Real-world Treatment Patterns and Clinical Outcomes for Metastatic Renal Cell Carcinoma in the Current Treatment Era

Shah, Neil; Sura, Sneha; Shinde, Reshma; Shi, Junxin; Singhal, Puneet K.; Robert, Nicholas J.; Vogelzang, Nicholas J.; Perini, Rodolfo F.; Motzer, Robert J.

doi:10.1016/j.euros.2022.12.015

Cited by 29 publications

(21 citation statements)

References 25 publications

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“…As a whole, our data suggest that this strategy should remain the preferred treatment. Outcomes in the second-line therapy setting showed no signi cant differences between treatment groups, ndings consistent with previous real-world data [11]. Multivariate analysis identi ed NC as a signi cant factor associated with longer PFS.…”

Section: Discussionsupporting

confidence: 88%

“…In the last few years, a number of phase III randomized clinical trials, utilizing sunitinib as the comparator arm, have established a novel standard of care incorporating immune checkpoint inhibitors (ICIs) in the management of advanced RCC [6][7][8][9][10][11]. Although there have been notable advances in treatment with the introduction of immunotherapy, patient strati cation remains an essential component of clinical decisionmaking and treatment selection for this patient population.…”

Section: Introductionmentioning

confidence: 99%

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Pembrolizumab-axitinib versus nivolumab-cabozantinib as first-line therapy in patients with metastatic renal cell carcinoma: a retrospective real-world comparison (ARON-1)

Santoni,

Roviello,

Grande

et al. 2024

Preprint

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Background The optimal first-line therapy for metastatic renal cell carcinoma (mRCC) remains uncertain, despite recent advancements in immune-based combinations. This retrospective study compares the effectiveness of pembrolizumab plus axitinib (PA) and nivolumab plus cabozantinib (NC) as first-line treatments for mRCC in a real-world setting. Methods Patient data were collected from 55 centres across 16 countries, encompassing individuals diagnosed with mRCC receiving first-line treatment with PA or NC between January 2016 and October 2023. Clinical and tumour features and treatment responses were recorded. The primary endpoints were overall response rate (ORR), overall survival (OS), progression-free survival (PFS), and time to second progression. Statistical analyses included Kaplan-Meier survival estimates, Cox proportional hazard models, and chi-square tests. Results A total of 760 patients with a median age of 64 years (range, 29–88) were included. Of them, 607 received PA, and only 153 NC. Median OS was 55.7 months and not reached (NR) for PA and NC, respectively (P = .51), while median PFS was longer with NC (27.6 months) than for PA (16.2 months, P = .003). Subgroup analysis suggested a PFS benefits for NC in male, younger patients, intermediate-risk group, clear cell histology, and lung involvement, as well as ORR favoured NC in good risk patients. Multivariate analysis identified first-line therapy as a significant factor associated with PFS. Conclusions In this certainly biased retrospective comparison, NC demonstrated superior ORR and longer PFS compared to PA in mRCC. These findings underscore the importance of considering individual patient characteristics and risk profiles when selecting first-line therapy for mRCC.

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Section: Discussionsupporting

confidence: 88%

Section: Introductionmentioning

confidence: 99%

Pembrolizumab-axitinib versus nivolumab-cabozantinib as first-line therapy in patients with metastatic renal cell carcinoma: a retrospective real-world comparison (ARON-1)

Santoni,

Roviello,

Grande

et al. 2024

Preprint

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“…Investigators discovered how immune escape pathways disrupt the positive effect of immune cell infiltration in ‘cluster 1’ but not in ‘cluster 2’. Their findings emphasize the genomics-based evaluation of immune-tumor crosstalk during patient selection strategies ( 12 ).…”

mentioning

confidence: 89%

“…Clear cell Renal Cell Carcinoma (ccRCC) is a heterogeneous, aggressive cancer representing ~70% of all RCCs ( 10 , 11 ). It is difficult to predict the outcome of extensively used ICB treatment in ccRCC based on known immune molecular biomarkers ( 12 ). Few genomics-based studies have explored immunologic mechanisms at the tumor-immune interface in ccRCC ( 13 ).…”

mentioning

confidence: 99%

Editorial: Lymphocyte functional crosstalk and regulation, volume II

Srivastava

Thounaojam

Marincola³

et al. 2023

Front. Immunol.

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“…In the CheckMate 214 trial, patients with intermediate or poor risk disease per the International mRCC Database Consortium (IMDC) risk stratification had significantly better objective response rate (ORR) and OS with the combination of ipilimumab and nivolumab as compared to sunitinib leading to its regulatory approval [5,6]. Though ipilimumab plus nivolumab is one of the commonly used first-line treatment regimens, not all patients benefit [6,7]. For instance, although durable partial and complete responses were seen in a subset of patients with intermediate or poor-risk disease in the CheckMate 214 study, a significant proportion (20%) of patients had primary progressive disease as the best response and ∼35% progressed within 6 months [6].…”

Section: Introductionmentioning

confidence: 99%

Genomic and Transcriptomic Characteristics of Tumors of Patients with Metastatic Clear Cell Renal Cell Carcinoma Clinically Benefiting from First-Line Treatment with Ipilimumab Plus Nivolumab

Tripathi,

Meza,

Sayegh

et al. 2023

KCA

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Background: Ipilimumab plus nivolumab is approved as a first-line treatment for intermediate or poor risk metastatic renal cell carcinoma (mRCC). However, ∼35% of patients progress within six months on ipilimumab plus nivolumab, and no validated genomic biomarkers predict the benefit. In this study, we explore the genomic and transcriptomic differences among patients with clear cell mRCC patients who either did or did not experience clinical benefit from first-line ipilimumab plus nivolumab therapy. Method: Patients with clear cell mRCC intermediate or poor IMDC risk scores, with available tumor whole exome with/without transcriptome sequencing before starting systemic therapy were included. Patients who developed a complete response, partial response, or stable disease for at least six months after initiating treatment were categorized into the ‘clinical benefit’ group, whereas the rest were classified as ‘no clinical benefit.’ Genomic alteration frequencies between the groups were assessed with a chi-square test. Differentially expressed genes and gene sets were identified via DeSeq2 and GSEA v4.2.3, respectively. Result: 53 patients with clear cell mRCC (37 clinical benefit and 16 no clinical benefit) were eligible and included. No significant difference was found in the genomic alteration frequencies between these groups. Baseline tumor transcriptomic data were available for 14 patients (9 clinical benefit and 5 no clinical benefit). The apical surface and pathways downregulated by KRAS signaling were enriched in the clinical benefit group, whereas inflammatory pathways were enriched in the no clinical benefit group. Conclusion: These findings suggest that tumor specific gene expression as assessed by RNA sequencing could serve as a potential biomarker of response to ipilimumab plus nivolumab therapy.

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Real-world Treatment Patterns and Clinical Outcomes for Metastatic Renal Cell Carcinoma in the Current Treatment Era

Cited by 29 publications

References 25 publications

Pembrolizumab-axitinib versus nivolumab-cabozantinib as first-line therapy in patients with metastatic renal cell carcinoma: a retrospective real-world comparison (ARON-1)

Pembrolizumab-axitinib versus nivolumab-cabozantinib as first-line therapy in patients with metastatic renal cell carcinoma: a retrospective real-world comparison (ARON-1)

Editorial: Lymphocyte functional crosstalk and regulation, volume II

Genomic and Transcriptomic Characteristics of Tumors of Patients with Metastatic Clear Cell Renal Cell Carcinoma Clinically Benefiting from First-Line Treatment with Ipilimumab Plus Nivolumab

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