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Open AccessArticle

Efficacy and Safety of Nivolumab and Ipilimumab for Advanced or Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Cohort Study

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Department of Urology, Graduate School of Medicine, Gifu University, Gifu 5011194, Japan
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Department of Urology, Kizawa Memorial Hospital, Minokamo 5058503, Japan
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Department of Urology, Gifu Prefectural General Medical Center, Gifu 5008717, Japan
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Department of Urology, Ogaki Municipal Hospital, Ogaki 5038502, Japan
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Department of Urology, Daiyukai Daiichi Hospital, Ichinomiya 4918551, Japan
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Department of Urology, Toyota Memorial Hospital, Toyota 4718513, Japan
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Department of Urology, Matsunami General Hospital, Hashima-gun 5016062, Japan
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Department of Urology, Gifu Municipal Hospital, Gifu 5008513, Japan
*
Author to whom correspondence should be addressed.
Academic Editor: Marco Iafolla
Curr. Oncol. 2021, 28(2), 1402-1411; https://doi.org/10.3390/curroncol28020133
Received: 29 January 2021 / Revised: 29 March 2021 / Accepted: 31 March 2021 / Published: 3 April 2021
(This article belongs to the Section Genitourinary Oncology)
We conducted a multicenter, retrospective study to evaluate the efficacy and safety of combination nivolumab plus ipilimumab (NIVO+IPI) in 35 patients with advanced or metastatic renal cell carcinoma (mRCC). In this study, we focused on patients who received NIVO+IPI and were stratified into intermediate- or poor-risk disease according to the International Metastatic Renal Cell Carcinoma Database Consortium model at five institutions in Japan. The primary endpoint was overall survival (OS). Secondary endpoints were disease control rate (DCR), best overall response (BOR), objective response rate (ORR), and progression-free survival (PFS). In addition, we evaluated the role of inflammatory cell ratios, namely neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), as predictive biomarkers in patients with mRCC. The median follow-up period was 1 year, and the 1-year OS rate was 95.8%. The ORR and DCR were 34.3% and 80.0%, respectively. According to BOR, four patients (11.4%) achieved complete response. According to NLR stratification, the 1-year PFS rates were 82.6% and 23.7% when the NLR was ≤4.6 and >4.6, respectively (p = 0.04). Based on PLR stratification, the 1-year PFS rates were 81.7% and 34.3% when the PLR was ≤188.1 and >188.1, respectively (p = 0.033). Although 71.4% of the patients experienced treatment-related adverse events (TRAEs) with NIVO+IPI, only four patients discontinued NIVO+IPI due to grade 3/4 TRAEs. Patients treated with NIVO+IPI as a first-line therapy for advanced or mRCC achieved relatively better oncological outcomes. Therefore, NIVO+IPI may have potential advantages and may lead to a treatment effect compared to those receiving targeted therapies. In addition, PLR >188.1 may be a useful predictive marker for mRCC patients who received NIVO+IPI. View Full-Text
Keywords: metastatic renal cell carcinoma; nivolumab; ipilimumab; immune-oncology treatments; platelet-to-lymphocyte ratio metastatic renal cell carcinoma; nivolumab; ipilimumab; immune-oncology treatments; platelet-to-lymphocyte ratio
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MDPI and ACS Style

Iinuma, K.; Kameyama, K.; Kawada, K.; Fujimoto, S.; Takagi, K.; Nagai, S.; Ito, H.; Ishida, T.; Kawase, M.; Kawase, K.; Nakai, C.; Kato, D.; Takai, M.; Nakane, K.; Koie, T. Efficacy and Safety of Nivolumab and Ipilimumab for Advanced or Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Cohort Study. Curr. Oncol. 2021, 28, 1402-1411. https://doi.org/10.3390/curroncol28020133

AMA Style

Iinuma K, Kameyama K, Kawada K, Fujimoto S, Takagi K, Nagai S, Ito H, Ishida T, Kawase M, Kawase K, Nakai C, Kato D, Takai M, Nakane K, Koie T. Efficacy and Safety of Nivolumab and Ipilimumab for Advanced or Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Cohort Study. Current Oncology. 2021; 28(2):1402-1411. https://doi.org/10.3390/curroncol28020133

Chicago/Turabian Style

Iinuma, Koji; Kameyama, Koji; Kawada, Kei; Fujimoto, Shota; Takagi, Kimiaki; Nagai, Shingo; Ito, Hiroki; Ishida, Takashi; Kawase, Makoto; Kawase, Kota; Nakai, Chie; Kato, Daiki; Takai, Manabu; Nakane, Keita; Koie, Takuya. 2021. "Efficacy and Safety of Nivolumab and Ipilimumab for Advanced or Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Cohort Study" Curr. Oncol. 28, no. 2: 1402-1411. https://doi.org/10.3390/curroncol28020133

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