Skeletal muscle density as a positive predictive factor for nivolumab therapy in patients with metastatic renal cell carcinoma.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17107-e17107
Author(s):  
Meltem Ekenel ◽  
Murat Sari ◽  
Samil Aliyev ◽  
Mert Basaran

e17107 Background: Immunotherapy has shown promising clinical responses in patients with metastatic Renal Cell Carcinoma (mRCC) at second-line therapy. Since objective response rates are highly variable, it is utmost important to identify patients who may benefit from immunotherapy to avoid unnecessary adverse effects and costs. Therefore, predictive as well as prognostic markers need to be studied extensively. To our knowledge, none of the body composition measurements such as fat content or skeletal muscle density have been assessed for this purpose. The objective of the current study is to analyze whether skeletal muscle (either muscle mass or muscle density) and adipose tissue play a prognostic role in patients with mRCC who were treated with immunotherapy at second line. Methods: We retrospectively analyzed 14 patients with mRCC who were progressed after tyrosine kinase inhibitor therapy and treated with Nivolumab between March 2016 and September 2019. Skeletal muscle density (SMD), skeletal muscle and adipose tissue were assessed with computed tomography imaging. Overall Survival (OS) and Progression Free Survival (PFS) were estimated by using the Kaplan-Meier method. Results: The median OS was 13,1 months and it was strongly associated with SMD; the median OS was significantly longer in patients with high SMD compared to patients with low SMD (6,9 months vs 18,5 months; P < 0,05). Also in our analysis, SMD separated the intermediate-risk group into 2 groups with different median OS periods, ranging from 8,1 months (95% confidence interval [95% CI], 5,1 months-11,1 months) in patients with intermediate-risk Heng score and low SMD to 21,5 months (95% CI, 14 months-27 months) in patients with an intermediate-risk Heng score and high SMD. Other parameters calculated for adipose tissue or skeletal muscle did not cause any significant change in survival analysis. Conclusions: High SMD appears to be associated with improved outcome in our small patient population. It could be a predictive factor when immunotherapy, Nivolumab, is considered for therapy of mRCC patients at second line.

Cancer ◽  
2013 ◽  
Vol 119 (18) ◽  
pp. 3377-3384 ◽  
Author(s):  
Sami Antoun ◽  
Emilie Lanoy ◽  
Roberto Iacovelli ◽  
Laurence Albiges-Sauvin ◽  
Yohann Loriot ◽  
...  

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e16065-e16065
Author(s):  
Kimiharu Takamatsu ◽  
Ryuichi Mizuno ◽  
Nozomi Hayakawa ◽  
Eiji Kikuchi ◽  
Takeo Kosaka ◽  
...  

e16065 Background: The later-line treatment of metastatic renal cell carcinoma (mRCC) has been drastically changing by the development of immune-oncology drugs and molecular targeted treatment in recent years. Although the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) model is useful for second-line setting, this model has the problem that over 50% patients are classified as intermediate risk group. The aim of this study is to evaluate whether the serum C-reactive protein (CRP) levels prior to second-line treatment could divide intermediate risk group patients. Methods: We retrospectively reviewed 150 mRCC patients received second-line molecular targeted therapy. We assessed the prognostic impact of serum CRP levels prior to second-line treatment initiation to predict overall survival (OS) especially in intermediate risk group. Results: The median OS from second-line treatment of whole cohort and intermediate risk group were 24.6 (95%confidence interval, 95%CI:18.2-31.0) and 23.6 (95%CI:15.1-32.1) months. Thirty-three out of 82 (40%) intermediate risk patients demonstrated elevated baseline CRP levels. The median OS of elevated and non-elevated CRP group were 13.4 (95%CI:5.9-20.8) and 29.4 (95%CI:25.5-33.5) months, respectively (p = 0.001). The serum CRP elevation could predict prognosis in intermediate risk patients treated with second-line treatment (HR 2.5,95%CI:1.4-4.2, p = 0.001). Conclusions: The serum CRP levels at second-line treatment initiation could divide intermediate risk mRCC patients into two prognostic subgroups.


2014 ◽  
Vol 32 (25) ◽  
pp. 2765-2772 ◽  
Author(s):  
Robert J. Motzer ◽  
Carlos H. Barrios ◽  
Tae Min Kim ◽  
Silvia Falcon ◽  
Thomas Cosgriff ◽  
...  

Purpose A multicenter, randomized phase II trial, RECORD-3, was conducted to compare first-line everolimus followed by sunitinib at progression with the standard sequence of first-line sunitinib followed by everolimus in patients with metastatic renal cell carcinoma. Patients and Methods RECORD-3 used a crossover treatment design. The primary objective was to assess progression-free survival (PFS) noninferiority of first-line everolimus compared with first-line sunitinib. Secondary end points included combined PFS for each sequence, overall survival (OS), and safety. Results Of 471 enrolled patients, 238 were randomly assigned to first-line everolimus followed by sunitinib, and 233 were randomly assigned to first-line sunitinib followed by everolimus. The primary end point was not met; the median PFS was 7.9 months for first-line everolimus and 10.7 months for first-line sunitinib (hazard ratio [HR], 1.4; 95% CI, 1.2 to 1.8). Among patients who discontinued first-line, 108 (45%) crossed over from everolimus to second-line sunitinib, and 99 (43%) crossed over from sunitinib to second-line everolimus. The median combined PFS was 21.1 months for sequential everolimus then sunitinib and was 25.8 months for sequential sunitinib then everolimus (HR, 1.3; 95% CI, 0.9 to 1.7). The median OS was 22.4 months for sequential everolimus and then sunitinib and 32.0 months for sequential sunitinib and then everolimus (HR, 1.2; 95% CI, 0.9 to 1.6). Common treatment-emergent adverse events during first-line everolimus or sunitinib were stomatitis (53% and 57%, respectively), fatigue (45% and 51%, respectively), and diarrhea (38% and 57%, respectively). Conclusion Everolimus did not demonstrate noninferiority compared with sunitinib as a first-line therapy. The trial results support the standard treatment paradigm of first-line sunitinib followed by everolimus at progression.


Sign in / Sign up

Export Citation Format

Share Document