Total neoadjuvant treatment for MRI-stratified high-risk rectal cancer: a single-center, single-arm, prospective Phase II trial (PKUCH-R02).

Background: Induction chemotherapy combined with neoadjuvant chemoradiotherapy has been recommended for patients with high-risk, locally advanced rectal cancer. However, the benefit of more intensive total neoadjuvant treatment (TNT) is unknown. This study aimed to assess the safety and efficacy of induction chemotherapy combined with chemoradiotherapy and consolidation chemotherapy for magnetic resonance imaging-stratified high-risk rectal cancer. Methods: This was a single-center, single-arm, prospective Phase II trial in Peking University Cancer Hospital (Beijing, China). Patients received three cycles of induction oxaliplatin and capecitabine (CapeOX) followed by chemoradiotherapy and two cycles of consolidation CapeOX. The primary end point was adverse event rate and the second primary end points were 3-year disease-free survival rate, completion of TNT, and pathological downstaging rate. Results: Between August 2017 and August 2018, 68 rectal cancer patients with at least one high risk factor (cT3c/3d/T4a/T4b, cN2, mesorectal fascia involvement, or extramural venous invasion involvement) were enrolled. The overall compliance of receiving the entire treatment was 88.2% (60/68). All 68 patients received induction chemotherapy, 65 received chemoradiotherapy, and 61 received consolidation chemotherapy. The Grade 3-4 adverse event rate was 30.8% (21/68). Nine patients achieved clinical complete response and then watch and wait. Five patients (7.4%) developed distant metastasis during TNT and received palliative chemotherapy. Fifty patients underwent surgical resection. The complete response rate was 27.9%. After a median follow-up of 49.2 months, the overall 3-year disease-free survival rate was 69.7%. Conclusions: For patients with high-risk rectal cancer, this TNT regimen can achieve favorable survival and complete response rates but with high toxicity. However, it is necessary to pay attention to the possibility of distant metastasis during the long treatment period.

Surgical complications after different therapeutic approaches for locally advanced rectal cancer.

BACKGROUND: Preoperative radiochemotherapy is widely used in locally advanced rectal cancer. It can improve local control of rectal cancer. However, some researchers believe it increases the incidence of surgical complications. They doubt its safety. Patients with locally advanced rectal cancer receive three different treatments in our hospital, including long-course radiochemotherapy, short-course radiotherapy, and surgery directly. We can compare their differences in postoperative complications. AIM: To investigate surgical complications caused by different preoperative radiotherapy regimens. METHODS: We retrospectively analyzed 1197 patients admitted between 2008 and 2010 with locally advanced rectal cancer. Three hundred and forty-six patients were treated with preoperative long-course radiochemotherapy (25 × 2 Gy) followed by total mesorectal excision (TME) 6-8 wk later, and 259 patients received short-course radiotherapy (10 × 3 Gy) and subsequently TME 7-10 d later. The remaining 592 patients underwent TME alone without neoadjuvant therapy. According to Clavien-Dindo classification, surgical complications were evaluated for up to 30 d after discharge from hospital. RESULTS: There were no deaths in 30 d in all groups after treatment. The major complications were anastomotic leakage and perineal wound complications. The results suggested that both long-course [odds ratio (OR) = 3.624, 95% confidence interval (CI): 1.689-7.775, P = 0.001] and short-course (OR = 5.150, 95%CI: 1.828-14.515, P = 0.002) radiotherapy were associated with anastomotic leakage. Temporary ileostomy was a protective factor for anastomotic leakage (OR = 6.211, 95%CI: 2.525-15.385, P < 0.001). The severity of anastomotic leakage did not increase in patients following preoperative radiotherapy (P = 0.411). Compared with TME alone, short-course radiotherapy was associated with an increase in perineal wound complications (OR = 5.565, 95%CI: 2.203-14.057, P < 0.001), but long-course radiotherapy seemed safe regarding this complication (OR = 1.692, 95%CI: 0.651-4.394, P = 0.280). Although the severity of perineal wound complications increased in patients following short-course radiotherapy (P < 0.001), additional intervention was not necessary. CONCLUSION: Radiotherapy increased the incidence but not severity of anastomotic leakage. Short-course radiotherapy was also accompanied with perineal wound complications, but intervention appeared unnecessary to ameliorate the complications.

Risk Factors for Nonclosure of a Temporary Defunctioning Ileostomy Following Anterior Resection of Rectal Cancer.

BACKGROUND: In patients with colorectal cancer, a defunctioning ileostomy is commonly constructed to reduce anastomotic complications. However, many patients do not undergo a subsequent procedure to have their temporary stoma closed. OBJECTIVE: This study investigated the incidence of nonclosure of ileostomies and identified factors associated with nonclosure. DESIGN: This study is a retrospective analysis of prospectively collected data. SETTING: This study was conducted at a tertiary referral cancer hospital. PATIENTS: A total of 296 patients who received anterior resection with a defunctioning ileostomy with protective intention from 2006 to 2013 were included. MAIN OUTCOME MEASURES: The primary outcomes measured were the incidence of nonclosure of ileostomy and associated risk factors. RESULTS: Patients were followed for a median time of 29 months (range, 21-100 months). At the end of the study, 51 (17.2%) patients were left with a permanent ileostomy. The median time interval from the creation of a defunctioning ileostomy to closure was 192 days (range, 14-865 days). Multivariate analyses using a logistic regression model showed that metastatic diseases (OR, 0.179, p < 0.001), Charlson Comorbidity Index score >1 (OR, 0.268; p < 0.01), and complications from the index surgery (OR, 0.391; p = 0.013) were significant independent risk factors for failing to close a defunctioning ileostomy. LIMITATIONS: Although our study has a large patient cohort, it is limited by its retrospective nature. It is difficult to fully evaluate stoma complications after hospital discharge, and the prevalence may be underestimated. CONCLUSION: One in 6 temporary ileostomies constructed during an elective anterior resection for rectal cancer was not closed. Patients should be told before the index surgery that there is a risk of nonclosure and possible complications associated with permanent ileostomy.

Intermediate Neoadjuvant Radiotherapy Combined With Total Mesorectal Excision for Locally Advanced Rectal Cancer: Outcomes After a Median Follow-Up of 5 Years.

BACKGROUND: We previously reported the oncologic results for intermediate neoadjuvant radiotherapy (nRT) plus total mesorectal excision (TME) for locally advanced rectal cancer in a retrospective study. The objective of the present study was to further investigate the efficacy and long-term outcomes after this nRT regimen. PATIENTS AND METHODS: From 2002 to 2011, 382 patients with resectable locally advanced rectal cancer were treated at the Peking University Cancer Hospital with 30 Gy of intermediate nRT in 10 fractions (biologic equivalent dose, 36 Gy) plus TME. Surgery, RT, and pathologic examination were standardized. The primary endpoints were local recurrence-free survival (LRFS), cancer-specific survival (CSS), and overall survival (OS). RESULTS: The median patient age at the initial treatment was 58 years (range, 22-85 years). The median patient follow-up time was 5.5 years. The estimated 5-year LRFS, CSS, and OS were 93.6%, 79.0%, and 73.6%, respectively. Of the 382 patients, 4 (1%), 4 (1%), 4 (1%), and 11 (2.9%) patients died of postoperative complications, secondary malignancies, cardiovascular and/or neurologic events, or other causes, respectively. Seven patients (1.8%) developed late-onset ileus and died after conservative treatment in peripheral hospitals. CONCLUSION: The 10-fraction intermediate nRT regimen reported in the present study is efficient and safe. The long-term outcome is acceptable. This treatment schedule is useful as an alternative that provides efficiency, patient convenience, and low medical costs.

Subcutaneous vacuum drains reduce surgical site infection after primary closure of defunctioning ileostomy.

PURPOSE: Surgical site infection (SSI) is the most common complication after primary closure of defunctioning ileostomy. We use a subcutaneous vacuum drain (SVD) in our institution to prevent infection. This study aimed to analyze the risk factors of SSI and to assess the utility of an SVD for preventing SSI in patients undergoing primary closure of ileostomy. METHODS: Patients undergoing ileostomy closure in the Department of Colorectal Surgery, Peking University Cancer Hospital, from September 2006 to March 2013, were included in this study. The clinical features of these patients with or without a subcutaneous drain were reviewed, and the complication rate of SSI was analyzed. The primary endpoints were the incidence and risk factors of SSI, and the secondary endpoints were the rate of overall complications and their management. RESULTS: A total of 245 consecutive patients were enrolled in the study. The overall incidence of SSI was 8.6%. Eighty-five (34.7%) patients received placement of an SVD. The use of SVDs was associated with a significantly lower incidence of SSI compared with primary closure (PC) without an SVD (1.2 vs. 12.5%, p = 0.001). Multivariate analyses showed that the presence of an SVD (odds ratio (OR) 0.063, p = 0.012), total operation time >90 min (OR 4.862, p = 0.002), and postoperative complications (OR 10.576, p < 0.001) were independent risk factors of SSI. CONCLUSIONS: This study shows that an SVD is effective for reducing SSI in patients undergoing PC of ileostomy. Further randomized trials are required to confirm our findings and to compare SVDs with purse-string sutures.

[Comparison of short-term postoperative outcomes between hand-assisted laparoscopic and conventional sigmoidectomy].

OBJECTIVE: To compare the safety and efficacy perioperatively between hand-assisted laparoscopic surgery (HALS) and conventional open sigmoidectomy. METHODS: Prospectively collected data on 115 patients with sigmoid colon cancer between January 2009 to June 2010 were analyzed. There were 62 patients in the HALS group and 53 in the conventional sigmoidectomy group (CS). Patient characteristics, operative parameters, and perioperative outcomes were compared. RESULTS: HALS patients were similar to CS patients in age(60.2 yrs vs. 63.4 yrs, P=0.163), gender (53.2% vs. 60.4% male, P=0.441), tumor size (4.7 cm vs. 5.3 cm, P=0.114) and tumor stage. The two groups were comparable in operative time [(122.4±32.0) min vs.(126.7±37.4) min, P=0.510], lymph node harvest (15.1±4.6 vs. 16.8±6.4, P=0.163), free margin length [(4.1±1.8) cm vs.(4.3±1.7) cm, P=0.601], and postoperative complications. However, HALS group had less intraoperative bleeding [(62.6±35.4) ml vs. (168.9±137.1) ml, P=0.000], shorter time to flatus [(2.3±0.8) d vs. (3.3±1.1) d, P=0.000], and shorter hospital stay [(8.8±2.7) d vs.(12.6±8.0) d, P=0.001]. CONCLUSIONS: HALS results in similar short-term outcomes compared to conventional surgery. HALS is safe and minimally invasive.

[Application of hand-assisted laparoscopic surgery (HALS) in colectomy].

OBJECTIVE: To evaluate the safety and efficacy of hand-assisted laparoscopic surgery (HALS) in colorectal tumors. METHODS: Clinical data of 70 patients with colorectal tumors were retrospectively analyzed. All the patients had received HALS colectomy in the Beijing Cancer Hospital. Lapdisc was used for the hand port at the umbilicus. Two additional trocars were used. RESULTS: There were 38 males and 32 females. The median age was 61(29-89) years. Diagnoses included sigmoid cancer(n=48), sigmoid adenoma(n=4), descending colon cancer (n=3), ascending colon cancer (n=1), rectal cancer (n=13), total colectomy(n=1). The operative time was (126.0±22.5) minutes. The intraoperative blood loss was (75.0±18.8) ml. The mean number of lymph node dissection was(16.8±4.2). The median postoperative hospital stay was 9.4 days. There were no perioperative deaths. One patient developed anastomotic stricture and two anastomotic leak, all of which were successfully managed with conservative treatment. CONCLUSION: HALS is a safe and effective technique for colectomy.