Abstract
BackgroundThe addition of bevacizumab to standard chemotherapy prolongs progression free survival in the first line treatment of epithelial ovarian cancer (EOC), but its cost/effectiveness is debated. We assessed the safety and activity of a lower dose of bevacizumab in pretreated advanced stage EOC.MethodsWe treated 15 patients, mostly with platinum resistant EOC, who had received a median of four prior cytotoxic regimens, with bevacizumab 5–7.5 mg/kg q21 days in combination with either carboplatin (n = 8), oral cyclofosfamide (n = 5) or weekly paclitaxel (n = 2). Bevacizumab was administered until disease progression. Tumor response was assessed by CA125 and fusion 18 F-FDG PET/contrast enhanced CT.ResultsThe median number of bevacizumab cycles was 21 (range 3–59). The median baseline CA125 was 272 U/ml and decreased to 15.2 U/ml at nadir. Tumor response was 4 complete response (CR) (26.7%) and 7 partial response (PR) (46.7%) by chemotherapy (CT), with an overall response rate of 73.4% (95% CI, 51.0 – 95.8) according to Response Evaluation Criteria In Solid Tumors (RECIST), and 6 CR (40%) and 4 PR (26.7%) by PET, for an overall metabolic response rate of 67% (95%CI, 42.8 – 90.6) according to PET Response Criteria in Solid Tumors (PERCIST). Median progression free survival (PFS) was 21 months and median overall survival (OS) was 24 months. Grade 3 adverse events related to bevacizumab were hypertension (n = 2), proteinuria (n = 1) and epistaxis (n = 5). Treatment was delayed in five patients for nasal bleeding or uncontrolled hypertension.ConclusionsLow-dose bevacizumab and chemotherapy was well tolerated and active in a heavily pretreated population of advanced EOC. Further studies should assess the activity of low dose bevacizumab in EOC.
Highlights
Ovarian cancer is the most lethal gynecologic malignant tumor in developed countries
We explored the activity and safety of 5–7.5 mg/ kg q21 bevacizumab in heavily pretreated patients mostly with platinum resistant epithelial ovarian cancer (EOC)
The patients received a median number of four prior cytotoxic regimens
Summary
Ovarian cancer is the most lethal gynecologic malignant tumor in developed countries It is generally diagnosed in advanced stage and cytotoxic chemotherapy is only partially effective. A number of phase-II trials have assessed the activity of bevacizumab in the treatment of recurrent EOC, with promising results [7,8], including patients with platinum resistant disease [9,10,11]. These trials were followed by three randomized phase-3 trial in first-line treatment of EOC: GOG 218, ICON 7 and OCEAN trial [12,13,14].
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