response rate (ORR), which was found to be 6.8%, with a disease control rate of 45.5%.
  • The treatment was generally well tolerated, with manageable side effects, and provided preliminary evidence supporting CDK4/6 as a therapeutic target in prostate cancer.
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Objective: Analysis of rechallenge with nivolumab as 5th-line therapy for locally and nodally failed laryngeal squamous cell carcinoma following conventional therapeutic modalities: radiotherapy, surgery and chemotherapy.

Observation: A 70-year-old male, with local and nodal progression of laryngeal squamous cell carcinoma after treatment with chemoradiotherapy and surgery, was initially treated for recurrence with carboplatin, 5-fluorouracile (FU) and cetuximab, followed by second-line nivolumab, and then two lines of conventional chemotherapy with paclitaxel and cetuximab followed by carboplatin and cetuximab. He underwent rechallenge with nivolumab in 5th line, achieving 12months' response, ongoing at the time of writing, and 42.

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Purpose: Primary analysis of the ongoing, single-arm, phase 2 LITESPARK-004 study (NCT03401788) showed clinically meaningful antitumor activity in von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) and other neoplasms with belzutifan treatment. We describe results of belzutifan treatment for VHL disease-associated pancreatic lesions [pancreatic neuroendocrine tumors (pNET) and serous cystadenomas].

Patients And Methods: Adults with VHL diagnosis based on germline VHL alteration, ≥1 measurable RCC tumor, no renal tumor >3 cm or other VHL neoplasm requiring immediate surgery, Eastern Cooperative Oncology Group performance status of 0 or 1, and no prior systemic anticancer treatment received belzutifan 120 mg once daily.

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Purpose: In a previous exploratory study, modeled early longitudinal prostate-specific antigen (PSA) kinetics observed within the 100-first treatment days with androgen deprivation therapy with or without docetaxel was associated with progression-free survival (PFS) and overall survival (OS) in patients with prostate cancer with rising PSA levels after primary local therapy. This prognostic value had to be confirmed in different settings. The objectives were to assess PSA kinetics modeling in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with chemotherapy in FIRSTANA trial and to investigate modeled PSA kinetic parameters prognostic/predictive value.

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Article Synopsis
  • The study examines how individual differences in drug absorption (pharmacokinetics) impact the effectiveness and side effects of cabozantinib in patients with metastatic renal cell carcinoma (mRCC).
  • Out of 78 patients analyzed, 67% experienced dose-limiting toxicity, and higher drug concentration in the blood was identified as a significant risk factor for these side effects.
  • The research suggests that monitoring drug levels early in treatment could help optimize cabozantinib therapy, particularly for frail patients starting on lower doses.
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Background: Preclinical and early clinical data suggest that the irreversible ErbB family blocker afatinib may be effective in urothelial cancers harbouring ERBB mutations.

Methods: This open-label, phase II, single-arm trial (LUX-Bladder 1, NCT02780687) assessed the efficacy and safety of second-line afatinib 40 mg/d in patients with metastatic urothelial carcinoma with ERBB1-3 alterations. The primary endpoint was 6-month progression-free survival rate (PFS6) (cohort A); other endpoints included ORR, PFS, OS, DCR and safety (cohorts A and B).

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