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.
Written by:
Bracarda S, Porta C, Boni C, Santoro A, Mucciarini C, Pazzola A, Cortesi E, Gasparro D, Labianca R, Di Costanzo F, Falcone A, Cinquini M, Caserta C, Paglino C, De Angelis V. Are you the author?
Azienda USL8, Arezzo, Italy; Azienda Ospedaliero-Universitaria di Perugia, Perugia, Italy.
Reference: Eur Urol. 2013 Feb;63(2):254-61.
doi: 10.1016/j.eururo.2012.08.027
PubMed Abstract
PMID: 22964169
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