Survival of women with early‐stage cervical cancer in the UK treated with minimal access and open surgery

摘要

The recent publication of two papers and an editorial in the New England Journal of Medicine1-3 has caused consternation in the gynaecological oncology community.4, 5 Both papers demonstrate a worse outcome for women undergoing radical hysterectomy by the minimal access route compared with open surgery and so question the dominant paradigm of the last decade that minimal access surgery is the preferred method by which to carry out radical surgery for cervical cancer. These studies raise many questions but the two most pressing are, first, have our patients been disadvantaged by our adoption of minimal access surgery and, second, how do we proceed as a gynaecological oncology community in the face of these data? Route of surgery for radical cervical surgery has been controversial for some time. Attempts to introduce a laparoscopically assisted radical vaginal hysterectomy in the 1990s were abandoned as it was generally felt to be less radical than the open procedure.6 Further developments in laparoscopic technique, however, allowed the development of the total laparoscopic radical hysterectomy, which was introduced in the early part of the twenty-first century.7 This operation has been adopted by many centres and has rapidly become the operation of choice for most surgeons and patients. However, in common with many other surgical procedures, this operation has been introduced on the basis of nonrandomised data, the evidence to support its use largely being in the form of retrospective data collections, reviewed in refs 8,9. These have been universally favourable until now, when these two, independent, studies demonstrate a poorer outcome for women who have undergone radical surgery via a minimal access route.1, 2 The first of these is the study by Ramirez et al.,1 the Laparoscopic Approach to Cervical Cancer (LACC) study, a large, well-designed international phase III trial. This trial was stopped early after an interim analysis showed a lower disease-free interval in the minimal access arm. Final analysis has confirmed this and shown a worse overall 3-year survival (93.8% versus 99.0%, hazard ratio 6.00) for women treated with minimal access surgery. These findings are supported by the epidemiological data presented by Melamed et al.2 in the second of the New England Journal of Medicine papers. During the time when this trial was recruiting, minimal access surgery has been widely introduced in the UK and elsewhere, and both women and clinicians will naturally question whether care has been compromised by this move. We therefore felt it important to carry out a pragmatic analysis to ensure that UK practice was not harming women. To achieve this we undertook a comprehensive analysis of the outcomes for women being treated for stage 1B1 cancers in eight major tertiary referral centres in the UK. To demonstrate that patient care had not been compromised, we compared the outcomes for women undergoing surgery in these eight centres, by whatever route, with the superior arm (those receiving open surgery) of the LACC study. A total of 779 cases of stage 1B1 cervical cancer were collated for our analysis. The clinical characteristics of the cases submitted are shown in Table 1. In comparison to the cases in the control arm of the LACC study,1 there were significant differences in the proportion of women with squamous tumours [56% (UK) versus 67% (LACC), P < 0.01], low-grade tumours (22% versus 10%, P < 0.05), presence of lymphovascular space invasion (37% versus 29%, P < 0.05) and tumours < 2 cm in diameter (58% versus 52%, P < 0.01). In all 597/779 (77%) women were treated with radical hysterectomy and of these, 463/779 (78%) were treated with a laparoscopic or robotic approach. Of the remainder, 7% were treated with simple hysterectomy, 6% with radical trachelectomy and 8% with a conisation procedure. All women underwent a lymph node assessment, usually in the form of a systematic pelvic node dissection, as part of their surgical man