TY - JOUR
T1 - Incidence of adverse events in minimally invasive vs open radical hysterectomy in early cervical cancer
T2 - results of a randomized controlled trial
AU - Obermair, Andreas
AU - Asher, Rebecca
AU - Pareja, Rene
AU - Frumovitz, Michael
AU - Lopez, Aldo
AU - Moretti-Marques, Renato
AU - Rendon, Gabriel
AU - Ribeiro, Reitan
AU - Tsunoda, Audrey
AU - Behan, Vanessa
AU - Buda, Alessandro
AU - Bernadini, Marcus Q.
AU - Zhao, Hongqin
AU - Vieira, Marcelo
AU - Walker, Joan
AU - Spirtos, Nick M.
AU - Yao, Shuzhong
AU - Chetty, Naven
AU - Zhu, Tao
AU - Isla, David
AU - Tamura, Mariano
AU - Nicklin, James
AU - Robledo, Kristy P.
AU - Gebski, Val
AU - Coleman, Robert L.
AU - Salvo, Gloria
AU - Ramirez, Pedro T.
N1 - Funding Information:
Supported by the National Cancer Institute under award number P30CA016672, which supports the MD Anderson Cancer Center Clinical Trials Support Resource; by a departmental research fund in the Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center; and by an unrestricted research grant specifically designated to the trial by Medtronic. The grant was used for administrative support and to fund the salary of a clinical trial coordinator. A.O. reports grants, personal fees, and other funding from Surgical Performance PTY LTD (not directly related to the subject of this article) and has a patent licensed to SurgicalPerformance Pty Ltd; M.F. reports grants and personal fees from Stryker (not directly related to the subject of this article); R.R. reports receiving speaker fees from Johnson & Johnson for talks on minimally invasive surgery; R.C. reports grants from the National Institutes of Health, Gateway Foundation, and VFoundation during the conduct of the study; grants and personal fees from AstraZeneca, Clovis, Genmab, Roche/Genentech, and Janssen; a grant from Merck; and personal fees from Tesaro, Medivation, Gamamab, Agenus, Regeneron, and OncoQuest (none of the grants or personal fees were directly related to the submitted article); A.T. reports personal fees from Roche and Astra Zeneca outside the submitted work. All other authors report no conflict of interest.
Publisher Copyright:
© 2019
PY - 2020/3
Y1 - 2020/3
N2 - Background: Standard treatment of early cervical cancer involves a radical hysterectomy and retroperitoneal lymph node dissection. The existing evidence on the incidence of adverse events after minimally invasive vs open radical hysterectomy for early cervical cancer is either nonrandomized or retrospective. Objective: The purpose of this study was to compare the incidence of adverse events after minimally invasive vs open radical hysterectomy for early cervical cancer. Study Design: The Laparoscopic Approach to Carcinoma of the Cervix trial was a multinational, randomized noninferiority trial that was conducted between 2008 and 2017, in which surgeons from 33 tertiary gynecologic cancer centers in 24 countries randomly assigned 631 women with International Federation of Gynecology and Obstetrics 2009 stage IA1 with lymph-vascular invasion to IB1 cervical cancer to undergo minimally invasive (n = 319) or open radical hysterectomy (n = 312). The Laparoscopic Approach to Carcinoma of the Cervix trial was suspended for enrolment in September 2017 because of an increased risk of recurrence and death in the minimally invasive surgery group. Here we report on a secondary outcome measure: the incidence of intra- and postoperative adverse events within 6 months after surgery. Results: Of 631 randomly assigned patients, 536 (85%; mean age, 46.0 years) met inclusion criteria for this analysis; 279 (52%) underwent minimally invasive radical hysterectomy, and 257 (48%) underwent open radical hysterectomy. Of those, 300 (56%), 91 (16.9%), and 69 (12.8%) experienced at least 1 grade ≥2 or ≥3 or a serious adverse event, respectively. The incidence of intraoperative grade ≥2 adverse events was 12% (34/279 patients) in the minimally invasive group vs 10% (26/257) in the open group (difference, 2.1%; 95% confidence interval, –3.3 to 7.4%; P=.45). The overall incidence of postoperative grade ≥2 adverse events was 54% (152/279 patients) in the minimally invasive group vs 48% (124/257) in the open group (difference, 6.2%; 95% confidence interval, –2.2 to 14.7%; P=.14). Conclusion: For early cervical cancer, the use of minimally invasive compared with open radical hysterectomy resulted in a similar overall incidence of intraoperative or postoperative adverse events.
AB - Background: Standard treatment of early cervical cancer involves a radical hysterectomy and retroperitoneal lymph node dissection. The existing evidence on the incidence of adverse events after minimally invasive vs open radical hysterectomy for early cervical cancer is either nonrandomized or retrospective. Objective: The purpose of this study was to compare the incidence of adverse events after minimally invasive vs open radical hysterectomy for early cervical cancer. Study Design: The Laparoscopic Approach to Carcinoma of the Cervix trial was a multinational, randomized noninferiority trial that was conducted between 2008 and 2017, in which surgeons from 33 tertiary gynecologic cancer centers in 24 countries randomly assigned 631 women with International Federation of Gynecology and Obstetrics 2009 stage IA1 with lymph-vascular invasion to IB1 cervical cancer to undergo minimally invasive (n = 319) or open radical hysterectomy (n = 312). The Laparoscopic Approach to Carcinoma of the Cervix trial was suspended for enrolment in September 2017 because of an increased risk of recurrence and death in the minimally invasive surgery group. Here we report on a secondary outcome measure: the incidence of intra- and postoperative adverse events within 6 months after surgery. Results: Of 631 randomly assigned patients, 536 (85%; mean age, 46.0 years) met inclusion criteria for this analysis; 279 (52%) underwent minimally invasive radical hysterectomy, and 257 (48%) underwent open radical hysterectomy. Of those, 300 (56%), 91 (16.9%), and 69 (12.8%) experienced at least 1 grade ≥2 or ≥3 or a serious adverse event, respectively. The incidence of intraoperative grade ≥2 adverse events was 12% (34/279 patients) in the minimally invasive group vs 10% (26/257) in the open group (difference, 2.1%; 95% confidence interval, –3.3 to 7.4%; P=.45). The overall incidence of postoperative grade ≥2 adverse events was 54% (152/279 patients) in the minimally invasive group vs 48% (124/257) in the open group (difference, 6.2%; 95% confidence interval, –2.2 to 14.7%; P=.14). Conclusion: For early cervical cancer, the use of minimally invasive compared with open radical hysterectomy resulted in a similar overall incidence of intraoperative or postoperative adverse events.
KW - LACC
KW - cervical cancer
KW - complication
KW - hysterectomy
KW - laparoscopic hysterectomy
KW - minimally invasive surgery
KW - postoperative adverse event
KW - radical hysterectomy
KW - robotic hysterectomy
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U2 - 10.1016/j.ajog.2019.09.036
DO - 10.1016/j.ajog.2019.09.036
M3 - Article
C2 - 31586602
AN - SCOPUS:85075930403
SN - 0002-9378
VL - 222
SP - 249.e1-249.e10
JO - American Journal of Obstetrics and Gynecology
JF - American Journal of Obstetrics and Gynecology
IS - 3
ER -