Patient-reported outcomes (PROs) in a phase III AXIS trial of axitinib versus sorafenib as second-line therapy for metastatic renal cell carcinoma (mRCC).

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. 4504-4504 ◽  
Author(s):  
D. Cella ◽  
B. Escudier ◽  
B. I. Rini ◽  
C. Chen ◽  
H. Bhattacharyya ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Patient Reported Outcomes ◽  
Phase Iii ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Patient Reported

scholarly journals Randomized Phase III Trial of Temsirolimus Versus Sorafenib As Second-Line Therapy After Sunitinib in Patients With Metastatic Renal Cell Carcinoma

2014 ◽  
Vol 32 (8) ◽  
pp. 760-767 ◽  
Author(s):  
Thomas E. Hutson ◽  
Bernard Escudier ◽  
Emilio Esteban ◽  
Georg A. Bjarnason ◽  
Ho Yeong Lim ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Clear Cell ◽  
Phase Iii ◽  
Second Line ◽  
Second Line Therapy ◽  
Phase Iii Trial ◽  
Line Therapy

Purpose This international phase III trial (Investigating Torisel As Second-Line Therapy [INTORSECT]) compared the efficacy of temsirolimus (mammalian target of rapamycin inhibitor) and sorafenib (vascular endothelial growth factor receptor [VEGFR] tyrosine kinase inhibitor) as second-line therapy in patients with metastatic renal cell carcinoma (mRCC) after disease progression on sunitinib. Patients and Methods In total, 512 patients were randomly assigned 1:1 to receive intravenous temsirolimus 25 mg once weekly (n = 259) or oral sorafenib 400 mg twice per day (n = 253), with stratification according to duration of prior sunitinib therapy (≤ or > 180 days), prognostic risk, histology (clear cell or non–clear cell), and nephrectomy status. The primary end point was progression-free survival (PFS) by independent review committee assessment. Safety, objective response rate (ORR), and overall survival (OS) were secondary end points. Results Primary analysis revealed no significant difference between treatment arms for PFS (stratified hazard ratio [HR], 0.87; 95% CI, 0.71 to 1.07; two-sided P = .19) or ORR. Median PFS in the temsirolimus and sorafenib arms were 4.3 and 3.9 months, respectively. There was a significant OS difference in favor of sorafenib (stratified HR, 1.31; 95% CI, 1.05 to 1.63; two-sided P = .01). Median OS in the temsirolimus and sorafenib arms was 12.3 and 16.6 months, respectively. Safety profiles of both agents were consistent with previous studies. Conclusion In patients with mRCC and progression on sunitinib, second-line temsirolimus did not demonstrate a PFS advantage compared with sorafenib. The longer OS observed with sorafenib suggests sequenced VEGFR inhibition may benefit patients with mRCC.

Patient-reported outcomes in a randomized trial of everolimus with metastatic renal cell carcinoma patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17516-e17516
Author(s):  
J. Beaumont ◽  
D. Cella ◽  
T. Hutson ◽  
S. Bracarda ◽  
V. Grünwald ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Patient Reported Outcomes ◽  
Phase Iii ◽  
Patient Reported ◽  
Secondary Analyses

e17516 Background: Patient-reported outcomes (PRO), including health-related quality of life (HRQL), were assessed in a Phase III trial of everolimus in metastatic renal cell carcinoma (mRCC) patients. Methods: Patients with mRCC were randomized (n=416) to receive everolimus or placebo plus best supportive care. Patients completed the FACT-Kidney Symptom Index- Disease Related Symptoms (FKSI-DRS) and EORTC-QLQ C30 at baseline and monthly during treatment. Karnofsky Performance Status (KPS) was also assessed at baseline and monthly during treatment. Primary analyses included time to deterioration defined as a decrease from baseline of at least 3 points for FKSI-DRS, at least 10% for EORTC Physical Function (PF) and Global Quality of Life (QL) scales, and at least 10 points for KPS. Secondary analyses considered tumor progressions that occurred prior to deterioration or censoring date as FKSI deterioration events and compared time to PRO deterioration by tumor progression. Comparisons were made using stratified log-rank tests and Cox proportional hazard models. Results: Time to deterioration in KPS was longer in the everolimus arm, and time to deterioration in FKSI-DRS was slightly longer ( Table ). There was no difference in time to deterioration in PF or QL. Secondary analyses showed median time to deterioration in FKSI-DRS was approximately doubled for the everolimus arm compared to placebo, and patients who progressed experienced a more rapid deterioration in FKSI-DRS and QL scores. Conclusions: Compared to placebo everolimus delayed progression of disease-related symptoms and KPS. No effect on time to deterioration of PF or QL could be determined. Secondary analyses suggest a delay in deterioration in kidney cancer related symptoms via tumor control. [Table: see text] [Table: see text]

scholarly journals Patient-reported outcomes for axitinib vs sorafenib in metastatic renal cell carcinoma: phase III (AXIS) trial

2013 ◽  
Vol 108 (8) ◽  
pp. 1571-1578 ◽  
Author(s):  
D Cella ◽  
B Escudier ◽  
B Rini ◽  
C Chen ◽  
H Bhattacharyya ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Patient Reported Outcomes ◽  
Phase Iii ◽  
Patient Reported

Everolimus Versus Axitinib as Second-line Therapy in Metastatic Renal Cell Carcinoma: Experience From Institut Gustave Roussy

2017 ◽  
Vol 15 (6) ◽  
pp. e1081-e1088 ◽  
Author(s):  
Annalisa Guida ◽  
Laurence Albiges ◽  
Lisa Derosa ◽  
Yohann Loriot ◽  
Christophe Massard ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy

Clinical Benefit of Everolimus as Second-Line Therapy in Metastatic Renal Cell Carcinoma: The French Retrospective SECTOR Study

2016 ◽  
Vol 14 (6) ◽  
pp. e595-e607 ◽  
Author(s):  
Stéphane Oudard ◽  
Florence Joly ◽  
Lionnel Geoffrois ◽  
Brigitte Laguerre ◽  
Nadine Houede ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Clinical Benefit ◽  
Renal Cell ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy

scholarly journals A prospective, open-label, interventional study protocol to evaluate treatment efficacy of nivolumab based on serum-soluble PD-L1 concentration for patients with metastatic and unresectable renal cell carcinoma

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e030522
Author(s):  
Yukari Bando ◽  
Nobuyuki Hinata ◽  
Takashi Omori ◽  
Masato Fujisawa
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Objective Response ◽  
Phase Iii ◽  
Power Calculation ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy

IntroductionNivolumab has been proven to prolong overall survival as a second-line therapy for patients with advanced renal cell carcinoma (RCC) in a phase III clinical trial. However, versatile biomarkers have not been established to predict the efficacy of nivolumab against target disease.Methods and analysisAfter registration, screening test and serum-soluble programmed cell death 1-ligand 1 (sPD-L1) measurement will be performed by using the ELISA; patients will be grouped into high sPD-L1 or low sPD-L1 groups. Nivolumab (240 mg every 2 weeks by intravenous drip infusion) will be administered to each participant. For this prospective study, statistical power calculation indicated that 48 participants with metastatic or unresectable RCC are needed to assess the efficacy of this method. The participants must be at the age of at least 20 years at the time of informed consent and require second-line therapy after failure of first-line therapy or discontinuation due to adverse effects. All data will be collected in our institution. The primary endpoint is progression-free survival, and secondary endpoints are overall survival and objective response rate. In this protocol, we will examine sPD-L1 as a promising predictive marker.Ethics and disseminationThis protocol was approved by the Kobe University Clinical Research Ethical Committee (C180067). Findings of this study will be widely disseminated through conference presentations, reports, factsheets and academic publications; further generalisation will also be discussed.Trial registration numberUMIN000027873.

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