BACKGROUND:Sorafenib has proven efficacy in metastatic renal cell carcinoma (mRCC). Interferon (IFN) has antiangiogenic activity that is thought to be both dose- and administration-schedule dependent. OBJECTIVE: To compare two different schedules of IFN combined with sorafenib. DESIGN, SETTING, AND PARTICIPANTS: Single-stage, prospective, noncomparative, randomized, open-label, multicenter, phase 2 study on previously untreated patients with mRCC and Eastern Cooperative Oncology Group performance status 0-2. INTERVENTION: Sorafenib 400mg twice daily plus subcutaneous IFN, 9 million units (MU) three times a week (Arm A) or 3 MU five times a week (Arm B). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary end points were progression-free survival (PFS) for each arm and safety. Data were evaluated according to an intent-to-treat analysis. RESULTS AND LIMITATIONS: A total of 101 patients were evaluated. Median PFS was 7.9 mo in Arm A and 8.6 mo in Arm B (p=0.049) and the median duration of response was 8.5 and 19.2 mo, respectively (p=0.0013). Nine partial responses were observed in Arm A, and three complete and 14 partial responses were observed in Arm B (17.6% vs 34.0%; p=0.058); 24 and 21 patients (47% and 42%), respectively, achieved stable disease. The most common grade 3-4 toxicities were fatigue plus asthenia (28% vs 16%; p=0.32) and hand-foot skin reactions (20% vs 18%). CONCLUSIONS:Sorafenib plus frequent low-dose IFN showed good efficacy and tolerability. Further investigations should be warranted to identify a possible positioning of this intriguing regimen (6% complete response rate) in the treatment scenario of mRCC.
RCT Entities:
BACKGROUND:Sorafenib has proven efficacy in metastatic renal cell carcinoma (mRCC). Interferon (IFN) has antiangiogenic activity that is thought to be both dose- and administration-schedule dependent. OBJECTIVE: To compare two different schedules of IFN combined with sorafenib. DESIGN, SETTING, AND PARTICIPANTS: Single-stage, prospective, noncomparative, randomized, open-label, multicenter, phase 2 study on previously untreated patients with mRCC and Eastern Cooperative Oncology Group performance status 0-2. INTERVENTION: Sorafenib 400mg twice daily plus subcutaneous IFN, 9 million units (MU) three times a week (Arm A) or 3 MU five times a week (Arm B). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary end points were progression-free survival (PFS) for each arm and safety. Data were evaluated according to an intent-to-treat analysis. RESULTS AND LIMITATIONS: A total of 101 patients were evaluated. Median PFS was 7.9 mo in Arm A and 8.6 mo in Arm B (p=0.049) and the median duration of response was 8.5 and 19.2 mo, respectively (p=0.0013). Nine partial responses were observed in Arm A, and three complete and 14 partial responses were observed in Arm B (17.6% vs 34.0%; p=0.058); 24 and 21 patients (47% and 42%), respectively, achieved stable disease. The most common grade 3-4 toxicities were fatigue plus asthenia (28% vs 16%; p=0.32) and hand-foot skin reactions (20% vs 18%). CONCLUSIONS:Sorafenib plus frequent low-dose IFN showed good efficacy and tolerability. Further investigations should be warranted to identify a possible positioning of this intriguing regimen (6% complete response rate) in the treatment scenario of mRCC.
Authors: Katerina Kubackova; Z Bortlicek; T Pavlik; B Melichar; Z Linke; P Pokorna; R Vyzula; J Prausova; T Buchler Journal: Target Oncol Date: 2014-10-12 Impact factor: 4.493
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
Authors: Fabian Hofmann; Eu Chang Hwang; Thomas Bl Lam; Axel Bex; Yuhong Yuan; Lorenzo So Marconi; Börje Ljungberg Journal: Cochrane Database Syst Rev Date: 2020-10-14