Comparison of nivolumab plus ipilimumab with tyrosine kinase inhibitors as first-line therapies for metastatic renal-cell carcinoma: a multicenter retrospective study

Kido, Koichi; Numakura, Kazuyuki; Tanaka, Toshikazu; Oikawa, Masaaki; Noro, Daisuke; Hosogoe, Shogo; Narita, Shintaro; Inoue, Takamitsu; Yoneyama, Takahiro; Ito, Hiroyuki; Nishimura, Suzushi; Hashimoto, Yasuhiro; Kawaguchi, Toshiaki; Habuchi, Tomonori; Οhyama, Chikara

doi:10.1007/s10147-020-01797-5

Cited by 11 publications

(11 citation statements)

References 32 publications

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“…In addition, PFS probability in the combined treatment group reached a plateau above 30% 22 . In real‐world clinical practice, several studies reported findings similar to those of the CheckMate 214 trial 23–26 . For example, Kido et al .…”

Section: Ipilimumab Plus Nivolumabmentioning

confidence: 72%

“…22 In real-world clinical practice, several studies reported findings similar to those of the CheckMate 214 trial. [23][24][25][26] For example, Kido et al reported the favorable oncological outcomes in treatment-na€ ıve aRCC patients receiving ipilimumab plus nivolumab therapy, including ORR (38.5%), PFS (median, 17 months), and OS (median, not reached); however, the incidence of AE-related treatment discontinuation in these patients was 69%. 23 These findings suggest that despite the frequent occurrence of severe irAEs, ipilimumab plus nivolumab therapy continues to demonstrate durable efficacy benefits over sunitinib in aRCC patients classified into intermediate or poor risk group after long-term follow-up.…”

Section: Ipilimumab Plus Nivolumabmentioning

confidence: 99%

“…As described above, some studies reported experience with the use of ipilimumab plus nivolumab in real-world clinical practice. [23][24][25][26] To our knowledge, however, only one study that compared multiple IO drug-based combination therapies performed in a sufficient number of untreated aRCC patients is available, as follows: Dudani et al analyzed findings from 113 and 75 treatment-na€ ıve aRCC patients who received IO-drug plus TKI combinations and ipilimumab plus nivolumab, respectively, from the IMDC dataset, and reported that there were no significant differences in key first-line outcomes, including TTF, TNT, and OS, between these two groups. 37 Since due to strict criteria for inclusion in RCTs, there are considerable differences in characteristics between real-world and RCT patient cohorts, it is encouraged to accumulate routine clinical experience with IO drug-based combination therapies for untreated aRCC patients in order to identify parameters to predict the clinical course during and after treatment with these combinations.…”

Section: Comparisons Among Io Drug-based Combination Therapiesmentioning

confidence: 99%

“…To date, there have been limited studies comparing routine clinical outcomes among IO drug‐based combination therapies for treatment‐naïve aRCC patients in a non‐randomized setting. As described above, some studies reported experience with the use of ipilimumab plus nivolumab in real‐world clinical practice 23–26 . To our knowledge, however, only one study that compared multiple IO drug‐based combination therapies performed in a sufficient number of untreated aRCC patients is available, as follows: Dudani et al .…”

Section: Comparisons Among Io Drug‐based Combination Therapiesmentioning

confidence: 99%

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Comprehensive assessments of immuno‐oncology drug‐based combination therapies as first‐line treatment for advanced renal cell carcinoma

et al. 2022

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Over the last decade, there have been substantial progress in the field of systemic therapy for advanced renal cell carcinoma. Through the transition from treatment with cytokines to molecular-targeted agents, and currently to immunooncology drugs, the prognostic outcomes of patients with advanced renal cell carcinoma have been markedly improved. In particular, based on the promising outcomes of recently conducted pivotal randomized clinical trials, immuno-oncology drug-based combination therapy by either dual immune checkpoint inhibition or combined inhibition of an immune checkpoint and tyrosine kinase, is currently regarded as a standard of care for treatment-na€ ıve advanced renal cell carcinoma patients. However, insufficient data are available with respect to the selection of optimal systemic therapies for advanced renal cell carcinoma in the first-line setting due to the lack of a head-to-head comparison between approved immuno-oncology drug-based combination therapies. In this review, therefore, we summarize interesting findings associated with first-line combination therapies for advanced renal cell carcinoma obtained from both randomized clinical trials and real-world clinical practices, in order to present useful guidance to help make treatment decisions for patients with treatment-na€ ıve advanced renal cell carcinoma.

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Section: Ipilimumab Plus Nivolumabmentioning

confidence: 72%

Section: Ipilimumab Plus Nivolumabmentioning

confidence: 99%

Section: Comparisons Among Io Drug-based Combination Therapiesmentioning

confidence: 99%

Section: Comparisons Among Io Drug‐based Combination Therapiesmentioning

confidence: 99%

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Comprehensive assessments of immuno‐oncology drug‐based combination therapies as first‐line treatment for advanced renal cell carcinoma

et al. 2022

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“…The OS rate was estimated by log‐rank test. The effect of trial eligibility on the OS was investigated by multivariate Cox regression analyses using the inverse probability of treatment weighting (IPTW) model 19,20 . We also calculated the hazard ratio (HR) with 95% confidence interval (95% CI) after controlling the potential confounders, including patient age, sex, performance status, tumor type, TNM stage, chemotherapy types (cisplatin‐based regimen or not), subsequent use of pembrolizumab, and liver metastasis.…”

Section: Methodsmentioning

confidence: 99%

The impact of eligibility for maintenance immunotherapy on prognosis in patients with unresectable or metastatic urothelial carcinoma

Ozaki

Tanaka

Noro³

et al. 2021

BJUI Compass

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Objectives To investigate the eligibility for maintenance immunotherapy and its impact on the prognosis of advanced urothelial carcinoma treated with first‐line chemotherapy, as the selection biases of the eligible population in the JAVELIN Bladder 100 trial remain unclear. Methods We retrospectively evaluated 213 patients (median age, 71 years) with unresectable locally advanced or metastatic urothelial carcinoma treated with platinum‐based first‐line chemotherapy between May 2003 and April 2021. The patients were categorized into the following two groups: progressive disease (PD) within four cycles (trial ineligible group) and non‐PD within four cycles (trial eligible group). The primary outcomes were the estimated proportion of trial eligible patients for maintenance immunotherapy. The secondary outcomes were the comparison of the overall survival in the trial eligible and ineligible groups and the impact of radiologic response at the second cycle on the fourth cycle. Results Among the 213 patients, 81 (38%) were included in the trial eligible group. The trial eligible group had a significantly longer overall survival than the trial ineligible group (P < 0.001). Of 166 patients who had no PD within two cycles, 85 (51%) patients experienced PD within four cycles. Patients with a complete response or partial response at the second cycle had a significantly lower rate of PD at the fourth cycle (42%) than those with stable disease at the second cycle (59%, P = 0.031). Conclusion We observed 38% of the trial eligible population. Overall survival was significantly different between the trial eligible and ineligible groups.

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Primary resistance to nivolumab plus ipilimumab therapy in patients with metastatic renal cell carcinoma

et al. 2023

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BackgroundNivolumab plus ipilimumab (NIVO+IPI) is the first‐line treatment for patients with metastatic renal cell carcinoma (mRCC). Approximately 40% of patients achieve a durable response; however, 20% develop primary resistant disease (PRD) to NIVO+IPI, about which little is known in patients with mRCC. Therefore, this investigation aimed to evaluate the clinical implication of PRD in patients with mRCC to select better candidates in whom NIVO+IPI can be initiated as first‐line therapy.MethodsThis multi‐institutional retrospective cohort study used data collected between August 2015 and January 2023. In total, 120 patients with mRCC treated with NIVO+IPI were eligible. Associations between immune‐related adverse events and progression‐free survival, overall survival (OS), and objective response rate were analyzed. The relationship between other clinical factors and outcomes was also evaluated.ResultsThe median observation period was 16 months (interquartile range, 5–27). The median age at NIVO+IPI initiation was 68 years in the male‐dominant population (n = 86, 71.7%), and most patients had clear cell histology (n = 104, 86.7%). PRD was recorded in 26 (23.4%) of 111 investigated patients during NIVO+IPI therapy. Patients who experienced PRD showed worse OS (hazard ratio: 4.525, 95% confidence interval [CI]: 2.315–8.850, p < 0.001). Multivariable analysis showed that lymph node metastasis (LNM) (odds ratio: 4.274, 95% CI: 1.075–16.949, p = 0.039) was an independent risk factor for PRD.ConclusionsPRD was strongly correlated with worse survival rates. LNM was independently associated with PRD in patients with mRCC receiving NIVO+IPI as first‐line therapy and might indicate that a candidate will not benefit from NIVO+IPI.

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Comparison of nivolumab plus ipilimumab with tyrosine kinase inhibitors as first-line therapies for metastatic renal-cell carcinoma: a multicenter retrospective study

Cited by 11 publications

References 32 publications

Comprehensive assessments of immuno‐oncology drug‐based combination therapies as first‐line treatment for advanced renal cell carcinoma

Comprehensive assessments of immuno‐oncology drug‐based combination therapies as first‐line treatment for advanced renal cell carcinoma

The impact of eligibility for maintenance immunotherapy on prognosis in patients with unresectable or metastatic urothelial carcinoma

Primary resistance to nivolumab plus ipilimumab therapy in patients with metastatic renal cell carcinoma

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