title: 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.
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/m2d1, 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.
authors.affiliation: Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"- IRCCS, Naples, Italy.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Daniele
authors.affiliation: Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.
authors.forename: Domenica
authors.initials: D
authors.lastname: Lorusso
authors.affiliation: Division of Gynaecologic Oncology, Department of Obstetrics and Gynaecology, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Scambia
authors.affiliation: Division of Medical Oncology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori "Fondazione G. Pascale" - IRCCS, Naples, Italy.
authors.forename: Sabrina C
authors.initials: SC
authors.lastname: Cecere
authors.affiliation: Medical Oncology Unit, Istituto Oncologico Veneto IOV-IRCCS, Padua, Italy.
authors.forename: Maria Ornella
authors.initials: MO
authors.lastname: Nicoletto
authors.affiliation: Medical Oncology Department, San Giovanni Calibita-Fatebenefratelli Hospital, Isola Tiberina, Rome, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Breda
authors.affiliation: Gynecology Department, European Institute of Oncology (IEO), Milan, Italy.
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Colombo
authors.affiliation: Department of Oncology, AO U.L.S.S., 13, Mirano, Italy.
authors.forename: Grazia
authors.initials: G
authors.lastname: Artioli
authors.affiliation: Department of Medical Oncology, G Rummo Hospital, Benevento, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Cannella
authors.affiliation: Medical Oncology Department, Santa Maria degli Angeli Hospital, Pordenone, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lo Re
authors.affiliation: Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Raspagliesi
authors.affiliation: Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.
authors.forename: Giuseppa
authors.initials: G
authors.lastname: Maltese
authors.affiliation: Division of Gynaecologic Oncology, Department of Obstetrics and Gynaecology, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Vanda
authors.initials: V
authors.lastname: Salutari
authors.affiliation: Division of Gynaecologic Oncology, Department of Obstetrics and Gynaecology, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Ferrandina
authors.affiliation: Division of Medical Oncology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori "Fondazione G. Pascale" - IRCCS, Naples, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Greggi
authors.affiliation: Medical Oncology Unit, Istituto Oncologico Veneto IOV-IRCCS, Padua, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Baldoni
authors.affiliation: Obstetrics and Gynecology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Alice
authors.initials: A
authors.lastname: Bergamini
authors.affiliation: Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"- IRCCS, Naples, Italy.
authors.forename: Maria Carmela
authors.initials: MC
authors.lastname: Piccirillo
authors.affiliation: Obstetric and Gynaecology Azienda Ospedaliera "Spedali Civili", Brescia, Italy.
authors.forename: Germana
authors.initials: G
authors.lastname: Tognon
authors.affiliation: Dipartimento di Oncologia, IRCCS Istituto di Ricerche Farmacologiche "Mario Negri", Milan, Italy.
authors.forename: Irene
authors.initials: I
authors.lastname: Floriani
authors.affiliation: Medical Statistics, Second University of Naples, Naples, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Signoriello
authors.affiliation: Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"- IRCCS, Naples, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Perrone
authors.affiliation: Division of Medical Oncology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori "Fondazione G. Pascale" - IRCCS, Naples, Italy. Electronic address: s.pignata@istitutotumori.na.it.
authors.forename: Sandro
authors.initials: S
authors.lastname: Pignata
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage; D016190:Carboplatin / Q000008:administration & dosage; D000077216:Carcinoma, Ovarian Epithelial; D003131:Combined Modality Therapy; D065426:Cytoreduction Surgical Procedures / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000628:therapy*; D010051:Ovarian Neoplasms / Q000628:therapy*; D017239:Paclitaxel / Q000008:administration & dosage
chemical_list: D000068258:Bevacizumab; D016190:Carboplatin; D017239:Paclitaxel
keywords: Bevacizumab; Interval debulking; Neoadjuvant; Ovarian cancer; Surgery