Objectives This study aimed to investigate the clinical benefit of dose-dense paclitaxel plus carboplatin (ddTC) with bevacizumab (Bev) therapy in neoadjuvant setting for advanced ovarian, fallopian tube and primary peritoneal cancer patients (UMIN-CTR: 000016176).
Methods Ovarian, fallopian tube or primary peritoneal cancer patients with estimated stage III-IV were included. They received paclitaxel (80 mg/m2) on day1, 8, 15, carboplatin (AUC 6.0 mg/mL x minute) on day 1, and Bev (15 mg/kg) on day 1 every 3 weeks as neoadjuvant chemotherapy. Interval debulking surgery (IDS) was performed after 3 cycles of ddTC+Bev therapy. The primary endpoint was rate of complete surgery. Secondary endpoints were response rate and adverse events.
Results Twenty-four patients were included in this study. The median age was 55.5 years (37–80 years), and high-grade serous carcinoma accounted for 18 patients. IDS was performed in all patients and the rate of complete surgery was 75%. The response rate in NAC was 79%, and CA125 declined below the cut-off in 58% of patients. Grade 4 hematological toxicities and grade 3/4 non-hematological toxicities were observed in 29% and 17% of patients during NAC respectively. Grade 3/4 perioperative complications were found in 29% of patients, but there was no gastrointestinal perforation or treatment-related death.
Conclusions Neoadjuvant ddTC+Bev therapy was well tolerated, and the sufficient rate of complete surgery in IDS was obtained.
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