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Eur Urol. 2013 Feb;63(2):254-61. doi: 10.1016/j.eururo.2012.08.027. Epub 2012 Aug 23.

Could interferon still play a role in metastatic renal cell carcinoma? A randomized study of two schedules of sorafenib plus interferon-alpha 2a (RAPSODY).

Author information

1
Azienda USL8, Arezzo, Italy. sergio.bracarda@usl8.toscana.it

Abstract

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.

PMID:
22964169
DOI:
10.1016/j.eururo.2012.08.027
[Indexed for MEDLINE]

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