scholarly journals Impact of Geographic Regions on Overall Survival in Patients With Metastatic Renal Cell Carcinoma: Results From an International Clinical Trials Database

2018 ◽  
pp. 1-14
Author(s):  
Andre P. Fay ◽  
Rana R. McKay ◽  
Xun Lin ◽  
Ronit Simantov ◽  
Toni K. Choueiri

Purpose Health determinants vary according to geographic region and may affect the outcomes of patients with metastatic renal cell carcinoma (mRCC) treated during clinical trials of targeted therapy. Here, we investigate the overall survival (OS) of patients with mRCC treated in the era of targeted therapy by geographic region. Methods We conducted a pooled analysis of patients with mRCC who were treated during phase II or III clinical trials. Clinical characteristics and survival data were collected. Statistical analyses were performed with the Kaplan-Meier method and log-rank test in univariable analysis. Results Overall, 4,736 patients were included in the analysis. Patient characteristics differed according to geographic region. No statistically significant differences in OS were observed when the United States/Canada (USC) was compared with the following other regions: Latin America, Asia/Oceania/Africa, and Eastern Europe. In a univariable analysis, OS differed among patients enrolled in trials in USC compared with Western Europe (20.3 v 17.4 months; hazard ratio, 1.15; 95% CI, 1.03 to 1.3; P = .015), but it did not differ in a multivariable analysis. All-grade treatment-related adverse events (AEs) were observed more frequently in USC. There were no significant differences in grade 3 to 5 AEs among groups. Conclusion Despite different baseline characteristics, OS was similar among patients enrolled in clinical trials across different geographic regions. Access to clinical trials as well as disease biology, AE reporting, and quality of care may contribute to potential differences in outcomes.

2014 ◽  
Vol 8 (11-12) ◽  
pp. 821 ◽  
Author(s):  
Juping Zhao ◽  
Xin Huang ◽  
Fukang Sun ◽  
Renyi Ma ◽  
Haofei Wang ◽  
...  

Introduction: We wanted to identify the prognostic factors for overall survival (OS) in Chinese patients with metastatic renal cell carcinoma (mRCC) treated with first-line targeted therapy (sorafenib or sunitinib).Methods: We retrospectively reviewed clinical data from 119 mRCC patients administered sorafenib or sunitinib at the Ruijin Hospital since 2007. OS rates were calculated by the Kaplan-Meier method. Each variable was investigated univariately and then multivariately using a stepwise algorithm. A multivariate Cox regression model analyzed baseline variables for prognostic significance.Results: The mean patient age was 57 ± 12 years; 37 patients (31%) received sorafenib and 82 (69%) received sunitinib. The mean OS was 22.7 ± 15.6 months (range: 2.8–68.7). OS rates at year 1, 3 and 5 were 74%, 57%, and 36%, respectively. Univariate analysis identified significant negative prognostic factors (p < 0.05) as Eastern Cooperative Oncology Group (ECOG) performance status ≥2, symptoms, no prior nephrectomy, microscopic necrosis, ≥2 metastatic sites, presence of liver, bone, or pancreas metastasis, hemoglobin less than the lower limit of normal (female <115 g/L, male <130 g/L), and serum alkaline phosphatase greater than the upper limit of normal (126 IU/L) at baseline, as well as a relative dose intensity of targeting agents in the first month (1M-RDI) of <50%. Multivariate analysis of OS identified 4 independent predictors: no symptoms, no bone or pancreas metastasis, and 1M-RDI of targeting agents (≥50%).Conclusions: With targeted therapy, there is some change in the prognostic factors for mRCC and target drug therapies (1M-RDI ≥50%) play an important role in the prognosis of mRCC. Continued progress in the identification of patient-specific prognostic factors for mRCC will require further advances in the understanding of tumour biology.


2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 590-590
Author(s):  
Yu-Wei Chen ◽  
Katherine Tullio ◽  
Moshe Chaim Ornstein ◽  
Petros Grivas ◽  
Jorge A. Garcia ◽  
...  

590 Background: Prognosis of metastatic renal cell carcinoma (mRCC) has significantly improved in the targeted therapy era. We aimed to investigate whether higher facility case volume (FCV) is associated with improved overall survival (OS) for mRCC. Methods: Patients diagnosed with mRCC from 2006-2012 were identified in the National Cancer Database. FCV was determined by the total cases of renal cell carcinoma (metastatic and non-metastatic) at each treating facility. Multivariable Cox regression model was used to investigate the association between FCV and OS. Covariates adjusted for were treatment modalities [targeted therapy, cytoreductive nephrectomy, and metastasectomy], tumor characteristics and patient sociodemographics. Results: There were 18,571 mRCC patients included in this study. The mean follow-up time was 13.2 months (median: 6; interquartile range: 2.3-17.9). After adjusting for baseline characteristics including treatment modalities (table), every increment of 100 FCV of the treating facility was associated with improved OS (AHR: 0.99, 95 CI: 0.98-0.99, p-value: 0.003). FCV was dichotomized at increasing percentiles (50th, 80th, 85th, 90th, and 95th). Improved OS was observed when high FCV was defined at 90th percentile (47 cases/year; AHR: 0.96, 95% CI: 0.92-0.99, p-value: 0.02) and 95th percentile (68 cases/year; AHR: 0.95, 95% CI: 0.91-0.98, p-value: 0.04) but not at 50th (8 cases/year), 80th (30 cases/year) or 85th percentile (38 cases/year). Conclusions: Our results suggest that treatment at hospitals with higher renal cell carcinoma FCV is associated with improved OS for patients diagnosed with mRCC in the targeted therapy era. Model is also adjusted for age, race, sex, insurance status, Charlson comorbidity score, tumor stage, nodal status, histology type, year of diagnosis, and zip code-level socioeconomic data (income, education level and residence type). [Table: see text]


Cancer ◽  
2010 ◽  
Vol 117 (12) ◽  
pp. 2637-2642 ◽  
Author(s):  
Daniel Y. C. Heng ◽  
Wanling Xie ◽  
Georg A. Bjarnason ◽  
Ulka Vaishampayan ◽  
Min-Han Tan ◽  
...  

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