A phase II study of bevacizumab and high-dose interleukin-2 in patients with metastatic renal cell carcinoma: a Cytokine Working Group (CWG) study.

Dandamudi UB, Ghebremichael M, Sosman JA, Clark JI, McDermott DF, Atkins MB, Dutcher JP, Urba WJ, Regan MM, Puzanov I, Crocenzi TS, Curti BD, Vaishampayan UN, Crosby NA, Margolin KA, Ernstoff MS
J Immunother. 2013 36 (9): 490-5

PMID: 24145360 · DOI:10.1097/CJI.0000000000000003

Overexpression of vascular endothelial growth factor in renal cell carcinoma (RCC) leads to angiogenesis, tumor progression, and inhibition of immune function. We conducted the first phase II study to estimate the efficacy and safety of bevacizumab with high-dose interleukin-2 (IL-2) therapy in patients with metastatic RCC. Eligible patients had predominantly clear cell metastatic RCC, measurable disease, a Karnofsky Performance Status of ≥80%, and adequate end-organ function. IL-2 (600,000 IU/kg) was infused intravenously every 8 hours (maximum 28 doses) during two 5-day cycles on days 1 and 15 of each 84-day course. Bevacizumab (10 mg/kg) was infused intravenously every 2 weeks beginning 2 weeks before initiating IL-2. Fifty of 51 eligible patients from 8 centers were enrolled. Median progression-free survival (PFS) was 11.2 months (90% confidence interval, 5.7-17.7), and 2-year PFS was 18% (90% confidence interval, 8%-27%). Responses included 4 complete (8%) and 11 partial (22%) responses. Toxicities did not exceed those expected from each agent alone. Combining IL-2 plus bevacizumab is feasible, with a response rate and PFS at least as high as reported previously for the single agents. The regimen did not appear to enhance the rate of durable major responses over that of IL-2 alone.

MeSH Terms (23)

Adult Aged Antibodies, Monoclonal, Humanized Antineoplastic Combined Chemotherapy Protocols Bevacizumab Carcinoma, Renal Cell Dose-Response Relationship, Drug Drug Administration Schedule Fatigue Female Follow-Up Studies Humans Hypotension Infusions, Intravenous Interleukin-2 Kaplan-Meier Estimate Karnofsky Performance Status Kidney Neoplasms Lymphopenia Male Middle Aged Neoplasm Metastasis Treatment Outcome

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