conservative surgery for early cancer of the distal rectum

Conservative Surgery for Early Cancer of the Distal Rectum Claudio Coco, M.D., Paolo Magistrelli, M.D., Pierluigi Granone, M.D., Giuliano Roncolini, M.D., Aurelio Picciocchi, M.D. From the Department of General Surgery (Semeiotica Chirurgica), Universita" Cattolica del Sacro Cuore, Rome, Italy

From 1967 through 1988, 36 patients underwent local excision of a distal rectal cancer as an initial operative procedure with curative intent. A diagnostic, preoperative protocol was performed to assess the histologic grade of the tumor, the depth of penetration in the rectal wall, and the presence of positive lymph nodes or distant metastases. All patients had a transanal local excision performed under general anesthesia. If preoperative criteria were not confirmed by histopathologic specimen examination, a major operation was advised. To increase the chance of local control, external adjuvant radiotherapy was used in T2 cancers. Postoperative mortality was 0 percent. The postoperative complication rate was 9.3 percent. The observed local recurrence rate was 3 percent, and the rectal cancer-specific death rate was 6 percent. We compared these results with those obtained in 70 concomitant patients operated on by us employing a traditional resection for Dukes' A rectal cancer. There are no statistically significant differences between groups. In light of our findings, a policy of curative local excision is justified in accurately selected cases of distal rectal cancer. [Key words: Rectum; Rectal cancer; Conservative treatment; Local excision]

Coco C, Magistrelli P, Granone P, Roncolini G, Picciocchi A. Conservative surgery for early cancer of the distal rectum. Dis Colon Rectum 1992;35:131-136.

T he standard surgical p rocedure for carc inoma

of the rec tum is low anter ior resect ion (LAR)

or abdominope r inea l resect ion (APR). However ,

conservative surgery for early cancer of the distal rec tum is receiving greater a t tent ion 1-4 since local

tumor excision (LE) p e r f o r m e d for cure in se lec ted patients has shown 1' 5 survival rates comparab le to

those achieved by more radical procedures .

Since APR is associated with cons iderable mortality and morbid i ty rates, especia l ly in o lder patients, and co los tomy is always required, there is

ev idence that some pat ients are jeopard ized by a major ablative opera t ion whereas a lesser procedure could be sufficient.

We report our expe r i ence with LE of early rectal cancer.

Address reprint requests to Dr. Coco: Istituto di Semeiotica Chirurgica, Universita' Cattolica del Sacro Cuore, L.go A. Ge- melli 8, 00168 Rome, Italy.

P A T I E N T S A N D M E T H O D S

From 1967 through 1988, 36 patients underwen t

local excision of a distal rectal cancer as an initial

operat ive p rocedure with curative intent. This con-

stituted 8.5 pe rcen t of all pat ients t reated for rectal

cancer in our depa r tmen t during that period. Local excisions p e r f o r m e d for in situ rectal carc inoma or

infiltration l imited to the mucosa were excluded.

We also exc luded mal ignant rectal polyps, patients with familial adenomatous polyposis coli, and pa-

tients who were treated palliatively. We inc luded

those patients in w h o m local excision was consid- e red insufficient pos topera t ive ly and for w h o m a

major opera t ion was advised later.

There were 19 males and 17 females with a mean

age of 65 + 11 years. Tumor sizes ranged f rom 1.5 to 4 cm in 35 patients. In one case, the d iamete r

was 5 cm but the tumor was very mobi l e on the rectal wall and was therefore cons idered for LE.

The average size was 3 + 0.8 cm in diameter . The

distance above the anal verge to the lowest edge of the tumor ranged f rom 2 to 8 cm, and the average

distance was 5 + 2 cm.

P a t i e n t S e l e c t i o n

A diagnostic, p reopera t ive protocol was per-

fo rmed to assess the histologic grade of the tumor,

the dep th of pene t ra t ion in the rectal wall, and the p resence of posit ive lymph nodes or distant metastases.

Along with history and digital examinat ion, pre- operat ive tests inc luded rec toscopy and biopsy,

bar ium e n e m a to exc lude other colonic lesions,

ca rc inoembryonic ant igen test, chest x-ray, and liver ul t rasound (US) scan. Before 1978 we used liver scint igraphy to assess the p resence of metastases. Since 1980, a compu te r tomograph ic scan of the pelvis has b e e n p e r f o r m e d to evaluate extrarec-

tal infiltration and nodal disease. Since 1985, we have used rectal e n d o s o n o g r a p h y to evaluate bo th

131

132 COCO ET AL Dis Colon Rectum, February 1992

tumor infiltration in the rectal wall and nodal status. Rectal lymphoscintigraphy was employed in six cases. Table 1 shows our present diagnostic, preoperative protocol.

The choice of local excision for definitive surgery with curative intent was based on the follow- ing criteria: tumor site in the distal rectum, exophytic growth, maximum diameter less than or equal to 4 cm, tumor freely mobile on the rectal wall, and technical feasibility of total excision of the tumor with an adequate margin of healthy tissue.

Contraindications to LE with curative intent were the possibility of doing an anterior resection, ex- tensive involvement of muscular rectal wall, the presence of clinically detectable retrorectal lymph nodes, a positive preoperative biopsy for a mucinous or poorly differentiated tumor, and high lev- els of tumor markers.

Postoperative Histologic Examination The postoperative histologic examination was

essential in evaluating the effectiveness of local excision as a curative operation. Surgical speci- mens were pinned to a corkboard and sent to the pathologist. Multiple sections were taken from around the periphery and from central areas of the specimen. 8 Histologic type, grade of malignancy, depth of invasion in the rectal wall, and absence of neoplastic infiltration in the specimen margins were evaluated. Local excision was considered curative when tumor was not mucinous, carcinoma was well or moderately differentiated (G1-G2), rectal wall infiltration was limited to submucosa or muscularis propria but not beyond it (T1-T2), and deep and lateral specimen margins were tumor free. If these criteria were not fulfilled, local excision was considered a "total biopsy" and an APR was recommended.

Operative Technique All patients had a transanal local excision per-

formed under general anesthesia. The anal canal was held open with a Parks TM (Waldemar-Link, Hamburg, Germany) retractor. A simple submu- cosal excision was used for freely mobile tumors judged as T1 (invasion limited to submucosa), or a full-thickness disk excision was employed in minimally tethered tumors judged as T2 (invasion of muscularis propria). Infiltration of a weak (1:300,000) adrenaline solution was generally used. 6

The rectal wall area to be removed was outlined by traction sutures of 3/0 silk, held together like "parachute" wires. 7 The rectal wall incision was made by needle diathermy 1 cm from the base of the tumor. The wound was usually closed with interrupted 3/0 Vicryl TM (Ethicon, Inc., Somerville, NJ) sutures. According to other authors, 1'3-7 no special measure was taken to prevent loose tumor cells from "seeding" in the wound created by LE.

Table 1. Preoperative Diagnostic Protocol

Rectal digital examination Rectoscopy and biopsy Barium enema Endorectal ultrasonography Pelvic CT scan Liver US scan Chest x-ray Tumor markers

Adjuvant Radiotherapy To increase the chance of local control, external

adjuvant radiotherapy was used in T2 cancers. A total dose of 4,700 cGy was given postoperatively, five fractions per week to a volume encompassing the primary lesion and the true pelvis. Patients with tumor limited to submucosa (T1) did not receive adjuvant treatment. Patients were followed at reg- ular intervals (generally every six months) by clinical examination, endoscopy, and laboratory and imaging studies. Pelvic CT scan and endorectal ultrasonography to detect the presence of extra- mucosal recurrence have been employed in the follow-up protocol since their introduction in our department.

RESULTS

All tumors were adenocarcinomas. Histopatho- logic findings are reported in Table 2. Cancer was confined to the submucosa in 20 (T1), extended into the muscularis propria in 15 (T2), and invaded perirectal fat in one (T3). Adenocarcinomas were well differentiated in 24 (G1), moderately differentiated in nine (G2), and poorly differentiated in three (G3). Margins were clear in 33, doubtful in one, and involved in two. No vascular or lymphatic invasion was present in any patient. After postoperative histologic examination, patients were di- vided into two groups. Group 1 included four patients in whom histologic criteria were not ful-

Vol. 35, NO. 2 CONSERVATIVE SURGERY IN RECTAL CANCER 133

Table 2. Pathology Features

Depth of 20 T1 15 T2 1 T3 invasion (T)

Grading (G) 24 G1 9 G2 3 G3 Completeness 33 complete 1 doubt- 2 incomplete

of excision ful

filled; local excision was considered only a total biopsy, and APR was advised. Group 2 included 32 patients in whom histologic criteria were fulfilled and local excision was considered a curative treatment. Postoperative x-radiotherapy was adminis- tered in T2 cases.

For both groups, postoperative mortality was 0 percent. Postoperative complications were 9.3 percent (3/36). In two cases, there was fecal inconti- nence that improved in the next three months. After radiotherapy, one patient developed proctitis, which required a temporary diverting colostomy.

The postoperative mortality observed in our department during the same period (1968-1988) after APR was 6.4 percent, and the complication rate was 16.5 percent.

Late Results

Of the four patients in Group 1 (Table 3), only one (T3, G3, margins involved) agreed to undergo APR. The operative specimen did not show residual tumor, and the patient had no evidence of disease (NED) after 24 months.

Three patients refused an early APR. The first (G3, doubtful margins) developed a squamous anal cancer after four years, which caused her death two years later. The second (margins involved) developed a local recurrence 14 months later that was treated by APR; he was NED three years after primary treatment. The third (G3) was NED after 26 months.

In Group 2, among the 32 patients for whom LE was considered curative, one developed a local recurrence with distant metastases and another developed distant metastases without any evidence of local recurrence. Their brief case reports follow.

A 46-year-old man had a 2.5-cm-wide tumor, 4 cm above the anal verge, treated initially by full- thickness local excision. Histology showed a moderately differentiated (G2) adenocarcinoma, pen- etrating into the muscularis propria with a 1-cm free margin. The patient was treated with 4,700 cGy postoperatively. Twenty-two months later,

there was local recurrence which extensively involved the extrarectal fat. The patient died of pul- monary metastases 29 months after primary treatment.

A 64-year-old man had a local excision of a 3- cm-wide tumor 7 cm above the anal verge. The specimen contained a well-differentiated (G1) adenocarcinoma confined to submucosa (T1). Mar- gins were clear. No additional treatment was required. Scintigraphic evidence of hepatic metastases appeared 2.5 years later. The patient died of liver failure six months after diagnosis with no evidence of local recurrence.

Four other patients died during the first five years of follow-up from unrelated diseases (liver cirrho- sis, gastric cancer, esophageal cancer, and myocar- dial infarction) with no signs of rectal cancer recurrences. During the follow-up period, two patients developed colon polyps, which were endoscopically removed.

The median follow-up of the 26 patients still in disease-free status was 68 months (minimum, 24 months).

Overall actuarial five-year survival calculated by the Kaplan-Meier method is 74 percent. If deaths unrelated to rectal cancer are excluded, corrected five-year survival rises to 90 percent. According to these data, the observed local recurrence rate is 3 percent (1/32) and the rectal cancer-specific death rate is 6 percent.

We compared these results with those obtained in 70 patients operated on by us employing a traditional resection for Dukes' A rectal cancer. This group was concomitant with, but not randomized to, the locally treated group. Both groups were comparable for stage, age, sex ratio, and grading. Results are reported in Table 4. The local recurrence rate was 6 percent, distant metastases rate 4 percent, rectal cancer-specific mortality 10 percent, and corrected five-year survival 89 percent, with a

Table 3. Group 1--Late Results

1. (T3, G3; margins involved.) APR. No residual tumor in operative specimen. NED after 24 months.

2. (G3; doubtful margins.) APR refused. Squamous anal cancer four years later. Died of anal cancer two years after that.

3. (Margins involved.) APR refused. Local recurrence 14 months later. APR. NED 29 months after APR.

4. G3. APR refused. NED 26 months later.

134 COCO ET AL Dis Colon Rectum, February 1992

Table 4. Comparison of Distant Results Between Local Excision

and Radical Operation for Dukes' A Rectal Cancer (Groups Concomitant but not Randomized)

Local Excision Radical Operation (32 Patients) (70 Patients)

Local recurrences 3% (1/32) 6% (4/70) Distant metas- 6% (2/32) 4% (3/70)

tases Cancer-specific 6% (2/32) 10% (7/70)

death rate Corrected 5-yr 90%* 89%i-

survival

* Median follow-up, 68 months. t Median follow-up, 62 months.

median follow-up of 62 months. There was no statistically significant difference for these vari- ables between groups.

DISCUSSION

The choice of local treatment for carefully selected rectal cancers is now frequently reported by many authorsP' 9-11 Different techniques have been suggested, such as excisional methods, 6'7'12 diathermy or electrocoagulation, 13-15 radiation therapy, 16-19 endoscopic transanal resection, 2~ laser therapy,21, 22 and cryosurgeryY

Why a Local Treatment?

In theory, local treatment could be curative for all Dukes' A rectal cancers in which tumor infiltration is limited to the rectal wall. Local treatment is probably not effective when the cancer has passed through the rectal wall (Dukes' B) and patients whose tumors involve lymph nodes (Dukes' C) cannot be appropriately treated by a conservative approach. The problem is the selection of patients based on the depth of tumor infiltration and nodal involvement. It is quite easy to assess the depth of tumor infiltration using surgical procedures. In fact, a careful histologic examination of the surgical specimen can modify a previously incorrect clinical stage.

A more difficult question is how to identify patients with involved nodes. There are two methods, the first of which is to assess nodal involvement preoperatively. Digital examination findings are related to clinical experience, 24 but they are not reliable. Computed tomography, 25' 26 nuclear magnetic resonance, 27'28 lymphoscintigraphy, z9 and, especially, rectal endosonography 3~ are more

accurate (75-85 percent) in detecting positive mesorectal nodes. The second method is to predict nodal involvement postoperatively with an accurate histologic examination of the surgical specimen. Morson 8'32 has demonstrated that there is only a 10 percent risk of metastases to regional lymph nodes when cancer is confined to the rectal wall; carcinoma is poorly differentiated in most cases. These results have been confirmed by other authors.5, 33 When both methods are used in patient selection, the risk of lymph node involvement is probably about five percent. Our rectal cancer- specific mortality (6 percent) seems to confirm this theory.

Although there is a small possibility of under- treatment, LE has several definite benefits. Post- operative mortality after LE in our cases was 0 percent, while after APR it was 6.4 percent. These differences between postoperative mortality after local treatment and radical resections are frequently reported in the literature and increase with ageP 4 A patient with positive nodes, even if he or she has a small primary tumor, is always classified as having a Dukes' C cancer, and the probability of five-year survival for this patient would be 30 to 40 percent even if a traditional radical operation were performed. Finally, the improvement in the quality of life without a permanent colostomy is obvious.

How to Select Patients

From 1980 to 1988, we selected--by digital examination, rectoscopy and biopsy, barium enema, and other tests to exclude distant metastases--24 patients with a low rectal tumor that was less than or equal to 4 cm, exophytic, well or moderately differentiated, deemed T1 or T2, and digitally suit- able for LE with curative intent. None of these patients was relegated to APR because of CT or US evidence of mesorectal node involvement. Only one case (4 percent) judged as T2 by digital examination was allocated to APR because of CT evidence of extrarectal spread. Postoperative histologic examination confirmed a T3 status.

Pelvic CT and endorectal US did not greatly affect traditional methods of patient selection. Therefore, it could also be reasonable to manage these cases without such investigations.

Why Surgery? Thirty-six patients were selected for LE, but the

histology of the surgical specimen confirmed the

Vol. 35, No. 2 CONSERVATIVE SURGERY IN RECTAL CANCER

Table 5. Results of Completely Excised, Favorable-Grade, T1-T2 Tumors

135

No. of Depth of Local Recurrence Cancer-Specific Authors Patients Infiltration (%) Death Rate (%)

Morson et a l p 91 T1 3 0 Hager et aL as 59 T1-12 10 3 Grigg et al. 1 16 T1 6 0 Knoch 11 94 T1 2 0 Whiteway et al. a8 19 T1-T2 0 0 Heberer et a13 a 36 T1-T2 3 5 De Cosse et al. 4 27 T1-T2 7 0

curative intent in only 32. Therefore , 11 percent of

our patients (4/36) would have been underesti- mated using a local t reatment such as radiotherapy or electrocoagulat ion. Nevertheless, only one of the three patients who refused to undergo APR had a recurrence related to the primary rectal cancer; the one patient who accepted a radical operat ion after LE had no residual tumor in the surgical

specimen. It is interesting to note that three of the four patients who failed after local excision refused further surgery. This refusal may be cons idered as a relative contraindication to local excision.

W h a t R e s u l t s c a n b e E x p e c t e d f r o m LE?

When well-differentiated, graded tumors are comple te ly r emoved in LE, results seem to be favorable, as summarized in Table 5. Local recurrences are less than 10 percent , and cancer-specific death rates range from 0 to 5 percent .

Even though the patients were concomitant but not randomized, our results (Table 4) do not show

any statistically significant difference be tween traditional radical operat ion and LE for Duke's A rectal cancer. However, we must acknowledge that tumors in the LE group, also if be longing to the same stage and comparable for age, sex ratio, and grading, were morphological ly more favorable, and this reduces the importance of comparison.

The higher inc idence of lymphatic metastases in cancer invading muscularis propria 32'33 led us to

use adjuvant postoperat ive radiotherapy in T2 tumors. The rationale of combin ing external irradiation with LE is that surgery will remove the gross tumor and adjuvant radiotherapy will destroy clinically occult lymphatic metastases. Although one of our patients n e e d e d a diverting colos tomy for acute proctitis, morbidi ty associated with adjuvant postoperat ive radiotherapy is general ly m i n i m a l F This combined treatment, according to o ther au-

thors, 37-39 seems justified by the potential ly en-

hanced local control but has not yet proved more effective than LE alone.

C O N C L U S I O N

In light of our findings and the results found in the literature, it is reasonable to suggest that a policy of curative LE is justified, perhaps even preferable, in accurately se lected cases of distal rectal cancer.

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conservative surgery for early cancer of the distal rectum

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