scholarly journals Sunitinib in Patients With Metastatic Renal Cell Carcinoma: Clinical Outcome According to International Metastatic Renal Cell Carcinoma Database Consortium Risk Group

2018 ◽  
Vol 16 (4) ◽  
pp. 298-304 ◽  
Author(s):  
Brian I. Rini ◽  
Thomas E. Hutson ◽  
Robert A. Figlin ◽  
Maria Josè Lechuga ◽  
Olga Valota ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Clinical Outcome ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Risk Group

Predictive factors associated with clinical outcome and safety in Korean patients with metastatic renal cell carcinoma treated with sunitinib

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16111-e16111
Author(s):  
M. Hong ◽  
H. Jeung ◽  
H. Chung ◽  
J. Ahn ◽  
J. Roh ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Clinical Outcome ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Predictive Factors ◽  
Renal Cell ◽  
Risk Group ◽  
Severe Toxicity ◽  
Asian Patients ◽  
Grade 3

e16111 Background: Sunitinib has become a standard treatment for metastatic renal cell carcinoma (RCC). The research for identifying patients who are more likely to benefit from this agent is quite limited, especially in Asian patients. Methods: In total, 81 histologically proven metastatic RCC patients who were treated with sunitinib were reviewed between Jan 2006 and Dec 2008. Tumor response was evaluated according to the RECIST criteria, and safety was assessed by NCI-CTC (version 3.0). Primary endpoint was progression-free survival (PFS) and secondary endpoints included overall survival (OS), overall response rate (ORR), disease control rate (DCR), and toxicities. Clinical features associated with clinical outcome were identified by univariate analysis; then, a stepwise modeling approach based on Cox's proportional hazards regression was used to identify independent prognostic factors to these endpoints. Results: Median age was 58 years (range, 29 to 73), and 33 patients received sunitinib as first-line systemic treatment. Clear cell type was predominant (85%). Patient distribution was 12% for favorable, 78% for intermediate, and 10% for poor group according to the MSKCC risk group. With the median follow-up of 26 months, median PFS was 16 months (95% CI, 8 –24) and median OS was 24 months (95% CI, 18 –30). ORR was 30% (95% CI, 19–40%) and DCR was 80% (95% CI, 70–89%). The most common grade 3/4 adverse events of sunitinib was thrombocytopenia (32%). Other severe toxicity included neutropenia (21%), anemia (19%), leucopenia (14%), fatigue (10%), stomatitis (10%). In multivariate analysis, the previous exposure to immunotherapy was related to longer PFS (P<.012). Performance status (ECOG 0–1) and corrected Ca level (8.5∼10.5 mg/dl) were associated with favorable ORR (P=.038) and DCR (p=0.008), respectively. Predictive factors for grade 3/4 thrombocytopenia were corrected Ca level (P=.018), poor MSKCC risk group (P=.025), and low WBC count (<4500/ul, P=.041). Conclusions: Compared to western reports, our data demonstrated comparable clinical efficacy in Asian patients, but different safety profile, especially in hematologic toxicities. This approach provides a tailored approach to predictive factors for targeted agents. No significant financial relationships to disclose.

Development of de novo psoriasis during nivolumab therapy for metastatic renal cell carcinoma: immunohistochemical analyses and clinical outcome

Apmis ◽  
2017 ◽  
Vol 125 (3) ◽  
pp. 259-263 ◽  
Author(s):  
Juan Ruiz-Bañobre ◽  
Ihab Abdulkader ◽  
Urbano Anido ◽  
Luis León ◽  
Rafael López-López ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Clinical Outcome ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
De Novo ◽  
Immunohistochemical Analyses

Clinical outcome of patients with metastatic renal cell carcinoma who interrupted VEGFR-TKI after achieving stable disease or better response.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 459-459
Author(s):  
Dong Hoe Koo ◽  
Inkeun Park ◽  
Jae-Lyun Lee ◽  
Jin-Hee Ahn ◽  
Dae Ho Lee ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Clinical Outcome ◽  
Cell Carcinoma ◽  
Disease Progression ◽  
Metastatic Renal Cell Carcinoma ◽  
Stable Disease ◽  
Renal Cell ◽  
Progression Free Survival ◽  
Free Survival

459 Background: The purpose of the this study is to evaluate the clinical outcome of VEGFR-TKIs interruption in patients with metastatic renal cell carcinoma (mRCC) after achieving stable disease (SD) or better response. Methods: A retrospective analysis of medical records and imaging studies was performed on all patients with mRCC treated with VEGFR-TKIs between January 2008 and July 2014 (n=505). Patients who achieved SD or better response under VEGFR-TKI and later discontinued VEGFR-TKIs for any reason with the exception of disease progression were included in the analysis. Outcomes analyzed were progression free survival (PFS) after VEGFR-TKIs discontinuation, patterns of disease progression, time to subsequent therapy (TST), response to VEGFR-TKI resumption, and time to treatment failure (TTF) after TKI resumption. Results: We identified 32 patients (sunitinib=20, sorafenib=7, and pazopanib=5). The responses to VEGFR-TKIs were CR (n=4), PR (n=11), SD (n=15), and controlled but non-measurable (n=2). Median time to interruption from the initiation of VEGFR-TKI therapy was 16.6 months (95% CI, 12.8-20.3). The main causes of VEGFR-TKI interruption was toxicity (n=19, 59.4%), will to have treatment holiday (n=7, 21.8%), patient’s refusal (n=3, 9.4%), and others (n=3, 9.4%). At the time of analysis, 16 patients had disease progression and 1 patient was dead. With a median follow-up duration of 56.6 months (range, 12.6-167.4), median PFS from VEGFR-TKI interruption was 23.8 months (95% CI, 12.5-35.0), and the median TST was 26.2 months (95% CI, 15.9-36.6). The progression was observed in pre-existing lesions in 7 patients (43.7%) or new lesions developed in 9 (56.3%). Among 11 patients who received VEGFR-TKI resumption, 2 patients (18.2%) achieved a PR and the stable disease was observed in 9 (81.8%) with a median TTF of VEGFR-TKI resumption of 6.2 months (95% CI, 4.0-8.4). Conclusions: In patients with mRCC controlled with VEGFR-TKIs, VEGFR-TKI could be interrupted at least temporarily when clinically warranted.

scholarly journals Outcomes According to MSKCC Risk Score with Focus on the Intermediate-Risk Group in Metastatic Renal Cell Carcinoma Patients Treated with First-Line Sunitinib: A Retrospective Analysis of 2390 Patients

Cancers ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 808
Author(s):  
Ondrej Fiala ◽  
Jindrich Finek ◽  
Alexandr Poprach ◽  
Bohuslav Melichar ◽  
Jindrich Kopecký ◽  
...  
Keyword(s):  
Risk Factors ◽  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Risk Score ◽  
Renal Cell ◽  
Risk Group ◽  
Intermediate Risk ◽  
First Line ◽  
The Impact

Background: The Memorial Sloan–Kettering Cancer Center (MSKCC) prognostic model has been widely used for the prediction of the outcome of metastatic renal cell carcinoma (mRCC) patients treated with systemic therapies, however, data from large studies are limited. This study aimed at the evaluation of the impact of the MSKCC score on the outcomes in mRCC patients treated with first-line sunitinib, with a focus on the intermediate-risk group. Methods: Clinical data from 2390 mRCC patients were analysed retrospectively. Progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) were analysed according to the MSKCC risk score. Results: ORR, median PFS, and OS for patients with one risk factor were 26.7%, 10.1, and 28.2 months versus 18.7%, 6.2, and 16.2 months, respectively, for those with two risk factors (ORR: p = 0.001, PFS: p < 0.001, OS: p < 0.001). ORR, median PFS, and OS were 33.0%, 17.0, and 44.7 months versus 24.1%, 9.0, and 24.1 months versus 13.4%, 4.5, and 9.5 months in the favourable-, intermediate-, and poor-risk groups, respectively (ORR: p < 0.001, PFS: p < 0.001, OS: p < 0.001). Conclusions: The results of the present retrospective study demonstrate the suitability of the MSKCC model in mRCC patients treated with first-line sunitinib and suggest different outcomes between patients with one or two risk factors.

scholarly journals Association Between Immune-related Adverse Events and Clinical Outcome Following Nivolumab Treatment in Patients With Metastatic Renal Cell Carcinoma

In Vivo ◽  
2020 ◽  
Vol 34 (5) ◽  
pp. 2647-2652
Author(s):  
KAZUO KOBAYASHI ◽  
YUSUKE IIKURA ◽  
MAKOTO HIRAIDE ◽  
TAKASHI YOKOKAWA ◽  
TAKESHI AOYAMA ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Clinical Outcome ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell

Prognostic biomarker exploration for patients with metastatic renal cell carcinoma receiving VEGFR TKI.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 491-491
Author(s):  
Inkeun Park ◽  
Yong Mee Cho ◽  
Jae-Lyun Lee ◽  
Jin-Hee Ahn ◽  
Dae Ho Lee ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Prognostic Factors ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Risk Group ◽  
Univariate Analysis ◽  
Multivariable Analysis ◽  
Coagulative Necrosis ◽  
Prognostic Importance

491 Background: To verify the prognostic importance of selected tumor tissue biomarkers in metastatic renal cell carcinoma (mRCC) patients (pts), we performed immunohistochemical (IHC) staining in tumor sample and statistical analyses. Methods: The clinicopathological features, treatment, and outcome of mRCC pts treated with vascular endothelial growth factor tyrosine kinase inhibitor (VEGFR TKI) between July 2006 and March 2011 at our center were reviewed. IHC staining for FGF base, FGFR1, 2, 3, and 4, HGF, PTEN, CAIX, pS6, HIF-1a, HIF-2a, IL-8, mTOR was done, and each specimen was scored based on the staining intensity and the percentage of positive cells. We performed univariate and multivariable analyses to verify prognostic factors for overall survival (OS). Results: We found 123 pts who met inclusion criteria. Most pts had clear cell carcinoma (107 pts, 87.0%). Fuhrman’s nuclear grade (NG) was 2 in 21 (17.1%), 3 in 49 (39.8%), and 4 in 52 (42.3%), respectively. Sarcomatoid change and coagulative necrosis were found in 51 pts and 58 pts. Using Heng’s criteria, 20 pts (16.3%), 87 (70.7%), and 16 (13.0%) belonged to favorable, intermediate, and poor risk group, respectively. First-line VEGFR TKIs prescribed were sunitinib (97 pts, 78.9%), sorafenib (23 pts, 18.7%), and pazopanib (3 pts, 2.4%). In univariate analysis, CAIX (less than 47.5% vs 47.5% or more, p=0.001), mTOR (20% or less vs more than 20%, p=0.0032), Heng risk group (good vs intermediate vs poor, p<0.001), sarcomatoid change (40% or less vs more than 40%, p<0.001), coagulative necrosis (20% or less vs more than 20%, p<0.001), Furhman NG (2 vs 3 vs 4, p=0.037) were statistically significant. In multivariable analysis, CAIX, Heng risk group, sarcomatoid change, and hyaline necrosis were identified as independent prognostic factors (Table). Conclusions: All investigated biomarkers but CAIX did not show prognostic importance for mRCC pts receiving VEGFR TKI. [Table: see text]

Sunitinib in patients with metastatic renal cell carcinoma: Clinical outcome according to IMDC risk group.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4584-4584
Author(s):  
Brian I. Rini ◽  
Thomas E. Hutson ◽  
Robert A. Figlin ◽  
Mariajose Lechuga ◽  
Olga Valota ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Retrospective Analysis ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Risk Group ◽  
Risk Groups ◽  
Phase Iii ◽  
Poor Risk ◽  
Phase Iii Study

4584 Background: In a phase III study (NCT00083889), treatment-naïve patients (pts) with metastatic renal cell carcinoma (mRCC) of all prognostic risk groups were treated with sunitinib or interferon-α (IFN-α). Since sunitinib has become the reference standard of care and serves as the comparator in multiple randomized trials sometimes restricted to prespecified risk groups, a retrospective analysis of outcome according to prognostic group from the phase III study was performed. Methods: Investigator-assessed efficacy data were analyzed for pts based on risk group (International mRCC Database Consortium [IMDC] criteria). The objective was to determine objective response rate (ORR), median progression-free survival (mPFS), and median overall survival (mOS) benchmarks by risk group. Results: Of sunitinib-treated pts, 134 were favorable, 205 were intermediate, and 34 were poor risk. The median sunitinib treatment duration/median number of cycles was 16.7 mo/12 cycles, 11.0 mo/8 cycles and 2.6 mo/2.0 cycles for favorable-, intermediate-, and poor-risk pts, respectively. ORR, PFS, and OS benchmarks for sunitinib-treated pts are shown in the Table. In sunitinib-treated intermediate-risk pts with 1 vs 2 risk factors, respectively: ORR was 43.3% vs 40.8%, mPFS (95% confidence interval [95% CI]) was 11.2 (9.7–13.6) vs 8.5 (5.6–10.7) mo, and mOS (95% CI) was 28.2 (23.0–not estimable) vs 16.3 (13.2–19.4) mo. Conclusions: This retrospective analysis provides ORR, PFS, and OS benchmarks for current and future clinical trial interpretation in mRCC pts with different prognostic risk treated with sunitinib. [Table: see text]

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