Surgical approach, preoperative LEEP/conization and patterns of recurrence and death in low-risk cervical cancer - exploratory analysis from the CCTG CX.5/SHAPE trial.

Background: SHAPE demonstrated that simple hysterectomy was not inferior to radical hysterectomy in patients with low-risk cervical cancer. To further understand the role of preoperative LEEP/conization, clear LEEP/conization margins and surgical approach, analyses were performed regarding patterns of recurrence and death.

Patients And Methods: Outcomes (pelvic recurrence, extrapelvic recurrence and cervical cancer-related death) by surgical approach (minimally invasive surgery [MIS] vs. open), LEEP/conization (yes vs. no, involved vs negative margins) and residual disease in the hysterectomy specimen (yes vs. no) are described with 3-year outcome rate estimated by Kaplan-Meier method and compared by Cox models.

Results: With a median follow up of 4.5 years, 25 (3.7%) recurrences (pelvic or extrapelvic) were observed from 680 patients who underwent simple (338) or radical (342) hysterectomy. At surgeons' discretion, MIS was performed in 524 (77%) and open surgery in 156 (23%). Overall, 19 recurrences occurred following MIS (3.6%) and six following open surgery (3.8%). Among 174 patients with clear margins after LEEP/conization, two (1.4%) developed pelvic recurrences after MIS and none after open surgery. Among the entire cohort, nine patients had extrapelvic recurrence, 7/524 (1.3%) following MIS and 2/156 (1.3%) following open surgery. However, no extrapelvic recurrence occurred after either MIS or open surgery among patients who had pre-hysterectomy LEEP/conization with clear margins. With regards to cervical cancer-related deaths, all occurred after MIS (5/524, 0.95%) and none after open surgery or after previous LEEP/conization with clear margins.

Conclusions: Similar rates of recurrence and death were observed between patients who underwent MIS and open surgery within the SHAPE cohort. No extrapelvic recurrences and death occurred in patients with clear margins following prior LEEP/conization, regardless of surgical approach. The concept of pre-hysterectomy LEEP/conization might help to triage the most effective surgical strategy in terms of surgical approach and radicality in low-risk cervical cancer patients to ensure safe outcomes.