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PO014/#364  Laparoscopic cytoreduction after neoadjuvant chemotherapy (LANCE): feasibility phase of a randomized trial
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  1. J Alejandro Rauh-Hain1,
  2. Alexander Melamed2,
  3. Rene Pareja3,
  4. Abdulrahman Sinno4,
  5. Leah Mcnally5,
  6. Neil Horowitz6,
  7. Pierandrea De Iaco7,
  8. Chad Michener8,
  9. Taymaa May9,
  10. Luc Van Lonkhuijzen10,
  11. Maria Iniesta1,
  12. Tina Suki1,
  13. Ying Yuan1,
  14. Robert Coleman11,
  15. Pedro Ramirez12 and
  16. Anna Fagotti13
  1. 1MD Anderson Cancer Center, Gynecologic Oncology and Reproductive Medicine, Houston, USA
  2. 2Massachusetts General Hospital, Obstetrics and Gynecology, Boston, USA
  3. 3Hospital General de Medellín, Gynecologic Oncology, Medellin, Colombia
  4. 4Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Obstetrics and Gynecology, Miami, USA
  5. 5Duke University, Obstetrics and Gynecology, Durham, USA
  6. 6Dana Farber Cancer Center, Gynecologic Oncology, Boston, USA
  7. 7University of Bologna, Obstetrics and Gynecology, Bologna, Italy
  8. 8Cleveland Clinic, Obstetrics and Gynecology, Cleveland, USA
  9. 9Princess Margaret Cancer Center, Gynecologic Oncology, Toronto, Canada
  10. 10Amsterdam University Medical Center, Gynecologic Oncology, Amsterdam, Netherlands
  11. 11US Oncology, Texas Oncology, Houston, USA
  12. 12Methodist Hospital, Obstetrics and Gynecology, Houston, USA
  13. 13Fondazione Policlinico A. Gemelli, Gynecologic Oncology, Rome, Italy

Abstract

Introduction In patients who respond to neoadjuvant chemotherapy (NACT) for advanced-stage epithelial ovarian cancer (EOC), minimally invasive surgery (MIS) may reduce the morbidity of surgery. Studies evaluating oncologic outcomes of minimally invasive interval cytoreductive surgery are largely retrospective.

Methods LANCE is a prospective, multicenter, international, randomized trial evaluating whether MIS is non-inferior to laparotomy in terms of disease-free survival, among patients with stage IIIC and IV EOC with normalization of CA125 after 3–4 cycles of NACT. The planned 100 patients were enrolled in a lead-in phase to assess the feasibility of the trial with respect to cross-over among those assigned to MIS, complete gross resection, and recruitment. Patients were randomized (1:1) to undergo open or MIS (laparoscopic or robotic) surgery. Surgeons applied maximal effort to resect all visible tumor, conversion to open surgery was performed when necessary to attain complete resection.

Results From September 2020-February 2023, 100 patients were randomized (51 open, 49 MIS). The mean age was 62 years, 67% had stage IIIC, and 54% received 3 cycles of NACT. Six patients randomized to MIS (12.2%;95%CI: 4.6–24.8%) underwent conversion to open surgery. Surgeons achieved complete gross resection in 87.5% (95%CI: 74.8–95.3%) and 83% (95%CI: 69.2–92.4%) of patients assigned to MIS and open (p=0.6). There were three (6.3%) intraoperative complications in the MIS group and three (6.4%) in the open group. Two patients (4.1%) in the MIS group experienced grade 4–5 adverse events following surgery.

Abstract PO014/#364 Table 1

Demographic and clinical characteristics (n = 100)

Conclusion/Implications Evaluation of MIS interval cytoreductive surgery is feasible, enrollment is ongoing in a definitive trial.

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