The radical vaginal trachelectomie: do we need it?

Conventional radical surgical treatment of carcinoma of the cervix uteri is standard treatment in women with stage 1b-2a disease. The survival rates are 90% and more if there are no metastases to the lymph nodes, and drop to 60% in those patients who have node metastases. For young women the consequence is loss of fertility.

Early stage carcinoma of the cervix (< 1b) has a very good prognosis with only hysterectomy or a conisation of the cervix. Survival rates are 98-100% (1).
The radical trachelectomie was introduced in 1987 by the French gynaecologist Daniel Dargent as an alternative for young patients with stage 1a1-2a carcinoma of the cervix, with the desire to preserve fertility (2).

Stage 1a
Patients with stage 1a1 are already for a long time treated with a conization if they want to keep their fertility. The result of this simple operation is 100% cure. Until now there has been no good argument to treat young women with stage 1a disease more radical than with a conization. So, a radical trachelectomie is not necessary in this particular group of women .

Stage 1a2-2a
From a number of studies it became evident that clear margins of amputation of the cervix, tumor size, depth of invasion, lymphatic vascular space invasion, and parametrial invasion are the most important issues in determining which therapy to start(3-5).

Clear margins
The status of the margins of the amputated cervix are a significant predictor of residual invasion (6). The distance between the edge of the tumor and the internal cervical os must be at least 15 mm. Furthermore, if the distance between the edge of the tumor and the superior margin of the removed specimen is less than 10 mm, radical trachelectomie can not be considered as a safe alternative of radical treatment because of the high chance of local recurrence. On the other hand, if the length of the remaining cervix is less than 5 mm wide, childbearing potential is dramatically reduced (7). Preoperative assessment consists of the use of colposcopy and MRI (3,7). Re-conization of another 3-5 mm should be performed if the margins are less than 5 mm, on the condition that sufficient cervix, 1 cm, remains in situ for fertility. If the margins cut through the tumor, a radical hysterectomy is recommended(8). A number of studies conclude that if negative margins are present on the amputated cervix specimen, the likelihood of finding invasive carcinoma in a subsequent hysterectomy specimen is low (9).

Tumor size
With the increase of tumor size, the risk of lymph node involvement and parametrial invasion increases. Stage 1 tumors with a diameter < 2 cm have been considered as a low risk group tumors(10).

Lymph vascular space invasion (LVSI) and lymph node metastases
The rate of positive pelvic lymph nodes varies from 12-30% in large series of patients with stage 1b (11).
The risk of recurrence and lymph node metastases increases, if the LVSI is positive and so there is automatically a correlation between the risk of recurrence and lymph node matastases and depth of stromal invasion (9,12-14). Even though the risk is very low, it should be emphasised that even in the patients with a depth less than 3 mm and with a negative LVSI, recurrences have been reported.

Parametrium invasion
Pathologic parametrial involvement in stage 1a and 1b1 cervical cancer is uncommon. A subgroup of patients can be identified as low risk based upon the absence of specific tumor factors. These include patients with tumor size 2 cm or less, negative pelvic lymph nodes and depth of tumor invasion of 10 mm or less (15). The rate of parametrial involvement in lymph node negative patients with tumors < 5ml, which corresponds with a spherical tumor of 2,1 cm) is 6,6%. Of them 1,7% had tumor deposit only in the lateral parametrium (11).

Histology
Special consideration has to be given to adenocarcinoma of the cervix. The multifocality of this disease and the presence of residual disease in hysterectomy specimen in patients who had free margins in their conization specimen makes them less suitable for a fertility saving procedure. If this procedure is chosen than a carefull examination of the remaining cervical canal during the operation, including an endocervical curettage, and repeated normal endocervical smears during follow up of at least one year, are needed.

Sequellae of the radical vaginal trachelectomie
As RVT is a modification of the Schauta procedure, the late sequellae of the procedure are comparable to the sequellae of the Schauta operation. The close anatomic relation between the inferior hypogastric plexus and the direct surrounding of the uterine cervix and the proximal vagina results in damage of the plexus when the medial part of the parametrium and the proximal part of the vagina are removed. This will lead to disturbed sexual function, voiding and defecation(16). These sequellae are only acceptable if the extent of the resection is indicated.

Since the incidence of parametrium invasion in a stage 1a and 1b1 patient is uncommon and the incidence of parametrial lymph node metastasis is very rare if the pelvic side wall nodes are negative, a parametrectomy in low risk patients leads to overtreatment, with a significant amount of late morbidity (16). Based on the presented data we advise only a conization in these low risk patients. In summary these are: young women who want to preserve their fertility, who have a squamous cell carcinoma with a tumor size less than 2 cm diameter, a depth of tumor invasion of less than 10 mm, safe clear margins, a negative LSVI status and negative pelvic lymph nodes.

Conclusion and protocol
Radical trachelectomy is a safe operation in young women with a cervix cancer =< stage 1b1.
However in the small group of patients in whom the procedure is indicated the parametrectomy and lymphadenectomy do not contribute to the cure rate but do contribute to the sequellae of the operation. In the other patients the risk of recurrence is to high to perform a RVT. For this reason we conclude that the RVT is no longer needed to preserve fertility in low risk early stage cervix cancer.
In summery we advise the following treatment protocol:
Stage 1a1: conization
Stage 1a2-1b1, < 2cm diameter: a pelvic lymphadenectomy. The nodes are carefully examined by the pathologist and if negative a large conization is performed.
The cone is checked on the margins, depth of invasion and LVSI. If the margins are free, the depth of invasion is less than 10 mm, and the LVSI is negative than the operation will suffice.
If the nodes are positive, we advise chemoradiation.
If the margins are not free a re-conization can be performed.
If the tumor invades > 10 mm, and or if the margins are still not free after re-conization a radical hysterectomy has to be performed because of the high risk of local recurrence.

References
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3. Peppercorn PD, Jeyarajah AR, Woolas R, Shepherd JH, Oram DH, Jacobs IJ, Armstrong P, Lowe D, Reznek RH. Role of MR imaging in the selection of patients with early cervical carcinoma for fertility preserving surgery : initial experience. Radiology 1999;212:395-399.
4. Siller BS, Alvarez RD, Conner WD, McCullough CH, Kilgore LC, Patridge EE, et al. T 2/3 vulvar cancer: a case control study of triple incision versus en bloc radical vulvectomy and inguinal lymphadenectomy. Gynecol Oncol 1995;57:335-339.
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11. Winter R, Haas J, Reich O, Koemetter R. Tamussino K, Lahousen M, petru E, Pickel H. Parametrial spread in cervical cancer in patients with negative pelvic lymph nodes. Gynecol Oncol 2002;84:252-257.
12. Creasman WT, Kohler MF. Is lymph vascular space involvement an independent prognostic factor in early cervical cancer? Gynecol Oncol 2004;92:525-529.
13. Mota F. Microinvasive squamous carcinoma of the cervix: treatment modalities. Acta Obstet Gynecol Scand 2003;82:505-9.
14. Ostor AG, Rome RM. Microinvasive squamous cell carcinoma of the cervix. A clinico-pathologic study of 200 cases with long-term follow-up. Int J Gynecol Cancer 1994;4:2564.
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Artikel The radical vaginal trachelectomie: do we need it? oleh:

Prof. A. Peter M. Heintz, MD, PhD.
The Dutch School of Gynecologic Oncology and Pelvic Surgery
And the University of Utrecht
Utrecht
The Netherlands