scholarly journals Comparing ITC Results From Lenvatinib Plus Everolimus For Second-Line Treatment of Advanced/Metastatic Renal Cell Carcinoma: Crossover Versus No Crossover

2017 ◽  
Vol 20 (9) ◽  
pp. A415-A416
Author(s):  
G Tremblay ◽  
SA Garib ◽  
G Meir ◽  
HJ McElroy ◽  
M Guo
2021 ◽  
Author(s):  
Ana Elena Martin-Aguilar ◽  
Haidé Nayeli Núñez-López ◽  
Juan C. Ramirez-Sandoval

Abstract Background: Sequential inhibition of the vascular endothelial growth factor (VEGF) pathway with sorafenib could be useful for patients with metastatic renal cell carcinoma (RCC). Our aim was to determine the activity and tolerability of sorafenib as a second-line therapy in advanced RCC initially treated with a different VEGF-tyrosine kinase inhibitor (TKI).Methods: A prospective observational cohort in Mexico (2012–2019). We included 132 subjects with metastatic RCC and who had progression despite treatment with sunitinib. The primary end-point was time to disease progression as evaluated every 12–16 weeks.Results: The mean age of the cohort was 59 years (interquartile range [IQR] 50-72), 96 (73%) were men, and 48 (36%) had a favorable prognosis according to the IMDC (International Metastatic RCC Database Consortium) prognostic model. The median progression-free survival (PFS) and overall-survival after the introduction of sorafenib treatment was 8.6 months (95% confidence interval [CI]: 6.7–10.5) and 40 months (95% CI: 34.5–45.4) respectively. The median overall survival from RCC diagnosis to death was 71 months (95% CI: 58.2–83.8). On multivariable analyses, age >65 years was associated with a longer PFS (HR 0.51; 95% CI: 0.31-0.86; p = 0.018). The median PFS in subjects aged >65 years was longer compared to subjects ≤65 years (14.0 [95% CI: 9.2–18.8] vs. 7.2 months [95% CI: 5.3–9.1]; p = 0.012). Adverse events grade ≥3 associated with sorafenib occurred in 38 (29%) patients.Conclusion: Sequential inhibition of VEGF with sorafenib as a second-line treatment may benefit patients with metastatic RCC, especially in subjects >65 years old.


2018 ◽  
Vol 4 (Supplement 2) ◽  
pp. 71s-71s
Author(s):  
K.A.R. Ku Nurhasni ◽  
J. Sabirin ◽  
S.E. Wan Puteh ◽  
M. Dahlui

Background: Axitinib has been suggested to be effective as a second line treatment of metastatic renal cell carcinoma. However, its adoption may be limited by its financial consequences. Therefore, a cost-utility analysis was conducted to estimate the economic value of axitinib as a second line treatment of metastatic renal cell carcinoma. Aim: This analysis will informed the decision makers on the potential use of axitinib in this population within the Ministry of Health facilities. Methods: A state transition model was developed using Microsoft Excel 2010 to simulate a hypothetical cohort of patient receiving axitinib or best supportive care over 5 years of time horizon. A monthly cycle was chosen without a half cycle correction. Three health states were included in the model as progression free, disease progression and dead. A 3% discount rate was applied as recommended in the Pharmacoeconomic Guidelines for Malaysia. Total costs were estimated using unit costs from local sources and published data. The clinical and utility parameters were derived from the published literatures. Results: The mean probabilistic incremental discounted cost and QALY for axitinib were RM 113,576.29 and 0.35413 respectively, yielded a probabilistic incremental cost-effectiveness ratio (ICER) of RM 320,719. Unavailability of the local price for axinitib may play a part in the higher estimation of ICER. Conclusion: Axitinib may not be considered as a cost-effective second line treatment of metastatic renal cell carcinoma as the ICER is beyond the value of 3 GDP per capita.


2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 544-544 ◽  
Author(s):  
Jose Manuel Ruiz Morales ◽  
J Connor Wells ◽  
Frede Donskov ◽  
Georg A. Bjarnason ◽  
Jae-Lyun Lee ◽  
...  

544 Background: Sunitinib (SU) and Pazopanib (PZ) have been compared head-to-head in the first-line phase III COMPARZ study in metastatic renal cell carcinoma (mRCC). We compared SU versus PZ, to confirm outcomes and subsequent second-line therapy efficacy in a population-based setting. Methods: We used the IMDC to assess overall survival (OS), progression-free survival (PFS), response rate (RR) and performed proportional hazard regression adjusting for IMDC prognostic groups. Second-line OS2 and PFS2 were also evaluated. Results: We obtained data from 3,606 patients with mRCC treated with either first line SU (n=3226) or PZ (n=380) with an overall median follow-up of 43.5 months (m) (CI95% 41.4 – 46.4). IMDC risk group distribution for favorable prognosis was 440 (17.3%) for SU vs 72 (25%) for PZ, intermediate prognosis 1414 (55.6%) for SU vs 153 (53%) for PZ, poor prognosis 689 (27.1%) for SU vs 62 (22%) for PZ, p= 0.0027. We found no difference between SU vs. PZ for OS (20.1 [CI95% 18.76-21.42] vs. 23.68 m [CI95% 19.54 - 28.81] p=0.19), PFS (7.22 [CI95% 6.76 - 7.78] vs. 6.83 m [CI95% 5.58 - 8.27] p=0.49). The RR was similar in both groups (Table 1). Adjusted HR for OS and PFS were 0.952 (CI95% 0.788 – 1.150 p=0.61) and 1.052 (CI95% 0.908 – 1.220 p = 0.49), respectively. We also found no difference in any second-line treatment between either post-SU vs. post-PZ groups for OS2 (12.88 [CI95% 11.89 – 14.19] vs. 12.91 m [CI95% 10.3 – 19.1] p=0.47) and PFS2 (3.67 [CI95% 3.38 – 3.87] vs. 4.53 m [CI95% 3.08 – 5.35] p=0.4). There was no statistical difference in OS2 and PFS2 if everolimus was used after SU or PZ (p = 0.33 and p = 0.41, respectively) or if axitinib was used after SU or PZ (p = 0.73 and p = 0.72, respectively). Conclusions: We confirmed in real world practice, that SU and PZ have similar efficacy in the first-line setting for mRCC and do not affect outcomes with subsequent second-line treatment. [Table: see text]


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