LACC Trial: Final Analysis on Overall Survival Comparing Open Versus Minimally Invasive Radical Hysterectomy for Early-Stage Cervical Cancer

Author(s): Pedro T. Ramirez, MD1; Kristy P. Robledo, PhD2; Michael Frumovitz, MD3; Rene Pareja, MD4,5; Reitan Ribeiro, MD6; Aldo Lopez, MD7; Xiaojian Yan, MD8; David Isla, MD9; Renato Moretti, MD10; Marcus Q. Bernardini, MD11; Val Gebski, MStat2; Rebecca Asher, MSc2; Vanessa Behan, BSN12; Robert L. Coleman, MD13; Andreas Obermair, MD12
Anjan J Patel MD

Dr. Anjan Patel's Thoughts

A nod to our gynecologic oncologists. Minimally invasive surgery was significantly inferior to open radical hysterectomy for early-stage cervical cancer.


Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.

The aim of this study was to compare overall survival between open and minimally invasive radical hysterectomy with participants followed for 4.5 years. The primary objective was to evaluate whether minimally invasive surgery was noninferior in disease-free survival (DFS) to abdominal radical hysterectomy. Secondary outcomes included overall survival. Sample size was based on DFS of 90% at 4.5 years and 7.2% noninferiority margin for minimally invasive surgery. A total of 631 patients were enrolled: 319 assigned to minimally invasive and 312 to open surgery. Of these, 289 (90.6%) patients underwent minimally invasive surgery and 274 (87.8%) patients open surgery. At 4.5 years, DFS was 85.0% in the minimally invasive group and 96% in the open group (difference of –11.1; 95% CI, –15.8 to –6.3; P = .95 for noninferiority). Minimally invasive surgery was associated with lower rate of DFS compared with open surgery (hazard ratio [HR], 3.91 [95% CI, 2.02 to 7.58]; P < .001). Rate of overall survival at 4.5 years was 90.6% versus 96.2% for the minimally invasive and open surgery groups, respectively (HR for death of any cause = 2.71 [95% CI, 1.32 to 5.59]; P = .007). Given higher recurrence rate and worse overall survival with minimally invasive surgery, an open approach should be standard of care.

Author Affiliations

1Department of Obstetrics and Gynecology, Houston, Methodist Hospital, Houston, TX; 2NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia; 3Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX; 4Clínica de Oncología Astorga, Medellín, Colombia; 5Instituto Nacional de Cancerología, Bogotá, Colombia; 7Departament of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru; 8First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China; 9Department of Oncological Gynecology, National Institute of Cancerology, Mexico City, Mexico; 10Department of Gynecologic Oncology, Hospital Israelita Albert Einstein, Sao Paolo, Brazil; 11Department of Obstetrics and Gynecology, University of Toronto, Toronto, ON, Canada; 12Queensland Centre for Gynaecological Cancer Research, The University of Queensland, St Lucia, QLD, Australia; 13Vaniam Group, Chicago, IL

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