Low dose interferon-α2b (IFN) + thalidomide (T) in patients (pts) with previously untreated renal cell cancer (RCC). Improvement in progression-free survival (PFS) but not quality of life (QoL) or overall survival (OS). A phase III study of the Eastern Cooperative Oncology Group (E2898)

Abstract

4516 Background: Both low dose IFN and T have anti-angiogenic properties (PNAS U S A. 1995 92:4562 & PNAS U S A. 1994 91:4082). We performed a randomized trial to assess the value of combining these two agents compared to low-dose IFN alone in RCC. Methods: Eligibility included no prior therapy, ECOG PS 0–2 and normal organ function. Treatment consisted of IFN 1 MIU SC BID alone or in combination with T (intra-pt dose escalation from 200 mg/day to 1,000 mg/day maximum). Patients were stratified according to prior nephrectomy, disease-free interval and ECOG performance status (PS). The study was designed to detect an improvement in PFS at 6 months of 35% compared to 20% in the std arm and was re-sized to detect a 50% improvement in median OS from 12 to 18 mos. Results: We enrolled 353 pts of whom 342 were eligible with a median age of 59 years (range 24–84) including 227M:115F with a median ECOG PS 1. 254 pts had undergone a prior nephrectomy and 236 had a disease-free interval of ≤1yr. Fatigue, myelosuppression and thrombotic events (12 vs 4) were greater in I+T arm. There was no difference in response rates or overall survival though progression-free survival was statistically significantly longer in the IFN+T arm (see table). QoL and fatigue scores were worse on the IFN+T arm. Conclusions: The addition of T to this IFN regimen modestly improves PFS but not OS and worsens QoL in RCC patients. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Celgene Celgene Schering