As reported in The Lancet Oncology by Michael Frumovitz, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues, there were no significant differences in quality of life, a secondary endpoint, for women undergoing open vs minimally invasive radical hysterectomy for cervical cancer in the phase III LACC trial.1 There were, however, differences in disease-free survival, the primary endpoint, and recurrence rates, both of which favored open radical hysterectomy.
As stated by the investigators: “In the phase III LACC trial and a subsequent population-level review, minimally invasive radical hysterectomy was shown to be associated with worse disease-free survival and higher recurrence rates than…open radical hysterectomy in patients with early-stage cervical cancer.”
Michael Frumovitz, MD
Study Details
In the noninferiority trial, 631 patients were randomly assigned between January 2008 and June 2017 to undergo open (n = 312) or minimally invasive (n = 319) surgery. Assessment of quality of life included the Functional Assessment of Cancer Therapy–Cervical (FACT-Cx), which was administered before surgery and at 1 and 6 weeks, 3 months, and 6 months after surgery (and at additional timepoints up to 54 months after surgery). The current analysis reported outcomes on the FACT-Cx at up to 3 months. Differences in quality of life over time between treatment groups were assessed in the modified intention-to-treat population, which included all patients who had surgery and completed at least one baseline and one follow-up questionnaire.
Key Findings
A total of 244 patients (78%) in the open-surgery group and 252 patients (79%) in the minimally invasive–surgery group were included in the analysis.
At baseline, there was no differences in the mean FACT-Cx total score between the open-surgery group and the minimally invasive–surgery group (129.3 vs 129.8). No differences in mean FACT-Cx total scores were observed between groups at 6 weeks after surgery (128.7 vs 130.0) or at 3 months after surgery (132.0 vs 133.0).
No significant differences were observed between groups in proportions of patients with at least 5% (36% vs 32%, P = .66) or at least 10% (18% vs 15%) improvement in FACT-Cx total scores at 6 weeks, and no significant differences were observed between groups in proportions of patients with at least 5% (39% vs 43%, P = .62) or at least 10% (23% vs 21%, P = .83) improvement in FACT-Cx total scores at 3 months.
The investigators concluded: “Since recurrence rates are higher and disease-free survival is lower for minimally invasive radical hysterectomy than for open surgery, and postoperative quality of life is similar between the treatment groups, gynecologic oncologists should recommend open radical hysterectomy for patients with early-stage cervical cancer.”
Disclosure: The study was funded by The University of Texas MD Anderson Cancer Center and Medtronic. For full disclosures of the study authors, visit thelancet.com.
REFERENCE
1. Frumovitz M, Obermair A, Coleman RL, et al: Quality of life in patients with cervical cancer after open versus minimally invasive radical hysterectomy (LACC): A secondary outcome of a multicentre, randomised, open-label, phase 3, non-inferiority trial. Lancet Oncol 21:851-860, 2020.
