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Feasibility of Interval Cytoreduction Following Neoadjuvant Chemotherapy With Carboplatin, Weekly Paclitaxel, and Bevacizumab for Advanced Ovarian Cancer—A Phase 1 Study
  1. Ritu Salani, MD, MBA,
  2. David M. O’Malley, MD,
  3. Larry J. Copeland, MD,
  4. David E. Cohn, MD,
  5. Floor J. Backes, MD,
  6. Jeffrey M. Fowler, MD and
  7. Eric L. Eisenhauer, MD
  1. Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Medical Center, Columbus, OH.
  1. Address correspondence and reprint requests to Ritu Salani, MD, MBA, Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, The Ohio State University, 320 W 10th Ave, M210 Starling Loving, Columbus, OH 43210. E-mail: ritu.salani{at}


Objective The objective of this study was to determine a dosing schedule of neoadjuvant chemotherapy using carboplatin, paclitaxel, and bevacizumab in women with advanced ovarian cancer, evaluating feasibility and outcomes from interval cytoreductive surgery (ICS).

Methods Using a “3+3” design, eligible patients received carboplatin (area under the curve, 5) and bevacizumab (15 mg/kg) every 3 weeks with escalating doses of weekly paclitaxel (60, 70, and 80 mg/m2) for 3 cycles. Patients then received 1 cycle of chemotherapy without bevacizumab followed by ICS. The primary objective was to determine a feasible dosing schedule. Secondary objectives included defining toxicity, response rates based on imaging, and surgical outcomes defined by residual disease following ICS and 30-day postoperative outcomes.

Results Nine patients were enrolled with a median age of 64 years. There were no dose-limiting toxicities, and weekly paclitaxel 80 mg/m2 was deemed feasible. During chemotherapy treatment, there were a total of 7 attributable grade 3 toxicities, which most commonly included neutropenia and thromboembolism. All patients demonstrated a response on imaging before surgery, with a median reduction in disease of 56.4% (range, 36.9%–100%). Optimal ICS was performed in all patients, and 78% had no gross residual tumor. There were no intraoperative complications; however, 1 patient experienced an anastomotic leak (grade 4) 10 days after surgery requiring repeat operation.

Conclusions A 4-cycle neoadjuvant regimen of carboplatin area under the curve of 5, weekly paclitaxel 80 mg/m2, and bevacizumab 15 mg/kg for cycles 1 to 3, followed by interval cytoreduction, was feasible. Optimal ICS was achieved in all patients, and surgery was associated with acceptable morbidity.

  • Neoadjuvant chemotherapy
  • Ovarian cancer
  • Bevacizumab
  • Interval cytoreductive surgery

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  • Study funding was provided by Genentech BioOncology, San Francisco, CA.

  • The authors declare no conflicts of interest.