TY - JOUR
T1 - Recurrence and survival after laparoscopy versus laparotomy without lymphadenectomy in early-stage endometrial cancer
T2 - Long-term outcomes of a randomised trial
AU - Reijntjes, Bianca
AU - van Suijlichem, Mieke
AU - Woolderink, Jorien M.
AU - Bongers, Marlies Y.
AU - Reesink-Peters, Nathalie
AU - Paulsen, Lasse
AU - van der Hurk, Pieter J.
AU - Kraayenbrink, Arjan A.
AU - Apperloo, Mirjam J.A.
AU - Slangen, Brigitte
AU - Schukken, Tineke
AU - Tummers, Fokkedien H.M.P.
AU - van Kesteren, Paul J.M.
AU - Huirne, Judith A.F.
AU - Boskamp, Dieuwke
AU - Lunter, Gerton
AU - de Bock, Geertruida H.
AU - Mourits, Marian J.E.
N1 - Funding Information: We thank all patient who participated in the original TLH-TAH trial, and therefore, in this trial. We thank Dr. Robert Sykes (www.doctored.org.uk) for providing editorial support. Publisher Copyright: © 2021 Elsevier Inc.
PY - 2021
Y1 - 2021
N2 - Background: Laparoscopic hysterectomy is accepted worldwide as the standard treatment option for early-stage endometrial cancer. However, there are limited data on long-term survival, particularly when no lymphadenectomy is performed. We compared the survival outcomes of total laparoscopic hysterectomy (TLH) and total abdominal hysterectomy (TAH), both without lymphadenectomy, for early-stage endometrial cancer up to 5 years postoperatively. Methods: Follow-up of a multi-centre, randomised controlled trial comparing TLH and TAH, without routine lymphadenectomy, for women with stage I endometrial cancer. Enrolment was between 2007 and 2009 by 2:1 randomisation to TLH or TAH. Outcomes were disease-free survival (DFS), overall survival (OS), disease-specific survival (DSS), and primary site of recurrence. Multivariable Cox regression analyses were adjusted for age, stage, grade, and radiotherapy with adjusted hazard ratios (aHR) and 95% confidence intervals (95%CI) reported. To test for significance, non-inferiority margins were defined. Results: In total, 279 women underwent a surgical procedure, of whom 263 (94%) had follow-up data. For the TLH (n = 175) and TAH (n = 88) groups, DFS (90.3% vs 84.1%; aHR[recurrence], 0.69; 95%CI, 0.31–1.52), OS (89.2% vs 82.8%; aHR[death], 0.60; 95%CI, 0.30–1.19), and DSS (95.0% vs 89.8%; aHR[death], 0.62; 95%CI, 0.23–1.70) were reported at 5 years. At a 10% significance level, and with a non-inferiority margin of 0.20, the null hypothesis of inferiority was rejected for all three outcomes. There were no port-site or wound metastases, and local recurrence rates were comparable. Conclusion: Disease recurrence and 5-year survival rates were comparable between the TLH and TAH groups and comparable to studies with lymphadenectomy, supporting the widespread use of TLH without lymphadenectomy as the primary treatment for early-stage, low-grade endometrial cancer.
AB - Background: Laparoscopic hysterectomy is accepted worldwide as the standard treatment option for early-stage endometrial cancer. However, there are limited data on long-term survival, particularly when no lymphadenectomy is performed. We compared the survival outcomes of total laparoscopic hysterectomy (TLH) and total abdominal hysterectomy (TAH), both without lymphadenectomy, for early-stage endometrial cancer up to 5 years postoperatively. Methods: Follow-up of a multi-centre, randomised controlled trial comparing TLH and TAH, without routine lymphadenectomy, for women with stage I endometrial cancer. Enrolment was between 2007 and 2009 by 2:1 randomisation to TLH or TAH. Outcomes were disease-free survival (DFS), overall survival (OS), disease-specific survival (DSS), and primary site of recurrence. Multivariable Cox regression analyses were adjusted for age, stage, grade, and radiotherapy with adjusted hazard ratios (aHR) and 95% confidence intervals (95%CI) reported. To test for significance, non-inferiority margins were defined. Results: In total, 279 women underwent a surgical procedure, of whom 263 (94%) had follow-up data. For the TLH (n = 175) and TAH (n = 88) groups, DFS (90.3% vs 84.1%; aHR[recurrence], 0.69; 95%CI, 0.31–1.52), OS (89.2% vs 82.8%; aHR[death], 0.60; 95%CI, 0.30–1.19), and DSS (95.0% vs 89.8%; aHR[death], 0.62; 95%CI, 0.23–1.70) were reported at 5 years. At a 10% significance level, and with a non-inferiority margin of 0.20, the null hypothesis of inferiority was rejected for all three outcomes. There were no port-site or wound metastases, and local recurrence rates were comparable. Conclusion: Disease recurrence and 5-year survival rates were comparable between the TLH and TAH groups and comparable to studies with lymphadenectomy, supporting the widespread use of TLH without lymphadenectomy as the primary treatment for early-stage, low-grade endometrial cancer.
KW - Endometrial cancer
KW - Hysterectomy
KW - Laparoscopic surgery
KW - Laparotomy
KW - Lymphadenectomy
KW - Recurrence
KW - Survival
UR - http://www.scopus.com/inward/record.url?scp=85121762285&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.ygyno.2021.12.019
DO - https://doi.org/10.1016/j.ygyno.2021.12.019
M3 - Article
C2 - 34955237
SN - 0090-8258
JO - Gynecologic Oncology
JF - Gynecologic Oncology
ER -