Minimally invasive radical hysterectomy is associated with lower rates of disease-free survival and overall survival than open abdominal radical hysterectomy, according to the results of a phase 3 clinical trial published in the New England Journal of Medicine.1The results are surprising, as previous retrospective studies comparing the 2 approaches concluded that minimally invasive hysterectomy was associated with better perioperative outcomes and that the survival rates between the 2 techniques did not differ significantly.2-5
This trial included 631 patients with stage IA1, IA2, or IB1 cervical cancer, and a histological subtype of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. A total of 319 patients were assigned to minimally invasive surgery; 84% of whom underwent laparoscopy, and 15.6% of whom underwent robot-assisted surgery. The remaining 312 patients were assigned to open surgery.
The trial was halted after the monitoring committee discovered that disease-free survival at 4.5 years was 10.6 percentage points lower in the minimally invasive surgery group than in the open surgery group (86% vs 96.5%). Survival at 3 years was also lower (93.8% vs. 99%). Furthermore, overall disease-free survival was lower (91.2% vs 97.1%) and remained significant even adjusting for age, body-mass index, stage of disease, lympho-vascular invasion, and lymph-node involvement.
“Our results call into question the findings in the literature suggesting that minimally invasive radical hysterectomy is associated with no difference in oncologic outcomes as compared with the open approach,” wrote the authors. The effect of these findings on future treatment recommendations remains to be seen.
1. Ramirez PT, Frumovitz M, Pareja R, et al.Minimally invasive versus abdominal radical hysterectomy for cervical cancer[published online October 31, 2018].N Engl J Med.doi:10.1056/NEJMoa1806395
2. Shazly SAM, Murad MH, Dowdy SC, Gostout BS, Famuyide AO. Robotic radical hysterectomy in early stage cervical cancer: a systematic review and meta-analysis. Gynecol Oncol.2015;138(2):457-471.
3. Sert BM, Boggess JF, Ahmad S, et al. Robot-assisted versus open radical hysterectomy: a multi-institutional experience for early-stage cervical cancer. Eur J Surg Oncol.2016;42(4):513-522.
4. Shah CA, Beck T, Liao JB, Giannakopoulos NV, Veljovich D, Paley P. Surgical and oncologic outcomes after robotic radical hysterectomy as compared to open radical hysterectomy in the treatment of early cervical cancer. J Gynecol Oncol.2017;28(6):e82.
5. Soliman PT, Frumovitz M, Sun CC, et al. Radical hysterectomy: a comparison of surgical approaches after adoption of robotic surgery in gynecologic oncology. Gynecol Oncol.2011;123(2):333-336.