Safety and efficacy of nivolumab for metastatic renal cell carcinoma: real‐world results from an expanded access programme

Giorgi, Ugo De; Cartenì, Giacomo; Giannarelli, Diana; Basso, Umberto; Galli, Luca; Cortesi, Enrico; Caserta, Claudia; Pignata, Sandro; Sabbatini, Roberto; Bearz, Alessandra; Buti, Sebastiano; Re, Giovanni Lo; Berruti, Alfredo; Bracarda, Sergio; Cognetti, Francesco; Rastelli, Francesca; Fornarini, Giuseppe; Porta, Camillo; Turci, D.; Sternberg, Cora N.; Procopio, Giuseppe

doi:10.1111/bju.14461

Cited by 77 publications

(59 citation statements)

References 20 publications

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“…We previously conducted an analysis of the Italian RCC EAP, which showed that efficacy and safety of nivolumab for the treatment of metastatic RCC were comparable to phase III results; OS, PFS, and ORR in our cohort were similar to the observations in the CheckMate 025 studies (1,20).…”

Section: Discussionsupporting

confidence: 78%

Association of Systemic Inflammation Index and Body Mass Index with Survival in Patients with Renal Cell Cancer Treated with Nivolumab

Giorgi

Procopio

Giannarelli

et al. 2019

Clinical Cancer Research

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170

135

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Purpose: Inflammation indexes and body mass index (BMI) are easily evaluated, predict survival, and are potentially modifiable. We evaluated the potential association of inflammatory indexes and BMI with the clinical outcome of patients with renal cell carcinoma (RCC) undergoing immune checkpoint inhibitor therapy.Experimental Design: A prospective cohort of patients with metastatic RCC treated with nivolumab enrolled in the Italian Expanded Access Program from July 2015 through April 2016 was examined. Reference measures of inflammation were identified for neutrophil-to-lymphocyte ratio (NLR)

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Section: Discussionsupporting

confidence: 78%

Association of Systemic Inflammation Index and Body Mass Index with Survival in Patients with Renal Cell Cancer Treated with Nivolumab

Giorgi

Procopio

Giannarelli

et al. 2019

Clinical Cancer Research

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170

135

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“…In this study, results suggested that AE profiles differ between nivolumab and axitinib. The AE status of the nivolumab-administered group in our study is similar to that of the Check Mate 025 study and the study by De Giorgi et al (1,12). The absence of subjective symptoms, such as nausea, maintains the quality of life (QOL) of the nivolumab-administered patients.…”

Section: Nivolumab N=9supporting

confidence: 86%

A comparative study of nivolumab and axitinib in terms of overall survival, treatment continuation, and cost for patients with metastatic renal cell carcinoma

et al. 2020

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Nivolumab and axitinib has recommended as a second-line treatment in patients with metastatic renal cell carcinoma (mRCC) after tyrosine kinase inhibitor treatment. In this study, overall survival (OS), treatment continuation, and the cost of nivolumab and axitinib-the second-line treatment agents for mRCC-were compared and examined. Herein, we retrospectively surveyed patients with pathologically confirmed mRCC, treated with nivolumab (n=9) or axitinib (n=16) at Ogaki Municipal Hospital (Ogaki, Japan) between January 2012 and May 2019. The treatment periods for the nivolumab-and axitinib-administered groups were 5.4 (range: 1.4-21.3) and 3.4 (range: 0.3-28.1) months, respectively (P=0.089). The postponement periods for the nivolumab-and axitinib-administered groups were 7 (range: 0-186) and 0 (range: 0-262) days, respectively, and the difference was statistically significant (P=0.008). The median OS for patients treated with nivolumab and axitinib was 12.3 (range: 1.5-25.5 months) and 9.2 (range: 2.2-55.0 months) months, respectively (P=0.633). The one-year cost estimates for axitinib and nivolumab in clinical practice were $60, 694.2 and $86,544.4, respectively (P=0.017). We found that despite frequent interruptions in nivolumab administration and a longer postpaonement period for the nivolumab-administered group than for the axitinib-administered group, both groups exhibit comparable treatment duration and OS.

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“…A study by Lalani et al on 142 patients treated with ICIs in any line confirmed that patients with a higher baseline NLR had a worse prognosis and reported that NLR decrease ≥25% during ICI treatment was significantly associated with improved outcomes (both PFS and OS) [162].…”

Section: Inflammation As Predictive Factormentioning

confidence: 93%

The Interplay between Inflammation, Anti-Angiogenic Agents, and Immune Checkpoint Inhibitors: Perspectives for Renal Cell Cancer Treatment

Brighi

Farolfi

Conteduca

et al. 2019

Cancers

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Treatment options for metastatic renal cell carcinoma (RCC) have been expanding in the last years, from the consolidation of several anti-angiogenic agents to the approval of immune checkpoint inhibitors (ICIs). The rationale for the use of immunomodulating agents derived from the observation that RCC usually shows a diffuse immune-cell infiltrate. ICIs target Cytotoxic T Lymphocytes Antigen 4 (CTLA-4), programmed death 1 (PD-1), or its ligand (PD-L1), showing promising therapeutic efficacy in RCC. PD-L1 expression is associated with poor prognosis; however, its predictive role remains debated. In fact, ICIs may be a valid option even for PD-L1 negative patients. The establishment of valid predictors of treatment response to available therapeutic options is advocated to identify those patients who could benefit from these agents. Both local and systemic inflammation contribute to tumorigenesis and development of cancer. The interplay of tumor-immune status and of cancer-related systemic inflammation is pivotal for ICI-treatment outcome, but there is an unmet need for a more precise characterization. To date, little is known on the role of inflammation markers on PD-1 blockade in RCC. In this paper, we review the current knowledge on the interplay between inflammation markers, PD-1 axis, and anti-angiogenic agents in RCC, focusing on biological rationale, implications for treatment, and possible future perspectives.

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Safety and efficacy of nivolumab for metastatic renal cell carcinoma: real‐world results from an expanded access programme

Cited by 77 publications

References 20 publications

Association of Systemic Inflammation Index and Body Mass Index with Survival in Patients with Renal Cell Cancer Treated with Nivolumab

Association of Systemic Inflammation Index and Body Mass Index with Survival in Patients with Renal Cell Cancer Treated with Nivolumab

A comparative study of nivolumab and axitinib in terms of overall survival, treatment continuation, and cost for patients with metastatic renal cell carcinoma

The Interplay between Inflammation, Anti-Angiogenic Agents, and Immune Checkpoint Inhibitors: Perspectives for Renal Cell Cancer Treatment

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