Completion of radical hysterectomy does not improve survival of patients with cervical cancer and intraoperatively detected lymph node involvement: ABRAX international retrospective cohort study.

Cervical cancer Pelvic lymphadenectomy Radical hysterectomy Radical hysterectomy abandonment Radical hysterectomy completion

Journal

European journal of cancer (Oxford, England : 1990)
ISSN: 1879-0852
Titre abrégé: Eur J Cancer
Pays: England
ID NLM: 9005373

Informations de publication

Date de publication:
01 2021
Historique:
received: 15 09 2020
revised: 12 10 2020
accepted: 28 10 2020
pubmed: 9 12 2020
medline: 24 4 2021
entrez: 8 12 2020
Statut: ppublish

Résumé

The management of cervical cancer patients with intraoperative detection of lymph node involvement remains controversial. Since all these patients are referred for (chemo)radiation after the surgery, the key decision is whether radical hysterectomy should be completed as originally planned, taking into account an additional morbidity associated with extensive surgical dissection prior to adjuvant treatment. The ABRAX study investigated whether completing a radical uterine procedure is associated with an improved oncological outcome of such patients. We performed retrospective analyses of 515 cervical cancer patients (51 institutions, 19 countries) who were referred for primary curative surgery between 2005 and 2015 (stage IA-IIB, common tumour types) in whom lymph node involvement was detected intraoperatively. Patients were stratified according to whether the planned uterine surgery was completed (COMPL group, N = 361) or abandoned (ABAND group, N = 154) to compare progression-free survival. Definitive chemoradiation was given to 92.9% patients in the ABAND group and adjuvant (chemo)radiation or chemotherapy to 91.4% of patients in the COMPL group. The risks of recurrence (hazard ratio [HR] 1.154, 95% confidence intervals [CI] 0.799-1.666, P = 0.45), pelvic recurrence (HR 0.836, 95% CI 0.458-1.523, P = 0.56), or death (HR 1.064, 95% CI 0.690-1.641, P = 0.78) were not significantly different between the two groups. No subgroup showed a survival benefit from completing radical hysterectomy. Disease-free survival reached 74% (381/515), with a median follow-up of 58 months. Prognostic factors were balanced between the two groups. FIGO stage and number of pelvic lymph nodes involved were significant prognostic factors in the whole study cohort. We showed that the completion of radical hysterectomy does not improve survival in patients with intraoperatively detected lymph node involvement, regardless of tumour size or histological type. If lymph node involvement is confirmed intraoperatively, abandoning uterine radical procedure should be considered, and the patient should be referred for definitive chemoradiation. NCT04037124.

Sections du résumé

BACKGROUND
The management of cervical cancer patients with intraoperative detection of lymph node involvement remains controversial. Since all these patients are referred for (chemo)radiation after the surgery, the key decision is whether radical hysterectomy should be completed as originally planned, taking into account an additional morbidity associated with extensive surgical dissection prior to adjuvant treatment. The ABRAX study investigated whether completing a radical uterine procedure is associated with an improved oncological outcome of such patients.
PATIENTS AND METHODS
We performed retrospective analyses of 515 cervical cancer patients (51 institutions, 19 countries) who were referred for primary curative surgery between 2005 and 2015 (stage IA-IIB, common tumour types) in whom lymph node involvement was detected intraoperatively. Patients were stratified according to whether the planned uterine surgery was completed (COMPL group, N = 361) or abandoned (ABAND group, N = 154) to compare progression-free survival. Definitive chemoradiation was given to 92.9% patients in the ABAND group and adjuvant (chemo)radiation or chemotherapy to 91.4% of patients in the COMPL group.
RESULTS
The risks of recurrence (hazard ratio [HR] 1.154, 95% confidence intervals [CI] 0.799-1.666, P = 0.45), pelvic recurrence (HR 0.836, 95% CI 0.458-1.523, P = 0.56), or death (HR 1.064, 95% CI 0.690-1.641, P = 0.78) were not significantly different between the two groups. No subgroup showed a survival benefit from completing radical hysterectomy. Disease-free survival reached 74% (381/515), with a median follow-up of 58 months. Prognostic factors were balanced between the two groups. FIGO stage and number of pelvic lymph nodes involved were significant prognostic factors in the whole study cohort.
CONCLUSION
We showed that the completion of radical hysterectomy does not improve survival in patients with intraoperatively detected lymph node involvement, regardless of tumour size or histological type. If lymph node involvement is confirmed intraoperatively, abandoning uterine radical procedure should be considered, and the patient should be referred for definitive chemoradiation.
CLINICAL TRIALS IDENTIFIER
NCT04037124.

Identifiants

pubmed: 33290995
pii: S0959-8049(20)31326-5
doi: 10.1016/j.ejca.2020.10.037
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT04037124']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

88-100

Informations de copyright

Copyright © 2020 Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of interest statement The authors declare that there are no conflicts of interest.

Auteurs

D Cibula (D)

Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital (Central and Eastern European Gynecologic Oncology Group, CEEGOG), Prague, Czech Republic. Electronic address: dc@davidcibula.cz.

L Dostalek (L)

Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital (Central and Eastern European Gynecologic Oncology Group, CEEGOG), Prague, Czech Republic.

P Hillemanns (P)

Department of Gynaecology and Obstetrics, Medical University Hannover, Hannover, Germany.

G Scambia (G)

Comprehensive Oncology Gynecology Operational Unit, Fondazione Policlinico Gemelli IRCCS (Italian Gynecological Oncology Group, MITO), Rome, Italy.

J Jarkovsky (J)

Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic.

J Persson (J)

Department of Obstetrics and Gynecology, Skåne University Hospital, Lund, Faculty of Medicine, Clinical Sciences, Lund University, Sweden.

F Raspagliesi (F)

Fondazione IRCCS Instituto Nazionale Tumori (Italian Gynecological Oncology Group, MITO), Milan, Italy.

Z Novak (Z)

Department of Gynecology, National Institute of Oncology (Central and Eastern European Gynecologic Oncology Group, CEEGOG), Budapest, Hungary.

A Jaeger (A)

University Medical Center Hamburg-Eppendorf (German Gynecological Oncology Group, AGO), Hamburg, Germany.

M E Capilna (ME)

First Obstetrics and Gynecology Clinic, University of Medicine and Pharmacy Targu Mures (Central and Eastern European Gynecologic Oncology Group, CEEGOG), Targu Mures, Romania.

V Weinberger (V)

Department of Gynecology and Obstetrics, Faculty of Medicine, Masaryk University (Central and Eastern European Gynecologic Oncology Group, CEEGOG), Brno, Czech Republic.

J Klat (J)

Department of Obstetrics and Gynecology, University Hospital Ostrava (Central and Eastern European Gynecologic Oncology Group, CEEGOG), Ostrava Poruba, Czech Republic.

R L Schmidt (RL)

Gynecologic Oncology Department, Barretos Cancer Hospital, Barretos, Brazil.

A Lopez (A)

Department of Gynecological Surgery, National Institute of Neoplastic Diseases, Lima, Peru.

G Scibilia (G)

Cannizzaro Hospital (Italian Gynecological Oncology Group, MITO), Catania, Italy.

R Pareja (R)

National Institute of Cancerology, Bogotá. Professor Universidad Pontificia Bolivariana, Medellín, Colombia.

A Kucukmetin (A)

Northern Gynaecological Oncology Centre, Queen Elizabeth Hospital, Gateshead, United Kingdom.

L Kreitner (L)

Gynecology Cancer Center, St. Franzis Hospital Munster (German Gynecological Oncology Group, AGO), Munster, Germany.

A El-Balat (A)

University Clinic Frankfurt, Goethe-University (German Gynecological Oncology Group, AGO), Frankfurt, Germany.

G J R Pereira (GJR)

Gynecology Oncology Department, Institute of Cancerology - Las Americas, Clinic Medellin, Medellin, Colombia.

S Laufhütte (S)

Department of Obstetrics and Gynecology, District Hospital Altotting (German Gynecological Oncology Group, AGO), Altotting, Germany.

D Isla-Ortiz (D)

Gynecology Oncology Center, National Institute of Cancerology Mexico, Mexico.

T Toptas (T)

Department of Gynecologic Oncology, Saglik Bilimleri University Antalya Research and Training Hospital, Antalya, Turkey.

B Gil-Ibanez (B)

Unit of Gynaecological Oncology, Institute Clinic of Gynaecology, Obstetrics, and Neonatology (ICGON), Barcelona, Spain.

I Vergote (I)

Department of Gynecology and Obstetrics, University Hospital Leuven, Leuven Cancer Institute (Belgium and Luxembourg Gynaecological Oncology Group, BGOG), Leuven, Belgium.

I Runnenbaum (I)

Department of Gynecology and Reproductive Medicine, Jena University Hospital, Friedrich Schiller University (German Gynecological Oncology Group, AGO), Jena, Germany.

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