A Phase II trial of intravenous bevacizumab, paclitaxel and intraperitoneal cisplatin followed by intravenous bevacizumab maintenance for treatment of stage II-III ovarian cancer
Year: 2015
Type: article
Study design: Clinical Trial
Abstract: Objective: Acceptance of intraperitoneal (IP) chemotherapy has not been widespread with anticipated toxicity commonly cited as a limitation of this therapy.We evaluated a modified IP regimen with IV bevacizumab to determine feasibility and assess toxicities.Methods: A phase II study was conducted in patients with advanced ovarian cancer following cytoreduction to < 1cm residual disease.The primary aim was to evaluate feasibility as defined as completion of 6 cycles.Patients received IV paclitaxel 135 mg/m 2 and IV bevacizumab 15 mg/kg (cycle 2-6) on day 1 followed by cisplatin 75 mg/m 2 IP day 2, repeated every 21 days x 6 cycles.Following primary therapy, patients received IV bevacizumab 15 mg/kg maintenance q21 days x 12 cycles.The FACT GOG NTX tool was used to prospectively monitor neuropathy scores over treatment.Results: 20 evaluable patients are presented including 85% with stage III disease, and 75% with no gross residual.85% received 6 cycles of IP therapy and 77% of these received all 12 cycles of maintenance.Scores for neuropathy worsened through cycle 6, peaked at 9 and improved by 18. Toxicity was acceptable with neutropenia the most common grade 3-4 adverse event, and 8 patients experienced grade 2-3 neuropathy.With a median follow-up of 63 months, the median PFS and OS is 50 and 71 months respectively.Conclusions: Adding IV bevacizumab to a modified IP regimen is feasible.As compared to GOG 172, the lower cisplatin dose and omission of day 8 IP paclitaxel may allow a higher completion rate.Despite modifications, neuropathy remains important issue in IP based cisplatin regimens.
Language: English
Subfield: Reproductive Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W2508779196
