Recurrence and survival after laparoscopy versus laparotomy without lymphadenectomy in early-stage endometrial cancer: Long-term outcomes of a randomised trial

Bianca Reijntjes; Mieke van Suijlichem; Jorien M Woolderink; Marlies Y Bongers; Nathalie Reesink-Peters; Lasse Paulsen; Pieter J van der Hurk; Arjan A Kraayenbrink; Mirjam J A Apperloo; Brigitte Slangen; Tineke Schukken; Fokkedien H M P Tummers; Paul J M van Kesteren; Judith A F Huirne; Dieuwke Boskamp; Gerton Lunter; Geertruida H de Bock; Marian J E Mourits

doi:10.1016/j.ygyno.2021.12.019

Recurrence and survival after laparoscopy versus laparotomy without lymphadenectomy in early-stage endometrial cancer: Long-term outcomes of a randomised trial

Bianca Reijntjes, Mieke van Suijlichem, Jorien M Woolderink, Marlies Y Bongers, Nathalie Reesink-Peters, Lasse Paulsen, Pieter J van der Hurk, Arjan A Kraayenbrink, Mirjam J A Apperloo, Brigitte Slangen, Tineke Schukken, Fokkedien H M P Tummers, Paul J M van Kesteren, Judith A F Huirne, Dieuwke Boskamp, Gerton Lunter, Geertruida H de Bock, Marian J E Mourits^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Pages (from-to)	265-270
Number of pages	6
Journal	Gynecologic Oncology
Volume	164
Issue number	2
DOIs	https://doi.org/10.1016/j.ygyno.2021.12.019
Publication status	Published - Feb 2022

Keywords

Adult
Aged
Aged, 80 and over
Carcinoma, Endometrioid/mortality
Disease-Free Survival
Endometrial Neoplasms/mortality
Female
Humans
Hysterectomy/methods
Laparoscopy/methods
Laparotomy/methods
Lymph Node Excision
Middle Aged
Neoplasm Grading
Neoplasm Recurrence, Local/epidemiology
Neoplasm Staging
Radiotherapy, Adjuvant
SURGERY
Recurrence
Endometrial cancer
Lymphadenectomy
RADIOTHERAPY
Laparoscopic surgery
Hysterectomy
Laparotomy
CARCINOMA

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10.1016/j.ygyno.2021.12.019

Cite this

Reijntjes, B., van Suijlichem, M., Woolderink, J. M., Bongers, M. Y., Reesink-Peters, N., Paulsen, L., van der Hurk, P. J., Kraayenbrink, A. A., Apperloo, M. J. A., Slangen, B., Schukken, T., Tummers, F. H. M. P., van Kesteren, P. J. M., Huirne, J. A. F., Boskamp, D., Lunter, G., de Bock, G. H., & Mourits, M. J. E. (2022). Recurrence and survival after laparoscopy versus laparotomy without lymphadenectomy in early-stage endometrial cancer: Long-term outcomes of a randomised trial. Gynecologic Oncology, 164(2), 265-270. https://doi.org/10.1016/j.ygyno.2021.12.019

@article{f73d0a07fa344ae8b8db7daf90bc0e29,

title = "Recurrence and survival after laparoscopy versus laparotomy without lymphadenectomy in early-stage endometrial cancer: Long-term outcomes of a randomised trial",

abstract = "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.",

keywords = "Adult, Aged, Aged, 80 and over, Carcinoma, Endometrioid/mortality, Disease-Free Survival, Endometrial Neoplasms/mortality, Female, Humans, Hysterectomy/methods, Laparoscopy/methods, Laparotomy/methods, Lymph Node Excision, Middle Aged, Neoplasm Grading, Neoplasm Recurrence, Local/epidemiology, Neoplasm Staging, Radiotherapy, Adjuvant, SURGERY, Recurrence, Endometrial cancer, Lymphadenectomy, RADIOTHERAPY, Laparoscopic surgery, Hysterectomy, Laparotomy, CARCINOMA",

author = "Bianca Reijntjes and {van Suijlichem}, Mieke and Woolderink, {Jorien M} and Bongers, {Marlies Y} and Nathalie Reesink-Peters and Lasse Paulsen and {van der Hurk}, {Pieter J} and Kraayenbrink, {Arjan A} and Apperloo, {Mirjam J A} and Brigitte Slangen and Tineke Schukken and Tummers, {Fokkedien H M P} and {van Kesteren}, {Paul J M} and Huirne, {Judith A F} and Dieuwke Boskamp and Gerton Lunter and {de Bock}, {Geertruida H} and Mourits, {Marian J E}",

year = "2022",

month = feb,

doi = "10.1016/j.ygyno.2021.12.019",

language = "English",

volume = "164",

pages = "265--270",

journal = "Gynecologic Oncology",

issn = "0090-8258",

publisher = "Elsevier Science",

number = "2",

}

Reijntjes, B, van Suijlichem, M, Woolderink, JM, Bongers, MY, Reesink-Peters, N, Paulsen, L, van der Hurk, PJ, Kraayenbrink, AA, Apperloo, MJA, Slangen, B, Schukken, T, Tummers, FHMP, van Kesteren, PJM, Huirne, JAF, Boskamp, D, Lunter, G, de Bock, GH & Mourits, MJE 2022, 'Recurrence and survival after laparoscopy versus laparotomy without lymphadenectomy in early-stage endometrial cancer: Long-term outcomes of a randomised trial', Gynecologic Oncology, vol. 164, no. 2, pp. 265-270. https://doi.org/10.1016/j.ygyno.2021.12.019

Recurrence and survival after laparoscopy versus laparotomy without lymphadenectomy in early-stage endometrial cancer: Long-term outcomes of a randomised trial. / Reijntjes, Bianca; van Suijlichem, Mieke; Woolderink, Jorien M et al.
In: Gynecologic Oncology, Vol. 164, No. 2, 02.2022, p. 265-270.

Research output: Contribution to journal › Article › Academic › peer-review

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

PY - 2022/2

Y1 - 2022/2

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 - Adult

KW - Aged

KW - Aged, 80 and over

KW - Carcinoma, Endometrioid/mortality

KW - Disease-Free Survival

KW - Endometrial Neoplasms/mortality

KW - Female

KW - Humans

KW - Hysterectomy/methods

KW - Laparoscopy/methods

KW - Laparotomy/methods

KW - Lymph Node Excision

KW - Middle Aged

KW - Neoplasm Grading

KW - Neoplasm Recurrence, Local/epidemiology

KW - Neoplasm Staging

KW - Radiotherapy, Adjuvant

KW - SURGERY

KW - Recurrence

KW - Endometrial cancer

KW - Lymphadenectomy

KW - RADIOTHERAPY

KW - Laparoscopic surgery

KW - Hysterectomy

KW - Laparotomy

KW - CARCINOMA

U2 - 10.1016/j.ygyno.2021.12.019

DO - 10.1016/j.ygyno.2021.12.019

M3 - Article

C2 - 34955237

SN - 0090-8258

VL - 164

SP - 265

EP - 270

JO - Gynecologic Oncology

JF - Gynecologic Oncology

IS - 2

ER -