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Background: Preoperative combined modality therapy followed by total mesorectal excision has emerged as the optimal treatment paradigm for locally advanced rectal cancer (T3 to 4, N1, or both). But its impact on postoperative complications has not been adequately evaluated. Our aims were to evaluate our comprehensive experience and identify factors predictive of complications in this patient population., Study Design: The study group consisted of 297 consecutive patients with locally advanced rectal adenocarcinoma treated with preoperative combined modality therapy (radiation: 5,040 cGy; chemotherapy: 5-FU-based) and then operation. Major complications were defined as those requiring medical or surgical treatment. A prospectively collected database was queried to determine the incidence of postoperative complications and associated clinicopathologic factors., Results: Median followup was 43.9 months (range 0.8 to 128.6 months). There were no postoperative mortalities (within 30 days of operation). But there were 145 major complications in 98 patients (33% of study population). The most common complications were small bowel obstruction (n = 32 [11%]) and wound infection (n = 31 [10%]). There were eight anastomotic leaks (4%) and nine pelvic abscesses (4%) in patients treated with low anterior resection (n = 210). Preoperative comorbidity was the only clinicopathologic factor associated with postoperative complications (p = 0.02). Postoperative complications had no significant impact on oncologic outcomes., Conclusions: Although postoperative mortalities are rare, complications requiring treatment can be anticipated in one-third of patients undergoing preoperative combined modality therapy and total mesorectal excision. A policy of selective fecal diversion after preoperative combined modality therapy and total mesorectal excision for locally advanced rectal cancer can achieve low rates of pelvic sepsis, but may lead to an increased incidence of small bowel obstruction.

Objective: Our aims were to (1) determine the long-term oncologic outcome for patients with rectal cancer treated with preoperative combined modality therapy (CMT) followed by total mesorectal excision (TME), (2) identify factors predictive of oncologic outcome, and (3) determine the oncologic significance of the extent of pathologic tumor response., Summary Background Data: Locally advanced (T3-4 and/or N1) rectal adenocarcinoma is commonly treated with preoperative CMT and TME. However, the long-term oncologic results of this approach and factors predictive of a durable outcome remain largely unknown., Methods: Two hundred ninety-seven consecutive patients with locally advanced rectal adenocarcinoma at a median distance of 6 cm from the anal verge (range 0-15 cm) were treated with preoperative CMT (radiation: 5040 centi-Gray (cGy) and 5-fluorouracil (5-FU)-based chemotherapy) followed by TME from 1988 to 2002. A prospectively collected database was queried for long-term oncologic outcome and predictive clinicopathologic factors., Results: With a median follow-up of 44 months, the estimated 10-year overall survival (OS) was 58% and 10 year recurrence-free survival (RFS) was 62%. On multivariate analysis, pathologic response >95%, lymphovascular invasion and/or perineural invasion (PNI), and positive lymph nodes were significantly associated with OS and RFS. Patients with a >95% pathologic response had a significantly improved OS (P = 0.003) and RFS (P = 0.002)., Conclusions: Treatment of locally advanced rectal cancer with preoperative CMT followed by TME can provide for a durable 10-year OS of 58% and RFS of 62%. Patients who achieve a >95% response to preoperative CMT have an improved long-term oncologic outcome, a novel finding that deserves further study.

Purpose: Preoperative radiotherapy for rectal cancer avoids radiation to the reconstructed rectum and may circumvent the detrimental effects on bowel function associated with postoperative radiotherapy. We compared the long-term functional results of patients who received preoperative radiotherapy, postoperative radiotherapy, or no radiotherapy in conjunction with low anterior resection and coloanal anastomosis to assess the impact of pelvic radiation on anorectal function., Methods: One hundred nine patients treated by low anterior resection and straight coloanal anastomosis for rectal cancer between 1986 and 1997 were assessed with a standardized questionnaire at two to eight years after resection. All radiotherapy was given to a total dose of 4,500 to 5,400 cGy with conventional doses and techniques. Most patients received concurrent 5-fluorouracil-based chemotherapy., Results: There were 39 patients in the preoperative radiotherapy group, 11 patients in the postoperative radiotherapy group, and 59 patients in the no radiotherapy group. The postoperative radiotherapy group reported a significantly greater number of bowel movements per 24-hour period (P < 0.01) and significantly more episodes of clustered bowel movements (P < 0.02) than either the preoperative radiotherapy group or the no radiotherapy group. No significant difference in anal continence or satisfaction with bowel function was found among the three groups., Conclusion: In this study of straight (nonreservoir) coloanal anastomoses, postoperative pelvic radiotherapy had significant adverse effects on anorectal function, with higher rates of clustering and frequency of defecation than with preoperative radiotherapy. No differences in continence rates were demonstrated, perhaps because of the sample size of the compared groups. We attribute the adverse effects of postoperative radiotherapy to irradiation of the neorectum, which is spared when treatment is given preoperatively. The deleterious effects of adjuvant radiation on long-term anorectal function can be reduced by preoperative treatment.

Two decades have passed since the late 1970s, which witnessed the introduction of total mesorectal excision (TME)-based operations for rectal cancers on both sides of the Atlantic. Since the introduction of TME, clinical experience has been reported widely in the form of single- and multisurgeon reports from wide geographic regions with multiple participants, and from specialty services with narrow focus and high levels of expertise. All of these published results conclude that in comparison with conventionally practiced blunt surgery for rectal cancer, TME-based (i.e., anatomically correct, sharply performed) operations are associated with significantly lower rates of pelvic (local) recurrences, a significantly higher rate of survival, and significantly lower long-term morbidity. The latter is accomplished through dramatically higher rates of sphincter preservation, and the preservation of both sexual and urinary functions. Overall, there is a remarkable similarity in the clinical results that have been reported from diverse centers. TME now forms the basis of large randomized clinical trials in which the role of adjuvant therapy is being reexamined. The current status of TME is reviewed, and the authors' clinical results of a consecutive series of 544 TME-based operations performed through 1998 are updated.

In the design of operations for rectal cancers, the focus is often on circumventing the local extent of disease and leaving the pelvis free of cancer. The local extent of disease may range from minimal intramural invasion to the direct extension of a primary tumor to pelvic sidewall structures, e.g., the internal iliac vessels. In the absence of distant spread, understanding the planes of pelvic anatomy may allow the knowledgeable surgeon to cure patients who would otherwise be declared unresectable. We present the four planes (and one rare situation) available for sharp dissection which allow for the resection of all but a few cases of locally advanced disease., (Copyright 2000 Wiley-Liss, Inc.)

Adjuvant chemoradiation therapy following resection of T3N0 rectal cancer is recommended in order to reduce the incidence of local recurrence and improve survival. However, recent experience with rectal cancer resection utilizing sharp dissection and total mesorectal excision has resulted in a reduction in local recurrence rates to as low as 5% without adjuvant treatment. The purpose of this study was to determine if rectal cancer resection utilizing sharp mesorectal excision alone is adequate treatment for local control of T3N0 rectal cancer. Between July 1986 and December 1993, 95 patients with T3N0M0 rectal cancer underwent resection with sharp mesorectal excision and did not receive any adjuvant therapy. Various prognostic factors were analyzed for their association with local recurrence and survival. Seventy-nine patients had a low anterior resection, 10 of whom had a coloanal anastomosis, and 16 had an abdominoperineal resection. The median follow-up was 53.3 months. Six patients had local recurrence, 12 had distant recurrence, and three had local and distant recurrences. The overall local recurrence rate was 9% crude and 12% 5-year actuarial. The overall crude recurrence rate was 22%. The 5-year disease-specific survival rate was 86.6% with an overall survival of 75%. Postoperative complications occurred in 18 patients (19%). Five patients (6%) had a documented anastomotic leak. Perioperative mortality was 3%. No technical factors, including type of resection (low anterior vs. abdominoperineal), location of tumor, or extent of resection margin, were significant for determining local recurrence. The only histopathologic marker significant for determining local recurrence was lymphatic invasion (P <0.04). Sharp mesorectal excision with low anterior resection or abdominoperineal resection for T3N0M0 rectal cancer results in a local recurrence rate of less than 10% without the use of adjuvant therapy. Therefore, in select patients with T3N0M0 rectal cancer, the standard use of adjuvant therapy for local control may not be justified.

Objective: To determine perioperative morbidity, survival, and local failure rates in a large group of consecutive patients with rectal cancer undergoing low anterior resection by multiple surgeons on a specialty service. The primary objective was to assess the surgical complications associated with preoperative radiation sequencing., Summary Background Data: The goals in the treatment of rectal cancer are cure, local control, and preservation of sphincter, sexual, and bladder function. Surgical resection using sharp perimesorectal dissection is important for achieving these goals. The complications and mortality rate of this surgical strategy, particularly in the setting of preoperative chemoradiation, have not been well defined., Methods: There were 1233 patients with primary rectal cancer treated at the authors' cancer center from 1987 to 1995. Of these, 681 underwent low anterior resection and/or coloanal anastomosis for primary rectal cancer. The surgical technique used the principles of sharp perimesorectal excision. Morbidity and mortality rates were compared between patients receiving preoperative chemoradiation (Preop RT, n = 150) and those not receiving preoperative chemoradiation (No Preop RT, n = 531). Recurrence and survival data were determined in patients undergoing curative resection (n = 583, 86%) among three groups of patients: those receiving Preop RT (n = 131), those receiving postoperative chemoradiation (Postop RT, n = 110), and those receiving no radiation therapy (No RT, n = 342)., Results: The perioperative mortality rate was 0.6% (4/681). Postoperative complications occurred in 22% (153/681). The operative time, estimated blood loss, and rate of pelvic abscess formation without associated leak were higher in the Preop RT group than the No Preop RT group. However, the overall complication rate, rate of wound infection, anastomotic leak, and length of hospital stay were no different between Preop RT and No Preop RT patients. With a median follow-up of 45.6 months, the overall actuarial 5-year recurrence rate for patients undergoing curative resection (n = 583) was 19%, with 4% having local recurrence only, 12% having distant recurrence, and 3% having both local and distant recurrence, for an overall local recurrence rate of 7%. The actuarial 5-year overall survival rate was 81%; the disease-free survival rate was 75% and the local recurrence rate was 10%. The overall survival rate was similar between Preop RT (85%), Postop RT (72%), and No RT (83%) patients (p = 0.10), whereas the disease-free survival rate was significantly worse for Postop RT (65%) patients compared with Preop RT (79%) and No RT (77%) patients (p = 0.04)., Conclusion: The use of preoperative chemoradiation results in increased operative time, blood loss, and pelvic abscess formation but does not increase the rate of anastomotic leaks or the length of hospital stay after low anterior resection for rectal cancer. The 5-year actuarial overall survival rate for patients undergoing curative resection exceeded 80%, with a local recurrence rate of 10%.

By precisely delivering a single, high dose fraction of intraoperative radiation under direct visualization while excluding surrounding normal dose-limiting tissues, IORT has improved the therapeutic ratio of tumor control to morbidity. Both IOERT and HDR-IORT represent effective means of delivering this therapy, and either may be chosen with equal confidence, depending upon the facilities available, physician preference, and the clinical situation. The extraordinary efforts often required in the management of these highly selected patients is justified by the improvement achieved in the enhanced local control rates and increased cure rates. Preoperative chemoradiation therapy followed by gross total resection and IORT affords the patient the highest likelihood of local control and survival. The importance of aggressive surgery in achieving gross total resection with pathologically negative margins is reflected by the dramatic correlation reported between margin status and local control. The high complication rate associated with this multidisciplinary therapy is, no doubt, multifactorial and may be attributed to the advanced disease state at presentation and the intensive multidisciplinary treatments administered. In an effort to eradicate disease and prolong survival, many consider these elevated complication rates acceptable, particularly in light of the complexity of these cases, as well as the morbidity and mortality associated with persistent disease in the pelvis.

Local and distant recurrence rates and disease-free and overall survival are markedly improved by total mesorectal excision, with little increase in morbidity, compared with other techniques of resection of rectal cancer. Adjuvant therapy is associated with significant morbidity and initial results suggest it may not be beneficial in the aggregate. Adjuvant therapy must be re-evaluated in trials using TME as standard operative technique. Different subgroups of patients, defined by clinical and pathological criteria will be best served by different forms of therapy and should be studied based on rates of local and distant recurrence. Selected groups of patients will be best served by undergoing no adjuvant therapy of any kind.

We have examined the results of abdominoperineal resection (APR) for primary cancer of the rectum performed in accordance with the principles of total mesorectal excision (TME) and autonomic nerve preservation (ANP). TME is defined as sharp pelvic dissection under direct vision between the parietal and visceral planes of the pelvic fascia. TME results in the resection of all mesorectal disease with intact, negative lateral or circumferential margins of resection. Statistical analysis was done of survival, local recurrence, and both sexual and urinary functions in a prospective database of consecutive patients. Operative mortality was 2% (3/148) due to cardiac disease. Overall survival was 60%, significantly worse than consecutive patients from the same database who were able to undergo sphincter preservation (81%) (p = 0.0003). Poorer survival was statistically related to the presence of positive lymph nodes (p = 0.0009). Overall, local recurrence rates were 5% (8/148) in patients without distant metastases, and 15% to 21% in patients with positive nodes. Positive lymph nodes, N2 disease, lymphatic vascular invasion, and perineural invasion were independent significant risk factors for local recurrence. Sexual function was preserved in approximately 57% of patients undergoing APR versus 85% of patients undergoing sphincter preservation. No significant urinary morbidity was encountered. Low rectal cancer requiring APR seems to be a disease with more locally advanced disease and adverse pathologic features than are seen with mid-rectal cancers treatable by low anterior resection. APR when performed in accordance with the principles of TME and ANP ensures the greatest likelihood of resecting all regional disease while preserving both sexual and urinary functions. Preoperative combined modality treatment may be warranted in all T3 or greater low rectal cancers.

Introduction: Pelvic recurrence is a significant problem following curative resection for rectal cancer. Although treatment options include surgery, chemotherapy, radiotherapy, or any combination of these, the role of surgery remains controversial in management of these patients., Purpose: In this study, we have attempted to define the patient with pelvic recurrence following curative rectal surgery who may benefit from reresection., Methods: A review of the prospective colorectal database at Memorial Sloan Kettering Cancer Center (MSKCC) between 1983 and 1991 identified 25 patients who had pelvic recurrence following a curative resection for rectal cancer and 52 patients who had their initial rectal surgery at an outside institution (OI) and their pelvic recurrence treated at MSKCC. Survival was calculated from time of recurrence by the Kaplan-Meier method, and survival comparisons were made by log-rank analysis. There were no differences between the two groups related to age, gender, type of initial surgery, stage, or use of adjuvant therapy., Results: For the MSKCC group, median time to initial recurrence was 18 months, and median survival was 40 months. Recurrence was symptomatic in 17 patients and asymptomatic in 8 patients. Pain and bleeding accounted for more than one-half of symptomatic recurrences. Of the 17 symptomatic recurrences, 11 (65 percent) had relief of preoperative symptoms. There were no clinical or pathologic factors identified of the primary tumor or recurrence that predicted improved survival following salvage therapy. It was not possible to preoperatively determine which patients could undergo curative reresection. For the OI group, median time to recurrence was 13.7 months, and median survival from time of initial recurrence was 31 months. Curative reresection was the only factor that predicted for improved survival compared with noncurative treatment (P = 0.02). A comparison of the two groups revealed that pelvic recurrence was more likely to be reresected for cure in the OI group vs. the MSKCC group (34/51 vs. 9/25; P < 0.02). There was no survival difference between the two groups when comparing curative with noncurative management of these patients., Conclusions: Symptoms from recurrent rectal cancer can be palliated with surgery. The only patients who had a survival benefit were those patients in the OI group whose disease could be completely resected. These differences in reresection rates may be attributable to the presence or absence of available planes for dissection around the recurrence in the OI group, as determined by the method of initial curative resection.

Rectal cancer persists as a significant worldwide problem. Currently, surgery is associated with a poor prognosis, a high likelihood of permanent colostomy and a high rate of local recurrence in patients with regional disease (transmural penetration or involvement of regional mesenteric lymph nodes). Functional changes such as impotence and bladder dysfunction remain distressingly common consequences of conventional surgery. Over the past two decades, a fundamental change in operative technique has taken place. Conventional surgery (which is performed using blunt technique along undefinable tissue planes) has given way to sharp dissection along definable planes. The technique known as total mesorectal excision (TME) or complete circumferential mesorectal excision (CCME) produces the complete resection of an intact package of the rectum and its surrounding mesorectum, enveloped within the visceral pelvic fasia with uninvolved circumferential margins. As a result of TME, 5-year survival figures have risen from 45-50% to 75%, local recurrence rates have declined from 30% to 5-8%, sphincter preservation has risen by at least 20% for mid- and lower rectal cancers, and the rates of impotence and bladder dysfunction have declined from 50-85% to 15% or less. Patients with rectal cancer can now have a good prognosis, and intact image and high quality of life. The integration of multidisciplinary radiation therapy and chemotherapy into the care of patients undergoing TME or CCME for rectal cancer is presently under clinical trial.

Sphincter-preserving operations represent an important model for integrating the goals of surgery for rectal cancers. These goals--the achievement of cure and local control and the preservation of autonomic visceral pelvic functions--are inherently related. Sphincter-preserving procedures are possible for patients with mid-rectal cancers (6 to 10 cm from the anal verge) and for highly selected patients with distal rectal cancers (< or = 5 cm from the anal verge). Total mesorectal excision, a new concept in resection with negative circumferential margins, dramatically enhances both cure and local control. Total mesorectal excision can be combined with sphincter preservation. Perioperative adjuvant therapy protocols have been combined with sphincter-preserving operations in many investigative settings. Functional outcomes and recent survival data seem to favor preoperative over postoperative radiation therapy. The currently changing standards of surgery for rectal cancer, which result in improved local control, should enhance long-term sphincter preservation in the future.