LANCE Trial Shows Feasibility of Minimally Invasive Surgery for Advanced Ovarian Cancer After Chemotherapy
核心洞察
A pilot phase of the LANCE trial demonstrates the feasibility of conducting a full-scale RCT comparing minimally invasive surgery (MIS) to laparotomy for interval cytoreductive surgery in advanced ovarian cancer (搜索).
The study met its primary endpoints, including patient accrual rate, low conversion rate from MIS to laparotomy, and comparable complete gross resection rates between the two surgical approaches.
Patients undergoing MIS experienced shorter postoperative hospital stays and reduced blood loss compared to those undergoing laparotomy, suggesting potential benefits in recovery.
The Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy (LANCE) trial has demonstrated the feasibility of using minimally invasive surgery (MIS) for interval cytoreductive surgery in patients with advanced epithelial ovarian cancer (搜索) (EOC) who have undergone neoadjuvant chemotherapy (NACT). The lead-in pilot phase of the international, open-label, noninferiority randomized controlled trial (RCT) met its predefined feasibility endpoints, paving the way for the ongoing phase 3 trial to compare the oncological efficacy of MIS versus laparotomy.
The study, conducted across 11 academic cancer centers in North America and Europe between September 2020 and February 2023, enrolled 100 women with stage IIIC or IV EOC who had a complete or partial response to 3-4 cycles of NACT. Participants were randomly assigned to either MIS or laparotomy. The primary feasibility endpoints included a patient accrual rate of at least 5.6 patients per month, conversion from MIS to laparotomy in less than 25% of patients, and a difference in complete gross resection rates of fewer than 20 percentage points between study arms.
The results, published in JAMA Network Open, indicated that all three feasibility endpoints were met. The accrual rate reached 5.9 patients per month. The conversion rate from MIS to laparotomy was 12.5% (95% CI, 4.7%-25.2%). Complete gross resection was achieved in 88% of patients in the MIS arm and 83% in the laparotomy arm (difference, 4.5 percentage points; 95% CI, -9.7 to 18.8).
Perioperative Outcomes
Patients in the MIS arm experienced shorter median postoperative hospital stays (1 day vs. 4 days; median difference, -3 days; 95% CI, -4 to -2 days) and lower estimated blood loss (100 mL vs. 200 mL; median difference, -100 mL; 95% CI, -166 to -33 mL) compared to the laparotomy arm. Postoperative complications were also significantly lower in the MIS arm (8% vs. 26%; RR, 0.33; 95% CI, 0.11-0.94).
Quality of Life
At the first postoperative visit, social functioning, as measured by the EORTC QLQ-C30, was significantly higher in the MIS arm (score difference, 10.1; 95% CI, 0.1-20.2). Other quality-of-life domains did not show significant differences between the two groups.
Implications and Future Directions
The study's findings suggest that MIS is a feasible approach for interval cytoreductive surgery after NACT in advanced EOC. "Results of this lead-in pilot phase of the LANCE trial showed that it is feasible to achieve an adequate patient accrual rate while maintaining a low rate of treatment crossover and achieving a comparable proportion of complete gross resection among patients randomly assigned to receive either MIS or laparotomy," the authors stated.
While the pilot study demonstrated feasibility and potential benefits in perioperative outcomes and social functioning, the authors caution that these findings do not justify the routine use of MIS without high-quality evidence of its oncological efficacy. The ongoing phase 3 of the LANCE trial aims to provide this evidence by comparing the oncological outcomes of MIS versus laparotomy in a larger patient population.
The LANCE trial is registered at ClinicalTrials.gov (NCT04575935).