Radical trachelectomy: need for a randomized controlled trial?

Abstract

Dear Editor, We read with interest the recent systematic review by Xu et al. which assessed the efficacy and safety of radical trachelectomy (RT) and radical hysterectomy (RH) for patients with early cervical cancer (1). The authors concluded that RT has similar efficacy and safety as RH for early cervical cancer surgical treatment. Moreover, it reduced blood loss and urine residual volumes and shortened the duration of post-operative hospital stay. The significant limitations of this meta-analysis (conclusions for all outcomes apart from five-year recurrence-free survival rate and blood transfusion based on only two trials) highlight the challenge of deciding which surgical procedure is optimal in treating the cancer. Overall, we agree with the authors and believe that, provided the treatment center and availability of trained personnel are appropriate, the gynecological surgeon should primarily consider either abdominal RT or vaginal RT, and not RH. This should only apply for patients diagnosed with early stage cervical cancer who wish to preserve their fertility. Vaginal RT is the standard treatment of 0–2cm size tumors. Our judgment, however, is that abdominal RT and vaginal RT should be equally considered for the treatment of these tumors. This is for two reasons. First, as the techniques for abdominal RT and routine radical hysterectomy are extremely similar, more trainee surgeons should potentially be able to master the operative techniques of abdominal RT relatively easily because radical hysterectomy is universally taught and reproducible in any gynecologic oncology center. Secondly, abdominal RT is a safer option with regards to bulky, exophytic or >2cm tumors because it offers an extensive radicality of parametrial, sacrouterine and pelvic lymphatic tissue resection. We cautiously predict that in our international cohort of more than 100 abdominal RT patients, it is this more extensive radicality which is the main contributing factor to our 98% survival rate, with two additional patients presenting with a recurrence (2). Ultimately, we believe that for patients wishing to preserve their fertility and diagnosed with early stage cervical cancer, the next stage of trachelectomy research should be a treatment comparison between abdominal and vaginal RT in a large-scale, multi-center, prospective randomized trial of abdominal RT vs. vaginal RT vs. cone biopsy and lymphadenectomy for lesion size 0–2cm, correlating recurrence rates and fertility outcomes as primary end-points. If fertility is no longer an issue, then vaginal RT vs. RH is also a valid trial. No such trials exist in the literature. We do not believe that it is ethically acceptable to do a trial of abdominal RT compared to vaginal RT for lesion size 2–4cm because of Dargent's high recurrence rates after vaginal RT of tumors >2cm (6/27) (3). Secondary aims should try to define the incidence of specific post-operative complications within the three trial groups, arrive at a more suitable method of pre-operative patient selection for a specific procedure and investigate how to apply adjuvant therapy in node positive patients. A closer look at surgical techniques employed in the formation of a neocervix, application of a permanent cervical cerclage suture (and timing: during abdominal RT or pregnancy) and the process of re-anastomosis are also worthy of study. To provide quality assurance of surgical technique between hospitals, a limited number of centers with recognized surgical skills to perform this procedure should be included first. Another trial option may be to randomize patients between either ‘a radical trachelectomy and lymphadenectomy (any approaches)’ and ‘simple trachelectomy and lymphadenectomy’ for small volume lesions, as recent literature is slowly suggesting that radical surgery is probably not necessary in most cases. We hope that information gained from the research proposed above would greatly improve our understanding of fertility-sparing surgery and ultimately demonstrate its appropriateness in treating the patient group highlighted in this study, with respect to oncological safety and pregnancy outcomes. The authors have stated explicitly that there are no conflicts of interest in connection with this article. None to declare.