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


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.


BACKGROUND
NCT00609401.
Department of Medical Oncology, Unit 1, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.
G
G
Procopio
E
E
Verzoni
S
S
Bracarda
S
S
Ricci
C
C
Sacco
L
L
Ridolfi
C
C
Porta
R
R
Miceli
N
N
Zilembo
E
E
Bajetta
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007376:Interleukin-2 / Q000008:administration & dosage; D053208:Kaplan-Meier Estimate; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000008:administration & dosage / Q000031:analogs & derivatives; D010671:Phenylurea Compounds / Q000008:administration & dosage; D016016:Proportional Hazards Models; D000077157:Sorafenib; D016896:Treatment Outcome
D007376:Interleukin-2; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib
first-line treatment; interleukin-2; renal cell carcinoma; sorafenib; targeted therapies