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

D Lorusso1, G Scambia, G Amadio

  • 1Department of Gynecologic Oncology, Catholic University of Rome, Rome, Italy.

British Journal of Cancer
|May 31, 2012
PubMed
Abstract

Insights

This study shows that combining NGR-hTNF with doxorubicin is tolerable and active in cancer patients. Higher peripheral blood lymphocyte counts may predict better outcomes, suggesting a potential biomarker for treatment response.

Area of Science:

  • Oncology
  • Immunotherapy
  • Pharmacology

Background:

  • NGR-hTNF (asparagine-glycine-arginine-human tumour necrosis factor) enhances antitumour immunity and doxorubicin delivery by targeting tumour vasculature.
  • This study investigates the combination of NGR-hTNF and doxorubicin in patients with advanced solid tumors.

Purpose of the Study:

  • To evaluate the tolerability and efficacy of NGR-hTNF plus doxorubicin in patients with solid tumors who progressed on platinum/taxane regimens.
  • To assess the response rate, progression-free survival (PFS), and overall survival (OS) of this combination therapy.

Main Methods:

  • A phase II clinical trial involving 37 patients with platinum-free intervals (PFI) <6 or 6-12 months.
  • Patients received NGR-hTNF (0.8 μg m(-2)) and doxorubicin (60 mg m(-2)) every 3 weeks.
  • Primary endpoint was the objective response rate based on Response Evaluation Criteria in Solid Tumors (RECIST).

Main Results:

  • The overall response rate was 23% (95% CI 12-39%), with 8 partial responses and 15 cases of stable disease among 35 assessable patients.
  • Median PFS was 5.0 months overall, with longer PFS observed in patients with PFI 6-12 months (7.8 months) compared to PFI <6 months (3.8 months).
  • Median OS was 17.0 months. Patients with higher baseline peripheral blood lymphocyte counts (PBLC) showed significantly improved PFS (P=0.01) and OS (P=0.001).

Conclusions:

  • The combination of NGR-hTNF and doxorubicin demonstrates tolerable activity and warrants further randomized testing, particularly in patients with PFI <6 months.
  • Peripheral blood lymphocyte count (PBLC) shows promise as a predictive blood-based biomarker for treatment response and survival outcomes.

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