Effects of preoperative chemoradiotherapy on anal sphincter functions and quality of life in rectal cancer patients High-dose preoperative radiation and full-thickness local excision Complementary use of local excision and transanal endoscopic microsurgery for rectal cancer after neoadjuvant chemoradiation Preoperative versus postoperative chemoradiotherapy for rectal cancer. Preoperative chemoradiation followed by transanal excision for rectal cancer. Patterns of recurrence following high-dose preoperative radiation and sphincter-preserving surgery for cancer of the rectum Local Excision After Preoperative Chemoradiotherapy for Rectal Cancer: Results of a Multicenter Phase II Clinical Trial Radical and local excisional methods of sphincter-sparing surgery after high-dose radiation for cancer of the distal 3 cm of the rectum Transanal Minimally Invasive Surgery (TAMIS) for Local Excision of Benign Neoplasms and Early-stage Rectal Cancer: Efficacy and Outcomes in the First 50 Patients Late patient-reported toxicity after preoperative radiotherapy or chemoradiotherapy in nonresectable rectal cancer: results from a randomized Phase III study. Long-term results using local excision after preoperative chemoradiation among selected T3 rectal cancer patients. Transanal Endoscopic Microsurgery for Local Excision of Rectal Lesions: Is There a Learning Curve Improved survival with preoperative radiotherapy in resectable rectal cancer.
Purpose Deterioration of anorectal function after long-course preoperative chemoradiotherapy combined with surgery for rectal cancer is poorly defined . We conducted a prospect i ve study to evaluate the acute and long term effects of preoperative chemoradiotherapy on anorectal function and quality of life of the patients . Methods There were 26 patients in surgery group and 31 patients in preoperative chemoradiotherapy group .  Anorectal function and quality of life of the patients were assessed by anorectal manometry , incontinence score , quality of life question naire . Results Significant lower resting pressures in both groups and lower maximal squeeze pressures in the preoperative chemoradiotherapy group were observed after postsurgical evaluations compared with the paired pretreatment ones . In the surgery group , both the Wexner continence score , FIQL score , and the rectoscopy score were comparable before and after surgery , whereas significant worsening in the Wexner score was observed in the preoperative chemoradiotherapy group postoperatively ( P < 0.01 ) . Significant reduction in anal canal resting pressures and squeeze pressures , Wexner score , and FIQL score were observed immediately after the completion of preoperative chemoradiotherapy . Significant lower maximal squeeze pressures and worsening of the Wexner scores were observed in the preoperative chemoradiotherapy group compared to the surgery group during the postoperative assessment s ( P < 0.05 and P < 0.01 , respectively ) . Conclusions Both total mesorectal excision and preoperative chemoradiotherapy may adversely affect the anorectal function . Careful selection of the patients who will benefit from neoadjuvant therapy and identifying the patients with a high risk of developing functional problems may help to improve functional outcomes for the treatment of rectal cancer Faced with the responsibility of treating patients with invasive distal rectal cancer who were medically unacceptable for the indicated radical surgery  , a prospect i ve study was initiated in which high dose preoperative radiation and full-thickness local excision were used . High dose preoperative radiation permitted full-thickness local excision of select cancers , which , by conventional st and ards , otherwise would have required radical surgery and permanent colostomy . Feasibility was measured on the basis of safety of the technique , control of the cancer , and the quality of anal sphincter function expected . Patients were selected initially because of their predicted inability to tolerate radical surgery , but indications were broadened to include those whose tumors had completely disappeared after irradiation . From 1984 to 1988 , 20 patients underwent 21 operative procedures for cancers located between 0 and 7 cm from the anorectal ring . This report is concerned with the 14 patients of this group who were observed for a minimum of 24 months .  High-dose preoperative radiation was administered for a total dose of 4500 cGy . Excision and repair were performed 4 to 6 weeks after completion of radiation therapy . Full-thickness disc or hemicircumferential excision was accomplished by transanal , transsphincteric , and transsacral techniques , which included , in several instances , excision of the sphincter mechanism and perineal body , and /or the vaginal wall . Full-thickness local excision after high-dose radiation therapy for rectal cancers has never been reported . Follow-up observation ranged from 24 to 48 months with a median of 31 months . Rectal reservoir function and sphincter control were good in 13 patients .  Local recurrence developed in three patients ( 21 percent ) , two of whom had postradiation therapy B2 mucinous cancers .  Three-year actuarial rate of local recurrence is 23 percent . One ( 7 percent ) patient died of recurrent disease . Actuarial Kaplan-Meier survival at 3 years is 61 percent . Based on the results of this small , select patient group , high-dose radiation therapy followed by full-thickness local excision appears to be a reasonable option for patients who can not tolerate radical surgery . This bimodal approach also may serve as an option for those who aregoodmedical risks , but for whom sphincter preservation is at stake , and to whom radical surgery offers limited benefits Background Neoadjuvant therapies have significantly improved local control and survival of patients with rectal cancer . Nevertheless , although a complete pathologic response can be achieved in 30 % of cases , a transabdominal surgical resection is always required . This study aim ed , for the first time , to test in the literature the feasibility of local excision combined with transanal endoscopic microsurgery ( TEM ) as a surgical option for patients treated with neoadjuvant chemoradiation . Methods Between July 1997 and December 2002 , 30 patients with rectal cancer affected by an extraperitoneal tumor entered a protocol consisting of neoadjuvant chemoradiation followed by surgery . The surgical treatment , consisting of open surgery , local excision , or TEM , was planned according to the patient ’s clinical response after chemoradiation and distance from the anal verge . Results A significant clinical downstaging was observed in eight patients . Five of these patients underwent TEM , and three had local excision . Consequently , open surgery was performed for 22 patients . Histology showed six cases of complete pathologic response : three in the open surgery group and three in the transanal excision group . After a mean follow-up period of 47 months , the disease-free survival rate was 77 % in the open surgery group and 100 % in TEM or local excision group . Conclusions The findings suggest the complementary feasibility of TEM and local excision after neoadjuvant chemoradiation . However , r and omized trials are needed to confirm the oncologic safety of this approach BACKGROUND Postoperative chemoradiotherapy is the recommended st and ard therapy for patients with locally advanced rectal cancer . In recent years , encouraging results with preoperative radiotherapy have been reported . We compared preoperative chemoradiotherapy with postoperative chemoradiotherapy for locally advanced rectal cancer . METHODS We r and omly assigned patients with clinical stage T3 or T4 or node-positive disease to receive either  preoperative or postoperative chemoradiotherapy . The preoperative treatment consisted of 5040 cGy delivered in fractions of 180 cGy per day , five days per week , and fluorouracil , given in a 120-hour continuous intravenous infusion at a dose of 1000 mg per square meter of body-surface area per day during the first and fifth weeks of radiotherapy . Surgery was performed six weeks after the completion of chemoradiotherapy . One month after surgery , four five-day cycles of fluorouracil ( 500 mg per square meter per day ) were given . Chemoradiotherapy was identical in the postoperative-treatment group , except for the delivery of a boost of 540 cGy . The primary end point was overall survival . RESULTS Four hundred twenty-one patients were r and omly assigned to receive preoperative chemoradiotherapy  and 402 patients to receive postoperative chemoradiotherapy . The overall five-year survival rates were 76 percent and 74 percent , respectively ( P=0.80 ) . The five-year cumulative incidence of local relapse was 6 percent for patients assigned to preoperative chemoradiotherapy and 13 percent in the postoperative-treatment group ( P=0.006 ) . Grade 3 or 4 acute toxic effects occurred in 27 percent of the patients in the preoperative-treatment group , as compared with 40 percent of the patients in the postoperative-treatment group ( P=0.001 ) ; the corresponding rates of long-term toxic effects were 14 percent and 24 percent , respectively ( P=0.01 ) . CONCLUSIONS Preoperative chemoradiotherapy , as compared with postoperative chemoradiotherapy , improved local control and was associated with reduced toxicity but did not improve overall survival BACKGROUND This study was conducted to assess the efficacy of preoperative chemoradiation followed by transanal excision among patients with locally advanced lower rectal cancer . METHODS Between May 1994 and June 2005 , 73 patients with locally advanced lower rectal cancer were treated with curative intent by preoperative chemoradiation followed by surgical resection . Transanal excision was performed in 9 patients due to either the absolute refusal of a permanent stoma by the patient ( n = 8) or medical comorbidity ( n = 1 ) . Sixty-four patients were treated by radical proctectomy . Preoperative 5-fluorouracil-based chemotherapy and pelvic radiation ( 4500 to 5040 cGy ) were followed by surgery 6 wk after treatment , and all patients except one with transanal excision received postoperative 5-fluorouracil-based chemotherapy during the first year after surgery . RESULTS The mean follow-up period was 91 mo ( range , 50 to 127 mo ) ; median follow-up was 94 mo . One local recurrence occurred at 30 mo after transanal excision ( 11.1 % ) ; 5 in 64 patients who received radical proctectomy ( 7.8 % ) experienced local recurrences . The disease-free survival rate at 10 y was 77.8 % in transanal excision group compared with a rate of 62.7 % among radical proctectomy patients ( P = 0.335 ) . The overall survival rate at 10 y was 88.9 % in transanal excision group compared with 74.2 % among radical proctectomy patients ( P = 0.424 ) . CONCLUSIONS Transanal excision after preoperative chemoradiation in highly-selected patients with locally advanced lower rectal cancer could probably be an acceptable alternative to conventional radical surgery . However , this approach should be prospect ively vali date d , and strict patient selection criteria should be used High-dose preoperative radiation with new sphincter-preserving surgical options for the management of distal and unfavorable cancers of the rectum is gaining recognition as an alternative to abdominoperineal resection and permanent colostomy . From 1976 to 1989 , 161 patients with cancer of the rectum were entered into a program of high-dose preoperative radiation and radical sphincter-preserving surgery . Selection was based on prospect i ve clinical staging of unfavorability or tumor location at a low level in the rectum . All patients received a minimum dose of 4,000 to 4,500 cGy over 4 1/2 weeks in fractional doses of 180 to 250 cGy . Patients with tumor fixation were given an additional boost of 1,000 to 1,500 cGy for a total of 5,500 to 6,000 cGy using a coned-down field . Surgery was carried out four to eight weeks following completion of radiation . Fourteen patients , found at surgery to have liver metastasis , were treated by palliative resection . One hundred forty-seven patients underwent radical curative surgery  with  sphincter  preservation . The surgical procedures performed were combined abdominotranssacral resection ( 63 ) , transanal-abdominal-transanal resection ( 53 ) , and anterior resection ( 31 ) . Follow-up ranged from a minimum of two years to 15 years , with a median of five years . There was no perioperative mortality . Anastomotic failure occurred in three patients , two of whom were reconstituted . Late diversion was required in 10 other patients , primarily for recurrent disease . One hundred thirty-four of the 147 patients ( 91 percent ) maintained long-term normal sphincter function . Pelvic-perineal recurrence was observed in 18 patients ( 12.4 percent ) , 12 of whom had fixed tumors located below the 6-cm level of the distal rectum . Median time to local recurrence was 24 months . Distant metastasis with or without local recurrence occurred in 35 patients , 22 of whom had fixed tumors below the 6-cm level of the rectum . Median time to distant metastasis was 17 months . Forty-three patients have died , 32 of disease . The overall five-year Kaplan-Meier actuarial survival for the total group of patients is 79 percent , with a disease-free survival of 73 percent . The findings of this study indicate that high-dose preoperative radiation used in combination with radical sphincter-preserving surgical techniques results in excellent local control of disease , improved survival , and enhanced quality of life with retention of normal anal sphincter function BACKGROUND : Transanal local excision has been suggested as an attractive approach for patients with rectal cancer who show a major clinical response after preoperative chemoradiotherapy . OBJECTIVE : To evaluate the impact of transanal local excision on the local recurrence of rectal cancer in patients who had a major clinical response after preoperative chemoradiotherapy .  DESIGN : Sequential 2-stage phase II study for early efficacy . SETTING : Multicenter study . PATIENTS : Patients with clinical T3 or low-lying T2 rectal adenocarcinoma that showed a major clinical response after a preoperative chemoradiotherapy .  Eligible patients underwent a full-thickness transanal local excision . According to their histopathology , the patients staged as ypT0 - 1 were observed , while the remaining patients were recommended to undergo a subsequent total mesorectal excision . MAIN OUTCOME MEASURES : A local recurrence rate of ⩽5 % was set as a successful rate for stopping the trial early after the first stage . RESULTS : The study group included 63 patients . Before chemoradiotherapy , patients were staged as clinical T3 ( n = 42 ) and T2 ( n = 21 ) . After the local excision , 43 patients fulfilled the criteria to be observed with no further treatment . Nine of the remaining 20 patients for whom a subsequent total mesorectal excision was recommended refused surgery . Two of these patients who refused surgery had intraluminal local recurrence ; both had a ypT2 tumor and underwent salvage surgery . The estimated cumulative 3-year overall survival , disease-free survival and local disease-free survival were 91.5 % ( 95 % CI : 75.9–97.2 ) , 91.0 % ( 95 % CI : 77.0–96.6 ) and 96.9 % ( 95 % CI : 80.3–99.5 ) , respectively . LIMITATIONS : The time of follow-up is still short and the sample size is limited . CONCLUSIONS : Our data suggest that local excision is a good option for patients with a major clinical response after chemoradiotherapy . A longer period of follow-up is required to confirm these findings Abstract Background : Despite conventional attitudes that interdict sphincter-preservation surgery ( SPS ) for cancers arising in the terminal 3 cm of rectum , we have selectively employed high-dose preoperative external radiation ( HDPER ) and either radical or local excisional SPS techniques for rectal cancer arising between the 0.5 and 3 cm levels above the anorectal ring . We have reported a preliminary experience with HDPER and full-thickness local excision ( FTLE ) and three different methods of radical SPS . We now describe our experience with a single method of radical excision , transanal abdominal transanal proctosigmoidectomy with coloanal anastomosis ( TATA ) and FTLE in conjunction with HDPER for cancers of the distal 3 cm of rectum based on specific guidelines . Methods : Since 1984 , 109 patients with cancers at or below the 3 cm level have been treated with HDPER in doses of 4,500–7,000 cGy and a sphincter-preserving radical or local excision method in a prospect i ve rectal cancer management program . Sixty-five patients ( group A ) underwent transanal abdominal transanal radical proctosigmoidectomy with coloanal anastomosis ( TATA ) and 44 patients ( group B ) underwent FTLE . Results : There was one death ( 1 % ) . Mean follow-up was 40 months . Local recurrence rates for groups A and B were 9 and 14 % , respectively . Kaplan-Meier 5-year actuarial survival was 85 and 90 % for groups A and B , respectively , and 87 % collectively . Conclusion : Experience with 109 patients with cancers of the distal 3 cm of rectum indicates that SPS can be accomplished by either radical or local excisional methods with acceptable local control and survival if HDPER and strict selection guidelines are employed BACKGROUND : Since its inception in 2009 , transanal minimally invasive surgery has been used increasingly in the United States and internationally as an alternative to local excision and transanal endoscopic microsurgery for local excision of neoplasms in the distal and mid rectum . Despite its increasing acceptance , the clinical benefits of transanal minimally invasive surgery have not yet been vali date d. OBJECTIVE : The aim of this study is to assess the adequacy of transanal minimally invasive surgery  for the local excision of benign and malignant lesions of the rectum . DESIGN : This is a retrospective analysis of consecutive patients who underwent transanal minimally invasive surgery for local excision of neoplasms at a single institution . SETTING S : The study was conducted by a single group of colorectal surgeons at a tertiary referral center . PATIENTS : Eligible patients with early-stage rectal cancer and benign neoplasms were offered transanal minimally invasive surgery as a means for local excision . Data from these patients were collected prospect ively in a registry . MAIN OUTCOME MEASURES : The primary outcome measures included the feasibility of transanal minimally invasive surgery for local excision , resection quality , and short-term clinical results . RESULTS : Fifty patients underwent transanal minimally invasive surgery between July 2009 and December 2011 . Twenty-five benign neoplasms , 23 malignant lesions , and 2 neuroendocrine tumors were excised . All lesions were excised using transanal minimally invasive surgery without conversion to an alternate transanal platform . The average length of stay was 0.6 days ( range , 0–6 ) , and 68 % of patients were discharged on the day of surgery . The average distance from the anal verge was 8.1 cm ( range , 3–14 cm ) . All lesions were excised completely with only 2 fragmented specimens ( 4 % ) . All specimens were removed with grossly negative margins , although 3 ( 6 % ) were found to have microscopically positive margins on final pathology . There were 2 recurrences ( 4 % ) at 6- and 18-month follow-up . Early complications occurred in 3 patients ( 6 % ) . No long-term complications were observed at a median follow-up of 20 months . LIMITATIONS : The study was limited by its retrospective nature and midterm follow-up . CONCLUSIONS : Transanal minimally invasive surgery is an advanced transanal platform that provides a safe and effective method for resecting benign neoplasms , as well as carefully selected , early-stage malignancies of the mid and distal rectum PURPOSE Preoperative chemoradiotherapy ( CRT ) is superior to radiotherapy ( RT ) in locally advanced rectal cancer , but the survival gain is limited . Late toxicity is , therefore , important . The aim was to compare late bowel , urinary , and sexual functions after CRT or RT . METHODS AND MATERIAL S Patients ( N = 207 ) with nonresectable rectal cancer were r and omized to preoperative CRT or RT ( 2 Gy × 25 ± 5-fluorouracil/leucovorin ) . Extended surgery was often required . Self-reported late toxicity was scored according to the LENT SOMA criteria in a structured telephone interview and with question naires European Organisation for Research and Treatment of Cancer ( EORTC ) Quality of Life Question naire ( QLQ-C30 ) , International Index of Erectile Function ( IIEF ) , and sexual function-vaginal changes question naire ( SVQ ) . RESULTS Of the 105 patients alive in Norway and Sweden after 4 to 12 years of follow-up , 78 ( 74 % ) responded . More patients in the CRT group had received a stoma ( 73 % vs. 52 % , p = 0.09 ) . Most patients without a stoma ( 7 of 12 in CRT group and 9 of 16 in RT group ) had incontinence for liquid stools or gas . No stoma and good anal function were seen in 5 patients ( 11 % ) in the CRT group and in 11 ( 30 % ) in the RT group ( p = 0.046 ) . Of 44 patients in the CRT group , 12 ( 28 % ) had had bowel obstruction compared with 5 of 33 ( 15 % ) in the RT group ( p = 0.27 ) . One-quarter of the patients reported urinary incontinence . The majority of men had severe erectile dysfunction . Few women reported sexual activity during the previous month . However , the majority did not have concerns about their sex life . CONCLUSIONS Fecal incontinence and erectile dysfunction are frequent after combined treatment for locally advanced rectal cancer . There was a clear tendency for the problems to be more common after CRT than after RT PURPOSE To assess the pelvic failure among patients with T3 rectal cancer treated with local excision after preoperative chemoradiation .  METHODS AND MATERIAL S Between January 1990 and June 2002 , 431 patients with clinical ly staged T3 rectal cancer were treated with preoperative chemoradiation followed by surgical resection . Full-thickness local excision [ Kraske ( n = 3 ) or a transanal excision ( n = 23 ) ] was performed in 26 patients because of patient refusal of abdominoperineal resection ( APR ) ( n = 13 ) , medical comorbidity ( n = 4 ) , physician preference after a complete clinical response ( n = 6 ) , and other reasons ( n = 3 ) . All patients were treated with continuous-infusion 5-fluorouracil ( 5-FU ) ( 300 mg/m(2 ) Monday to Friday ) and concomitant pelvic radiation ( 45 Gy in 25 fractions with a 3-field belly board technique ) . Ten local-excision patients received a concomitant boost during the last week of therapy ( 1.5-Gy second daily fractions ) for a total dose of 52.5 Gy . Similar preoperative treatment was followed by total mesorectal excision in 405 patients . Among the local-excision patients , the median tumor size was 3.5 cm ( range , 0.5 - 7 cm ) . Well-differentiated or moderately-differentiated histology was present in all but 3 cases , and endoscopic ultrasound staging examination was performed in 25 of 26 patients . Based on CT findings , 1 patient was node positive . The median circumference involved by tumor was 33 % , ( 20%-75 % ) . The median distance from the anal verge was 3 cm ( range , 1 - 8 cm ) . RESULTS The mean follow-up was 46 months ( range , 5 - 109 months ) in the local-excision group . In the local-excision group , 19 of 26 patients had only residual scarring noted on digital rectal examination and rigid proctoscopy before surgery . Fourteen patients ( 54 % ) had a complete histologic response to chemoradiation , 9 patients ( 35 % ) had microscopic residual disease , and 3 patients ( 12 % ) had gross residual disease . Two intrapelvic recurrences occurred at 76 and 20 months among the 26 patients treated with local excision ( 6 % 5-year actuarial pelvic recurrence rate ) . This rate compared with an 8 % 5-year actuarial pelvic recurrence rate among T3 patients treated with mesorectal excision and a 6 % pelvic recurrence rate in the subgroup of mesorectal-excision patients with a complete clinical response to preoperative chemoradiation . One additional local-excision patient recurred in an inguinal lymph node after local excision and subsequently died of metastatic disease . A total of 2 local-excision patients died of metastatic rectal cancer . Actuarial overall survival at 5 years was 86 % in the local-excision group compared with 81 % among mesorectal-excision patients ( p = NS ) , and 85 % in patients with a complete clinical response to chemoradiation followed by mesorectal excision by APR or LAR ( p = NS ) . CONCLUSIONS In an experience stimulated by patient refusal of APR , highly selected patients who responded well to conventional external-beam radiotherapy ( CXRT ) were selected to undergo local excision . Most of these patients had pathologic complete response . Local control and survival rates are comparable to those achieved with chemoradiation followed by mesorectal excision . This strategy should be prospect ively studied in a group of patients with low rectal cancer who have no clinical evidence of tumor after chemoradiation Background : Transanal endoscopic microsurgery ( TEM ) is a minimally invasive technique for the local resection of benign and stage T1 rectal lesions in selected patients , associated with lower morbidity and mortality rates than open surgery . We present our initial results and assess whether experience influences outcome after TEM . Methods : This was a prospect i ve descriptive survey . All patients undergoing TEM for tubulovillous adenoma or carcinoma between 2002 and 2007 were included . Results : A total of 105 patients were included . Median age was 68 years . Median distance of the lesion from the anal verge was 7.0 cm ; median operating time was 90 min . In 10 patients , the peritoneum was opened . Six procedures were converted to ( low ) anterior resections . Postoperative staging revealed 77 tubulovillous adenomas , 22 stage T1 , 5 stage T2 and 1 stage T3 carcinomas ; tumor resection was radical in 86 % . The postoperative complication rate was 7.6 % . Length of hospital stay , operating time and complications significantly diminished over time . After a median follow-up of 27 months , 8 recurrences occurred ( 7.6 % ) . Conclusion : TEM is a safe technique with low morbidity and recurrence rates . Over time , experience leads to a reduction in operation time , lenght of patients ’ hospital stay and complication rate .  TEM remains the treatment of choice for benign lesions and stage T1 rectal carcinomas in selected patients BACKGROUND Adjuvant radiotherapy for rectal cancer has been extensively studied , but no trial has unequivocally demonstrated improved overall survival with radiotherapy , despite a reduction in the rate of local recurrence . METHODS Between March 1987 and February 1990 , we r and omly assigned 1168 patients younger than 80 years of age who had resectable rectal cancer to undergo preoperative irradiation ( 25 Gy delivered in five fractions in one week ) followed by surgery within one week or to have surgery alone .  RESULTS The irradiation did not increase postoperative mortality . After five years of follow-up , the rate of local recurrence was 11 percent ( 63 of 553 patients ) in the group that received radiotherapy before surgery and 27 percent ( 150 of 557 ) in the group treated with surgery alone ( P<0.001 ) . This difference was found in all subgroups defined according to Dukes ' stage . The overall five-year survival rate was 58 percent in the radiotherapy-plus-surgery group and 48 percent in the surgery-alone group ( P=0.004 ) . The cancer-specific survival rates at nine years among patients treated with curative resection were 74 percent and 65 percent , respectively ( P=0.002 ) . CONCLUSIONS A short-term regimen of high-dose preoperative radiotherapy reduces rates of local recurrence and improves survival among patients with resectable rectal cancer
Background Low rectal cancer is conventionally managed with neoadjuvant chemoradiotherapy ( CRT ) followed by radical surgery ( RS ) .
In patients who refuse a stoma or are unfit for RS , an alternative approach may be the use of pre-op CRT and local excision ( LE ) where tumours are responsive .
The aim of this systematic review is to determine whether differences exist in local recurrence ( LR ) , overall survival ( OS ) and disease-free ( DFS ) survival between patients treated with CRT + LE and CRT + RS .