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Background: Adding modified FOLFOX6 (folinic acid, fluorouracil, and oxaliplatin) after chemoradiotherapy and lengthening the chemoradiotherapy-to-surgery interval is associated with an increase in the proportion of rectal cancer patients with a pathological complete response., Objective: The purpose of this study was to analyze disease-free and overall survival., Design: This was a nonrandomized phase II trial., Settings: The study was conducted at multiple institutions., Patients: Four sequential study groups with stage II or III rectal cancer were included., Intervention: All of the patients received 50 Gy of radiation with concurrent continuous infusion of fluorouracil for 5 weeks. Patients in each group received 0, 2, 4, or 6 cycles of modified FOLFOX6 after chemoradiation and before total mesorectal excision. Patients were recommended to receive adjuvant chemotherapy after surgery to complete a total of 8 cycles of modified FOLFOX6., Main Outcome Measures: The trial was powered to detect differences in pathological complete response, which was reported previously. Disease-free and overall survival are the main outcomes for the current study., Results: Of 259 patients, 211 had a complete follow-up. Median follow-up was 59 months (range, 9-125 mo). The mean number of total chemotherapy cycles differed among the 4 groups (p = 0.002), because one third of patients in the group assigned to no preoperative FOLFOX did not receive any adjuvant chemotherapy. Disease-free survival was significantly associated with study group, ypTNM stage, and pathological complete response (p = 0.004, <0.001, and 0.001). A secondary analysis including only patients who received ≥1 cycle of FOLFOX still showed differences in survival between study groups (p = 0.03)., Limitations: The trial was not randomized and was not powered to show differences in survival. Survival data were not available for 19% of the patients., Conclusions: Adding modified FOLFOX6 after chemoradiotherapy and before total mesorectal excision increases compliance with systemic chemotherapy and disease-free survival in patients with locally advanced rectal cancer. Neoadjuvant consolidation chemotherapy may have benefits beyond increasing pathological complete response rates. See Video Abstract at http://links.lww.com/DCR/A739.

Local excision (LE) of early-stage rectal cancer avoids the morbidity associated with radical surgery but has historically been associated with inferior oncologic outcomes. Newer techniques, including transanal endoscopic microsurgery (TEM) and transanal minimally invasive surgery (TAMIS), have been developed to improve the quality of LE and extend the benefits of LE to tumors in the more proximal rectum. This article provides an overview of conventional LE, TEM, and TAMIS techniques, including indications for their use and pertinent literature on their associated outcomes for rectal cancer., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Patients with locally advanced rectal cancer who achieve a pathological complete response to neoadjuvant chemoradiation have an improved prognosis. The need for surgery in these patients has been questioned, but the proportion of patients achieving a pathological complete response is small. We aimed to assess whether adding cycles of mFOLFOX6 between chemoradiation and surgery increased the proportion of patients achieving a pathological complete response., Methods: We did a phase 2, non-randomised trial consisting of four sequential study groups of patients with stage II-III locally advanced rectal cancer at 17 institutions in the USA and Canada. All patients received chemoradiation (fluorouracil 225 mg/m(2) per day by continuous infusion throughout radiotherapy, and 45·0 Gy in 25 fractions, 5 days per week for 5 weeks, followed by a minimum boost of 5·4 Gy). Patients in group 1 had total mesorectal excision 6-8 weeks after chemoradiation. Patients in groups 2-4 received two, four, or six cycles of mFOLFOX6, respectively, between chemoradiation and total mesorectal excision. Each cycle of mFOLFOX6 consisted of racemic leucovorin 200 mg/m(2) or 400 mg/m(2), according to the discretion of the treating investigator, oxaliplatin 85 mg/m(2) in a 2-h infusion, bolus fluorouracil 400 mg/m(2) on day 1, and a 46-h infusion of fluorouracil 2400 mg/m(2). The primary endpoint was the proportion of patients who achieved a pathological complete response, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00335816., Findings: Between March 24, 2004, and Nov 16, 2012, 292 patients were registered, 259 of whom (60 in group 1, 67 in group 2, 67 in group 3, and 65 in group 4) met criteria for analysis. 11 (18%, 95% CI 10-30) of 60 patients in group 1, 17 (25%, 16-37) of 67 in group 2, 20 (30%, 19-42) of 67 in group 3, and 25 (38%, 27-51) of 65 in group 4 achieved a pathological complete response (p=0·0036). Study group was independently associated with pathological complete response (group 4 compared with group 1 odds ratio 3·49, 95% CI 1·39-8·75; p=0·011). In group 2, two (3%) of 67 patients had grade 3 adverse events associated with the neoadjuvant administration of mFOLFOX6 and one (1%) had a grade 4 adverse event; in group 3, 12 (18%) of 67 patients had grade 3 adverse events; in group 4, 18 (28%) of 65 patients had grade 3 adverse events and five (8%) had grade 4 adverse events. The most common grade 3 or higher adverse events associated with the neoadjuvant administration of mFOLFOX6 across groups 2-4 were neutropenia (five in group 3 and six in group 4) and lymphopenia (three in group 3 and four in group 4). Across all study groups, 25 grade 3 or worse surgery-related complications occurred (ten in group 1, five in group 2, three in group 3, and seven in group 4); the most common were pelvic abscesses (seven patients) and anastomotic leaks (seven patients)., Interpretation: Delivery of mFOLFOX6 after chemoradiation and before total mesorectal excision has the potential to increase the proportion of patients eligible for less invasive treatment strategies; this strategy is being tested in phase 3 clinical trials., Funding: National Institutes of Health National Cancer Institute., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: Transanal endoscopic microsurgery, a minimally invasive procedure for treatment of early-stage rectal cancer, carcinoid tumors, and adenomas, is shown to be a safe procedure with very low perioperative morbidity., Objective: We aimed to compare the outcomes of transanal endoscopic microsurgery at a large volume tertiary care center with the existing literature., Design: We retrospectively reviewed a prospectively collected database of 325 transanal endoscopic microsurgery procedures and looked for risk factors associated with complications. Indications for transanal endoscopic microsurgery included rectal adenocarcinomas, adenomas, and carcinoids., Setting: Procedures were performed by a single surgeon at a large-volume tertiary care center., Patients: Patients were enrolled over a 20-year period, and data were collected on demographics, perioperative details, tumor characteristics, and complications., Interventions: Transanal endoscopic microsurgery was performed on all 325 patients., Main Outcome Measures: Main outcome measures were urinary retention, late bleeding requiring intervention, dehiscence, peritoneal cavity entry, conversion to abdominal approach, fecal soiling, and rectovaginal fistula., Results: Intraoperative bleeding was associated with larger tumor size, whereas postoperative bleeding requiring intervention was not associated with any factors studied. Peritoneal cavity entry and urinary retention were more likely if the tumor was in either the anterior or lateral position in the rectum. The peritoneal cavity was entered in 9 patients, and conversion to abdominal approach occurred in 1 patient. Intraoperative bleeding, by surgeon's choice, and urinary retention, by patient's choice, were associated with a greater likelihood of admission to the inpatient ward. Fecal soiling was not reported by patients and not recorded., Limitations: This study was limited because it was a retrospective analysis, Conclusions: Transanal endoscopic microsurgery is an extremely safe procedure, offering very low perioperative morbidity. The overall morbidity found in our study was 10.5%, on par with published data for large series of 21%, 7.7%, and 14.9%. In contrast, complications from radical resection are reported at 18% to 55%.

Background: Transanal endoscopic microsurgery is a safe option for proximal rectal tumors in morbidly obese patients for whom transabdominal pelvic dissection often is fraught with morbidity., Methods: From a database of 318 patients who underwent transanal endoscopic microsurgery, we report a retrospective case-control study of 9 patients with a body mass index range of 35 to 66 with sessile rectal lesions 6 to 15 cm from the anal verge who underwent transanal endoscopic microsurgery. Case subjects were compared with 15 controls and matched for age, tumor type, and level of tumor. The average body mass index of controls was 30 (P < .001). By using t test analysis, perioperative outcomes (surgical time, blood loss, and hospital length of stay) and postoperative complications were compared., Results: Sessile tumors were located 7 to 11 cm from the anal verge with a diameter of 1 to 4 cm. Patient and tumor factors such as age, distal tumor margin from anal verge, and tumor diameter were not significantly different between case subjects and controls. Surgical blood loss, surgical time, and hospital length of stay were not significantly different between the 2 groups. One complication occurred among the cases. No complications occurred in the control group. All patients had complete surgical resections with negative margins., Conclusions: Transanal endoscopic microsurgery in morbidly obese patients is a safe, feasible, and a viable alternative to low anterior resection., (Copyright © 2012 Elsevier Inc. All rights reserved.)