Minimally Invasive Surgery in Advanced epithelial ovarian cancer: Study evaluates Outcomes in Face of Complications

Cytoreductive surgery, whether performed as the initial treatment or following neoadjuvant chemotherapy (NACT) for advanced epithelial ovarian cancer (EOC), fallopian tube carcinoma, and primary peritoneal cancer, poses significant risks of complications. These complications can delay the timely delivery of chemotherapy, extend hospital stays and lead to readmissions, ultimately affecting survival rates negatively. Recent study evaluates the feasibility of conducting a randomized clinical trial (RCT) to compare the efficacy of minimally invasive surgery (MIS) against traditional laparotomy for patients with advanced-stage epithelial ovarian cancer (EOC) who have responded to neoadjuvant chemotherapy (NACT). The research is part of the Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy (LANCE) trial, which focuses on patients with stage IIIC or IV EOC, specifically those showing a complete or partial response to NACT.

Pilot Phase Details

The pilot phase, initiated in September 2020 and concluding with the enrollment of the 100th patient in February 2023, included participants from 11 academic cancer centers across North America and Europe. Inclusion criteria encompassed adult patients exhibiting elevated cancer antigen 125 (CA-125) levels and a partial or complete radiologic response after 3-4 cycles of NACT. Patients were randomly assigned to either an MIS arm, involving laparoscopic or robotic surgery, or a laparotomy control arm. Outcomes were assessed primarily on feasibility metrics such as patient accrual rates, conversion rates from MIS to laparotomy, and rates of complete gross resection. The study successfully enrolled 100 patients (median age 63 years), with 49 in the MIS group and 51 in the laparotomy group. The results indicated a patient accrual rate of 5.9 patients per month, surpassing the predefined threshold. Conversion from MIS to laparotomy occurred in 12.5% of the MIS group, which met the pre-established criterion of being below 25%. Overall, complete gross resection was achieved in 88% of the MIS group and 83% of the laparotomy group, reflecting a small absolute difference that was well within acceptable limits.

Secondary Outcomes

Secondary outcomes reported that patients in the MIS arm experienced significantly shorter postoperative hospital stays (median of 1 day vs. 4 days for laparotomy) and lower estimated blood loss. However, there were more postoperative complications in the laparotomy group (26% compared to 8% in the MIS group), suggesting a possible advantage of MIS in reducing complications. No substantial differences in overall health-related quality of life were noted, aside from marginally higher social functioning in the MIS group. These findings provide preliminary evidence supporting the feasibility of the LANCE trial and suggest that MIS may be associated with fewer complications and shorter recovery times compared to laparotomy in the surgical management of advanced EOC. Further research in the form of a full-scale RCT is warranted to establish the oncological effectiveness of MIS.

Key Points

- The study assesses the feasibility of a randomized clinical trial comparing minimally invasive surgery (MIS) with traditional laparotomy for patients with advanced-stage epithelial ovarian cancer (EOC) who responded to neoadjuvant chemotherapy (NACT), as part of the LANCE trial.

- The pilot phase, running from September 2020 to February 2023, included 100 patients from 11 academic cancer centers in North America and Europe, with a median age of 63 years. Patients met specific inclusion criteria, including elevated CA-125 levels and radiologic responses to NACT.

- Participants were randomly allocated to either the MIS group, which involved laparoscopic or robotic surgery, or the laparotomy control group. Key feasibility metrics assessed were patient accrual rates, conversion rates from MIS to laparotomy, and rates of complete gross resection.

- The trial successfully enrolled 100 patients, achieving a patient accrual rate of 5.9 per month and maintaining a conversion rate from MIS to laparotomy at 12.5%, below the threshold of 25%. Complete gross resection was accomplished in 88% of the MIS cohort and 83% of the laparotomy cohort.

- Secondary outcomes indicated that the MIS arm had significantly shorter postoperative hospital stays (median 1 day) and lower estimated blood loss compared to the laparotomy group (median 4 days), along with fewer postoperative complications (8% in MIS vs. 26% in laparotomy).

- Overall health-related quality of life did not show substantial differences between groups, though the MIS group reported marginally better social functioning. These preliminary findings support the feasibility of the LANCE trial and suggest potential advantages of MIS in terms of lower complications and quicker recovery, warranting further investigation in a full-scale RCT.

Reference –

J. Rauh-Hain et al. (2024). Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy In High-Grade Epithelial Ovarian Cancer. *JAMA Network Open*, 7. https://doi.org/10.1001/jamanetworkopen.2024.46325