Andreas Obermair1, Rebecca Asher2, Rene Pareja3, Michael Frumovitz4, Aldo Lopez5, Renato Moretti-Marques6, Gabriel Rendon7, Reitan Ribeiro8, Audrey Tsunoda8, Vanessa Behan9, Alessandro Buda10, Marcus Q Bernadini11, Hongqin Zhao12, Marcelo Vieira13, Joan Walker14, Nick M Spirtos15, Shuzhong Yao16, Naven Chetty17, Tao Zhu18, David Isla19, Mariano Tamura6, James Nicklin20, Kristy P Robledo2, Val Gebski2, Robert L Coleman4, Gloria Salvo4, Pedro T Ramirez4. 1. Queensland Centre for Gynaecological Cancer Research, University of Queensland, Centre for Clinical Research, RBWH, Herston, QLD Australia. Electronic address: Obermair@powerup.com.au. 2. National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Camperdown, Sydney, NSW Australia. 3. Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogotá and Clínica de Oncología Astorga, Medellín, Colombia. 4. Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. 5. Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru. 6. Gynecologic Oncology Division, Oncologic Center, Hospital Israelita Albert Einstein, São Paulo-SP, Brazil. 7. Instituto de Cancerologia-Las Americas, Medellín, Colombia. 8. Department of Surgery, Erasto Gaertner Hospital, Curitiba, Brazil. 9. Queensland Centre for Gynaecological Cancer Research, University of Queensland, Centre for Clinical Research, RBWH, Herston, QLD Australia. 10. Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza MB, Italy. 11. Department of Gynecologic Oncology, Princess Margaret Cancer Center, Ontario, Canada. 12. Department of Gynecology, First Affiliated Hospital of Wenzhou Medical College, Ouhai, Wenzhou, China. 13. Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos, Brazil. 14. Department of Gynecologic Oncology, Stephenson Cancer Center, University of Oklahoma, Norman, OK. 15. Division of Gynecologic Oncology, Women's Cancer Center of Nevada, LV. 16. Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China. 17. Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane, QLD, Australia. 18. Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China. 19. Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico. 20. Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital and The University of Queensland, Brisbane, QLD, Australia.
Abstract
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%) underwentminimally 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. Crown
RCT Entities:
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 IB1cervical 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. Crown
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