Dose-finding trial of a combined regsimen with bevacizumab, immunotherapy, and chemotherapy in patients with metastatic renal cell cancer: An italian oncology group for clinical research (GOIRC) study

Sebastiano Buti, Silvia Lazzarelli, Matteo Dalla Chiesa, Cecilia Simonelli, Giovanni Lo Re, Arvin Lheshi, Spazzapan Simon, Rodolfo Mattioli, Caterina Caminiti, Giancarlo Mazza, Maddalena Donini, Rodolfo Passalacqua

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)735-741
Number of pages7
JournalJournal of Immunotherapy
Volume33
Issue number7
DOIs
Publication statusPublished - Sep 2010

Keywords

  • advanced kidney cancer
  • antiangiogenic
  • chemoimmunitherapy
  • combination

ASJC Scopus subject areas

  • Immunology
  • Immunology and Allergy
  • Cancer Research
  • Pharmacology

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