Abstract
Objectives To assess the tolerability and efficacy of bevacizumab with carboplatin and weekly paclitaxel as first-line adjuvant therapy for advanced stage ovarian cancer. Methods After IRB approval, this single-institution, phase II study enrolled patients with stage III or IV epithelial ovarian cancer after primary cytoreductive surgery to treatment with carboplatin (AUC 5), weekly paclitaxel (80 mg/m2), and bevacizumab (15 mg/kg) every 3 weeks for at least 6 cycles. The primary endpoint was tolerability of at least 4 cycles of therapy, with a target treatment success rate of > 60%. Secondary endpoints included progression-free survival (PFS) and response rate. Plasma biomarkers were analyzed by the multiplex ELISA assays. Results Thirty-three patients were enrolled with 30 evaluable patients receiving at least one cycle of combination treatment. Twenty-three patients (77%) were able to complete at least 4 cycles of therapy per protocol, and the posterior probability that the treatment success rate is > 60% is 0.77. Twenty-one patients (70%) were able to complete ≥ 6 cycles of therapy. Median PFS was 22.4 months for patients with optimal (R0) compared to 16.9 months for optimal ≤ 1 cm (HR 1.71, 95% CI 0.58–4.98, p = 0.33), and 16.9 months for suboptimal > 1 cm (HR 3.75, 95% CI 1.05–13.34, p = 0.04) disease. Increases in mean Flt-3L was significantly higher in responders versus non-responders (83.4 vs. 28 pg/mL, p = 0.05). Conclusions Adjuvant bevacizumab with dose-dense chemotherapy is associated with acceptable toxicity and a high likelihood of completing 4 cycles of therapy. Dynamic changes in Flt-3L may represent a predictive marker to treatment response.
Original language | English (US) |
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Pages (from-to) | 41-46 |
Number of pages | 6 |
Journal | Gynecologic oncology |
Volume | 147 |
Issue number | 1 |
DOIs | |
State | Published - Oct 2017 |
Keywords
- Bevacizumab
- Biomarker
- Ovarian cancer
ASJC Scopus subject areas
- Oncology
- Obstetrics and Gynecology
MD Anderson CCSG core facilities
- Biostatistics Resource Group