Phase II trial of bevacizumab with dose-dense paclitaxel as first-line treatment in patients with advanced ovarian cancer

Nicole D. Fleming, Robert L. Coleman, Celestine Tung, Shannon N. Westin, Wei Hu, Yunjie Sun, Priya Bhosale, Mark F. Munsell, Anil K. Sood

Research output: Contribution to journalArticlepeer-review

15 Scopus citations

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 languageEnglish (US)
Pages (from-to)41-46
Number of pages6
JournalGynecologic oncology
Volume147
Issue number1
DOIs
StatePublished - Oct 2017

Keywords

  • Bevacizumab
  • Biomarker
  • Ovarian cancer

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

MD Anderson CCSG core facilities

  • Biostatistics Resource Group

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