Open surgery a better option than minimally invasive hysterectomy in early cervical cancer?
Undergoing a minimally invasive radical hysterectomy leads to worse survival outcomes compared with open surgery in patients with early cervical cancer, according to final results of the LACC trial presented at SGO 2022.
Participants were 631 patients with FIGO 2009 stage IA1 (LVSI)–IB1 cervical cancer of squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma histology. They were randomized 1:1 to undergo either open or minimally invasive hysterectomy (n=312 and 319, respectively). The present analysis at a median 4.5 years of follow up includes 255 and 271 patients, respectively.
The rate of disease-free survival (DFS) at 4.5 years in the intention-to-treat population was greater in patients assigned to open surgery than those assigned to minimally invasive surgery (MIS; 96.0 percent vs 85.0 percent; pnoninferiority=0.95). [SGO 2022, abstract LBA10]
At 4.5 years, DFS was significantly reduced among patients assigned to MIS compared with open surgery (hazard ratio [HR], 3.91, 95 percent confidence interval [CI], 2.02–7.58; p<0.0001).
Progression-free survival was also reduced among patients who underwent MIS compared with open surgery (HR, 3.99, 95 percent CI, 2.12–7.51; p<0.0001), as was disease-specific survival (HR, 2.64, 95 percent CI, 1.18–5.93; p=0.02). The cumulative incidence of local or regional recurrence was also greater with MIS than open surgery (HR, 4.70, 95 percent CI, 1.95–11.37; p=0.001).
Overall survival was also reduced with MIS than open surgery (HR, 2.71, 95 percent CI, 1.32–5.59; p=0.007).
Sixty patients had no evidence of residual disease in the final hysterectomy specimen. In this specific population, there were no recurrences among patients who underwent open surgery and two in those who underwent MIS, with no deaths in either group.
“We cannot determine whether there is equivalency or noninferiority [for] the two approaches when there is no residual disease, given that there were no events recorded in these groups,” remarked study author Professor Pedro Ramirez from The University of Texas MD Anderson Cancer Center, Houston, Texas, US.
Exploratory analysis showed that among patients with tumour size ≥2 cm, DFS was significantly worse with MIS than open surgery (HR, 4.25, 95 percent CI, 1.73–10.4; p=0.002), though the risk was not estimable in patients with tumour size <2 cm (0 and seven events in the open and MIS groups, respectively). Among patients with no previous conization, DFS was significantly reduced among patients who underwent MIS than open surgery (HR, 5.85, 95 percent CI, 2.47–13.9; p<0.0001), with no significant between-group difference among patients with prior conization (HR, 1.27; p=0.69).
Eleven and 37 patients who underwent open surgery and MIS, respectively, experienced disease recurrence. Among patients who experienced recurrence, carcinomatosis rates were increased among patients who underwent MIS compared with open surgery (24 percent vs 0 percent). The most common sites of recurrence among those who underwent open surgery were vault, distant, and multiple sites (27 percent each), while among those who underwent MIS, 38 percent had multiple sites of recurrence and 27 percent recurrence affecting the pelvis.
Prior research has suggested that minimally invasive radical hysterectomy is tied to lower DFS and OS rates, higher risk of recurrence, and shorter OS compared with open abdominal radical hysterectomy in early-stage cervical cancer. [N Engl J Med 2018;379:1895-1904; JAMA Oncology 2020;6:1019-1027; N Engl J Med 2018;379:1905-1914]
“DFS at 4.5 years when all patients had been followed [showed that] MIS was worse when compared to the open approach. Minimally invasive radical hysterectomy was associated with higher rates of loco/regional recurrences and mortality,” said Ramirez. “The outcomes remain unknown for tumours <2 cm as the event rates were low,” he noted.