Overall survival for sorafenib plus interleukin-2 compared with sorafenib alone in metastatic renal cell carcinoma (mRCC): final results of the ROSORC trial
G Procopio, E Verzoni, S Bracarda, S Ricci, C Sacco, L Ridolfi, C Porta, R Miceli, N Zilembo, E Bajetta, Italian Trials in Medical Oncology (ITMO) group, S Cascinu, R Berardi, R Labianca, C Messina, V Amoroso, V Ferrari, M Aglietta, C Ortega, G Conti, R Nespoli, L Isa, M Bregni, G Vitali, A Ardizzoia, U Basso, C Paglino, C Caserta, A Mecozzi, M Guidoboni, A Bertolini, G Procopio, E Verzoni, S Bracarda, S Ricci, C Sacco, L Ridolfi, C Porta, R Miceli, N Zilembo, E Bajetta, Italian Trials in Medical Oncology (ITMO) group, S Cascinu, R Berardi, R Labianca, C Messina, V Amoroso, V Ferrari, M Aglietta, C Ortega, G Conti, R Nespoli, L Isa, M Bregni, G Vitali, A Ardizzoia, U Basso, C Paglino, C Caserta, A Mecozzi, M Guidoboni, A Bertolini
Abstract
Background: 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.
Patients and methods: 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.
Results: 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.
Conclusions: This outcome suggests a synergistic effect of the subsequent therapies following sorafenib failure.
Clinicaltrialsgov identifier: NCT00609401.
Keywords: first-line treatment; interleukin-2; renal cell carcinoma; sorafenib; targeted therapies.
Source: PubMed