title: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy as upfront therapy for advanced epithelial ovarian cancer: multi-institutional phase-II trial.
abstract: OBJECTIVE
  The primary end-point of this multi-institutional phase-II trial was to assess results in terms of overall survival after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in treatment-naive epithelial ovarian cancer (EOC) with advanced peritoneal involvement. Secondary end-points were treatment morbi-mortality and outcome effects of time to subsequent adjuvant systemic chemotherapy (TTC).
  
  
  METHODS
  Twenty-six women with stage III-IV EOC were prospectively enrolled in 4 Italian centers to undergo CRS and closed-abdomen HIPEC with cisplatin and doxorubicin. Then they received systemic chemotherapy with carboplatin (AUC 6) and paclitaxel (175 mg/m(2)) for 6 cycles.
  
  
  RESULTS
  Macroscopically complete cytoreduction was achieved in 15 patients; only minimal residual disease (≤2.5 mm) remained in 11. Major complications occurred in four patients and postoperative death in one. After a median follow-up of 25 months, 5-year overall survival was 60.7% and 5-year progression-free survival 15.2% (median 30 months). Excluding operative death, all the patients underwent systemic chemotherapy at a median of 46 days from combined treatment (range: 29-75). The median number of cycles per patient was 6 (range: 1-8). The time to chemotherapy did not affect the OS or PFS.
  
  
  CONCLUSIONS
  In selected patients with advanced stage EOC, upfront CRS and HIPEC provided promising results in terms of outcome. Morbidity was comparable to aggressive cytoreduction without HIPEC. Postoperative recovery delayed the initiation of adjuvant systemic chemotherapy but not sufficiently to impact negatively on survival. These data warrant further evaluation in a randomized clinical trial.
authors.affiliation: Peritoneal Surface Malignancy Program, Department of Surgery, National Cancer Institute, via Venezian 1, 20133 Milan, Italy. marcello.deraco@istitutotumori.mi.it
authors.forename: Marcello
authors.initials: M
authors.lastname: Deraco
authors.forename: Shigeki
authors.initials: S
authors.lastname: Kusamura
authors.forename: Salvatore
authors.initials: S
authors.lastname: Virzì
authors.forename: Francesco
authors.initials: F
authors.lastname: Puccio
authors.forename: Antonio
authors.initials: A
authors.lastname: Macrì
authors.forename: Ciro
authors.initials: C
authors.lastname: Famulari
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Solazzo
authors.forename: Serena
authors.initials: S
authors.lastname: Bonomi
authors.forename: Domenico Rosario
authors.initials: DR
authors.lastname: Iusco
authors.forename: Dario
authors.initials: D
authors.lastname: Baratti
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D000077216:Carcinoma, Ovarian Epithelial; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D006979:Hyperthermia, Induced / Q000379:methods*; D007274:Injections, Intraperitoneal; D008875:Middle Aged; D009367:Neoplasm Staging; D009375:Neoplasms, Glandular and Epithelial / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D010051:Ovarian Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D010534:Peritoneal Neoplasms / Q000401:mortality / Q000556:secondary / Q000628:therapy*
chemical_list: D000970:Antineoplastic Agents