Efficacy and safety of preoperative chemoradiotherapy with S-1 for advanced rectal cancer: a phase II study

Background: Preoperative chemoradiotherapy (CRT) for patients with rectal cancer is not yet established in Japan. We aimed to evaluate the efficacy and safety of preoperative CRT with S-1, a fixed-dose combination of tegafur, gimeracil, and oteracil potassium. Materials and methods: We conducted a prospective, interventional, non-randomized single-center study. Radiotherapy was administered at a total dose of 45 Gy (1.8 Gy in 25 fractions) for five weeks. S-1 was administered orally for nine weeks (five weeks during and four weeks after radiotherapy) at a dose of 80 mg/m2/day. The endpoint was the pathological complete response (pCR) rate. Results: Twenty-eight patients were finally enrolled. The following patient characteristics were recorded: clinical Stage (II: n = 12, III: n = 16), median age (66 years, range 40–77 years), male/female ratio (20/8), and lesion site (Ra-Rb:3/Rb:23/Rb-P:2). Preoperative treatment was completed in 27 patients (96%). Treatment abandonment occurred because of diarrhea. Grade 3 or higher adverse events were observed in one (4%) patient with two events. No serious adverse events occurred in the ≥ 70 years group. The response rate was 68% in all patients and 68% among elderly patients. Radical resection was achieved in all patients, including 19 (68%) who underwent sphincter-preserving surgery. The pCR rate was 11% (three patients). The five-year disease-free survival rate was 68%, and the overall survival rate was 82%. Local recurrence occurred in only one patient five years after surgery. Conclusion: Preoperative CRT with S-1 alone may be a safe and acceptable regimen from the perspective of adverse events and oncological outcomes. Trial registration: UMIN Clinical Trial Registry: UMIN000013598.  Registered 1 April 2014, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R00001588

Clinical feasibility of sphincter-preserving resection with transanal rectal dissection for low-lying rectal cancer in Japanese patients: a single-center cohort study

Aim: Recently, the transanal down-to-up rectal dissection, a new approach to improve the difficult total mesorectal excision (TME) for low-lying rectal cancer, has been popularized. This study assessed the long-term oncologic and functional outcomes after sphincter-preserving resection combined with transanal rectal dissection (TARD) under direct vision for both complete TME and preservation of the internal anal sphincter (IAS) as much as possible to clarify the clinical feasibility of this approach.Methods: A prospective cohort study was conducted in 90 Japanese patients between April 2003 and March 2012.Results: Abdominoperineal resection (APR) was needed in 17 patients (18.9%) including 14 salvage APRs. Local recurrences occurred in 5 sphincter-preserving resection patients (6.8%). No significant between-group differences were observed in overall survival or 5-year disease-free survival. A significant benefit of preserving the internal anal sphincter completely in sphincter-preserving resection was found on the Wexner incontinence score (P = 0.005), low anterior resection syndrome score (P = 0.002), and visual analogue scale (P = 0.047).Conclusion: TARD, performed under direct vision for both complete TME and preservation of the IAS as much as possible in sphincter-preserving resections for low-lying rectal cancers in Japanese patients, does not negatively impact oncologic outcomes and could have the benefit of minimizing postoperative anorectal dysfunction by preserving the internal anal sphincter

Comparative outcomes between palliative ileostomy and colostomy in patients with malignant large bowel obstruction

Objectives: Palliative stoma creation should be considered in patients at high risk of colonic metallic stent failure. However, it is unclear whether ileostomy or colostomy is superior. This study compared short-term outcomes between palliative ileostomy and colostomy. Methods: We identified 82 patients with malignant large bowel obstruction, caused by various advanced cancers, between January 2005 and December 2016. We compared short-term outcomes between the ileostomy group (n = 33) and the colostomy group (n = 49). Results: For all 82 patients, clinical success was achieved. Three patients with ileostomy died within 30 days of ostomy formation. The ileostomy group had statistically significant differences in median operative time (113 vs. 129 minutes, p = 0.045) and blood loss (8 vs. 40 g, p = 0.037) in comparison with the colostomy group. No statistically significant differences were observed in the surgical complications (30.3 vs. 38.8%, p = 0.431), in the median period to oral intake (3 vs. 4 days, p = 0.335) and in the hospital stay after surgery (32 vs. 27 days, p = 0.509) between the two groups. Overall stoma-related complications occurred in 27 (32.9%) patients. Stoma-related complications occurred more frequently in the ileostomy group (16/33 vs. 11/49 patients, p = 0.014). High output stoma (6 patients) and irritation (5 patients) occurred more frequently in the ileostomy group. Conclusions: Palliative colostomy is superior to ileostomy due to fewer stoma-related complications. When ileostomy is required, aggressive interventions for high output stomas should be implemented

Comparative study between colonic metallic stent and anal tube decompression for Japanese patients with left-sided malignant large bowel obstruction

Abstract Background Surgical management of malignant bowel obstruction carries with high morbidity and mortality. Placement of a trans-anal decompression tube (TDT) has traditionally been used for malignant bowel obstruction as a bridge to surgery. Recently, colonic metallic stent (CMS) as a bridge to surgery for malignant bowel obstruction, particularly left-sided malignant large bowel obstruction (LMLBO) caused by colorectal cancer, has been reported to be both a safe and feasible option. The aim of this retrospective study is to evaluate the clinical effects of CMS for LMLBO as a bridge to surgery compared to TDT. Methods Between January 2000 and December 2015, we retrospectively evaluated outcomes of 59 patients with LMLBO. We compared the outcomes of 26 patients with CMS for LMLBO between 2013 and 2015 (CMS group) with those of 33 patients managed with TDT between 2003 and 2011 (TDT group) by the historical study. LMLBO was defined as a large bowel obstruction due to a colorectal cancer that was diagnosed by computed tomography and required emergent decompression. Results All patients in the CMS group were successfully decompressed (p = 0.03) and could initiate oral intake after the procedure (p <  0.01). Outcomes in the CMS group were superior to the TDT group in the following areas: duration of tube placement (p <  0.01), surgical approach (p <  0.01), operation time (p <  0.01), number of resected lymph nodes (p <  0.001), and rate of curative resection (p <  0.01). However, no significant differences were found in the overall postoperative complication rate (p = 0.151), surgical site infection rate (p = 0.685), hospital length of stay (p = 0.502), and the need for permanent ostomy (p = 0.745). The 3-year overall survival rate of patients in the CMS and TDT groups was 73.0% and 80.9%, respectively, and this was not significant (p = 0.423). Conclusions Treatment with CMS for patients with LMLBO as a bridge to surgery is safe and demonstrated higher rates of resumption of solid food intake and temporary discharge prior to elective surgery compared to TDT. Oncological outcomes during mid-term were equivalent