Details

Autor(en) / Beteiligte

• PROCOPIO, G
• VERZONI, E
• BRACARDA, S
• RICCI, S
• SACCO, C
• RIDOLFI, L
• PORTA, C
• MICELI, R
• ZILEMBO, N
• BAJETTA, E

Titel

Overall survival for sorafenib plus interleukin-2 compared with sorafenib alone in metastatic renal cell carcinoma (mRCC): final results of the ROSORC trial

Ist Teil von

• Annals of oncology, 2013-12, Vol.24 (12), p.2967-2971

Ort / Verlag

Oxford: Oxford University Press

Erscheinungsjahr

2013

Quelle

MEDLINE

Beschreibungen/Notizen

• The ROSORC trial, a randomised, phase II trial comparing sorafenib plus interleukin (IL-2) versus sorafenib alone as first-line treatment of metastatic renal cell carcinoma (mRCC) failed to demonstrate differences in progression-free survival (PFS). Updated overall survival (OS) results are reported. In this study, 128 patients were randomised to receive sorafenib 400 mg twice daily plus subcutaneous IL-2 4.5 million international units (MIU) five times per week for 6 weeks every 8 weeks (arm A) or sorafenib alone (arm B). OS was estimated with the Kaplan-Meier method and compared with the two-sided log-rank test. After a median follow-up of 58 months (interquartile range: 28-63 months), the median OS was 38 and 33 months in arms A and B, respectively (P = 0.667). The 5-year OS was 26.3% [95% confidence interval (CI) 15.9-43.5) and 23.1% (95% CI 13.2-40.5) for the combination- and single-agent arm, respectively. Most of the patients who were refractory to first-line treatment were subsequently treated with different targeted agents; they had a median survival greater than expected. This outcome suggests a synergistic effect of the subsequent therapies following sorafenib failure. NCT00609401.