| The following article features coverage from the SGO 2022 Annual Meeting on Women’s Cancer. Click here to read more of Cancer Therapy Advisor’s conference coverage. |
Open radical hysterectomy provides better long-term outcomes when compared with minimally invasive surgery (MIS) in patients with early-stage cervical cancer, according to final results from the LACC trial.
Open radical hysterectomy was associated with superior disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) at a median follow-up of 4.5 years.
These data were presented at the SGO 2022 Annual Meeting on Women’s Cancer by Pedro Ramirez, MD, of the University of Texas MD Anderson Cancer Center in Houston.
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The LACC trial (ClinicalTrials.gov Identifier: NCT00614211) enrolled patients with stage IA1-IB1 primary adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the uterine cervix. The 631 patients were randomly assigned to undergo open surgery (n= 319) or MIS (n=312).
The median follow-up was 4.5 years. There were 255 patients in the open surgery arm and 271 in the MIS arm who completed follow-up.
The primary outcome was DFS, and it was superior in the open surgery arm for both the intention-to-treat (ITT) and per-protocol (PP) populations.
In the ITT population (n=631), the 4.5-year DFS rate was 96% in the open surgery arm and 85% in the MIS arm. In the PP population (n=526), the DFS rates were 97.3% and 86%, respectively. The hazard ratio (HR) for DFS in the ITT population was 3.91 (95% CI, 2.02-7.58; P <.0001).
“When we presented the data initially in 2018, the recurrence rate with minimally invasive surgery was 4 times higher than for open surgery,” Dr Ramirez said. “After completion of 4.5 years of follow-up on all of the patients, it still remains the same.”
The MIS approach was also associated with significantly worse PFS and OS, as well as a higher risk of local/regional recurrence in the ITT population.
The HR for cumulative local/regional recurrence was 4.70 (95% CI, 1.95-11.37; P =.001). The HR for PFS was 3.99 (95% CI, 2.12-7.51; P <.0001), and the HR for OS was 2.71 (95% CI, 1.32-5.59; P =.007).
“The overall survival remained worse, 3 times worse, for the minimally invasive approach compared to the open approach,” Dr Ramirez noted.
Dr Ramirez and colleagues also conducted an exploratory analysis evaluating outcomes by tumor size and conization status as well as rates of carcinomatosis.
The analysis revealed worse DFS with MIS for patients with tumors greater than 2 cm (HR, 4.25; 95% CI, 1.73-10.4; P =.002). Outcomes for patients with tumors smaller than 2 cm remain unclear, as DFS event rates are low, Dr Ramirez said.
The analysis also revealed worse DFS with MIS for patients without prior conization (HR, 5.85; 95% CI, 2.47-13.9; P <.0001) but no significant difference between the study arms for patients with prior conization (HR, 1.27; 95% CI, 0.39-4.17; P =.69).
In addition, rates of carcinomatosis at recurrence were higher with MIS than with open surgery (24% and 0%, respectively).
Dr Ramirez emphasized that the study was not designed or powered to look at these exploratory outcomes.
Disclosures: Dr Ramirez reported having no conflicts of interest.
Read more of Cancer Therapy Advisor’s coverage of SGO 2022 by visiting the conference page.
Reference
Ramirez P, Frumovitz M, Pareja R, et al. Open vs. minimally invasive radical hysterectomy in early cervical cancer: LACC trial final analysis. Presented at SGO 2022; March 18-21, 2022. Abstract LBA 10.
