Neutrophil Number After Interferon-Alfa Treatment is an Independent Predictive Marker of Overall Survival in Metastatic Renal Cell Carcinoma

2012 ◽  
Vol 10 (3) ◽  
pp. 180-184 ◽  
Author(s):  
Takeshi Azuma ◽  
Yukihide Matayoshi ◽  
Yasushi Nagase ◽  
Masaya Oshi
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Predictive Marker ◽  
Interferon Alfa ◽  
Neutrophil Number

Nephrectomy Followed by Interferon Alfa-2b Compared With Interferon Alfa-2b Alone for Metastatic Renal Cell Cancer

2021 ◽  
pp. 113-118
Author(s):  
Christopher Weight
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell Cancer ◽  
Renal Cell ◽  
Performance Status ◽  
Cell Cancer ◽  
Interferon Alfa ◽  
Cytoreductive Nephrectomy

This chapter summarizes the findings of a landmark trial of cytoreductive nephrectomy in patients with metastatic renal cell carcinoma performed in the interferon era. All enrolled patients had a good performance status. It found overall survival extended by about 3 months in the cytoreductive-nephrectomy-plus-interferon arm versus the interferon-only arm.

Phase III Trial of Bevacizumab Plus Interferon Alfa-2a in Patients With Metastatic Renal Cell Carcinoma (AVOREN): Final Analysis of Overall Survival

2010 ◽  
Vol 28 (13) ◽  
pp. 2144-2150 ◽  
Author(s):  
Bernard Escudier ◽  
Joaquim Bellmunt ◽  
Sylvie Négrier ◽  
Emilio Bajetta ◽  
Bohuslav Melichar ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Final Analysis ◽  
Interferon Alfa ◽  
Phase Iii ◽  
First Line ◽  
Phase Iii Trial

PurposeA phase III trial of bevacizumab combined with interferon alfa-2a (IFN) showed significant improvements in progression-free survival (PFS) in metastatic renal cell carcinoma (mRCC). Here, we report overall survival (OS) data.Patients and MethodsSix hundred forty-nine patients with previously untreated mRCC were randomly assigned to receive bevacizumab (10 mg/kg every 2 weeks) plus IFN (9 MIU subcutaneously three times a week; n = 327) or IFN plus placebo (n = 322) in a multicenter, randomized, double-blind, phase III trial. The primary end point was OS. Final analysis of the secondary end point (PFS) was reported earlier.ResultsMedian OS was 23.3 months with bevacizumab plus IFN and 21.3 months with IFN plus placebo (unstratified hazard ratio [HR] = 0.91; 95% CI, 0.76 to 1.10; P = .3360; stratified HR = 0.86; 95% CI, 0.72 to 1.04; P = .1291). Patients (> 55%) in both arms received at least one postprotocol antineoplastic therapy, possibly confounding the OS analysis. Patients receiving postprotocol therapy including a tyrosine kinase inhibitor had longer median OS (bevacizumab plus IFN arm: 38.6 months; IFN plus placebo arm: 33.6 months; HR = 0.80; 95% CI, 0.56 to 1.13). Tolerability was similar to that reported previously.ConclusionBevacizumab plus IFN is active as first-line treatment in patients with mRCC. Most patients with mRCC receive multiple lines of therapy, so considering the overall sequence of therapy when selecting first-line therapy may optimize patient benefit.

Sunitinib Versus Interferon Alfa in Metastatic Renal Cell Carcinoma

2021 ◽  
pp. 119-122
Author(s):  
Christopher Weight
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Kinase Inhibitor ◽  
Progression Free Survival ◽  
Common Adverse Event ◽  
Interferon Alfa ◽  
Free Survival

This chapter summarizes the findings of one of the earliest trials of targeted therapy with a protein kinase inhibitor in patients with previously untreated, metastatic renal cell carcinoma who received either systemic sunitinib or interferon alfa. The study found better progression-free survival and overall survival in patients who received sunitinib. Diarrhea was the most common adverse event in the sunitinib group and was much more frequent compared to the interferon alfa group

Economic evaluation of temsirolimus on the basis of the results of the ARCC (Advanced Renal-Cell Carcinoma) study

2009 ◽  
Vol 10 (2) ◽  
pp. 93-97
Author(s):  
Simona De Portu ◽  
Giacomo Carteni ◽  
Andrea Belisari
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Economic Evaluation ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Poor Prognosis ◽  
Interferon Alfa ◽  
Italian Context ◽  
The Cost

Introduction: metastatic renal cell carcinoma (mRCC) is highly resistant to chemotherapeutics, rendering limited antitumor effect. Temsirolimus, a specific inhibitor of the mammalian target of rapamycin kinase, may benefit patients with this disease. The Global ARCC Trial (Temsirolimus, Interferon Alfa, or Both for Advanced Renal-Cell Carcinoma) compared temsirolimus alone or temsirolimus plus interferon alfa with interferon alfa alone in mRCC. It has demonstrated that, as compared with interferon alfa, temsirolimus improved overall survival among patients with metastatic renal-cell carcinoma and a poor prognosis while the addition of temsirolimus to interferon did not improve survival. Aim: the objective of our study was to investigate the pharmacoeconomic impact in the Italian context of temsirolimus vs interferon alfa in patients with metastatic renal-cell carcinoma and a poor prognosis. Methods: economic evaluation is based on clinical outcome data from the ARCC trial and was carried out conducting a cost/effectiveness analysis, comparing economic and clinical consequences of temsirolimus (25 mg weekly) vs interferon alfa (18 MU 3 times weekly) in the perspective of the Italian National Health Service. Direct medical costs included in the analysis were drug costs, costs associated with the management of treatment-related serious adverse events (grade 3 and 4), cost related to progression and best supportive care. Effects were measured in terms of overall survival. A sensitivity analysis was performed. Results: the cost of temsirolimus or interferon alfa therapy amounted to approximately € 14,000 and € 2,000 patient respectively. The cost of hospitalization related to drug toxicity was about € 1,500 for temsirolimus and € 2,100 for interferon alfa. Temsirolimus shows an incremental cost per patient per month saved of € 3,767. Sensitivity analysis demonstrates that cost consequences parameters are sensitive to fluctuation. Discussion: this study is the first economic evaluation of ARCC trial based on the Italian context. This evaluation found that temsirolimus therapy in patients with metastatic renal-cell carcinoma and a poor prognosis is cost-effective.

Randomized Phase II/III Trial of Interferon Alfa-2a With and Without 13-cis-Retinoic Acid in Patients With Progressive Metastatic Renal Cell Carcinoma: The European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Group (EORTC 30951)

2005 ◽  
Vol 23 (18) ◽  
pp. 4172-4178 ◽  
Author(s):  
Nina Aass ◽  
Pieter H.M. De Mulder ◽  
Gerald H.J. Mickisch ◽  
Peter Mulders ◽  
Allan T. van Oosterom ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Retinoic Acid ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Combined Therapy ◽  
Interferon Alfa ◽  
Randomized Phase Ii

Purpose A randomized phase II/III trial was conducted to determine whether combination treatment with 13-cis-retinoic acid (13-CRA) plus interferon alfa-2a (IFN-α-2a) was superior to IFN-α-2a alone in patients with progressive metastatic renal cell carcinoma. Patients and Methods Three hundred twenty patients were randomly assigned to treatment with IFN-α-2a plus 13-CRA or to IFN-α-2a alone. IFN-α-2a was given daily subcutaneously, starting at a dose of 3 million units (MU). The dose was escalated every 7 days from 3 to 9 MU by increments of 3 MU. Patients randomly assigned to combination therapy received oral 13-CRA 1 mg/kg/d plus IFN-α-2a. Results Median time to progression was 5.1 months for patients treated with the combination and 3.4 months for patients on IFN-α-2a alone (P = .008). Progression-free survival rates at 6 months were 43% for patients receiving combined therapy and 30% for patients on IFN-α-2a, and at 12 months, 27% and 17%, respectively. Median overall survival was 17.3 months for patients on IFN-α-2a and 13-CRA, and 13.2 months for patients treated with IFN-α-2a (P = .048). Twenty-two percent of the patients receiving the combination stopped treatment due to toxicity, as compared with 16% on IFN-α-2a. Conclusion Progression-free and overall survival for patients with progressive metastatic renal cell carcinoma treated with IFN-α-2a plus 13-CRA were significantly longer compared with patients on IFN-α-2a alone (P = .007 and P = .048, respectively). Improvement in efficacy in the combination arm was accompanied by increased, though not serious, toxicity.

scholarly journals Efficacy and Safety of Nivolumab and Ipilimumab for Advanced or Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Cohort Study

2021 ◽  
Vol 28 (2) ◽  
pp. 1402-1411
Author(s):  
Koji Iinuma ◽  
Koji Kameyama ◽  
Kei Kawada ◽  
Shota Fujimoto ◽  
Kimiaki Takagi ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Objective Response ◽  
Predictive Biomarkers ◽  
Progression Free Survival ◽  
Predictive Marker ◽  
Efficacy And Safety ◽  
Lymphocyte Ratio

We conducted a multicenter, retrospective study to evaluate the efficacy and safety of combination nivolumab plus ipilimumab (NIVO+IPI) in 35 patients with advanced or metastatic renal cell carcinoma (mRCC). In this study, we focused on patients who received NIVO+IPI and were stratified into intermediate- or poor-risk disease according to the International Metastatic Renal Cell Carcinoma Database Consortium model at five institutions in Japan. The primary endpoint was overall survival (OS). Secondary endpoints were disease control rate (DCR), best overall response (BOR), objective response rate (ORR), and progression-free survival (PFS). In addition, we evaluated the role of inflammatory cell ratios, namely neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), as predictive biomarkers in patients with mRCC. The median follow-up period was 1 year, and the 1-year OS rate was 95.8%. The ORR and DCR were 34.3% and 80.0%, respectively. According to BOR, four patients (11.4%) achieved complete response. According to NLR stratification, the 1-year PFS rates were 82.6% and 23.7% when the NLR was ≤4.6 and >4.6, respectively (p = 0.04). Based on PLR stratification, the 1-year PFS rates were 81.7% and 34.3% when the PLR was ≤188.1 and >188.1, respectively (p = 0.033). Although 71.4% of the patients experienced treatment-related adverse events (TRAEs) with NIVO+IPI, only four patients discontinued NIVO+IPI due to grade 3/4 TRAEs. Patients treated with NIVO+IPI as a first-line therapy for advanced or mRCC achieved relatively better oncological outcomes. Therefore, NIVO+IPI may have potential advantages and may lead to a treatment effect compared to those receiving targeted therapies. In addition, PLR >188.1 may be a useful predictive marker for mRCC patients who received NIVO+IPI.

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