Elsevier

Gynecologic Oncology

Volume 103, Issue 2, November 2006, Pages 506-511
Gynecologic Oncology

Radical vaginal trachelectomy (RVT) combined with laparoscopic pelvic lymphadenectomy: Prospective multicenter study of 100 patients with early cervical cancer

https://doi.org/10.1016/j.ygyno.2006.03.040Get rights and content

Abstract

Objective.

The aim of this prospective clinical multicenter study “Uterus 6” of the German Association of Gynecologic Oncologists (AGO) was to prove the recurrence rate of patients treated with pelvic lymphadenectomy and radical vaginal trachelectomy (RVT). We also wanted to prove the surgical safety of RVT.

Methods.

Between March 1995 and November 2005, we intend to treat 108 patients with cervical cancer (TNM stage 1A1, L1 n = 18, 1A2 n = 21, 1B1 n = 69) by RVT. Eight patients were excluded since the study criteria were not met after RVT (tumor size >2 cm, neuroendocrine tumor type, tumor-involved resection margins, or positive pelvic lymph nodes). Thus, 100 patients were treated by RVT according to protocol. With 4 recurrences in a sample size of 100 patients, an upper limit of the 95% confidence interval (including continuity correction) of 10.5% was calculated. Recruitment had to be stopped if five or more recurrences occurred.

Results.

The median follow-up time was 29 (1–128) months. Three (3%) recurrences occurred in 100 patients treated with RVT according to protocol. Thus, the upper confidence limit was 9.2%. The projected 5-year recurrence-free and overall survival rates were 97% and 98%. The average duration of surgery was 253 (115–402) min. Perioperative complications were: postoperative bleeding, embolism of the external iliac artery, retroperitoneal lymphocele, or paralytic ileus in one patient, respectively.

Conclusions.

RVT combined with laparoscopic pelvic and parametric lymphadenectomy for treatment of patients with early stage cervical cancer ≤2 cm results in a recurrence-free survival of more than 90.8%.

Introduction

The prognosis of women with lymph node negative, early stage cancer of the cervix is excellent, with a 5-year survival rate of greater than 90% [1], [2], [3]. RVT in combination with pelvic lymph node dissection has emerged as an alternative to the standard treatment, i.e. radical hysterectomy or chemoradiation, for patients who desire preservation of fertility [4], [5], [6].

Recently, published data [7], [8], [9], [10] suggest that RVT may have a low risk of recurrence and is, thus, a reasonable therapeutic curative approach for low-risk cervical cancer patients. However, only limited data or metaanalyses are available, and no clear hypothesis was formulated in these case series for expected oncologic safety for all patients treated with RVT. Thus, it still remains open if this approach is as effective as standard radical hysterectomy in terms of recurrence. Therefore, we initiated a prospective clinical evaluation to prove the oncological safety for all patients with early cervical cancer treated with RVT (study “Uterus 6” of the German Association of Gynecologic Oncologists). In addition, the characteristics and complications of the surgical procedure were studied.

Section snippets

Patients and methods

Between March 1995 and November 2005, all women fulfilling the following criteria were offered participation in the study at the Departments of Gynecology, University of Cologne, Charité Berlin and Jena, Germany: age ≥18 years, performance status ≤2 (WHO), signed informed consent of the patient (preoperative), patient with histopathologically confirmed cervical cancer (squamous, adenosquamous, or adenocancer, stage 1A1, L1, or 1A2 or 1B1 with ≤2 cm diameter) by punch or cone biopsy. In

Results

In the cohort of 108 patients treated primarily by RVT, the median age was 32 (21–41) years and the median weight 63 (45–98) kg with a median Quetelet index of 22 (16–34). 92 patients were nulligravidae. Invasive cancer was diagnosed by cone biopsy in 100 (92%) and by punch biopsy in 8 (8%) patients. In 11/39 (28%) patients with stage 1A1, L1, or 1A2 and 33/59 (56%) patients with stage 1B1, tumor-involved margins of cone biopsy specimen were found. The stage of disease (TNM) was distributed

Discussion

Parametric lymph nodes and/or lymph vessels may contain tumor cells in up to 8% of patients with negative pelvic lymph nodes [18]. Patients with stage 1A1 or 1A2 may develop pelvic recurrence in up to 3% when treated by simple hysterectomy [19]. In the majority of these recurrent patients, vessel infiltration was found retrospectively in the primary tumor. When radical hysterectomy is performed in patients with stage 1A2, in 3%, single metastasis is found in the parametrium [19]. Thus, the risk

Acknowledgments

Dedicated to Daniel Dargent MD, who established this surgical technique which allows women with cervical cancer to fulfil their family life. We thank Mitchel Hofmann, MD for critical review of the manuscript.

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