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Buti S.,Azienda Istituti Ospitaleri di Cremona | Lazzarelli S.,Azienda Istituti Ospitaleri di Cremona | Chiesa M.D.,Azienda Istituti Ospitaleri di Cremona | Simonelli C.,Centro Of Riferimento Oncologico | And 8 more authors.
Journal of Immunotherapy | Year: 2010

The aim of this study was to look for the maximum tolerated dose (MTD) of gemcitabine and 5-fluorouracil in a new regimen also containing the antiangiogenic bevacizumab and immunotherapy (IT) for the treatment of metastatic renal cell cancer. The primary objective of this multicenter dose-finding study was to establish the MTD of chemotherapy (CT) in combination with fixed doses of IT and bevacizumab. The secondary objective was to assess the combination,s activity. Five escalated dose levels of CT with intravenous gemcitabine and 5-fluorouracil (days 1 and 8 every 28d), were associated together with intravenous bevacizumab (10mg/kg on days 1 and 15 every 28d), subcutaneous interleukin-2 (1MIU/m bid on days 8, 9, 15, 16, and 1MIU/m/d on days 10-12 and 17-19), and interferon-α-2a (3MIU on days 10, 12, 17, 19). Of the 27 enrolled patients, 59% had been pretreated. The MTD was not reached. The highest CT dose studied was gemcitabine 1000mg/m and 5-fluorouracil 600mg/m. More frequent grade 3 to 4 toxicities included neutropenia (63%), thrombocytopenia (33%), and fever (26%). The response rate was 33% according to the Response Evaluation Criteria in Solid Tumors. This is the first study that explored the feasibility and safety of combined bevacizumab, IT, and CT in metastatic renal cell cancer. The activity of this regimen is interesting and its efficacy warrants further trials. Copyright © 2010 by Lippincott Williams & Wilkins.

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