External Validation of the MSKCC and IMDC Risk Models in Patients Treated with Targeted Therapy as a First-line and Subsequent Second-line Treatment: A Japanese Multi-institutional Study

Tanaka, Nobuyuki; Mizuno, Ryuichi; Ito, Keiichi; Shirotake, Suguru; Yasumizu, Yota; Masunaga, Ayako; Ito, Y.; Miyazaki, Yasumasa; Hagiwara, Masaru; Kanao, Kent; Mikami, Shuji; Nakagawa, Ken; Momma, Tetsuo; Masuda, Takeshi; Asano, Tomohiko; Oyama, Masafumi; Oya, Mototsugu

doi:10.1016/j.euf.2015.11.001

Cited by 26 publications

(20 citation statements)

References 26 publications

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“…In this study, we developed a hypothesisgenerating risk scoring system using three variables to represent risk from number and sites of metastatic disease (D_Met), body composition (BMI), and inflammation (MLR). This builds upon previously established data on the effectiveness of the IMDC criteria in predicting survival in patients with mRCC treated with VEGF-targeted therapy [6,7,22]. The results from our study indicate that incorporation of risk factors such as sites of metastatic disease, body composition, and a more accurate inflammatory marker may improve prediction of survival in patients with mRCC treated with ICI.…”

Section: Discussionsupporting

confidence: 79%

Novel Risk Scoring System for Patients with Metastatic Renal Cell Carcinoma Treated with Immune Checkpoint Inhibitors

et al. 2019

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Background The International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria are the gold standard for risk‐stratifying patients with metastatic renal cell cancer (mRCC). We developed a novel risk scoring system for patients with mRCC treated with immune checkpoint inhibitors (ICIs). Methods We performed a retrospective analysis of 100 ICI‐treated patients with mRCC at Winship Cancer Institute from 2015 to 2018. Several baseline variables were collected, including markers of inflammation, body mass index (BMI), and sites of metastatic disease, and all were considered for inclusion in our risk scoring system. Upon variable selection in multivariable model, monocyte‐to‐lymphocyte ratio (MLR), BMI, and number and sites of metastases at baseline were used for risk score calculation. Patients were categorized using four‐level risk groups as good (risk score = 0), intermediate (risk score = 1), poor (risk score = 2), or very poor (risk score = 3–4). Cox's proportional hazard model and the Kaplan‐Meier method were implemented for survival outcomes. Results Most patients were male (66%) with clear cell renal cell carcinoma (72%). The majority (71%) received anti–programmed cell death protein‐1 monotherapy. Our risk scoring criteria had higher Uno's concordance statistics than IMDC in predicting overall survival (OS; 0.71 vs. 0.57) and progression‐free survival (0.61 vs. 0.58). Setting good risk (MLR <0.93, BMI ≥24, and D_Met = 0) as the reference, the OS hazard ratios were 29.5 (95% confidence interval [CI], 3.64–238.9), 6.58 (95% CI, 0.84–51.68), and 3.75 (95% CI, 0.49–28.57) for very poor, poor, and intermediate risk groups, respectively. Conclusion Risk scoring using MLR, BMI, and number and sites of metastases may be an effective way to predict survival in patients with mRCC receiving ICI. These results should be validated in a larger, prospective study. Implications for Practice A risk scoring system was created for patients with metastatic renal cell carcinoma treated with immune checkpoint inhibitors. The results of this study have significant implications for practicing oncologists in the community and academic setting. Importantly, these results identify readily available risk factors that can be used clinically to risk‐stratify patients with metastatic renal cell carcinoma who are treated with immune checkpoint inhibitors.

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Section: Discussionsupporting

confidence: 79%

Novel Risk Scoring System for Patients with Metastatic Renal Cell Carcinoma Treated with Immune Checkpoint Inhibitors

et al. 2019

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“…The IMDC risk model has been validated multiple times for patients treated with first-line through fourth-line targeted therapy [8][9][10][11] and has been used in clinical practice for treatment decision making as well as in trial design and data interpretation. In this study, patients in the favorable IMDC risk group had significantly higher median OS, TTD, and ORR compared with patients in the intermediate, poor, or combined intermediate and poor risk groups.…”

Section: Discussionmentioning

confidence: 99%

Real-World Assessment of Clinical Outcomes Among First-Line Sunitinib Patients with Clear Cell Metastatic Renal Cell Carcinoma (mRCC) by the International mRCC Database Consortium Risk Group

et al. 2020

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Background. International Metastatic Renal Cell Carcinoma (mRCC) Database Consortium (IMDC) risk groups are important when considering therapeutic options for first-line treatment. Materials and Methods. Adult patients with clear cell mRCC initiating first-line sunitinib between 2010 and 2018 were included in this retrospective database study. Median time to treatment discontinuation (TTD) and overall survival (OS) were estimated using Kaplan-Meier analysis. Outcomes were stratified by IMDC risk groups and evaluated for those in the combined intermediate and poor risk group and separately for those in the intermediate risk group with one versus two risk factors. Results. Among 1,769 patients treated with first-line sunitinib, 318 (18%) had favorable, 1,031 (58%) had intermediate, and 420 (24%) had poor IMDC risk. Across the three risk groups, patients had similar age, gender, and sunitinib initiation year. Median TTD was 15.0, 8.5, and 4.2 months in the favorable, intermediate, and poor risk groups, respectively, and 7.1 months in the combined intermediate and poor risk group. Median OS was 52.1, 31.5, and 9.8 months in the favorable, intermediate, and poor risk groups, respectively, and 23.2 months in the combined intermediate and poor risk group. Median OS (35.1 vs. 21.9 months) and TTD (10.3 vs. 6.6 months) were significantly different between intermediate risk patients with one versus two risk factors. Conclusion. This real-world study found a median OS of 52 months for patients with favorable IMDC risk treated with first-line sunitinib, setting a new benchmark on clinical outcomes of clear cell mRCC. Analysis of intermediate risk group by one or two risk factors demonstrated distinct clinical outcomes. The Oncologist 2020;25:422-430Implications for Practice: This analysis offers a contemporary benchmark for overall survival (median, 52.1 months; 95% confidence interval, 43.4-61.2) among patients with clear cell metastatic renal cell carcinoma who were treated with sunitinib as first-line therapy in a real-world setting and classified as favorable risk according to International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk group classification. This study demonstrates that clinical outcomes differ between IMDC risk groups as well as within the intermediate risk group based on the number of risk factors, thus warranting further consideration of risk group when counseling patients about therapeutic options and designing clinical trials.

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“…As prognoses in mRCC have improved, more precise stratifications based on risk factors have been required. In the molecular‐targeted therapy era, the IMDC risk classification is a standard risk‐based stratification . Whereas the IMDC classification includes inflammatory markers, such as neutrophil and platelet count, several studies have suggested that systemic inflammation measured by NLR and CRP also plays a key role in prognosis in mRCC .…”

Section: Introductionmentioning

confidence: 99%

“…In the molecular-targeted therapy era, the IMDC risk classification is a standard riskbased stratification. 12,13 Whereas the IMDC classification includes inflammatory markers, such as neutrophil and platelet count, several studies have suggested that systemic inflammation measured by NLR and CRP also plays a key role in prognosis in mRCC. [14][15][16] Recently, the CAR, a novel inflammation-based prognostic score, has shown outstanding prognostic value in several cancers.…”

Section: Introductionmentioning

confidence: 99%

C‐reactive protein/albumin ratio is a predictive factor for prognosis in patients with metastatic renal cell carcinoma

et al. 2019

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Objectives To evaluate the effect of pretreatment C‐reactive protein/albumin ratio and modified Glasgow prognostic score on the prognosis in patients with metastatic renal cell carcinoma. Methods A retrospective study was carried out in 176 patients with metastatic renal cell carcinoma who received first‐line tyrosine kinase inhibitors. The effect of adding inflammatory prognostic scores to the International Metastatic Renal Cell Carcinoma Database Consortium model (International Metastatic Renal Cell Carcinoma Database Consortium‐C‐reactive protein/albumin ratio and International Metastatic Renal Cell Carcinoma Database Consortium‐Glasgow prognostic score models) on overall survival was evaluated using receiver operating characteristic curves. The prognostic value of inflammatory prognostic scores (C‐reactive protein/albumin ratio‐modified Glasgow prognostic score) was tested using the Kaplan–Meier method and Cox proportional regression models. Results Patients were stratified into two groups using the cut‐off value of 0.05: C‐reactive protein/albumin ratio‐low (<0.05) and C‐reactive protein/albumin ratio‐high (≥0.05). The area under the curve was significantly higher in the International Metastatic Renal Cell Carcinoma Database Consortium‐C‐reactive protein/albumin ratio model (0.720) than that of the International Metastatic Renal Cell Carcinoma Database Consortium model (0.689) and the International Metastatic Renal Cell Carcinoma Database Consortium‐modified Glasgow prognostic score model (0.703). Significant differences were observed in overall survival stratified by the number of risk factors in the International Metastatic Renal Cell Carcinoma Database Consortium‐C‐reactive protein/albumin ratio risk model between one or two and three or four factors (P < 0.001), and three or four and five or more factors (P = 0.001). For the patients in the International Metastatic Renal Cell Carcinoma Database Consortium intermediate‐risk group, overall survival was significantly different between the C‐reactive protein/albumin ratio‐low and ‐high groups (P = 0.001), whereas it was not significantly different between the patients with one and two International Metastatic Renal Cell Carcinoma Database Consortium risk factors (P = 0.106). Conclusion The C‐reactive protein/albumin ratio is a simple and independent predictor of overall survival in patients with metastatic renal cell carcinoma. The predictive activity was significantly improved in the International Metastatic Renal Cell Carcinoma Database Consortium‐C‐reactive protein/albumin ratio model compared with the International Metastatic Renal Cell Carcinoma Database Consortium/International Metastatic Renal Cell Carcinoma Database Consortium‐modified Glasgow prognostic score models.

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External Validation of the MSKCC and IMDC Risk Models in Patients Treated with Targeted Therapy as a First-line and Subsequent Second-line Treatment: A Japanese Multi-institutional Study

Cited by 26 publications

References 26 publications

Novel Risk Scoring System for Patients with Metastatic Renal Cell Carcinoma Treated with Immune Checkpoint Inhibitors

Novel Risk Scoring System for Patients with Metastatic Renal Cell Carcinoma Treated with Immune Checkpoint Inhibitors

Real-World Assessment of Clinical Outcomes Among First-Line Sunitinib Patients with Clear Cell Metastatic Renal Cell Carcinoma (mRCC) by the International mRCC Database Consortium Risk Group

C‐reactive protein/albumin ratio is a predictive factor for prognosis in patients with metastatic renal cell carcinoma

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