OBJECTIVE: • To retrospectively evaluate the effect of subsequent tyrosine kinase inhibitors (TKIs) after first-line bevacizumab + interferon-α2a (IFN) or IFN + placebo in the phase III AVOREN (Avastin and Roferon in Renal Cell Carcinoma) trial. PATIENTS AND METHODS: • A total of 649 patients with untreated metastatic renal cell carcinoma (mRCC) were randomized to receive IFN (9 MIU three times a week for up to 1 year) in combination with bevacizumab (10 mg/kg every 2 weeks) or placebo until disease progression. • The protocol allowed the use of any post-protocol anti-cancer therapy for patients with progressive disease or those in whom the trial therapy was discontinued. Data regarding the timing and type of subsequent therapy were recorded and overall survival (OS) analysed. RESULTS: • Patients were randomized to bevacizumab + IFN (n= 327) or IFN + placebo (n= 322); 180 (55%) patients in thebevacizumab + IFN, and 202 (63%) in the IFN + placebo arm, received post-protocol anti-cancer therapy. • TKIs were the most common post-protocol therapy, received by 113 (35%) and 120 (37%) patients in the bevacizumab + IFN and IFN + placebo arms, respectively. • The median OS in patients who received any subsequent TKI was 38.6 months in the bevacizumab + IFN arm and 33.6 months in IFN + placebo arm [hazard ratio (HR), 0.80; 95% confidence interval (CI), 0.56-1.13; P= 0.203]. In an additional retrospective analysis that censored patients who received subsequent TKIs, median OS was 25.0 and 20.7 months, respectively, in the bevacizumab + IFN and IFN + placebo arms (HR, 0.84; 95% CI, 0.67-1.05; P= 0.123). CONCLUSIONS: • These retrospective exploratory data of sequential bevacizumab + IFN followed by TKIs in patients able to receive multiple lines of therapy suggest that sequential therapy could be a promising approach to improve patient outcomes in mRCC.
RCT Entities:
OBJECTIVE: • To retrospectively evaluate the effect of subsequent tyrosine kinase inhibitors (TKIs) after first-line bevacizumab + interferon-α2a (IFN) or IFN + placebo in the phase III AVOREN (Avastin and Roferon in Renal Cell Carcinoma) trial. PATIENTS AND METHODS: • A total of 649 patients with untreated metastatic renal cell carcinoma (mRCC) were randomized to receive IFN (9 MIU three times a week for up to 1 year) in combination with bevacizumab (10 mg/kg every 2 weeks) or placebo until disease progression. • The protocol allowed the use of any post-protocol anti-cancer therapy for patients with progressive disease or those in whom the trial therapy was discontinued. Data regarding the timing and type of subsequent therapy were recorded and overall survival (OS) analysed. RESULTS: • Patients were randomized to bevacizumab + IFN (n= 327) or IFN + placebo (n= 322); 180 (55%) patients in the bevacizumab + IFN, and 202 (63%) in the IFN + placebo arm, received post-protocol anti-cancer therapy. • TKIs were the most common post-protocol therapy, received by 113 (35%) and 120 (37%) patients in the bevacizumab + IFN and IFN + placebo arms, respectively. • The median OS in patients who received any subsequent TKI was 38.6 months in the bevacizumab + IFN arm and 33.6 months in IFN + placebo arm [hazard ratio (HR), 0.80; 95% confidence interval (CI), 0.56-1.13; P= 0.203]. In an additional retrospective analysis that censored patients who received subsequent TKIs, median OS was 25.0 and 20.7 months, respectively, in the bevacizumab + IFN and IFN + placebo arms (HR, 0.84; 95% CI, 0.67-1.05; P= 0.123). CONCLUSIONS: • These retrospective exploratory data of sequential bevacizumab + IFN followed by TKIs in patients able to receive multiple lines of therapy suggest that sequential therapy could be a promising approach to improve patient outcomes in mRCC.
Authors: Elena García-Martínez; Melody Smith; Aitziber Buqué; Fernando Aranda; Francisco Ayala de la Peña; Alejandra Ivars; Manuel Sanchez Cánovas; Ma Angeles Vicente Conesa; Jitka Fucikova; Radek Spisek; Laurence Zitvogel; Guido Kroemer; Lorenzo Galluzzi Journal: Oncoimmunology Date: 2018-02-15 Impact factor: 8.110
Authors: Susanne Unverzagt; Ines Moldenhauer; Monika Nothacker; Dorothea Roßmeißl; Andreas V Hadjinicolaou; Frank Peinemann; Francesco Greco; Barbara Seliger Journal: Cochrane Database Syst Rev Date: 2017-05-15