Anal sphincter conservation for patients with adenocarcinoma of the distal rectum: long-term results of radiation therapy oncology group protocol 89-02.

Russell AH         Int J Radiat Oncol Biol Phys 2000 Jan 15;46(2):313-22

Between September 21, 1989 and November 1, 1992, a Phase II trial of sphincter-sparing therapy was conducted for patients with clinically mobile rectal cancers located below the pelvic peritoneal reflection. Protocol treatment was designed for patients who were, in the judgement of their attending surgeon, unsuitable for anal sphincter conservation in the context of anterior resection, and would have required abdominoperineal resection (APR) as conventional surgical therapy. Primary cancers were estimated to be 4 cm or less in largest clinical diameter, and occupied 40% or less of the rectal circumference.   Protocol surgery was intended to remove the primary cancer by en-bloc, transmural excision of an ellipse of rectal wall by transanal, transcoccygeal, or trans-sacral technique, while conserving the anal sphincter. Based on tumor size, T classification, grade, and adequacy of surgical margins, patients were allocated to one of three treatment assignments: observation, or adjuvant treatment with 5-fluorouracil (5-FU) and one of two different dose levels of local-regional radiation. With minimum follow-up of 5 years and median follow-up of 6.1 years, 11 patients have failed: 3 patients recurred local-regionally only, 3 patients had distant failure alone, and 5 patients manifested local-regional and distant failure. Eight patients died of intercurrent illness. Local-regional failure correlated with T-category revealed: T1 1/27 (4%), T2 4/25 (16%), and T3 3/13 (23%). Local-regional failure escalated with percentage involvement of the rectal circumference: 2/31 (6%) among patients with cancers involving 20% or less of the rectal circumference, and 6/34 (18%) among patients with cancers involving 21-40% of the circumference. Distant dissemination rose with T-category with 1/27 (4%) T1, 3/25 (12%) T2, and 4/13 (31%) T3 patients manifesting hematogenous spread. Eight patients (12%) required temporary or permanent colostomy. Five of 8 patients with local-regional recurrence achieved local-regional control with management including surgery, although 4 of these patients subsequently developed distant dissemination. Three patients (5%) had persistent, uncontrolled, local disease. Actuarial freedom from pelvic relapse at 5 years is 88% based on the entire study population, and 86% for the less favorable patients treated with adjuvant radiation and 5-FU. CONCLUSION: Conservative, sphincter-sparing therapy is a feasible alternative treatment for selected patients with limited cancer involving the middle and lower rectum. Risk of both local and distant failure appears to escalate with increasing T-category (depth of invasion). Results achieved in the multi-institutional, cooperative group setting approximate results reported from single institutions.

Sphincter-sparing treatment for distal rectal adenocarcinoma.

Steele GD Jr, Ann Surg Oncol 1999 Jul-Aug;6(5):433-41.

University of Chicago, IL 60637

BACKGROUND: Studies suggest that the anal sphincter can be preserved in some patients with distal rectal adenocarcinoma (DRA), but this has not been validated in any prospective multi-institutional trial. METHODS: To test the hypothesis that the anal sphincter can be preserved in some patients with DRA, the Cancer and Leukemia Group B and collaborators reviewed 177 patients who had T1/T2 adenocarcinomas < or = 4 cm in diameter, which encompassed < or = 40% of bowel wall circumference, and were < or = 10 cm from the dentate line. Of the 177 patients, 59 patients who were eligible for the study had T1 adenocarcinomas and received no further treatment; 51 eligible T2 patients received external beam irradiation (5400 cGY/30 fractions 5 days/week) and 5-fluorouracil (500 mg/m2 IV d1-3, d29-31) after local excision. RESULTS: At 48 months median follow-up, 6-year survival and failure-free survival rates of the eligible patients are 85% and 78% respectively. Three patients died of unrelated disease. Two patients were treated for second primary colorectal tumors; both remain disease free (NED). Another eight patients died of disease, four with distant recurrence only. One T1 patient is alive with distant disease. Two T1 and seven T2 patients experienced isolated local recurrences; all underwent salvage abdominoperineal resection (APR). After APR, one T1 and four of seven T2 patients were NED at the time of last visit (2-7 years). One T1 patient died of local and distant disease. Three of seven T2 patients died with distant disease. CONCLUSIONS: We conclude that sphincter preservation can be achieved with excellent cancer control without initial sacrifice of anal function in most patients. After local recurrence, salvage resection appears effective, but longer follow-up time of local and distant disease-free survival is advised before extrapolation to patients with T3 primaries.

Conservative management of rectal cancer with local excision and postoperative adjuvant therapy.

Wagman R, Minsky BD Int J Radiat Oncol Biol Phys 1999 Jul 1;44(4):841-6

Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.

BACKGROUND: To determine the local control, survival, and functional outcome of local excision plus postoperative therapy for patients with rectal cancer. METHODS: A total of 39 patients underwent a local excision (2 with snare excision of a T1 polyp and 37 with full-thickness local excision) followed by postoperative radiation therapy +/- 5-FU-based chemotherapy. The median follow-up was 41 months, and 11 patients had positive margins. RESULTS: The 5-year actuarial colostomy-free survival was 87% and overall survival was 70%. Crude local failure increased with T stage: 0% T1, 24% T2, and 25% T3. Of the 8 patients (21%) who developed local failure, 5 underwent salvage APR and were locally controlled. Actuarial local failure at 5 years was 31% for T2 disease and 27% for the total patient group. In the 32 patients with an intact sphincter, 94% had good to excellent sphincter function. CONCLUSION: Although local failure in patients with T2 tumors has increased since our prior report, the survival, sphincter function, and local salvage rates are acceptable. Local excision and postoperative therapy remains a reasonable alternative to APR in selected patients.

Local excision and chemoradiation for low rectal T1 and T2 cancers is an effective treatment.

Le Voyer TE, Hoffman JP, Cooper H, Ross E, Sigurdson E, Eisenberg B.     Am Surg 1999 Jul;65(7):625-30

Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, USA.

Lesions located in the distal third of the rectum are usually treated with abdominoperineal resection or a low anterior resection with a coloanal anastomosis. However, in a select group of patients with favorable histology and a low probability of lymphatic spread, sphincter-sparing procedures will afford long-term disease-free survival and cure without the need for extensive, complicated surgery. We performed a 10-year retrospective review, including pathologic examination of specimens by a single pathologist, in an attempt to identify factors associated with a decreased disease-free survival. Thirty-five patients (median age, 71 years; range, 48-88) with low rectal carcinomas were treated with full-thickness disc excision (with or without chemoradiation), with curative intent. Median follow-up was 46 months (range, 8-120). There were 15 T1, 16 T2, and 4 T3 lesions. Tumors with poor histologic factors or greater than T1 received adjuvant radiation (with or without 5-fluorouracil). Four patients developed a local failure at a median of 21.5 months (range, 9-30) and were salvaged with abdominoperineal resection. The 5-year cancer-specific survival was 91 per cent. Negative margins approached statistical significance (P < 0.07) in influencing local control. We conclude that, when combined with chemoradiation for lesions deeper than submucosa or with adverse histologic factors, local resection of rectal cancer is an effective treatment in selected patients.

High-dose preoperative radiation and the challenge of sphincter-preservation surgery for cancer of the distal 2 cm of the rectum.

Mohiuddin M, Regine WF, Marks GJ, Marks JW.  Int J Radiat Oncol Biol Phys 1998 Feb 1;40(3):569-74

University of Kentucky, Department of Radiation Medicine, Lexington 40536-0084, USA.

PURPOSE: Sphincter-preserving surgery for the management of distal rectal cancer is gaining recognition as an alternative to abdominoperineal resection and loss of anal function. The use of high-dose preoperative radiation appears to enhance the options for sphincter preservation, even in the most distal segments of the rectum. MATERIALS AND METHODS: Seventy patients with tumors located in the distal 2 cm of the rectum received a minimum dose of 40 to 45 Gy over 4 1/2 weeks at 1.8 to 2.5 Gy per fraction. Patients with unfavorable tumors were given an additional boost of 10 to 15 Gy. Surgery was performed 5 to 10 weeks following completion of radiation. Radical surgical resection was performed in 48 patients and full thickness local excision in 22. Follow-up ranged from a minimum of 1 year to a maximum of 10 years, with a median of 4 years. RESULTS: There was one perioperative mortality. Two patients did not have their colostomy closed because of complications. Late diversion was required in 4 patients, primarily for recurrent disease. Sixty patients (86%) maintained long-term satisfactory sphincter function. Local recurrence was observed in 9 patients (13%) and distant metastases in 12 patients (17%). The overall five-year actuarial survival rate was 82%. The 5-year survival and local recurrence for postradiation pathological stage of disease was: T0, T1, T2, N0--95% and 8%, T3, T4, N0--91% and 4%, T(any) N+--50% and 41%, respectively. CONCLUSION: High-dose preoperative radiation, in properly selected patients with rectal cancers of the distal 2 cm, offers opportunities for sphincter-preserving surgical resection with excellent local control, survival, and enhanced quality of life.