Feasibility and outcome of interval debulking surgery (IDS) after carboplatin-paclitaxel-bevacizumab (CPB): A subgroup analysis of the MITO-16A-MaNGO OV2A phase 4 trial

Gynecol Oncol. 2017 Feb;144(2):256-259. doi: 10.1016/j.ygyno.2016.12.011. Epub 2016 Dec 16.

Abstract

Background: Few data are available on the outcome of surgery after a bevacizumab-containing regimen. The MITO 16A- MaNGO OV2A phase 4 trial evaluates the outcomes of first-line CPB in a clinical-practice-like setting. Here we present the results of the subgroup of patients undergoing IDS after neoadjuvant treatment or suboptimal primary surgery.

Methods: 400 chemonaïve epithelial ovarian cancer patients, age≥18, ECOG PS 0-2 were eligible to receive C (AUC 5 d1, q21) plus P (175mg/m2 d1, q21) and B (15mg/kg d1 q21) for 6cycles followed by B maintenance until cycle 22nd.

Results: 79 patients (20%) underwent IDS. Overall, 74 patients received at least one administration of B before IDS. Median age was 61.2, 70% of the patients had FIGO IIIC disease. The median number of cycles before IDS was 3 both for chemotherapy and bevacizumab respectively. A residual disease ≤1cm was achieved in 64 patients (86.5%). Four percent of the patients experienced fever and 4% required blood transfusion after surgery. Surgical wound infection and/or dehiscence, pelvic abscess, intestinal sub-occlusion and fistula were experienced by one patient each.

Conclusions: In the MITO16A-MaNGO OV2A phase 4 trial, combined chemotherapy and bevacizumab did not hamper IDS and the rate of perioperative complications was similar to what expected without bevacizumab. These data support the hypothesis that adding bevacizumab to first line chemotherapy for ovarian cancer might not be denied to patients for whom IDS is planned.

Keywords: Bevacizumab; Interval debulking; Neoadjuvant; Ovarian cancer; Surgery.

Publication types

  • Clinical Trial, Phase IV

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bevacizumab / administration & dosage
  • Carboplatin / administration & dosage
  • Carcinoma, Ovarian Epithelial
  • Combined Modality Therapy
  • Cytoreduction Surgical Procedures / methods*
  • Feasibility Studies
  • Female
  • Humans
  • Middle Aged
  • Neoplasms, Glandular and Epithelial / therapy*
  • Ovarian Neoplasms / therapy*
  • Paclitaxel / administration & dosage

Substances

  • Bevacizumab
  • Carboplatin
  • Paclitaxel