Minimally invasive compared to open surgery in patients with low-risk cervical cancer following simple hysterectomy: An exploratory analysis from the Gynegologic Cancer Intergroup/Canadian Cancer Trials Group CX.5/SHAPE trial.

Objective: The Laparoscopic Approach to Cervical Cancer trial demonstrated that minimally invasive radical hysterectomy was associated with worse disease-free survival and overall survival among women with early-stage cervical cancer. It is unknown whether this applies to patients with low-risk disease following simple hysterectomy.

Methods: Among patients who underwent simple hysterectomy in the Simple Hysterectomy And PElvic node assessment trial, univariate and multivariate Cox models were used to assess the association of minimally invasive versus open surgery with clinical outcomes, including pelvic and extra-pelvic recurrence-free survival, overall recurrence-free survival, and overall survival. Other variables included age, race, performance status, body mass index, stage, histologic type and grade, diagnostic procedure, lymphovascular space invasion before surgery and on final pathology, lymph node status, residual disease, and lesions >2 cm on final pathology.

Results: A total of 338 patients underwent simple hysterectomy. Of those, 281 (83%) were performed by minimally invasive surgery and 57 (17%) by open surgery. With a median follow-up of 4.5 years, a total of 12 (4.3%) recurrences were observed in 281 patients having simple hysterectomy by minimally invasive surgery versus 3 in 57 (5.3%) having open surgery (p = .73 from Fisher exact test). Although not randomized, the 2 groups were comparable except for histology and residual disease in the hysterectomy specimen. Patients with minimally invasive surgery had more adenocarcinoma and less adenosquamous compared to open surgery (35.9% versus 22.9% and 3.6% versus 14%, respectively; p = .005). Significantly fewer patients treated by minimally invasive surgery had residual disease in the hysterectomy specimen compared to open surgery (43.1 versus 57.9%; p = .04). No statistically significant difference between minimally invasive and open surgery in pelvic and extra-pelvic recurrence-free survival, overall recurrence-free survival, or overall survival was found.

Conclusion: Our data indicate no statistical evidence that minimally invasive surgery is associated with poorer clinical outcomes for patients meeting the SHAPE criteria who underwent simple hysterectomy. Because the surgical approach was not a randomization factor, a large prospective trial is needed to confirm our results before a routine simple hysterectomy by minimally invasive surgery can be recommended.