Photo Credit: Mohammed Haneefa Nizamudeen

Initial results from the LANCE trial show comparable rates of resection with minimally invasive surgery and laparotomy in advanced epithelial ovarian cancer.

A lead-in pilot phase of a randomized clinical trial found similar rates of complete gross resection with minimally invasive surgery (MIS) and laparotomy in patients with advanced-stage epithelial ovarian cancer (EOC), according to a study published in JAMA Network Open.

That finding, along with a low rate of conversion from MIS to laparotomy to attain complete resection and promising patient accrual, points to the feasibility of a full-scale randomized clinical trial comparing the oncological efficacy of MIS and laparotomy, the researchers wrote.

“Despite the absence of high-quality evidence of its safety and effectiveness, MIS is increasingly used to treat advanced EOC,” J. Alejandro Rauh-Hain, MD, MPH, and colleagues wrote.

Study Parameters

The lead-in phase of the open-label Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy (LANCE) trial included 100 women at 11 academic cancer centers in North America and Europe. Participants had stage IIIC or IV epithelial ovarian, fallopian, or primary peritoneal carcinoma with normal cancer antigen 125 levels and complete or partial response to neoadjuvant chemotherapy.

Among participants, 49 were randomly assigned to interval cytoreductive surgery performed using MIS and 51 to laparotomy.

Three primary end points for the lead-in phase were used to gauge the feasibility of a full-scale, non-inferiority randomized clinical trial: patient accrual rate of at least 5.6 patients per month by the last month, conversion from MIS to laparotomy in less than 25% of patients, and a less than 20% difference in complete gross resection rates between study arms.

Results From Lead-In Phase

In the final month of the lead-in phase, the rate of patient accrual was 5.9 patients per month, the researchers reported. The rate of conversion from MIS to laparotomy was 12.5%.

Finally, complete gross reduction rates were 88% in the MIS arm and 83% in the laparotomy arm, for a difference of 4.5 percentage points.

“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 researchers wrote. “Therefore, phase 3 of the LANCE trial, which will compare the oncological efficacy of MIS vs laparotomy, is feasible. Enrollment in this phase is ongoing.”