Activity and safety of NGR-hTNF, a selective vascular-targeting agent, in previously treated patients with advanced hepatocellular carcinoma

A. Santoro, T. Pressiani, G. Citterio, G. Rossoni, G. Donadoni, F. Pozzi, L. Rimassa, N. Personeni, S. Bozzarelli, G. Rossoni, S. Colombi, F. G. De Braud, F. Caligaris-Cappio, A. Lambiase, C. Bordignon

Research output: Contribution to journalArticle

Abstract

Background:Hepatocellular carcinoma (HCC) is a highly vascularised and poor-prognosis tumour. NGR-hTNF is a vascular-targeting agent consisting of human tumour necrosis factor-alpha fused to the tumour-homing peptide NGR, which is able to selectively bind an aminopeptidase N overexpressed on tumour blood vessels.Methods:Twenty-seven patients with advanced-stage disease resistant to either locoregional (59%; range, 1-3), systemic treatments (52%; range, 1-3) or both (33%) received NGR-hTNF 0.8 gm-2 once every 3 weeks. The primary aim of the study was progression-free survival (PFS).Results:No grade 3-4 treatment-related toxicities were noted. Common toxicity included mild-to-moderate, short-lived chills (63%). Median PFS was 2.3 months (95% CI: 1.7-2.9). A complete response ongoing after 20 months was observed in a sorafenib-refractory patient and a partial response in a Child-Pugh class-B patient, yielding a response rate of 7%. Six patients (22%) experienced stable disease. The disease control rate (DCR) was 30% and was maintained for a median PFS time of 4.3 months. Median survival was 8.9 months (95% CI: 7.5-10.2). In a subset of 12 sorafenib-resistant patients, the response rate was 8% and the median survival was 9.5 months.Conclusion:NGR-hTNF was well tolerated and showed single-agent activity in HCC. Further investigation in HCC is of interest.

Original languageEnglish
Pages (from-to)837-844
Number of pages8
JournalBritish Journal of Cancer
Volume103
Issue number6
DOIs
Publication statusPublished - Sep 7 2010

Keywords

  • hepatocellular carcinoma
  • NGR-hTNF
  • vascular-targeting agent

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

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