Phase II study of NGR-hTNF in combination with doxorubicin in relapsed ovarian cancer patients
British Journal of Cancer,
Clinical Article
Lorusso D et al. – Tolerability and activity of this combination warrant further randomised testing in patients with PFI<6.
Methods- Patients progressing after >/= 1 platinum/taxane-based regimen received NGR-hTNF 0.8 ug/m2 and doxorubicin 60 mg/m2 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.
- 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 PFI<6; 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 PFI<6, 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).
