Publications by authors named "Motzer R"

Background: Post-chemotherapy retroperitoneal lymph node dissection (pcRPLND) is integral to multimodal treatment of patients with metastatic non-seminomatous germ cell tumors (NSGCT). We review pathologic and long-term outcomes of pcRPLND following first-line chemotherapy with a focus on residual mass size and primary tumor histology. Our goal was to identify new predictive approaches that can refine surgical indications.

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Lenvatinib plus pembrolizumab significantly improved efficacy versus sunitinib in treatment of advanced renal cell carcinoma (aRCC) in the phase 3 CLEAR study. We report results of an exploratory post hoc analysis of tumor response data based on baseline metastatic characteristics of patients who received lenvatinib plus pembrolizumab versus sunitinib, at the final overall survival analysis time point of CLEAR (cutoff: July 31, 2022). Treatment-naïve adults with aRCC were randomized to: lenvatinib (20 mg PO QD in 21-day cycles) plus pembrolizumab (n = 355; 200 mg IV Q3W); lenvatinib plus everolimus (not reported here); or sunitinib (n = 357; 50 mg PO QD; 4 weeks on/2 weeks off).

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Background: In the phase III JAVELIN Renal 101 trial (NCT02684006), first-line treatment with avelumab + axitinib resulted in significantly longer progression-free survival (PFS) and a higher objective response rate (ORR) versus sunitinib in patients with advanced renal cell carcinoma (aRCC). We report the final analysis, including the primary analysis of overall survival (OS).

Patients And Methods: Patients with untreated aRCC (any prognostic risk score) were enrolled.

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Background: In CLEAR, lenvatinib + pembrolizumab (L + P) significantly improved efficacy versus sunitinib in first-line treatment of patients with advanced renal cell carcinoma (aRCC). We report results from CLEAR biomarker analyses.

Patients And Methods: Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) and next-generation sequencing assays (whole exome sequencing/RNA sequencing) were carried out on archival tumor specimens.

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Background: The Fast Real-time Assessment of Combination Therapies in Immuno-ONcology study in patients with aRCC (FRACTION-RCC) was designed to assess new immuno-oncology (IO) combinations in patients with advanced renal cell carcinoma (aRCC). We present results in IO-naive patients treated with nivolumab (NIVO) + relatlimab (RELA) or NIVO + ipilimumab (IPI) in track 1.

Methods: The open-label, randomised, phase II FRACTION-RCC trial enrolled patients with aRCC from 32 hospitals and cancer centres across six countries.

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Purpose: Clinical trials enable renal cell carcinoma (RCC) patients to receive promising investigational agents, yet access may be limited. Telemedicine (TM) is an increasingly utilized platform that can expand access, but perspectives on its use in clinical trial care are unknown.

Patients And Methods: A prospective study was conducted between Jan 2023 - Oct 2023 at Memorial Sloan Kettering Cancer Center.

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Article Synopsis
  • * Researchers found that higher FOLH1 expression was linked to increased tumor angiogenesis but did not show a consistent relationship with immune features, and it positively impacted progression-free survival (PFS) in patients treated with sunitinib.
  • * The findings suggest that FOLH1 could be used as a noninvasive biomarker to guide treatment decisions for m-ccRCC patients, which may
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  • The review focuses on the recent advancements in treatment options for metastatic renal cell carcinoma (mRCC), highlighting the importance of selecting appropriate first- and second-line therapies based on the latest evidence.
  • First-line treatments include immune checkpoint inhibitor combinations and tyrosine kinase inhibitors, with four regimens approved internationally; however, treatment decisions are complicated by the absence of head-to-head trials and standardized biomarkers.
  • Clinicians must consider various factors, such as the IMDC risk score and patient preferences, when transitioning between treatment lines to ensure personalized and effective care for mRCC patients.
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  • Immune-oncology strategies are improving treatment for renal cell carcinoma (RCC), especially with the introduction of immunotherapy in the perioperative setting.
  • Adjuvant therapy with pembrolizumab has shown benefits in disease-free survival post-surgery but there's limited support for neoadjuvant therapies outside trials; both strategies have their risks and challenges.
  • While adjuvant immunotherapy is now a standard treatment, understanding the optimal use of neoadjuvant approaches is still unclear and requires further research in biomarker development and clinical trials.
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  • The CheckMate 914 trial investigated the effectiveness of adjuvant nivolumab monotherapy compared to placebo in patients with localized renal cell carcinoma (RCC) at high risk of recurrence after surgery.
  • Despite enrolling 825 patients, the results showed that nivolumab did not significantly improve disease-free survival (DFS) compared to placebo.
  • Additionally, safety data indicated that adverse events were reported at different rates among the treatment groups, but overall, the trial did not achieve its primary goal of improved DFS for nivolumab.
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  • A study compared the combination treatment of tivozanib and nivolumab against tivozanib alone for patients with advanced renal cell carcinoma who progressed after one or two prior therapies, focusing on the post-immune checkpoint inhibitor (ICI) setting.
  • The TiNivo-2 trial included 343 patients from 190 sites across multiple continents, with the primary goal of evaluating progression-free survival (PFS) as the main outcome.
  • Results showed that the median PFS was 5.7 months for the combination therapy and 7.4 months for tivozanib monotherapy, indicating no significant advantage for the combination treatment based on the hazard ratio.
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Background: Molecular profiles of renal cell carcinoma (RCC) brain metastases (BMs) are not well characterized. Effective management with locoregional therapies, including stereotactic radiosurgery (SRS), is critical as systemic therapy advancements have improved overall survival (OS).

Objective: To identify clinicogenomic features of RCC BMs treated with SRS in a large patient cohort.

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Background: Nivolumab plus ipilimumab (NIVO+IPI) has demonstrated superior overall survival (OS) and durable response benefits versus sunitinib (SUN) with long-term follow-up in patients with advanced renal cell carcinoma (aRCC). We report updated analyses with 8 years of median follow-up from CheckMate 214.

Patients And Methods: Patients with aRCC (N = 1096) were randomized to NIVO 3 mg/kg plus IPI 1 mg/kg Q3W × four doses, followed by NIVO (3 mg/kg or 240 mg Q2W or 480 mg Q4W); or SUN (50 mg) once daily for 4 weeks on, 2 weeks off.

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Article Synopsis
  • Immunotherapy, like the combination of nivolumab and ipilimumab (NIVO+IPI), can lead to prolonged disease control and treatment-free survival (TFS) for cancer patients, even after stopping treatment, which is not accounted for by standard survival measures.
  • A study analyzed data from 1,096 advanced renal cell carcinoma patients to estimate TFS, comparing those treated with NIVO+IPI against sunitinib (SUN), focusing on both survival time and treatment-related adverse events (TRAEs).
  • Results showed that 48% of patients on NIVO+IPI were alive after 5 years, with a significant difference in mean TFS compared to SUN, particularly in favorable-risk patients, highlighting the importance of considering
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Background: Immunotherapy-based combinations have emerged as standard therapies for patients with metastatic renal cell carcinoma (mRCC). Pembrolizumab, a PD-1 inhibitor, combined with epacadostat, an indoleamine 2,3-deoxygenase 1 selective inhibitor, demonstrated promising antitumor activity in a phase 1 study in advanced solid tumors, including mRCC.

Methods: KEYNOTE-679/ECHO-302 was a randomized, open-label, parallel-group, multicenter, phase 3 study (NCT03260894) that compared pembrolizumab plus epacadostat with sunitinib or pazopanib as first-line treatment for mRCC.

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Importance: Immuno-oncology agents have changed the treatment paradigm for metastatic renal cell carcinoma (mRCC). Such therapies improve survival but can impose considerable health care resource use (HCRU) and associated costs, necessitating their examination.

Objective: To compare HCRU, costs, and clinical outcomes among patients receiving first-line pembrolizumab plus axitinib (P+A) or ipilimumab plus nivolumab (I+N).

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Purpose: Paclitaxel, ifosfamide, and cisplatin (TIP) is an established salvage regimen for germ cell tumors (GCT) on the basis of a phase II trial, but efficacy on a large patient cohort including patients with unfavorable risk features and long-term outcomes has not been reported. Herein, we report updated treatment efficacy and long-term follow-up with TIP.

Patients And Methods: Patients with GCT who received TIP after cisplatin-based chemotherapy were eligible.

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Article Synopsis
  • Treatment options for non-clear cell renal cell carcinoma (nccRCC) patients are limited, but a phase 2 trial of cabozantinib plus nivolumab showed a 48% objective response rate (ORR).
  • In a median follow-up of 34 months, patients experienced a median progression-free survival (PFS) of 13 months and median overall survival (OS) of 28 months, indicating promising efficacy.
  • No new safety concerns were identified, suggesting that cabozantinib and nivolumab could provide sustained responses for patients with metastatic nccRCC.
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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: Nivolumab plus cabozantinib (NIVO + CABO) was approved for first-line treatment of advanced renal cell carcinoma (aRCC) based on superiority versus sunitinib (SUN) in the phase III CheckMate 9ER trial (18.1 months median survival follow-up per database lock date); efficacy benefit was maintained with an extended 32.9 months of median survival follow-up.

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