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Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer & Survival after Minimally Invasive Radical Hysterectomy for Early-Stage and stage IA2 or IB1Cervical Cancer 

16-11-2018 12:09

Read the two abstracts from the NEJM

Abstract 1:

Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer

Pedro T. Ramirez, M.D., Michael Frumovitz, M.D., Rene Pareja, M.D., Aldo Lopez, M.D., Marcelo Vieira, M.D., Reitan Ribeiro, M.D., Alessandro Buda, M.D., Xiaojian Yan, M.D., Yao Shuzhong, M.D., Naven Chetty, M.D., David Isla, M.D., Mariano Tamura, M.D., et al.

BACKGROUND

There are limited data from retrospective studies regarding whether survival outcomes after laparoscopic or robot-assisted radical hysterectomy (minimally invasive surgery) are equivalent to those after open abdominal radical hysterectomy (open surgery) among women with early-stage cervical cancer.

METHODS

In this trial involving patients with stage IA1 (lymphovascular invasion), IA2, or IB1 cervical cancer and a histologic subtype of squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, we randomly assigned patients to undergo minimally invasive surgery or open surgery. The primary outcome was the rate of disease-free survival at 4.5 years, with noninferiority claimed if the lower boundary of the two-sided 95% confidence interval of the between-group difference (minimally invasive surgery minus open surgery) was greater than −7.2 percentage points (i.e., closer to zero).

RESULTS

A total of 319 patients were assigned to minimally invasive surgery and 312 to open surgery. Of the patients who were assigned to and underwent minimally invasive surgery, 84.4% underwent laparoscopy and 15.6% robot-assisted surgery. Overall, the mean age of the patients was 46.0 years. Most patients (91.9%) had stage IB1 disease. The two groups were similar with respect to histologic subtypes, the rate of lymphovascular invasion, rates of parametrial and lymph-node involvement, tumor size, tumor grade, and the rate of use of adjuvant therapy. The rate of disease-free survival at 4.5 years was 86.0% with minimally invasive surgery and 96.5% with open surgery, a difference of −10.6 percentage points (95% confidence interval [CI], −16.4 to −4.7). Minimally invasive surgery was associated with a lower rate of disease-free survival than open surgery (3-year rate, 91.2% vs. 97.1%; hazard ratio for disease recurrence or death from cervical cancer, 3.74; 95% CI, 1.63 to 8.58), a difference that remained after adjustment for age, body-mass index, stage of disease, lymphovascular invasion, and lymph-node involvement; minimally invasive surgery was also associated with a lower rate of overall survival (3-year rate, 93.8% vs. 99.0%; hazard ratio for death from any cause, 6.00; 95% CI, 1.77 to 20.30).

CONCLUSIONS

In this trial, minimally invasive radical hysterectomy was associated with lower rates of disease-free survival and overall survival than open abdominal radical hysterectomy among women with early-stage cervical cancer. (Funded by the University of Texas M.D. Anderson Cancer Center and Medtronic; LACC ClinicalTrials.gov number, NCT00614211.)

Supported by a departmental research fund in the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, and by a grant from Medtronic.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article was published on October 31, 2018, at NEJM.org.

 

Abstract 2:

Survival after Minimally Invasive Radical Hysterectomy for Early-Stage Cervical Cancer

Alexander Melamed, M.D., M.P.H., Daniel J. Margul, M.D., Ph.D., Ling Chen, M.D, M.P.H., Nancy L. Keating, M.D., M.P.H., Marcela G. del Carmen, M.D., M.P.H., Junhua Yang, M.S., Brandon-Luke L. Seagle, M.D., Amy Alexander, M.D., Emma L. Barber, M.D., Laurel W. Rice, M.D., Jason D. Wright, M.D., Masha Kocherginsky, Ph.D., et al.

BACKGROUND

There are limited data from retrospective studies regarding whether survival outcomes after laparoscopic or robot-assisted radical hysterectomy (minimally invasive surgery) are equivalent to those after open abdominal radical hysterectomy (open surgery) among women with early-stage cervical cancer.

METHODS

In this trial involving patients with stage IA1 (lymphovascular invasion), IA2, or IB1 cervical cancer and a histologic subtype of squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, we randomly assigned patients to undergo minimally invasive surgery or open surgery. The primary outcome was the rate of disease-free survival at 4.5 years, with noninferiority claimed if the lower boundary of the two-sided 95% confidence interval of the between-group difference (minimally invasive surgery minus open surgery) was greater than −7.2 percentage points (i.e., closer to zero).

RESULTS

A total of 319 patients were assigned to minimally invasive surgery and 312 to open surgery. Of the patients who were assigned to and underwent minimally invasive surgery, 84.4% underwent laparoscopy and 15.6% robot-assisted surgery. Overall, the mean age of the patients was 46.0 years. Most patients (91.9%) had stage IB1 disease. The two groups were similar with respect to histologic subtypes, the rate of lymphovascular invasion, rates of parametrial and lymph-node involvement, tumor size, tumor grade, and the rate of use of adjuvant therapy. The rate of disease-free survival at 4.5 years was 86.0% with minimally invasive surgery and 96.5% with open surgery, a difference of −10.6 percentage points (95% confidence interval [CI], −16.4 to −4.7). Minimally invasive surgery was associated with a lower rate of disease-free survival than open surgery (3-year rate, 91.2% vs. 97.1%; hazard ratio for disease recurrence or death from cervical cancer, 3.74; 95% CI, 1.63 to 8.58), a difference that remained after adjustment for age, body-mass index, stage of disease, lymphovascular invasion, and lymph-node involvement; minimally invasive surgery was also associated with a lower rate of overall survival (3-year rate, 93.8% vs. 99.0%; hazard ratio for death from any cause, 6.00; 95% CI, 1.77 to 20.30).

CONCLUSIONS

In this trial, minimally invasive radical hysterectomy was associated with lower rates of disease-free survival and overall survival than open abdominal radical hysterectomy among women with early-stage cervical cancer. (Funded by the University of Texas M.D. Anderson Cancer Center and Medtronic; LACC ClinicalTrials.gov number, NCT00614211.)

Supported by a departmental research fund in the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, and by a grant from Medtronic.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article was published on October 31, 2018, at NEJM.org.

 

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