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A multinational phase II trial of bevacizumab with low-dose interferon-α2a as first-line treatment of metastatic renal cell carcinoma: BEVLiN.

AbstractBACKGROUND:
Avastin and Roferon in Renal Cell Carcinoma (AVOREN) demonstrated efficacy for bevacizumab plus interferon-α2a (IFN; 9 MIU tiw) in first-line metastatic renal cell carcinoma (mRCC). We evaluated bevacizumab with low-dose IFN in mRCC to determine whether clinical benefit could be maintained with reduced toxicity.
METHODS:
BEVLiN was an open-label, single-arm, multinational, phase II trial. Nephrectomized patients with treatment-naive, clear cell mRCC and favourable/intermediate Memorial Sloan-Kettering Cancer Center scores received bevacizumab (10 mg/kg every 2 weeks) and IFN (3 MIU thrice weekly) until disease progression. Descriptive comparisons with AVOREN patients having favourable/intermediate MSKCC scores treated with bevacizumab plus IFN (9 MIU) were made. Primary end points were grade ≥3 IFN-associated adverse events (AEs) and progression-free survival (PFS). All grade ≥3 AEs and bevacizumab/IFN-related grade 1-2 AEs occurring from first administration until 28 days after last treatment were reported.
RESULTS:
A total of 146 patients were treated; the median follow-up was 29.4 months. Any-grade and grade ≥3 IFN-associated AEs occurred in 53.4% and 10.3% of patients, respectively. The median PFS and overall survival were 15.3 [95% confidence interval (CI): 11.7-18.0] and 30.7 months (95% CI: 25.7-not reached), respectively. The ORR was 28.8%.
CONCLUSIONS:
Compared with a historical control AVOREN subgroup, low-dose IFN with bevacizumab resulted in a reduction in incidence rates of IFN-related AEs, without compromising efficacy [NCT00796757].
AuthorsB Melichar, S Bracarda, V Matveev, B Alekseev, S Ivanov, A Zyryanov, R Janciauskiene, E Fernebro, P Mulders, S Osborne, S Jethwa, G Mickisch, M Gore, R J A van Moorselaar, M Staehler, N Magne, J Bellmunt,
JournalAnnals of oncology : official journal of the European Society for Medical Oncology / ESMO (Ann Oncol) Vol. 24 Issue 9 Pg. 2396-402 (Sep 2013) ISSN: 1569-8041 [Electronic] England
PMID23803225 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal, Humanized
  • Interferon-alpha
  • Recombinant Proteins
  • VEGFA protein, human
  • Vascular Endothelial Growth Factor A
  • Bevacizumab
  • interferon alfa-2a
Topics
  • Adult
  • Angiogenesis Inhibitors (adverse effects, therapeutic use)
  • Antibodies, Monoclonal, Humanized (administration & dosage, therapeutic use)
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
  • Bevacizumab
  • Carcinoma, Renal Cell (drug therapy, mortality)
  • Disease-Free Survival
  • Female
  • Humans
  • Immunotherapy
  • Interferon-alpha (administration & dosage, therapeutic use)
  • Kidney Neoplasms (drug therapy, mortality)
  • Male
  • Middle Aged
  • Neovascularization, Pathologic (drug therapy)
  • Recombinant Proteins (administration & dosage, therapeutic use)
  • Treatment Outcome
  • Vascular Endothelial Growth Factor A (antagonists & inhibitors)
  • Young Adult

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