Validation of the IMDC Prognostic Model in Patients With Metastatic Renal-Cell Carcinoma Treated With First-Line Axitinib: A Multicenter Retrospective Study

Konishi, Sakae; Numakura, Kazuyuki; Narita, Shintaro; Inoue, Takamitsu; Saito, Mitsuru; Tokui, Noriko; Yamamoto, Hayato; Yoneyama, Takahiro; Hashimoto, Yasuhiro; Yoshikawa, Kunio; Narita, Satoshi; Kawaguchi, Toshiaki; Habuchi, Tomonori; Οhyama, Chikara

doi:10.1016/j.clgc.2019.07.006

Cited by 10 publications

(10 citation statements)

References 35 publications

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“…The main reason might be the short follow‐up periods and the regional bias in Japan. Approximately 1.5‐fold longer median survival time has been reported in previous studies in Japan than in North America or Europe 14,15,17–22 . Health insurance systems and racial differences could be possible reasons.…”

Section: Discussionmentioning

confidence: 82%

“…Approximately 1.5-fold longer median survival time has been reported in previous studies in Japan than in North America or Europe. 14,15,[17][18][19][20][21][22] Health insurance systems and racial differences could be possible reasons. The public health insurance system for its citizens in Japan covers almost every standard treatment, including surgery, targeted therapy and immunotherapy.…”

Section: Discussionmentioning

confidence: 99%

“…As several studies have suggested the utility of CRP value on prognosis, it might be useful to consider the efficacy of nivolumab plus ipilimumab therapy. 17,22,[24][25][26][27] Further studies are necessary to validate the role of CRP value on the immunotherapy response. We found no ORR difference between patients with intermediate-risk 1 and 2 of IMDC in the present study.…”

Section: Discussionmentioning

confidence: 99%

“…2e). As several studies have suggested the utility of CRP value on prognosis, it might be useful to consider the efficacy of nivolumab plus ipilimumab therapy 17,22,24–27 . Further studies are necessary to validate the role of CRP value on the immunotherapy response.…”

Section: Discussionmentioning

confidence: 99%

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Efficacy and safety of first‐line nivolumab plus ipilimumab in patients with metastatic renal cell carcinoma: A multicenter retrospective study

Tanaka¹,

Hatakeyama²,

Numakura³

et al. 2020

Int J of Urology

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To investigate the efficacy and safety of first-line nivolumab plus ipilimumab for patients treated with metastatic renal cell carcinoma. Methods: We retrospectively evaluated 52 metastatic renal cell carcinoma patients who were treated with nivolumab plus ipilimumab between August 2015 and January 2020. Data on patient characteristics, treatment parameters and adverse events were obtained. Oncological outcomes were assessed according to the International Metastatic Renal Cell Carcinoma Database Consortium prognostic model. Furthermore, differences in treatment parameters between patients with objective response (responders) and non-responders were compared. Results: The median age and follow-up periods were 69 years and 8.2 months, respectively. The 1-year progression-free survival and overall survival rates were 55% and 75%, respectively. The objective response rate was 39%, and it was significantly different between the International Metastatic Renal Cell Carcinoma Database Consortium intermediate-and poor-risk groups (52% vs 24%). We observed 36 (69%) any immunerelated adverse events, and 19 (37%) severe immune-related adverse events (grades III-V). The International Metastatic Renal Cell Carcinoma Database Consortium poor-risk group and higher value of initial C-reactive protein (≥1.0 mg/dL) were significantly associated with non-responders. Patients with two factors (the International Metastatic Renal Cell Carcinoma Database Consortium poor-risk group plus C-reactive protein ≥1.0 mg/dL) had a significantly poor overall survival than those with none or a single factor. Conclusions: In our experience, treatment response to nivolumab plus ipilimumab is comparable with that of the CheckMate 214 clinical trial, but the incidence of treatmentrelated adverse events is lower. The International Metastatic Renal Cell Carcinoma Database Consortium poor-risk group and initial C-reactive protein value might have a prognostic value for poor survival.

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Section: Discussionmentioning

confidence: 82%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Efficacy and safety of first‐line nivolumab plus ipilimumab in patients with metastatic renal cell carcinoma: A multicenter retrospective study

Tanaka¹,

Hatakeyama²,

Numakura³

et al. 2020

Int J of Urology

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“…Two prognostic factors of OS were identified in our study. Poor IMDC risk score 14,15 and spindle histology 16 , which have already been identified as markers of poor prognosis in second-line axitinib treatment cohorts, were shown to also be prognostic markers in the first-line axitinib setting. Although VEGFR-TKI monotherapy is still considered usable in all IMDC risk categories by both the European Association of Urology and the National Comprehensive Cancer Network treatment guidelines for mRCC 17,18 , the efficacy of VEGFR-TKIs does not satisfy us.…”

Section: Discussionmentioning

confidence: 81%

First-line axitinib therapy is less effective in metastatic renal cell carcinoma with spindle histology

Numakura

Kobayashi

Muto

et al. 2020

Sci Rep

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Axitinib, a vascular endothelial growth factor receptor-tyrosine kinase inhibitor, will be used in combination first-line therapies against metastatic renal cell carcinoma (mRCC), but its effects as a first-line monotherapy are unclear. Thus, we aimed to elucidate pretreatment clinical factors that predict the prognosis of patients with mRCC receiving first-line axitinib therapy. We enrolled 63 patients with mRCC treated with axitinib as first-line therapy between Nov. 2003 and Jul. 2018. Progression-free survival (PFS) and overall survival (OS) were assessed using the Wald χ2 statistic in Cox proportional hazards regression. Median patient age was 67 (range: 25–85) years. Seven (11.1%) patients were classified as being at favorable risk, 33 (52.4%) at intermediate risk, and 23 (36.5%) at poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk classification system. Median follow-up duration after axitinib initiation was 14 (range: 1–72) months. Median PFS and OS were 18 months and 65 months, respectively. Cox regression analyses of clinical predictors revealed that high C-reactive protein (CRP) levels were significantly correlated with shorter PFS [hazard ratio (HR), 1.63; 95% confidence interval (CI) 1.7–4.0)], whereas spindle cells and poor IMDC risk scores were related to worse OS (HR, 2.87 and 2.88, respectively; 95% CI 1.4–11.0 and 1.1–8.5, respectively). Thus, patients with mRCC and spindle histology or poor IMDC risk scores had worse OS, and those with high CRP levels had shorter PFS in first-line axitinib treatment. Other therapies might be more suitable for initial management of such patients.

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Outcomes of axitinib versus sunitinib as first‐line therapy to patients with metastatic renal cell carcinoma in the immune‐oncology era

et al. 2021

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Validation of the IMDC Prognostic Model in Patients With Metastatic Renal-Cell Carcinoma Treated With First-Line Axitinib: A Multicenter Retrospective Study

Cited by 10 publications

References 35 publications

Efficacy and safety of first‐line nivolumab plus ipilimumab in patients with metastatic renal cell carcinoma: A multicenter retrospective study

Efficacy and safety of first‐line nivolumab plus ipilimumab in patients with metastatic renal cell carcinoma: A multicenter retrospective study

First-line axitinib therapy is less effective in metastatic renal cell carcinoma with spindle histology

Outcomes of axitinib versus sunitinib as first‐line therapy to patients with metastatic renal cell carcinoma in the immune‐oncology era

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