Primary Renal Tumour Response in Patients Treated with Nivolumab for Metastatic Renal Cell Carcinoma: Results from the GETUG-AFU 26 NIVOREN Trial

Courcier, Jean; Dalban, Cécile; Laguerre, Brigitte; Ladoire, Sylvain; Barthélémy, Philippe; Oudard, Stéphane; Joly, Florence; Gravis, Gwénaëlle; Chevreau, Christine; Geoffrois, L.; Deluche, Élise; Rolland, Frédéric; Topart, Delphine; Culine, Stéphane; Négrier, Sylvie; Mahammedi, Hakim; Tantot, Florence; Jamet, Antoine; Escudier, Bernard; Flippot, Ronan; Albigès, Laurence

doi:10.1016/j.eururo.2021.05.020

Cited by 20 publications

(14 citation statements)

References 11 publications

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“…A lower mPFS, mOS, and ORR (of 2.7 months, 15.9 months and 16%, respectively) was observed in those patients than expected from the Check-Mate 025 study results [3,22]. Moreover, among patients with an evaluable primary renal tumor, only 6% experienced shrinkage of more than 30% [22]. In a meta-analysis investigating the efficacy of first-line ICI combination therapies compared to singleagent VEGFR-TKI sunitinib in mRCC patients with and without previous CN, the benefit of immunotherapy combinations seemed not to differ between those two subgroups [19].…”

Section: Discussionmentioning

confidence: 78%

“…More recently, the phase II GETUG-AFU-26 NIVOREN trial explored the impact of nivolumab in 111 patients, mainly with intermediate (45%) and poor (49%) IMDC risk, who did not undergo upfront CN [22]. A lower mPFS, mOS, and ORR (of 2.7 months, 15.9 months and 16%, respectively) was observed in those patients than expected from the Check-Mate 025 study results [3,22]. Moreover, among patients with an evaluable primary renal tumor, only 6% experienced shrinkage of more than 30% [22].…”

Section: Discussionmentioning

confidence: 99%

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The prognostic value of the previous nephrectomy in pretreated metastatic renal cell carcinoma receiving immunotherapy: a sub-analysis of the Meet-URO 15 study

et al. 2022

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Background Nephrectomy is considered the backbone of managing patients with localized and selected metastatic renal cell carcinoma (mRCC). The prognostic role of nephrectomy has been widely investigated with cytokines and targeted therapy, but it is still unclear in the immunotherapy era. Methods We investigated the Meet-URO-15 study dataset of 571 pretreated mRCC patients receiving nivolumab as second or further lines about the prognostic role of the previous nephrectomy (received in either the localized or metastatic setting) in the overall population and according to the Meet-URO score groups. Results Patients who underwent nephrectomy showed a significantly reduced risk of death (HR 0.44, 95% CI 0.32–0.60, p < 0.001) with a longer median overall survival (OS) (35.9 months vs 12.1 months), 1-year OS of 71.6% vs 50.5% and 2-years OS of 56.5% vs 22.0% compared to those who did not. No significant interaction between nephrectomy and the overall five Meet-URO score risk groups was observed (p = 0.17). It was statistically significant when merging group 1 with 2 and 3 and group 4 with 5 (p = 0.038) and associated with a longer OS for the first three prognostic groups (p < 0.001), but not for groups 4 and 5 (p = 0.54). Conclusions Our study suggests an overall positive impact of the previous nephrectomy on the outcome of pretreated mRCC patients receiving immunotherapy. The clinical relevance of cytoreductive nephrectomy, optimal timing and patient selection deserves further investigation, especially for patients with Meet-URO scores of 1 to 3, who are the once deriving benefit in our analyses. However, that benefit is not evident for IMDC poor-risk patients (including the Meet-URO score groups 4 and 5) and a subgroup of IMDC intermediate-risk patients defined as group 4 by the Meet-URO score.

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Section: Discussionmentioning

confidence: 78%

Section: Discussionmentioning

confidence: 99%

The prognostic value of the previous nephrectomy in pretreated metastatic renal cell carcinoma receiving immunotherapy: a sub-analysis of the Meet-URO 15 study

et al. 2022

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“…It should be noted that, in these pivotal trials, the majority of patients had previously undergone an upfront cytoreductive nephrectomy prior to systemic therapy. Recent data have suggested that an ICI treatment effect on the primary tumor is rather rare [17]. However, in exploratory subgroup analyses, immunotherapy-based strategies appeared to provide benefit, regardless of the prior nephrectomy status [18][19][20].…”

Section: Discussionmentioning

confidence: 97%

Oncological Outcomes of Delayed Nephrectomy After Optimal Response to Immune Checkpoint Inhibitors for Metastatic Renal Cell Carcinoma

Pignot

Thiery‐Vuillemin

Albigès

et al. 2022

European Urology Oncology

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“…В подгруппе пациентов с высокой экспрессией сигнатуры Teff атезолизумаб в комбинации с бевацизумабом способствовал увеличению медианы ВБП в сравнении с сунитинибом в монорежиме (ОР, 0,59; 95 % ДИ, 0,47-0,75). При этом, в другом клиническом исследовании (NIVOREN), в котором 324 пациента метастатическим ПКР получали ниволумаб в монотерапии, было показано отсутствие предиктивной роли ангиогенной и Т-эффекторной генетических сигнатур в отдельности [25]. Однако комбинация данных сигнатур коррелировала с ответом на терапию.…”

Section: Discussionunclassified

Experience of the nivolumab use in patients with metastatic renal cell carcinoma provided under the expanded access program in Russia. Subgroup analysis of the correlation between expression markers and the effectiveness of nivolumab therapy

Karpova

Иванов²,

Милейко³

et al. 2022

Malignant Tumours

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Nivolumab was registered in Russia in December 2016 as a monotherapy for advanced renal cell carcinoma (RCC) and it remains a second‑line treatment choice for patients with disease progression after the use of tyrosine kinase inhibitors. Even though immunotherapy has already proven to be an effective approach for the treatment of RCC, predictive biomarkers for the rational selection of patients remain unidentified.Seventy‑five patients with metastatic renal cell carcinoma (mRCC) who received nivolumab in the 2nd and subsequent lines of therapy from 2015 to 2020 under the expanded access program were enrolled in this study. The objective response rate was 21,3 %. Median progression‑free survival (PFS) was 5,5 months. Median overall survival (OS) was not reached.To analyze molecular biomarkers correlated with the response to immunotherapeutic treatment, we performed whole‑transcriptome RNA sequencing of 16 samples (FFPE) in 15 patients with the assessment of the expression level for individual genes (PDCD1, CD274, CD8A, CD8B, CD4) and gene signatures (Angio, Teff, Myeloid Inflammation).Disease control rates were not different for the subgroups of patients with high and low expression of any of the signatures examined, and further principal component analysis did not reveal clustering of patients with and without objective response.Further studies on a larger sample of patients will help confirm or deny the predictive role of biomarkers selected for analysis in a heterogeneous population of RCC patients.

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Primary Renal Tumour Response in Patients Treated with Nivolumab for Metastatic Renal Cell Carcinoma: Results from the GETUG-AFU 26 NIVOREN Trial

Cited by 20 publications

References 11 publications

The prognostic value of the previous nephrectomy in pretreated metastatic renal cell carcinoma receiving immunotherapy: a sub-analysis of the Meet-URO 15 study

The prognostic value of the previous nephrectomy in pretreated metastatic renal cell carcinoma receiving immunotherapy: a sub-analysis of the Meet-URO 15 study

Oncological Outcomes of Delayed Nephrectomy After Optimal Response to Immune Checkpoint Inhibitors for Metastatic Renal Cell Carcinoma

Experience of the nivolumab use in patients with metastatic renal cell carcinoma provided under the expanded access program in Russia. Subgroup analysis of the correlation between expression markers and the effectiveness of nivolumab therapy

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