Annals of Surgical Oncology 10:664-668 (2003)
© 2003 Society of Surgical Oncology
Results After Rectal Cancer Resection With In-Continuity Partial Vaginectomy and Total Mesorectal Excision
L. Ruo, MD,
P.B. Paty, MD,
B.D. Minsky, MD,
W.D. Wong, MD,
A.M. Cohen, MD and
J.G. Guillem, MD, MPH
From the Departments of Surgery (LR, PBP, WDW, AMC, JGG) and Radiation Oncology (BDM), Colorectal Service, Memorial Sloan-Kettering Cancer Center, New York, New York.
Correspondence: Address correspondence and reprint requests to: J. G. Guillem, MD, Room C-1077, Colorectal Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021; Fax: 646-422-2318; E-mail: guillemj{at}mskcc.org
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ABSTRACT
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Background: Although sharp mesorectal excision reduces circumferential margin involvement and local recurrence, a concomitant partial vaginectomy may be required in women with locally advanced rectal cancer.
Methods: Sixty-four patients requiring a partial vaginectomy during resection of primary rectal cancer were identified. Survival was determined by the Kaplan-Meier method, and distributions were compared by the log-rank test.
Results: Locally advanced disease was reflected by presentation with malignant rectovaginal fistulae (n = 6) or cancers described as bulky or adherent/tethered to the rectovaginal septum (n = 32). Thirty-five patients received adjuvant radiation with or without chemotherapy. At a median follow-up of 22 months, 27 (42%) patients developed recurrent disease, with most of these occurring at distant sites. The 5-year overall survival was 46%, with a median survival of 44 months. The 2-year local recurrence–free survival was 84%. The crude local failure rate was 16% (10 of 64), and local recurrence was more common in patients with a positive as opposed to a negative microscopic margin (2 [50%] of 4 vs. 8 [13%] of 60, respectively). Positive nodal status had a significant effect on overall survival (P < .001).
Conclusions: Partial vaginectomy is indicated for locally advanced rectal cancers involving the vagina. The results are most favorable in patients with negative surgical margins and node-negative disease.
Key Words: Rectal cancer • Vaginectomy • Resection margins • Mesorectal excision
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INTRODUCTION
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Because of its juxtaposition and communicating lymphatic pathways,1 local recurrence may be found in the posterior vaginal wall after rectal cancer surgery.2–4 In-continuity posterior vaginectomy has therefore been advocated for epidermoid cancers and melanoma of the anal canal during abdominoperineal resection (APR).5,6 However, there is limited information on the outcomes for excision of the posterior vaginal wall or uterus along with rectal adenocarcinomas that involve anterior genital structures. For locally advanced anteriorly located rectal cancer, an extended resection with in-continuity posterior vaginectomy is advocated when rectovaginal septum involvement is known or suspected. The purpose of our study was 2-fold: (1) to evaluate the clinical features of female patients with primary rectal cancers involving the anterior reproductive organs requiring partial vaginectomy and (2) to identify factors associated with favorable outcome.
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METHODS
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On the basis of a review of the computerized prospective Colorectal Service database at Memorial Sloan-Kettering Cancer Center (MSKCC), 2034 resections for primary rectal adenocarcinomas performed between 1986 and 1999 were identified. Of these resections, 1209 were in men and 825 in women. Of the 825 women, 64 (8%) underwent partial vaginectomy in conjunction with total mesorectal excision. The median age of this cohort was 60.5 years, with a range of 33 to 82 years. Patients included in this study population underwent radical resections in the form of APR (n = 49), low anterior resection (n = 6), or posterior exenteration (n = 9). Indications for in-continuity vaginectomy included an anterior-based tumor that was tethered, adherent, or fixed to the posterior vagina; clinical evidence of direct tumor involvement, as manifested by ulceration through the vaginal wall or formation of a malignant rectovaginal fistula; and the inability to develop a plane in the rectovaginal septum without leaving residual tumor. In-continuity excision of the posterior vaginal wall was achieved by making a transverse incision in the posterior fornix and extending the dissection along the lateral walls of the vagina. Although the vaginal defect was left open in most patients, eight had myocutaneous flap reconstruction and six had omental pedicle flaps rotated into the pelvis.
At MSKCC, patients with unresectable or locally advanced rectal tumors (clinically bulky or tethered and ultrasound T3 or N1 lesions) are eligible to receive preoperative radiation and 5-fluorouracil (5-FU)-based chemotherapy in an attempt to reduce the bulk of the tumor, facilitate sphincter preservation, and enhance local regional control. Use of adjuvant chemoradiation was infrequent before publication of the National Institutes of Health Consensus Conference guidelines,7 which established the benefit of adjuvant therapy over surgery alone for locally advanced rectal cancer. Preoperative pelvic radiation with or without 5-FU–based chemotherapy was given to 29 patients with deeply invading tumors or those in whom resectability could be enhanced. All but three patients received a minimum of 4500 cGy (range, 2200–5580 cGy). In one patient treated at MSKCC, early discontinuation was attributed to toxicity. The other two patients were treated at other institutions, and details on therapy were not available. Resections were performed 
BORDER="0">4 weeks after the completion of radiation. Postoperative pelvic radiation (5040–5580 cGy) was administered in an additional eight patients; all had confirmed locally advanced rectal cancer (pT4 or node positive) and had not received preoperative therapy. Patients who were treated at MSKCC received pelvic radiation with or without 5-FU–based chemotherapy according to previously published techniques.8
Survival was determined by the Kaplan-Meier method and analyzed by several clinicopathologic risk factors, which included adjuvant radiotherapy and chemotherapy (RT/chemo), histological vaginal involvement, poor histological features, and nodal status. Poor histological features were defined by the presence of at least one of the following: poor differentiation, lymphovascular invasion, perineural invasion, or the presence of a mucinous component. Survival distributions were compared by the log-rank test, and P < .05 was considered significant.
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RESULTS
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At the time of clinical presentation, six patients had malignant rectovaginal fistulae. Thirty-two patients had locally advanced rectal cancers, described as bulky or adherent/tethered to the rectovaginal septum. In 18 patients, the tumor was considered to be confined to the rectal wall but was anteriorly located. The clinical extent of the tumor was not documented in eight patients. In keeping with locally advanced disease, 37 of 64 patients received adjuvant therapy, with most of these (29 of 37) receiving preoperative RT/chemo. At the time of surgery, 53 of 64 patients had suspected clinical involvement of adjacent structures, as documented in the operative report. However, only 22 patients had histologically confirmed T4 cancers, and approximately one third of these were classified as node-negative cancers (Table 1). By American Joint Committee on Cancer stage, 2 were stage 0 (as a result of complete response to preoperative RT/chemo), 12 were stage I, 18 were stage II, 21 were stage III, and 11 were stage IV.
There was no perioperative mortality, and 17 complications occurred in 16 patients, for a perioperative morbidity rate of 25% (Table 2). Most of the morbidity was related to wound complications, including two perineal (rectovaginal) fistulae. Other complications were typical of general surgical procedures and consisted of urinary retention (n = 4), peripheral neuropathy (n = 1), metabolic encephalopathy (n = 1), phlebitis (n = 1), deep venous thrombosis (n = 1), and bowel obstruction (n = 1). Long-term urinary dysfunction in the form of inadequate bladder emptying (n = 6) and varying degrees of incontinence (n = 4) developed in 10 patients. Information on sexual dysfunction after posterior vaginectomy was not retrievable.
After a median follow-up of 22 months (range, 3–114 months), recurrence had developed in 27 patients; 8 were localized to the pelvis, 17 occurred at distant sites, and 2 had both local and distant failure. The median time to recurrence was 11 months. Local recurrence–free survival was 84% at 2 years (Fig. 1). The crude local failure rate was 16% (10 of 64). There was no significant difference in crude local failure rate among those who did (5 [13.5%] of 37) and did not (5 [18.5%] of 27) receive adjuvant chemoradiation. Among the 10 patients who developed local failure with or without concomitant distant recurrence, 5 received adjuvant chemoradiation, all before surgery. However, a positive microscopic margin seemed to be associated with a much higher local failure rate (2 [50%] of 4 vs. 8 [13%] of 60). Overall survival after rectal resection with partial vaginectomy was 46% at 5 years, with a median survival of 44 months (Fig. 2). Of the clinicopathologic factors analyzed, positive nodal status was the only variable found to significantly affect overall survival (Fig. 3).
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FIG. 1. Local recurrence–free survival in patients after total mesorectal excision and in-continuity vaginectomy.
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FIG. 3. Overall survival in patients after total mesorectal excision and in-continuity vaginectomy, stratified by nodal status.
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DISCUSSION
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Residual disease as a source of local pelvic recurrence after rectal cancer surgery in women is common.2 Failure in the vagina occurs in 24% to 28% of cases, whereas recurrence in the uterus is found in 6% to 7% of cases.3,4 In a report by Veazey and McBride,9 the pelvic recurrence rate was 4% among female patients after APR who underwent previous or concomitant hysterectomy, but it was 36% in those whose uterus was left in situ. Although local failure may be the result of inadequate resection, implantation of tumor cells, or residual nodal metastases, anatomical factors such as a thin rectovaginal septum (particularly in postmenopausal patients) and patterns of lymphatic drainage may also play a role.1 Block and Enquist1 mapped out lymphatic pathways from the rectum by using injection of vital dyes at the anal verge and 2, 4, or 6 inches above it. Drainage from the lower third of the anorectum was directed toward the posterior vaginal wall. Drainage from the middle third of the rectum up to 10 cm from the anal verge proceeded to portions of the rectovaginal septum and the posterior vaginal wall.
Although proponents of extended resections for rectal cancer in women argue that involvement of the posterior vaginal wall may be overlooked in >20% of patients without extended resections,10 there are limited data on the actual advantage of in-continuity vaginectomy for locally advanced rectal cancer in women. In a previous report by Buhre et al.,11 pelvic recurrence developed in 4 of 18 patients undergoing curative resection. In a separate study, these authors found significantly (P = .03) fewer local recurrences in women (3 [6.5%] of 46) than men (15 [21.1%] of 71), which happened to correlate with a higher proportion of extended anterior resections in women.12 By comparison, the risk of distant metastases was equivalent between sexes. In a more recent review, in-continuity excision of the posterior vaginal wall, uterus, or both was considered necessary in almost half the patients to ensure a complete resection.13 Only 3 of 46 women, in contrast to 18 of 95 men, developed local recurrence (P = .02). With a median follow-up of 8 years, the risk of local recurrence at 5 years was 9% for women and 27% for men (P < .05). In our study, the 2-year local recurrence–free survival was 84% (Fig. 1). Local failure occurred in 10 patients, accounting for 16% of the entire cohort. This rate is somewhat higher compared with previously published local recurrence rates from our institution of 6% to 7% for resection of primary rectal cancer by low anterior resection or APR.14,15 However, those estimates included only patients undergoing curative (R0) resections. Considering that most of the patients in this study had locally advanced rectal cancer, the recurrence rates are comparable to those reported in similarly staged cancers. Although all these patients underwent resection with removal of gross disease, four patients had positive microscopic margins. Local recurrence occurred in 2 (50%) of these patients, compared with 8 (13%) of 60 patients in those who had negative microscopic margins. Although the number of patients involved is quite small and statistical comparisons are not feasible, these data support previous reports on the prognostic significance of a negative resection margin for patients with rectal cancer.16–18 Adjuvant chemoradiation did not seem to reduce the risk of local failure, because half (5 of 10) of the patients with pelvic recurrence received adjuvant therapy, whereas the other half did not.
A study of extended resections for primary locally advanced rectal adenocarcinomas revealed that 57% of lesions adherent to the pelvic wall and vagina had histological evidence of adjacent organ invasion.19 However, in approximately 50% of patients, there is no evidence of histological involvement.20 A similar result was found in our study, in which 22 (42%) of 53 rectal cancers suspected of adjacent organ involvement at surgery were actually proven to be T4 on histological analysis. Therefore, preoperative identification of those patients who may benefit from in-continuity vaginectomy is difficult. The use of endoluminal and/or transvaginal sonography may be helpful in determining the depth of tumor penetration, particularly with respect to the posterior vaginal wall. However, preoperative imaging currently remains imperfect with respect to T and N stage.
The 5-year overall survival of our study population was 46%, with a median survival of 44 months (Fig. 2). Analysis of survival by several clinicopathologic factors—including adjuvant RT/chemo, direct invasion of the posterior vaginal wall, the presence of poor histological features, and nodal status—was performed. Positive nodal status was a significant predictor of poor outcome in our study (P = .0003) and has proven to be among the strongest prognostic factors in patients with colorectal cancer21 (Fig. 3). The effect of metastatic spread to regional nodes is a consideration in the management of locally advanced rectal cancer because bulky tumors with established organ invasion may not have nodal involvement.19,22 In our study, 7 of 22 T4 rectal cancers were node negative (Table 1). Without adequate resection margins to encompass adjacent tissues involved by tumor, this group of patients would have an increased risk of local failure for tumors with an otherwise good prognosis. Because the ability to select patients with nodal metastases is imperfect with current preoperative staging, patients with locally advanced rectal cancer should undergo in-continuity resection with the expectation of a good prognosis in node-negative tumors.
There was no perioperative mortality, and the perioperative morbidity rate was 25%. Most of the wound complications were minor superficial infections, although two patients had nonhealing perineal fistulae. There were 10 patients with urinary dysfunction but few significant complications. Only one of these patients continues to require self-catheterization. The urinary dysfunction previously described for rectal resections combined with hysterectomy, vaginectomy, or both most commonly occurred in association with bladder prolapse, thereby causing difficulty with voiding.
In summary, partial vaginectomy in conjunction with total mesorectal excision is most commonly performed for distal, locally advanced rectal cancers that require APR and may be accomplished with acceptable morbidity, even in the context of multimodality therapy. This in-continuity approach should be considered when involvement of the rectovaginal septum is suspected either on preoperative assessment or on the basis of intraoperative findings. This recommendation is based, in part, on the inability to definitively identify patients with adjacent tissue invasion before surgery and the risk of local failure if complete resection with negative surgical margins is not obtained. Patients with node-negative disease can expect prolonged survival with this curative approach.
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FOOTNOTES
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Primary rectal cancer resection with in-continuity vaginectomy was performed in 64 women with locally advanced disease. Survival was better in patients with node-negative cancers, and local pelvic recurrence was diminished if resection was achieved with negative surgical margins.
Received for publication April 16, 2002.
Accepted for publication February 28, 2003.
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ABSTRACT
INTRODUCTION
