Subclassification of the intermediate-risk group in patients with advanced renal cell carcinoma.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16537-e16537
Author(s):  
Maria Zapata-Garcia ◽  
Maria Zurera Berjaga ◽  
Alba Moratiel Pellitero ◽  
Marta Gascon Ruiz ◽  
Andrea Sesma Goñi ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Prognostic Factors ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Cox Regression ◽  
Risk Group ◽  
Intermediate Risk ◽  
First Line ◽  
Poor Risk ◽  
Prognosis Group

e16537 Background: Renal cell carcinoma (RCC) have low prevalence but it incidence is increasing. For a correct therapeutic approach, it is important to carry out a correct prognostic stratification. Several prognostication systems have been proposed. One of the most commonly used is the one developed by Heng. It is based on IMDC database. This classification includes six prognostic factors (hemoglobin, neutrohils, platelets, serum calcium, Karnosky Performance Status and time from diagnosis to initiaton treatment) to divide patients into three gorups. The relevance of IMDC prognostic criterio, in the era of immunotherapy, remains to be established. In the absence of alternative criteria, these prognostication system continue to be used. A great prognostic disparity has been observed in the intermediate prognosis group. This raises the need to divide this group into two. Thus, patients included in it would be better selected. Methods: Observational, single-center, retrospective study, based on a cohort of 107 patients with advanced RCC, recruited from January 2006 to December 2019. Main objective: Evaluate whether survival of patients with intermediate prognosis (treated with antiangiogenic in first-line) is different depending on the presence of one or two prognostic factors. Descriptive and survival analysis (OS and PFS) were performed. In addition, the influence of prognostic factors on OS and PFS were compared using the log-rank test and Cox regression. Results: In the overall population, median overall survival (OS) was 26.86 months (95% CI: 21.09-32.63) and median PFS was 18.41 months (95% CI: 14.02-22.79). Median OS were, in favorable-risk 42.24 months (95% CI: 29.62-54.62), in intermediate-risk 27,24 (95% CI: 19.44-35-03) and in poor-risk 8.00 (95% CI: 4.54-11.45). Median PFS were in favorable-risk 30.53 months (95% CI:20.92-40.13), in intermediate-risk 17,16 (95% CI:11.54-22.78) and poor-risk 6.13 (95% CI:3.02-9.25). Median OS and PFS, in patients with intermediate-risk, with a single risk factor were 33.79 (95% CI 23.17-44.41) and 20.97 months (95% CI 13.35-28.59), compared to 14.88 (95% CI 8.80-20.95) and 10.59 months (95% CI 4.87-16.32) in those with two risk factors. The results were statistically significant in OS (p = 0.01) and PFS (p = 0.037). Conclusions: The differences in median OS and PFS, within the intermediate prognosis group (1 or 2 RF), confirm the existence of two subgroups of patients. Patients with 1 RF are similar to those with favorable-risk. These results are important since, the presence of 1 or 2 RF, would condition the choice of TKIs as part of the first-line treatment combination. More studies are needed to better subclassify the intermediate risk group when optimizing the best treatments for each patient.

Association of hypothyroidism with improved outcomes in first-line treatment of renal cell carcinoma with sunitinib.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 466-466 ◽  
Author(s):  
Flavio Augusto Ismael Pinto ◽  
Augusto Akikubo Rodrigues Pereira ◽  
Maria Nirvana Formiga ◽  
Marcello Ferretti Fanelli ◽  
Ludmilla T. D. Chinen ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Prognostic Factors ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Kinase Inhibitor ◽  
Univariate Analysis ◽  
Intermediate Risk ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

466 Background: Sunitinib, a multitarget tyrosine-kinase inhibitor, has become a standard of care for first-line low and intermediate risk metastatic renal cell carcinoma (mRCC). Sunitinib-induced hypothyroidism and hypertension have been correlated with better outcomes in those patients. Methods: Fifty patients with mRCC, treated in the first-line with sunitinib, were retrospective analyzed at one brazilian institution, for overall survival (OS), progression free survival (PFS), overall response rate (ORR) and toxicity. We evaluated clinical and laboratory parameters, such as hypothyroidism (TSH level > 5,5 mIU/L) and hypertension, to identify prognostic factors. Results: The median age of patients was 58 years (range: 37-73 years), 82% were male, 54% were ECOG 0 or 1, and 76% were classified in low or intermediate risk. Nefrectomy was performed in 96% of cases. Lung and bone were the most common sites of metastases. The incidence of hypothyroidism and hypertension during treatment were 40% and 34%, respectively. ORR for the entire population was 40% and it was statistically superior in patients that developed hypothyroidism during treatment (90% vs. 20%; p<0,0001). Median survival and PFS were 21.7 months (10.65-17.70 months, 95% CI) and 14.2 months (15.77-27.58 months, 95% CI), respectively. In univariate analysis, ECOG (p<0,0001), MSKCC criteria (p<0,0001), hypothyroidism (p<00001) and hypertension (p=0,001) were associated with OS. In multivariate analysis, ECOG (p<0,0001), MSKCC criteria (p<0,0001) and hypothyroidism (p<00001) were independent prognostic factors for OS. The most common severe adverse events (G3-4) were asthenia (14%), diarrhoea (6%), neutropenia (14%), thrombocytopenia (10%), hand-foot syndrome (6%) and hypertension (8%). Conclusions: Efficacy in survival and toxicity profile of sunitinib in first-line treatment of mRCC in patients out of clinical trials were comparable to prior studies. Hypothyroidism, MSKCC criteria and ECOG were independent prognostic factors for survival.

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.

Validation and Extension of the Memorial Sloan-Kettering Prognostic Factors Model for Survival in Patients With Previously Untreated Metastatic Renal Cell Carcinoma

2005 ◽  
Vol 23 (4) ◽  
pp. 832-841 ◽  
Author(s):  
Tarek M. Mekhail ◽  
Rony M. Abou-Jawde ◽  
Gabriel BouMerhi ◽  
Sareena Malhi ◽  
Laura Wood ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Prognostic Factors ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Median Overall Survival ◽  
Intermediate Risk ◽  
Survival Times ◽  
Poor Risk ◽  
Expanded Criteria

Purpose To validate the Motzer et al prognostic factors model for survival in patients with previously untreated metastatic renal cell carcinoma (RCC) and to identify additional independent prognostic factors. Patients and Methods Data were collected on 353 previously untreated metastatic RCC patients enrolled onto clinical trials between 1987 and 2002. Results Four of the five prognostic factors identified by Motzer were independent predictors of survival. In addition, prior radiotherapy and presence of hepatic, lung, and retroperitoneal nodal metastases were found to be independent prognostic factors. Using the number of metastatic sites as surrogate for individual sites (none or one v two or three sites), Motzer’s definitions of risk groups were expanded to accommodate these two additional prognostic factors. Using this expanded criteria, favorable risk is defined as zero or one poor prognostic factor, intermediate risk is two poor prognostic factors, and poor risk is more than two poor prognostic factors. According to Motzer’s definitions, 19% of patients were favorable risk, 70% were intermediate risk, and 11% were poor risk; median overall survival times for these groups were 28.6, 14.6, and 4.5 months, respectively (P < .0001). Using the expanded criteria, 37% of patients were favorable risk, 35% were intermediate risk, and 28% were poor risk; median overall survival times of these groups were 26.0, 14.4, and 7.3 months, respectively (P < .0001). Conclusion These data validate the model described by Motzer et al. Additional independent prognostic factors identified were prior radiotherapy and sites of metastasis. Incorporation of these additional prognostic factors into the Motzer et al model can help better define favorable risk, intermediate risk, and poor risk patients.

scholarly journals Prognostic Factors in De Novo Metastatic Renal Cell Carcinoma: A Report From the Latin American Renal Cancer Group

2021 ◽  
pp. 671-685
Author(s):  
Diego Abreu ◽  
Gustavo Carvalhal ◽  
Guillermo Gueglio ◽  
Ignacio Tobia ◽  
Patricio Garcia ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Prognostic Factors ◽  
Cell Carcinoma ◽  
Latin American ◽  
Renal Cell ◽  
Cox Regression ◽  
De Novo ◽  
Risk Group ◽  
External Validation ◽  
Prognostic Information

PURPOSE To assess the effect of clinical and pathological variables on cancer-specific and overall survival (OS) in de novo metastatic patients from a collaborative of primarily Latin American countries. PATIENTS AND METHODS Of 4,060 patients with renal cell carcinoma diagnosed between 1990 and 2015, a total of 530 (14.5%) had metastasis at clinical presentation. Relationships between clinical and pathological parameters and treatment-related outcomes were analyzed by Cox regression and the log-rank method. RESULTS Of 530 patients, 184 (90.6%) had died of renal cell carcinoma. The median OS of the entire cohort was 24 months. American Society of Anesthesiology classification 3-4 (hazard ratio [HR]: 1.64), perirenal fat invasion (HR: 2.02), and ≥ 2 metastatic organ sites (HR: 2.19) were independent prognostic factors for 5-year OS in multivariable analyses. We created a risk group stratification with these variables: no adverse risk factors (favorable group), median OS not reached; one adverse factor (intermediate group), median OS 33 months (HR: 2.04); and two or three adverse factors (poor risk group), median OS 14 months (HR: 3.58). CONCLUSION Our study defines novel prognostic factors that are relevant to a Latin American cohort. With external validation, these easily discerned clinical variables can be used to offer prognostic information across low- and middle-income countries.

scholarly journals Survival outcomes and independent response assessment with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma: 42-month follow-up of a randomized phase 3 clinical trial

2020 ◽  
Vol 8 (2) ◽  
pp. e000891 ◽  
Author(s):  
Robert J Motzer ◽  
Bernard Escudier ◽  
David F McDermott ◽  
Osvaldo Arén Frontera ◽  
Bohuslav Melichar ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Complete Response ◽  
Intermediate Risk ◽  
First Line ◽  
Phase 3 ◽  
Poor Risk ◽  
Risk Patients

BackgroundThe extent to which response and survival benefits with immunotherapy-based regimens persist informs optimal first-line treatment options. We provide long-term follow-up in patients with advanced renal cell carcinoma (aRCC) receiving first-line nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib (SUN) in the phase 3 CheckMate 214 trial. Survival, response, and safety outcomes with NIVO+IPI versus SUN were assessed after a minimum of 42 months of follow-up.MethodsPatients with aRCC were enrolled from October 16, 2014, through February 23, 2016. Patients stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and region were randomized to nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every 3 weeks for four doses, followed by nivolumab (3 mg/kg) every 2 weeks; or SUN (50 mg) once per day for 4 weeks (6-week cycle). Primary endpoints: overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) per independent radiology review committee in IMDC intermediate-risk/poor-risk patients. Secondary endpoints: OS, PFS, and ORR in the intention-to-treat (ITT) population and safety. Favorable-risk patient outcomes were exploratory.ResultsAmong ITT patients, 550 were randomized to NIVO+IPI (425 intermediate/poor risk; 125 favorable risk) and 546 to SUN (422 intermediate/poor risk; 124 favorable risk). Among intermediate-risk/poor-risk patients, OS (HR, 0.66; 95% CI, 0.55–0.80) and PFS (HR, 0.75; 95% CI, 0.62–0.90) benefits were observed, and ORR was higher (42.1% vs 26.3%) with NIVO+IPI versus SUN. In ITT patients, both OS benefits (HR, 0.72; 95% CI, 0.61–0.86) and higher ORR (39.1% vs 32.6%) were observed with NIVO+IPI versus SUN. In favorable-risk patients, HR for death was 1.19 (95% CI, 0.77–1.85) and ORR was 28.8% with NIVO+IPI versus 54.0% with SUN. Duration of response was longer (HR, 0.46–0.54), and more patients achieved complete response (10.1%–12.8% vs 1.4%–5.6%) with NIVO+IPI versus SUN regardless of risk group. The incidence of treatment-related adverse events was consistent with previous reports.ConclusionsNIVO+IPI led to improved efficacy outcomes versus SUN in both intermediate-risk/poor-risk and ITT patients that were maintained through 42 months’ minimum follow-up. A complete response rate >10% was achieved with NIVO+IPI regardless of risk category, with no new safety signals detected in either arm. These results support NIVO+IPI as a first-line treatment option with the potential for durable response.Trial registration numberNCT02231749.

scholarly journals Significance of upfront cytoreductive nephrectomy stratified by IMDC risk for metastatic renal cell carcinoma in targeted therapy era – a multi-institutional retrospective study

2022 ◽  
Author(s):  
Renpei Kato ◽  
Sei Naito ◽  
Kazuyuki Numakura ◽  
Shingo Hatakeyama ◽  
Tomoyuki Koguchi ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Survival Benefit ◽  
Cox Regression ◽  
Time Varying ◽  
Intermediate Risk ◽  
Cytoreductive Nephrectomy ◽  
Poor Risk ◽  
Time Varying Covariates

Abstract Background This retrospective multicenter study aimed to evaluate the survival benefit of upfront cytoreductive nephrectomy (CN) in metastatic renal cell carcinoma (RCC) patients stratified by International Metastatic RCC Database Consortium (IMDC) risk criteria. Methods We reviewed the medical records in the Michinoku Database between 2008 and 2019. Patients who received upfront CN, systemic therapy without CN (no CN) and CN after drug therapy (deferred CN) were analyzed. To exclude selection bias due to patient characteristics, baseline clinical data were adjusted by inverse probability of treatment weighting (IPTW). Overall survival (OS) was compared between upfront CN and non-upfront CN (no CN plus deferred CN). Associations between time-varying covariates including systemic therapies and OS stratified by IMDC risk criteria were analyzed by IPTW-adjusted Cox regression method. Results Of 259 patients who fulfilled the selection criteria, 107 were classified in upfront CN and 152 in non-upfront CN group. After IPTW-adjusted analysis, upfront CN showed survival benefit compared to non-upfront CN in patients with IMDC intermediate risk (median OS: 52.5 versus 31.3 months, p < 0.01) and in patients with IMDC poor risk (27.2 versus 11.4 months, p < 0.01). In IPTW-adjusted Cox regression analysis of time-varying covariates, upfront CN was independently associated with OS benefit in patients with IMDC intermediate risk (hazard ratio 0.52, 95% confidence interval 0.29–0.93, p = 0.03) and in patients with IMDC poor risk (0.26, 0.11–0.59, p < 0.01). Conclusions Upfront CN may confer survival benefit in RCC patients with IMDC intermediate and poor risk.

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