Radical metastasectomy followed by sorafenib versus observation in patients withclear cell renal cell carcinoma: extended follow -up of efficacy results from the randomized phase II RESORT trial

Mennitto, Alessia; Verzoni, Elena; Cognetti, Francesco; Miceli, Rosalba; Milella, Michèle; Mosca, Alessandra; Chiuri, V.E.; Bearz, Alessandra; Morelli, Franco; Ortega, Cinzia; Atzori, Francesco; Donini, Maddalena; Claps, Mélanie; Guadalupi, Valentina; Sepe, Pierangela; Cappelletti, Vera; Braud, Filippo G. De; Procopio, Giuseppe

doi:10.1080/17512433.2021.1879639

Cited by 9 publications

(19 citation statements)

References 24 publications

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“…Seventeen studies did not meet the inclusion criteria or were irrelevant to the review question. Ultimately, 2 studies met the inclusion criteria and were included in the meta-analysis, comprising 197 RCC patients [11,12].…”

Section: Study Identification and Selectionmentioning

confidence: 99%

Targeted Therapy Following Metastasectomy for Metastatic Renal Cell Carcinoma: A Systematic Review and Meta-analysis

Gu,

Jung,

Kwon

et al. 2024

J Urol Oncol

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Purpose: The aim of this study was to assess the effects of tyrosine kinase inhibitors (TKIs) following metastasectomy in patients with metastatic renal cell carcinoma (mRCC).Materials and Methods: A systematic search of multiple electronic databases was conducted. The inclusion criteria encompassed randomized clinical trials evaluating the use of TKIs after metastasectomy in mRCC patients. Study outcomes were relapse-free survival (RFS)/disease-free survival (DFS), overall survival (OS), and adverse events of TKIs.Results: Two studies with 197 randomized participants that compared TKIs following metastasectomy versus metastasectomy alone were identified. According to these studies, TKIs following metastasectomy may result in little to no difference in RFS/DFS (hazard ratio [HR], 1.01; 95% confidence interval [CI], 0.65–1.57; I2=29%; low-certainty evidence). TKIs after metastasectomy may slightly increase OS, but the CI crossed the line of no effect (HR, 0.80; 95% CI, 0.06–9.87; I2=86%; low-certainty evidence). TKIs after metastasectomy likely resulted in a large increase in adverse events (risk ratio, 2.76; 95% CI: 1.65–4.62; I2=not applicable; moderatecertainty evidence).Conclusions: TKIs following metastasectomy did not improve RFS/DFS, but slightly improved OS. It is likely that TKIs following metastasectomy increase adverse events compared to surgery only. The certainty of evidence ranged from moderate (signaling confidence that the reported effect size is likely close to the true effect) to low (indicating that the true effect may be substantially different from the effect estimate). The findings of this study should help to inform future guidelines and clinical decision-making at the point of care.

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Section: Study Identification and Selectionmentioning

confidence: 99%

Targeted Therapy Following Metastasectomy for Metastatic Renal Cell Carcinoma: A Systematic Review and Meta-analysis

Gu,

Jung,

Kwon

et al. 2024

J Urol Oncol

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“…However, this prospective study confirmed that, in well-selected patients, surgery of metastases is associated with better survival. 43 , 53 …”

Section: The Long Road To the Post-operative Treatmentmentioning

confidence: 99%

“…However, this prospective study confirmed that, in well-selected patients, surgery of metastases is associated with better survival. 43,53 Similarly, the E2810 trial, a randomized, double-blind, placebo-controlled multicenter study, demonstrated that pazopanib did not improve DFS compared with placebo. 54 As previously reported, the updated analysis of KEYNOTE-564 confirmed M1 NED patients as a subgroup with the highest benefit of pembrolizumab.…”

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confidence: 99%

Optimal Choice of Adjuvant Treatment for Renal Cell Carcinoma Following Nephrectomy

Bottiglieri¹,

Sepe²,

Stellato³

et al. 2022

CMAR

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Renal cell carcinoma (RCC) is the fourteenth most common cancer worldwide. In about 55% of cases, it is diagnosed at a localised and/or locally advanced stage and therefore amenable to a curative approach. Although nephrectomy still represents the cornerstone of non-metastatic RCC (nmRCC) treatment, a relapse is observed in about 25–30% of patients undergoing curative surgery. Prognosis is drastically influenced by lymph nodal involvement. After the first disappointing results with a cytokine-based strategy, tyrosine kinase inhibitors (TKIs) were tested as adjuvant agents. Despite their efficacy in the metastatic setting, results in terms of disease-free survival (DFS) are not unequivocal and the overall survival (OS) benefit has not been demonstrated. Moreover, their toxicity profile induced a remarkable percentage of patients to discontinue the treatment. On the contrary, the KEYNOTE-564 trial showed the benefit of adjuvant pembrolizumab compared with placebo in terms of DFS with promising results in term of OS. Patients included were at intermediate or high risk of relapse, or patients with no evidence of disease after metastasectomy (M1 NED). The updated analysis presented at the American Society of Clinical Oncology Genito-Urinary (ASCO GU) 2022 confirmed the benefit of pembrolizumab versus placebo over time, although OS data are still immature. A longer follow-up and the several ongoing trials with immune checkpoint inhibitors (ICIs) will provide further data about adjuvant immuno-oncology (IO). Furthermore, the patients’ selection based on clinical or biological features will be crucial in order to identify who benefits most from treatments.

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“…AEs were higher in the sorafenib arm vs. observation (84% vs. 31%, respectively), with a treatment discontinuation rate of 19% in the sorafenib arm. With 42 months follow-up, median RFS was 21 months in the sorafenib arm and RFS probability was 32% (95% CI 18–57%) at 48 months (HR, 1.35 (95% CI 0.72–2.54)) compared to the observation arm where median RFS was 35 months and RFS probability was 44% (95% CI 30–65%) at 48 months [ 29 ].…”

Section: Vegfr Tki Adjuvant Clinical Trialsmentioning

confidence: 99%

The Continuing Question of Adjuvant Therapy in Clear Cell Renal Cell Carcinoma

Berg

McGregor

2022

Cancers

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Treatment advances in kidney cancer continually evolve. The focus of treatment options continues with oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) or intravenous immune checkpoint inhibitors (ICIs). Multiple trials exploring the role of adjuvant treatment after cytoreductive nephrectomy in high-risk clear cell renal cell carcinoma are currently ongoing. The discovery of biomarkers may help determine which patients benefit from these treatments, but these are not yet available outside clinical studies. Trials with combination therapies are also ongoing, especially using novel therapies with new mechanisms of action, and will hopefully provide more clues on proper patient and therapy selection in the adjuvant setting.

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Radical metastasectomy followed by sorafenib versus observation in patients withclear cell renal cell carcinoma: extended follow -up of efficacy results from the randomized phase II RESORT trial

Cited by 9 publications

References 24 publications

Targeted Therapy Following Metastasectomy for Metastatic Renal Cell Carcinoma: A Systematic Review and Meta-analysis

Targeted Therapy Following Metastasectomy for Metastatic Renal Cell Carcinoma: A Systematic Review and Meta-analysis

Optimal Choice of Adjuvant Treatment for Renal Cell Carcinoma Following Nephrectomy

The Continuing Question of Adjuvant Therapy in Clear Cell Renal Cell Carcinoma

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