title: Minimally invasive interval debulking surgery in ovarian neoplasm (MISSION trial-NCT02324595): a feasibility study.
abstract: BACKGROUND
  Laparoscopy has acquired an increasing role in the management of ovarian cancer. Laparoscopic cytoreduction could represent a new frontier for selected patients after neoadjuvant chemotherapy (NACT).
  
  
  OBJECTIVE
  We sought to assess feasibility and early complication rate of minimally invasive (MI) interval debulking surgery (IDS) in stage III-IV epithelial ovarian cancer (EOC) patients after NACT.
  
  
  METHODS
  This is a phase II multicentric study in advanced EOC cases with clinical complete response after NACT, according to Gynecologic Cancer Intergroup and Response Evaluation Criteria In Solid Tumors criteria. Institutional review board approval was obtained and all patients signed written informed consent to be included in the protocol. The study was registered in clinicaltrials.gov (NCT02324595) and was named "MISSION" trial. For patients meeting inclusion criteria, surgical procedures started with diagnostic laparoscopy to confirm preoperative findings and assess surgical complexity. MI-IDS included hysterectomy, bilateral salpingo-oophorectomy, appendectomy, omentectomy, peritonectomy, and bowel resection. Pelvic and/or aortic lymphadenectomy was not considered as standard procedure in these cases. Intraoperative and postoperative outcomes, time to restart chemotherapy, survival rate, and quality of life data were registered.
  
  
  RESULTS
  From December 2013 through February 2015, of 184 advanced EOC patients considered eligible for IDS, 52 (28.2%) met inclusion criteria and were enrolled in the study. For 22 (12%) of them, standard laparotomic approach was preferred because of intraoperative surgeon evaluation. Thirty (16.3%) patients received the planned treatment of MI-IDS. Median age was 61 (range 39-81) years and median body mass index was 24 (range 20-31) kg/m(2). Median numbers of NACT cycles was 4 (range 3-7). Median operative time was 285 (range 124-418) minutes and median estimated blood loss was 100 (range 50-200) mL. Surgical procedures included 28 (93.3%) hysterectomy and bilateral salpingo-oophorectomy, 29 (96.6%) omentectomy, 2 (6.6%) appendectomy, 11 (36.6%) regional peritonectomy, and 1 (3.4%) bowel resection. A residual tumor of 0 cm was reached in 29 (96.6%) patients and 0.5 cm in only 1 (3.4%) case. The vast majority of patients were discharged on postoperative day 2 (range 2-3). No early postoperative complications were registered. Median time to restart chemotherapy was 20 (10-30) days and all patients successfully completed the cycles. Histological findings showed 3 (10%) complete response, 9 (30%) microscopic residual disease, and 18 (60%) evidence of macroscopic residual disease. With a median follow-up of 10.5 month, 5 peritoneal and 2 lymph nodal recurrences were observed. Psychometric test revealed moderate discomfort in the vast majority of patients (66.7%). All patients are still alive.
  
  
  CONCLUSIONS
  Invasive-IDS in patients with clinically complete response to NACT seems to be feasible and safe in terms of perioperative outcomes, psycho-oncological impact, and survival rate. The equivalence between MI surgery and laparotomy needs to be confirmed with a longer follow-up and a larger number of patients.
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy. Electronic address: gueliallettis@gmail.com.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Gueli Alletti
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Carolina
authors.initials: C
authors.lastname: Bottoni
authors.affiliation: Department of Medicine and Aging Sciences, University "G.D'Annunzio" of Chieti-Pescara, Chieti, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Fanfani
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Valerio
authors.initials: V
authors.lastname: Gallotta
authors.affiliation: Division of Gynecologic Oncology, "Giovanni Paolo II," Department of Obstetrics and Gynecology, University of Molise, Campobasso, Italy.
authors.forename: Vito
authors.initials: V
authors.lastname: Chiantera
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Barbara
authors.initials: B
authors.lastname: Costantini
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Cosentino
authors.affiliation: Department of Gynecology, Policlinic of Abano Terme, Abano Terme, Padua, Italy.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Ercoli
authors.affiliation: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Scambia
authors.affiliation: Minimally Invasive Gynecology, St Maria Hospital, University of Perugia, Terni, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Fagotti
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001062:Appendectomy; D017024:Chemotherapy, Adjuvant; D065426:Cytoreduction Surgical Procedures / Q000523:psychology; D005187:Fallopian Tubes / Q000601:surgery; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007044:Hysterectomy; D007422:Intestines / Q000601:surgery; D010535:Laparoscopy; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009364:Neoplasm Recurrence, Local; D018365:Neoplasm, Residual; D009852:Omentum / Q000601:surgery; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000601:surgery*; D010052:Ovariectomy; D010537:Peritoneum / Q000601:surgery
keywords: advanced ovarian cancer; interval debulking surgery; laparoscopic cytoreduction; minimally invasive surgery; neoadjuvant chemotherapy; quality of life