Sorafenib as first- or second-line therapy in patients with metastatic renal cell carcinoma in a community setting
Giuseppe ProcopioLisa DerosaAngela GernoneFranco MorelliTeodoro SavaFable ZustovichUgo De GiorgiVittorio FerrariRoberto SabbatiniDonatello GasparroAlessandra FeliciLuciano BurattiniNicola CalvaniGiovanni Lo ReGiuseppe Luigi BannaMaria Pia BrizziMimma RizzoLibero CiuffredaRoberto IacovelliFrancesco FerraùEleonora TaibiSergio BracardaCamillo PortaEnzo GalligioniA. Contu
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Abstract:
The Italian Retrospective Analysis of Sorafenib as First or Second Target Therapy study assessed the efficacy and safety of sorafenib in metastatic renal cell carcinoma patients treated in the community.Patients receiving first- or second-line single-agent sorafenib between January 2008 and December 2010 were eligible. Retrospective data collection started in 2012 and covers at least 1-year follow-up. The primary end point was overall survival (OS).Median OS was 17.2 months (95% CI: 15.5-19.6): 19.9 months (95% CI: 15.9-25.3) in patients treated with first-line sorafenib and 16.3 months (95% CI: 13.1-18.2) with second-line sorafenib. Overall median (95% CI) progression-free survival was 5.9 months (95% CI: 4.9-6.7): 6.6 (95% CI: 4.9-9.3) and 5.3 months (95% CI: 4.3-6.0) in first- and second-line patients, respectively.The efficacy and safety of sorafenib in routine community practice was generally good, especially in relation to OS in patients treated in the second line, where results were similar to those seen in recent prospective clinical trials.Keywords:
Clinical endpoint
First line therapy
The approval of sorafenib (Nexavar®) launched a new era of targeted therapy for advanced renal cell carcinoma (RCC). Sorafenib was the first oral multikinase inhibitor available for use in RCC, demonstrating a significant clinical benefit for patients living with this disease in the Phase III Treatment Approaches in Renal Cancer Global Evaluation Trial (TARGET). As other targeted agents have emerged and expanded options for patients with RCC, understanding the optimal role of targeted therapies in different treatment settings has become more important. This article reviews the expansive clinical evidence supporting the use of sorafenib in RCC, including analyses across a variety of subpopulations, and examines the impact of sorafenib on clinical practice and its future role in RCC.
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The Italian Retrospective Analysis of Sorafenib as First or Second Target Therapy study assessed the efficacy and safety of sorafenib in metastatic renal cell carcinoma patients treated in the community.Patients receiving first- or second-line single-agent sorafenib between January 2008 and December 2010 were eligible. Retrospective data collection started in 2012 and covers at least 1-year follow-up. The primary end point was overall survival (OS).Median OS was 17.2 months (95% CI: 15.5-19.6): 19.9 months (95% CI: 15.9-25.3) in patients treated with first-line sorafenib and 16.3 months (95% CI: 13.1-18.2) with second-line sorafenib. Overall median (95% CI) progression-free survival was 5.9 months (95% CI: 4.9-6.7): 6.6 (95% CI: 4.9-9.3) and 5.3 months (95% CI: 4.3-6.0) in first- and second-line patients, respectively.The efficacy and safety of sorafenib in routine community practice was generally good, especially in relation to OS in patients treated in the second line, where results were similar to those seen in recent prospective clinical trials.
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Abjective To evaluate the initial therapeutic effect of sorafenib for metastatic renal cell carcinoma.Methods The patient with metastatic renal cell carcinoma was taken sorafenib,at the dosage of 400 mg,two times per day.Results The metastatic tumor volume of 4 cases with advanced renal cell carcinoma significantly decreased(PR),and 1 dispeared completely(CR),1 progressed moderately after 3 months(SD).Conclusion Sorafenib can suppress tumor growth efficiently in metastatic renal cell carcinoma,postpone its progression,and show the major benefit for these patient′s survival.
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Objective To explore the efficacies and adverse events of sorafenib in the treatment of advanced metastatic renal cell carcinoma.Methods A total of 57 patients with advanced kidney cancer were recruited from our hospital from April 2007 to October 2011.They were divided into sorafenib group (A,n=24) and sorafenib+
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Read the full review for this Faculty Opinions recommended article: Brivanib versus sorafenib as first-line therapy in patients with unresectable, advanced hepatocellular carcinoma: results from the randomized phase III BRISK-FL study.
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Primary hepatocarcinoma is one of the most common malignancies in clinic,of which the most common pathological type is hepatocellular carcinoma( HCC). Sorafenib is the first and also the only molecular targeted drug approved in many countries for the treatment of HCC,but its efficacy is limited. After taking the drug for a period,most patients emerge disease progression because of resistance to the drug. Currently,the standard second-line treatment isn't available for these patients. This article reviews the latest research progress of second-line therapy for the HCC patients resisting to sorafenib.
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What's known on the subject? and What does the study add? Targeted agents with a similar or different target molecule are often used sequentially in the treatment of metastatic RCC. Two tyrosine kinase inhibitors, sorafenib and sunitinib, have been reported to show little cross-resistance, when used sequentially. In addition, a recent report showed that sunitinib rechallenge could potentially benefit selected patients. This case series shows that patients once refractory to sorafenib could regain disease control on rechallenge with sorafenib during sequential treatment. Outcomes of the sorafenib rechallenge were not significantly affected by the response to the initial sorafenib treatment or by the duration of intervening treatments between first sorafenib and rechallenge.To investigate clinical outcomes of sorafenib rechallenge during sequential therapy for patients with metastatic renal cell carcinoma (RCC).Patients with metastatic RCC who received sorafenib rechallenge after failed treatment first with sorafenib and subsequently with other agents, were retrospectively reviewed for patient characteristics, best response, progression-free survival (PFS), and adverse events (AEs).Of the 14 patients who received sorafenib rechallenge, 12 were evaluable for response. Eleven patients had previously undergone nephrectomy, and 10 had previously received systemic therapy, mostly interferon-α (nine patients) and interleukin-2 (six patients), with a median duration of 9 months. The best responses after the first sorafenib therapy were partial response (PR) in two patients, stable disease (SD) in seven, and progressive disease (PD) in two. The median PFS was 5.7 months. Initial sorafenib therapy was discontinued because of PD in eight patients and AEs in four patients. Rechallenge with sorafenib was undertaken after a 7.6 month median interval from the initial sorafenib challenge. Eight patients achieved SD on sorafenib rechallenge and median PFS was 5.4 (95% confidence interval, 3.8-7.0) months. The outcome of the sorafenib rechallenge was not significantly affected by the response to the initial sorafenib treatment or by the duration of treatments received between first sorafenib and rechallenge. No severe AE was newly observed on the rechallenge.In the systemic treatment of advanced RCC, it was suggested that patients once refractory to sorafenib could regain disease control on rechallenge with sorafenib during sequential treatment.
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