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PHOENIX -- Minimally invasive hysterectomy for patients with early cervical cancer resulted in significantly worse outcomes compared with open surgery, according to the final analysis of the Laparoscopic Approach to Cervical Cancer (LACC) trial, confirming .

In the intention-to-treat population, the disease-free survival (DFS) rate at 4.5 years -- the study's primary outcome -- was 96.0% with the open surgery approach versus 85.0% with minimally invasive surgery (MIS), with similar DFS rates of 97.3% and 86.0% in the per-protocol analysis, reported Pedro T. Ramirez, MD, of the University of Texas MD Anderson Cancer Center in Houston.

"When we presented the data in 2018, the recurrence rate for MIS was four times higher than for open surgery," Ramirez said during a late-breaking abstract session during the Society of Gynecologic Oncology annual meeting. "And after completion of 4.5 years follow-up on all of the patients, it still remains the same."

DFS events occurred in 43 patients in the MIS arm versus 11 patients in the open surgery arm (HR 3.91, 95% CI 2.02-7.58, P<0.0001).

"No one can argue the clinical significance here. We are tasked with understanding why," said discussant Kristin Bixel, MD, of the Ohio State University Comprehensive Cancer Center in Columbus.

She noted that the recurrence patterns by surgical approach suggest that "something we are doing surgically is changing the distribution of recurrence."

"I definitely had to work through five stages of grief after the initial presentation in 2018," Bixel said. "I've reached acceptance of the fact that if we are to perform MIS radical hysterectomy in the future, we need to do better. We need to be critical of our surgical technique, find opportunities to improve, and then study it again."

The investigators also found that progression-free survival (PFS) was worse for MIS compared with open surgery, with 48 patients in the MIS arm experiencing events compared with 12 in the open surgery arm (HR 3.99, 95% CI 2.12-7.51, P<0.0001), which was consistent with the 2018 findings.

Patients in the MIS arm also had worse disease-specific survival (HR 2.64, 95% CI 1.18-5.93, P=0.02), cumulative local/regional recurrence (HR 4.70, 95% CI 1.95-11.37, P=0.001), and overall survival (HR 2.71, 95% CI 1.32-5.59, P=0.007).

Ramirez noted that since his team published its initial findings in 2018, national and international guidelines have changed their recommendations and now consider open radical hysterectomy as the new standard approach for patients with early cervical cancer. This final analysis confirms that patients with early cervical cancer "should not undergo the minimally invasive approach outside of a clinical trial," he said.

Initial results from the LACC trial reported on DFS and overall survival (OS) at 4.5-year follow-up among 60% of the patients, while the final analysis reported on 100% of the eligible patients.

The trial included 631 patients, 312 who were randomly assigned to open surgery (with 255 completing follow-up) and 319 to MIS (with 271 completing follow-up).

Ramirez and colleagues also conducted an exploratory analysis assessing outcomes by tumor size, conization status, and carcinomatosis rates.

They found that 21% of MIS patients with tumors ≥2 cm had DFS events compared with about 5% of patients who had open surgery (HR 4.25, 95% CI 1.73-10.4, P=0.002).

Ramirez emphasized that while the trial was not designed to answer the question of the effect of tumor size on surgical outcomes, "this highlights the fact that for larger tumors, there is clearly a disadvantage to minimally invasive surgery in terms of the difference in recurrence events."

As for tumors less than 2 cm, the investigators found that no DFS events occurred among 65 patients who underwent open surgery versus seven DFS events among 75 MIS patients.

"It is important to highlight this because comments have been made that if patients have tumors less than 2 cm, then perhaps it is appropriate to proceed with minimally invasive surgery," Ramirez noted.

In looking at patients who did not have previous conization, there were worse outcomes for those who underwent MIS (HR 5.85, 95% CI 2.47-13.9, P<0.0001). Among patients who did have a previous cone, there was no difference between the two arms (HR 1.27, 95% CI 0.39-4.17, P=0.69).

When there were recurrences in the open surgery arm, no patients manifested with carcinomatosis versus 24% of patients in the MIS arm.

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