Abstract
IntroductionBevacizumab and gemcitabine are key drugs for treating recurrent epithelial ovarian cancer. However, information about the combination of bevacizumab and gemcitabine is insufficient. We conducted a phase II study to assess the feasibility, clinical activity, and toxicity of this combination chemotherapy.MethodsThis study included women with platinum-resistant recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer who received one to three regimens of platinum-based chemotherapy between April 1, 2015 and December 31, 2018. The patients received bevacizumab 15 mg/kg intravenously on day 1 and gemcitabine 1000 mg/m2 intravenously on days 1 and 8 every 21 days until disease progression or unacceptable toxicity. The primary endpoint was the completion rate of three cycles of chemotherapy. This study was registered in the University Medical Information Network (UMIN) Clinical Trials Registry (UMIN000016619).ResultsAmong the 19 patients, 18 (95%) received ≥3 and 9 (47%) received ≥6 cycles of the study therapy. The objective response rate was 42% (complete response of 16% and partial response of 26%), and the clinical control rate was 84%. Hematological toxicity included neutropenia grade 3/4 in 9 patients (47%), anemia grade 3/4 in 2 (11%), and thrombocytopenia grade 3/4 in 1 (5%). One patient (5%) had grade 3 hypertension, and 1 (5%) had grade 3 protein urea. Possibly related grade 3 pulmonary toxicity was observed in 1 patient. Three patients needed dose reduction of gemcitabine to 800 mg/m2 due to treatment delay by 15 to 21 days on day1. There was no treatment delay more than 14 days on day 8. The median progression-free survival duration was 5.1 months and median overall survival duration was 21.3 months.ConclusionThe combination chemotherapy with gemcitabine and bevacizumab was feasible, effective and safe. This combination chemotherapy may be explored in a further randomized trial.
Highlights
Bevacizumab and gemcitabine are key drugs for treating recurrent epithelial ovarian cancer.information about the combination of bevacizumab and gemcitabine is insufficient
Full list of author information is available at the end of the article
The Creative Commons Public Domain Dedication waiver applies to the data made available in this article, unless otherwise stated
Summary
Bevacizumab and gemcitabine are key drugs for treating recurrent epithelial ovarian cancer.information about the combination of bevacizumab and gemcitabine is insufficient. In the AURELIA trial, the addition of bevacizumab to single-agent chemotherapy significantly improved the response rate (single-agent chemotherapy vs bevacizumab combination therapy: 11.8% vs 27.3%, p = 0.001) and progression free survival (PFS) duration (median PFS, 3.4 vs 6.7 months; hazard ratio, 0.48; 95% confidence interval: 0.38 to 0.60, p < 0.001) without problematic toxicity in patients with platinum-resistant recurrent ovarian cancer [1]. Based on these findings, bevacizumab combined with single-agent chemotherapy became one of the standard treatments for platinum-resistant recurrent ovarian cancer. There is no prospective study of this combination chemotherapy
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
