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#236 Laparoscopic cytoreduction after neoadjuvant chemotherapy (LANCE): feasibility phase of a randomized trial
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  1. Jose Alejandro Rauh-Hain1,
  2. Alexander Melamed2,
  3. Rene Pareja3,
  4. Abdulrahman Sinno4,
  5. Leah Mcnally5,
  6. Nel 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 T Ramirez12 and
  16. Anna Fagotti13
  1. 1MD Anderson Cancer Center, Houston, USA
  2. 2Massachusetts General Hospital, Boston, USA
  3. 3Hospital General de Medellín, Medellin, Colombia
  4. 4Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Miami, USA
  5. 5Duke University, Durham, USA
  6. 6Dana Farber Cancer Center, Boston, USA
  7. 7University of Bologna, Bologna, Italy
  8. 8Cleveland Clinic, Cleveland, USA
  9. 9Princess Margaret Cancer Center, Toronto, Canada
  10. 10Amsterdam University Medical Center, Amsterdam, Netherlands Antilles
  11. 11Texas Oncology, Houston, USA
  12. 12Methodist Hospital, Houston, USA
  13. 13Fondazione Policlinico A. Gemelli, Rome, Italy

Abstract

Introduction/Background 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.

Methodology 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.

Abstract #236 Table 1

Demographic and clinical characteristics (n = 100)

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.

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

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