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Neoadjuvant therapy followed by local excision and two-stage total mesorectal excision: a new strategy for sphincter preservation in locally advanced ultra-low rectal cancer.

ABSTRACT: BACKGROUND:With the increased usage of neoadjuvant chemoradiotherapy, improved surgical technique and stapling devices, sphincter-preserving resection has become more frequent for patients with rectal cancer. However, as for locally advanced ultra-low rectal cancer, sphincter-preservation is still facing an enormous challenge. OBJECTIVE:To introduce an NLT strategy of sphincter-preservation-neoadjuvant therapy (NT) followed by local excision (LE) and two-stage total mesorectal excision (TME)-into the treatment of locally advanced ultra-low rectal cancer (lesions with anal sphincter invasion). METHODS:From October 2010 to October 2011, nine patients with locally advanced rectal cancer located less than 3 cm from the anal verge were treated by the NLT strategy. All patients had shown good clinical response to NT. The LE procedure was carried transanally 6-8 weeks after completion of the NT. TME was performed to dissect mesorectal lymph nodes 4-6 weeks after LE. RESULTS:Of the nine patients, the lesion was assessed as T2 in two, T3 in five, and T4 in two before NT, and lymph node metastasis was detected in five patients. The median distance from the tumor to the anal verge was 2.5 cm (range: 1-3 cm). The median follow-up was 27 months (range: 24-34 months). No distant metastasis was detected. Only one patient (11.1%) developed local recurrence at 12 months post-operatively and then underwent abdomino-perineal resection. The remaining eight patients had preserved long-term continence and the median Wexner score at two years post-operation was 4 (range: 2-6). CONCLUSION:The new NLT strategy can achieve sphincter-preservation in some patients with ultra-low rectal cancer, with favorable oncological outcome and preservation of normal anal sphincter function.

SUBMITTER: Wang T

PROVIDER: S-EPMC3920994 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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Neoadjuvant therapy followed by local excision and two-stage total mesorectal excision: a new strategy for sphincter preservation in locally advanced ultra-low rectal cancer.

Wang Ting T Wang Jianping J Deng Yanhong Y Wu Xiaojian X Wang Lei L

Gastroenterology report 20140121 1

<h4>Background</h4>With the increased usage of neoadjuvant chemoradiotherapy, improved surgical technique and stapling devices, sphincter-preserving resection has become more frequent for patients with rectal cancer. However, as for locally advanced ultra-low rectal cancer, sphincter-preservation is still facing an enormous challenge.<h4>Objective</h4>To introduce an NLT strategy of sphincter-preservation-neoadjuvant therapy (NT) followed by local excision (LE) and two-stage total mesorectal exc ...[more]

PMID: 24760235

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Project description:BackgroundPreoperative chemoradiotherapy (PCRT) followed by surgery and adjuvant chemotherapy is the current standard treatment for stage II/III rectal cancer. However, radiotherapy in the pelvic area is commonly associated with complications such as anastomotic leakage, sexual dysfunction, and fecal incontinence. Recently, the MERCURY study showed that preoperative high-resolution magnetic resonance imaging (MRI) helped to selectively avoid PCRT. It remains unclear whether PCRT is necessary in patients who can achieve a negative circumferential resection margin (CRM) with surgery alone and in patients with cT1-2N1 or cT3N0 without CRM involvement and lateral lymph node metastasis. This study aims to evaluate the efficacy of upfront radical surgery with total mesorectal excision (TME) followed by adjuvant chemotherapy with folinic acid (or leucovorin), fluorouracil, and oxaliplatin (FOLFOX) versus the current standard treatment in patients with surgically resectable, locally advanced rectal cancer.MethodsThis study, named TME-FOLFOX, is a prospective, open-label, multicenter, phase II randomized trial. Patients with locally advanced rectal cancer will be randomized to receive PCRT followed by TME and adjuvant chemotherapy (arm A) or upfront radical surgery with TME followed by adjuvant FOLFOX chemotherapy (arm B). Clinical stage II/III rectal cancer without CRM involvement and lateral lymph node metastasis will be defined using preoperative MRI. The primary endpoint is 3-year disease-free survival (DFS). Secondary endpoints include 5-year DFS, local recurrence rate, systemic recurrence rate, cost-effectiveness, and overall survival. We hypothesized that our experimental group (arm B) will have a 3-year DFS of 75% and a non-inferiority margin of 15%.DiscussionIdentifying whether patients require PCRT is one of the critical issues in locally advanced rectal cancer. This study aims to elucidate whether PCRT may not be required for all patients with stage II/III rectal cancer, especially for the MRI-based intermediate-risk group (with cT1-2N1 or cT3N0) without CRM involvement and lateral lymph node metastasis. If the findings indicate that our proposed treatment, which omits PCRT, is non-inferior to the standard treatment, then patients may avoid unnecessary radiation-related toxicity, have a shorter treatment duration, and save on medical costs.Trial registrationClinicalTrials.gov, NCT02167321. Registered on 19 June 2014.

Project description:ImportanceProponents of novel transanal total mesorectal excision (TME) suggest the procedure overcomes the technical and oncologic challenges of conventional approaches for treating rectal cancer. Recently, however, there has been controversy regarding the oncologic safety of the procedure.ObjectiveTo assess the association of transanal TME with the incidence of local recurrence (LR) of cancer and the probability of remaining free of LR during follow-up.Design, setting, and participantsThis multicenter cohort study used data from 8 high-volume rectal cancer academic institutions from across Canada on all consecutive patients with primary rectal cancer treated by transanal TME at the participating centers. The study was conducted between January 2014 and December 2018, and data were analyzed from April 1, 2020, to September 15, 2020.ExposureTransanal TME.Main outcomes and measuresThe incidence of LR was reported as a direct measure of quality of resection. The cumulative probability of LR- and systemic recurrence (SR)-free survival at 36 months was estimated. Local recurrence and SR were defined as radiologic or endoscopic evidence of 1 or more new lesions in or outside the pelvis, respectively, documented during surveillance after the removal of the primary tumor.ResultsOf 608 total patients included in the analysis, 423 (69.6%) were male; the median age was 63 years (interquartile range [IQR], 54-70 years). Local recurrence was identified in 22 patients (3.6%) after a median follow-up of 27 months (IQR, 18-38 months). The median time to LR was 13 months (IQR, 9-19 months). Sixteen of the 22 patients with LR (72.7%) were male, 14 (63.6%) received neoadjuvant chemoradiation, and 12 (54.5%) had American Joint Committee on Cancer stage III disease. Of those with LR, 16 (72.7%) had a negative circumferential radial margin and 20 (90.9%) had a negative distal resection margin, 2 (9.1%) experienced conversion to open surgery, and 15 (68.2%) also developed SR. The probability of LR-free survival at 36 months was 96% (95% CI, 94%-98%). According to the Cox proportional hazards regression model, the hazard ratio of LR was estimated to be 4.2 (95% CI, 2.9-6.2) times higher among patients with a positive circumferential radial margin than among those with a negative circumferential radial margin.Conclusions and relevanceIn this cohort study, transanal TME performed by experienced surgeons was associated with an incidence of LR and SR that is in line with the published literature on open and laparoscopic TME, suggesting that transanal TME may be an acceptable approach for management of rectal cancer.

Dataset Information

Neoadjuvant therapy followed by local excision and two-stage total mesorectal excision: a new strategy for sphincter preservation in locally advanced ultra-low rectal cancer.

Publications

Neoadjuvant therapy followed by local excision and two-stage total mesorectal excision: a new strategy for sphincter preservation in locally advanced ultra-low rectal cancer.

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