Phase II study of NGR-hTNF in combination with doxorubicin in relapsed ovarian cancer patients

D. Lorusso, G. Scambia, G. Amadio, A. Di Legge, A. Pietragalla, R. De Vincenzo, V. Masciullo, M. Di Stefano, G. Mangili, G. Citterio, M. Mantori, A. Lambiase, C. Bordignon

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The NGR-hTNF (asparagine-glycine-arginine-human tumour necrosis factor) is able to promote antitumour immune responses and to improve the intratumoural doxorubicin uptake by selectively damaging tumour blood vessels. Methods: Patients progressing after ≥ 1 platinum/taxane-based regimen received NGR-hTNF 0.8 g m -2 and doxorubicin 60 mg m -2 every 3 weeks. Primary endpoint was a Response Evaluation Criteria in Solid Tumors-defined response rate with a target of more than 6 out of 37 responding patients. Results: A total of 37 patients with platinum-free interval lower than 6 months (PFI=6; n=25), or between 6 and 12 months (PFI=6-12; n=12) were enrolled. Median baseline peripheral blood lymphocyte count (PBLC) was 1.6 per ml (interquartile range, 1.2-2.1). In all, 18 patients (49%) received more than 6 cycles. Febrile neutropaenia was registered in one patient (3%). Among 35 assessable patients, 8 (23%; 95% CI 12-39%) had partial response (2 with PFI6; 6 with PFI=6-12) and 15 (43%) had stable disease (10 with PFI=6; 5 with PFI=6-12). Median progression-free survival (PFS) was 5.0 months for all patients, 3.8 months for patients with PFI6, and 7.8 months for patients with PFI=6-12. Median overall survival (OS) was 17.0 months. Patients with baseline PBLC higher than the first quartile had improved PFS (P=0.01) and OS (P=0.001). Conclusion: Tolerability and activity of this combination warrant further randomised testing in patients with PFI=6. The role of PBLC as a blood-based biomarker deserves further investigation.

Original languageEnglish
Pages (from-to)37-42
Number of pages6
JournalBritish Journal of Cancer
Volume107
Issue number1
DOIs
Publication statusPublished - Jun 26 2012

Keywords

  • doxorubicin
  • NGR-hTNF
  • ovarian cancer
  • vascular targeting agent

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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