Randomized Phase II Trial of First-Line Treatment With Sorafenib Versus Interferon Alfa-2a in Patients With Metastatic Renal Cell Carcinoma Export

@article{citeulike:5206111, abstract = {PurposeAn open-label, phase II study to evaluate progression-free survival (PFS), overall best response, adverse events (AEs), and patient-reported outcomes with sorafenib versus interferon alfa-2a (IFN-{alpha}-2a) in patients with untreated, advanced renal cancer. Patients and MethodsA total of 189 patients were randomly assigned to oral sorafenib 400 mg twice daily or to subcutaneous IFN-{alpha}-2a 9 million U three times weekly (period 1). Sorafenib patients who progressed were dose-escalated to 600 mg twice daily; IFN-{alpha}-2a patients who progressed were switched to sorafenib 400 mg twice daily (period 2). ResultsIn period 1 PFS was similar for sorafenib-treated (n = 97; 5.7 months) and IFN-{alpha}-2a-treated patients (n = 92; 5.6 months); more sorafenib-treated patients had tumor shrinkage (68.2\% v 39.0\%). Common drug-related AEs (Grades [\≥] 3) for sorafenib were hand-foot skin reaction (11.3\%), diarrhea (6.2\%), and rash/desquamation (6.2\%); for IFN-{alpha}-2a, these were fatigue (10.0\%), nausea (3.3\%), flu-like syndrome (2.2\%), and anorexia (2.2\%). Sorafenib-treated patients reported fewer symptoms, better quality of life (QOL), and greater treatment satisfaction. In period 2, 41.9\% of patients who received sorafenib 600 mg twice daily (n = 43) experienced tumor reduction (median PFS, 3.6 months). After the switch to sorafenib 400 mg twice daily, tumors were reduced in 76.2\% of 50 patients (median PFS, 5.3 months). AEs were mostly grade 1 to 2; no increase in AEs of grades [\≥] 3 occurred after sorafenib dose escalation. ConclusionIn this study, sorafenib resulted in similar PFS as IFN-{alpha}-2a in patients with untreated RCC. However, sorafenib-treated patients experienced greater rates of tumor size reduction, better QOL, and improved tolerability. Both dose escalation of sorafenib after progression and a switch to sorafenib after progression on IFN-{alpha}-2a resulted in clinical benefit. 10.1200/JCO.2008.19.3342}, author = {Escudier, Bernard and Szczylik, Cezary and Hutson, Thomas E. and Demkow, Tomasz and Staehler, Michael and Rolland, Frederic and Negrier, Sylvie and Laferriere, Nicole and Scheuring, Urban J. and Cella, David and Shah, Sonalee and Bukowski, Ronald M.}, citeulike-article-id = {5206111}, citeulike-linkout-0 = {http://dx.doi.org/10.1200/JCO.2008.19.3342}, citeulike-linkout-1 = {http://jco.ascopubs.org/cgi/content/abstract/27/8/1280}, citeulike-linkout-2 = {http://view.ncbi.nlm.nih.gov/pubmed/19171708}, citeulike-linkout-3 = {http://www.hubmed.org/display.cgi?uids=19171708}, day = {10}, doi = {10.1200/JCO.2008.19.3342}, journal = {J Clin Oncol}, keywords = {rcc}, month = {March}, number = {8}, pages = {1280--1289}, posted-at = {2009-07-20 04:00:39}, priority = {2}, title = {Randomized Phase II Trial of First-Line Treatment With Sorafenib Versus Interferon Alfa-2a in Patients With Metastatic Renal Cell Carcinoma}, url = {http://dx.doi.org/10.1200/JCO.2008.19.3342}, volume = {27}, year = {2009} }

TY - JOUR ID - citeulike:5206111 L3 - citeulike-article-id:5206111 N2 - PurposeAn open-label, phase II study to evaluate progression-free survival (PFS), overall best response, adverse events (AEs), and patient-reported outcomes with sorafenib versus interferon alfa-2a (IFN-{alpha}-2a) in patients with untreated, advanced renal cancer. Patients and MethodsA total of 189 patients were randomly assigned to oral sorafenib 400 mg twice daily or to subcutaneous IFN-{alpha}-2a 9 million U three times weekly (period 1). Sorafenib patients who progressed were dose-escalated to 600 mg twice daily; IFN-{alpha}-2a patients who progressed were switched to sorafenib 400 mg twice daily (period 2). ResultsIn period 1 PFS was similar for sorafenib-treated (n = 97; 5.7 months) and IFN-{alpha}-2a-treated patients (n = 92; 5.6 months); more sorafenib-treated patients had tumor shrinkage (68.2% v 39.0%). Common drug-related AEs (Grades [≥] 3) for sorafenib were hand-foot skin reaction (11.3%), diarrhea (6.2%), and rash/desquamation (6.2%); for IFN-{alpha}-2a, these were fatigue (10.0%), nausea (3.3%), flu-like syndrome (2.2%), and anorexia (2.2%). Sorafenib-treated patients reported fewer symptoms, better quality of life (QOL), and greater treatment satisfaction. In period 2, 41.9% of patients who received sorafenib 600 mg twice daily (n = 43) experienced tumor reduction (median PFS, 3.6 months). After the switch to sorafenib 400 mg twice daily, tumors were reduced in 76.2% of 50 patients (median PFS, 5.3 months). AEs were mostly grade 1 to 2; no increase in AEs of grades [≥] 3 occurred after sorafenib dose escalation. ConclusionIn this study, sorafenib resulted in similar PFS as IFN-{alpha}-2a in patients with untreated RCC. However, sorafenib-treated patients experienced greater rates of tumor size reduction, better QOL, and improved tolerability. Both dose escalation of sorafenib after progression and a switch to sorafenib after progression on IFN-{alpha}-2a resulted in clinical benefit. 10.1200/JCO.2008.19.3342 IS - 8 JF - J Clin Oncol EP - 1289 TI - Randomized Phase II Trial of First-Line Treatment With Sorafenib Versus Interferon Alfa-2a in Patients With Metastatic Renal Cell Carcinoma VL - 27 SP - 1280 KW - rcc AU - Escudier, Bernard AU - Szczylik, Cezary AU - Hutson, Thomas AU - Demkow, Tomasz AU - Staehler, Michael AU - Rolland, Frederic AU - Negrier, Sylvie AU - Laferriere, Nicole AU - Scheuring, Urban AU - Cella, David AU - Shah, Sonalee AU - Bukowski, Ronald PY - 2009/03/10/ UR - http://dx.doi.org/10.1200/JCO.2008.19.3342 ER -