Many ESGO members and our colleagues worldwide have been expecting to hear ESGO’s response after the New England Journal of Medicine papers challenged the role of minimal invasive surgery in early cervical cancer, an approach which was, until now, favoured in the ESGO guidelines. The ESGO Council has deliberated on this and, after extensive internal discussion, unanimously supports the statement revising our recommendation that is released below.
The statement reflects our intent to reconcile several priorities: We must take into account the available level-one evidence, fully inform the patients, avoid industry- or technology-driven positions, and, at the same time, encourage investigation into possible ways to overcome the flaws of the minimal access approach and into the definition of sub-groups of patients to which the approach could be safely offered. A forthcoming oral presentation at the 2019 ASCO meeting is an example (see the abstract here).
Interestingly, a Swedish study will be published soon in the European Journal of Cancer. A new international randomised controlled study is also ongoing. Other data from Germany and Korea will be available in the near future. We also await with great interest the results of the ongoing European retrospective cohort study led by Luis Chiva. Over 150 participating centres from 36 countries have volunteered.
We can predict that this statement will not meet unanimous approval and that it may have to be revised in the future. The message is that we believe it is hasty to ban minimal access surgery; however, its use must be strictly monitored, and we must not forget that the key issue is radicality.
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Updated recommendation: Open approach is the gold standard
A randomised study by Ramirez et al. and an epidemiological study by Melamed et al. (1–2), found that the minimal invasive surgery approach for radical hysterectomy for cervical cancer is associated with shorter disease-free and overall survival than open surgery. These findings were confirmed in a recent population-based survey in England (3). In light of the results obtained by these studies, the ESGO Scientific Committee and Council herewith issue a statement that the current ESGO recommendation regarding the approach for radical surgery for cervical cancer (“Minimal invasive approach is favoured” (4)) is no longer valid and should be removed and replaced by “Open approach is the gold standard”.
ESGO suggests that all minimally invasive surgical procedures for cervical cancer be prospectively recorded, including tumour characteristics and technical details, and performed only in highly specialised centres by appropriately trained surgeons. If minimal access surgery is offered and accepted by the patient, every effort should be made to avoid spillage of tumour cells in the peritoneal cavity (e.g., avoiding crushing lymph nodes, banning vaginal or uterine manipulators, and closing the vaginal cuff in order to avoid any contact between tumour and peritoneal cavity). Patients must be informed about the available prospective and retrospective evidence on survival, complications, and quality of life relating to the two surgical approaches.
As the reasons for the observed overall detrimental effect of minimal access surgery are not clear, and as the available research was not designed to identify subgroups potentially amenable to minimal access surgery and/or to investigate the preventive effect of the above-mentioned precautions, another trial, incorporating specific precautions and strictly defined quality-assurance criteria, should be developed.
Denis Querleu, David Cibula, Nicole Concin, Anna Fagotti, Annamaria Ferrero, Christina Fotopoulou, Pawel Knapp, Dina Kurdiani, Jonathan Ledermann, Mansoor Mirza, Philippe Morice, Jordi Ponce, Elzbieta van der Steen, Cagatay Taskiran, Pauline Wimberger, Kamil Zalewski, Cristiana Sessa
May 27, 2019
1. Ramirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, et al. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. New Eng J Med. 2018 ; 379:1895-1904
2. Melamed A, Margul DJ, Chen L, Keating NL, Del Carmen MG, Yang J, et al. Survival after Minimally Invasive Radical Hysterectomy for Early-Stage Cervical Cancer. New Eng J Med . 2018 ; 379:1905-1914
4. Cibula D, Potter R, Planchamp F, Avall-Lundqvist E, Fischerova D, Haie Meder C, et al. The European Society of Gynaecological Oncology/European Society for Radiotherapy and Oncology/European Society of Pathology Guidelines for the Management of Patients With Cervical Cancer. Int J Gynecol Cancer. 2018;28:641-655
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The European Society of Gynaecological Oncology (ESGO) is the leading European organisation with more than 2,500 professionals involved in treatment, care and research of gynaecologic cancers.
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