Diverting ileostomy versus no diversion after low anterior resection for rectal cancer: A prospective, randomized, multicenter trial.

BACKGROUND: This study sought to determine whether a protective diverting ileostomy improves short-term outcomes in patients with rectal resection and colonic J-pouch reconstruction for low anastomoses. Criteria for the use of a proximal stoma in rectal resections with colonic J-pouch reconstruction have not been defined sufficiently. METHODS: In a multicenter prospective study, rectal cancer patients with anastomoses below 8 cm treated with low anterior resection and colonic J-pouch were randomized to a defunctioning loop ileostomy or no ileostomy. The primary study endpoint was the rate of anastomotic leakage, and the secondary endpoints were surgical complications related to primary surgery, stoma, or stoma closure. RESULTS: From 2004 to 2014, a total of 166 patients were randomized to 1 of the 2 study groups. In the intention-to-treat analysis, the overall leakage rate was 5.8% in the stoma group and 16.3% in the no stoma group (P = .0441). However, some patients were not treated according to randomization and only 70% of our patients with low anastomoses received a pouch. Therefore, we performed a second analysis as to actual treatment. In this analysis, as well, leakage rates (P = .044) and reoperation rates for leakage (P = .021) were significantly higher in patients without a stoma. In multivariate analysis, male gender (P = .0267) and the absence of a stoma (P = .0092) were significantly associated with anastomotic leakage. CONCLUSION: Defunctioning loop ileostomy should be fashioned in rectal cancer patients with anastomoses below 6 cm, particularly in male patients, even if reconstruction was done with a J-pouch.

Impact of postoperative complications on long-term survival after resection for rectal cancer.

BACKGROUND: The relevance of type and severity of postoperative complications after curative resection for rectal cancer on survival and recurrence rates is a matter of controversy. OBJECTIVE: The aim of this study was to investigate the impact of postoperative complications on long-term outcome after resection for rectal cancer. DESIGN: This study is a retrospective analysis of prospectively collected data. SETTINGS: The study was conducted at a university teaching hospital by a specialized colorectal team. PATIENTS: Between January 1984 and October 2008, 811 patients with rectal cancer underwent curative resection. Patients who experienced postoperative complications were divided into a minor complication group (grades I and II) and a major complications group (grades III and IV) according to the Clavien classification. MAIN OUTCOME MEASURES: The influence of several pathological and clinical factors, including complications in terms of overall and disease-free survival, was tested and compared in univariate and multivariate analyses. RESULTS: Curative resection was performed in 811 patients; median age was 65 years. The Kaplan-Meier estimates (± SE) for 5- and 10-year overall cumulative survival were 70.3% ± 1.8% and 54.5% ± 2.4%; Kaplan-Meier estimates for 5- and 10-year disease-free survival were 64.0% ± 1.8% and 50.9% ± 2.3%. One hundred sixty-five patients (20.3%) had minor complications, and 103 patients (12.7%) had major complications. Twelve patients (1.48%) died within 30 days after surgery. There was no significant difference between patients with no complications, patients with minor complications, and patients with major complications in terms of overall (p = 0.41) or disease-free survival (p = 0.32). LIMITATIONS: A possible limitation of our study is that the data represent a cohort study from a single center. CONCLUSION: Following resection for rectal cancer, the severity of postoperative complications (minor or major) according to a standardized classification system does not demonstrate a statistically significant effect on either overall or disease-free survival.

Preoperative treatment with capecitabine, bevacizumab and radiotherapy for primary locally advanced rectal cancer--a two stage phase II clinical trial.

BACKGROUND AND PURPOSE: The aim of this single-arm multicenter phase II clinical trial was to assess the feasibility and tolerability of preoperative radiotherapy and simultaneous capecitabine and bevacizumab. Secondary endpoints were downstaging-rate and induction of complete pathological response. MATERIAL AND METHODS: Patients with cT3 rectal cancer were eligible. Capecitabine (825 mg/sqm twice daily on radiotherapy-days weeks 1-4) and bevacizumab (5 mg/kg on days 1, 15 and 29) were administered concurrently to pelvic radiotherapy (1.8 Gy daily up to 45 Gy in 5 weeks). Surgery followed 6-8 weeks later. A two-stage trial was designed with early termination at eight patients if more than three patients had experienced a common toxicity criteria ≥grade 3 according to the NCI CTC guidelines. RESULTS: In the first stage eight patients were enrolled. Median age was 70 years (range 55-76) and ECOG PS 0/1 (%) was 87.5/12.5. Major side effects were mostly intestinal bleeding (grade 3, 25%), diarrhea (grade 3, 25%), perianal and abdominal pain (grades 3 and 4, 25%) followed by anemia (grade 3, 12.5%). Tumor downstaging was observed in 37.5% of patients with complete pathological response in two patients (25%). CONCLUSIONS: After interim analysis of feasibility and tolerability, accrual was terminated according to protocol due to ≥grade 3 toxicities in 50% of patients. Complete pathological response was seen in 25% of patients but was accompanied by considerable toxicity. Further clinical trials are needed to clarify the role of bevacizumab in this setting.

Influence of pT3 subgroups on outcome of R0-resected colorectal tumors.

OBJECTIVE: Evaluate whether depth of infiltration within T3 colorectal tumors influences long-term oncologic outcome. PATIENTS AND METHODS: Patients with stage pT3 colon and rectal tumors were divided into four subgroups according to the depth of infiltration. The influence on overall and disease-free survival was tested for each subgroup and compared in univariate and multivariate analyses. RESULTS: A total of 368 patients were evaluated, with a median follow-up time of 92.5 months. In 181 patients with colon cancer 5- and 10-year overall survival rates were 82.7% and 65.0%, respectively, and 5- and 10-year disease-free survival rates were 80.9% and 64.4%, respectively. For 187 patients, rectal cancer 5- and 10-year overall survival rates were 69.0% and 50.5%, respectively, and disease-free survival rates were 61.3% and 47.5%, respectively. In either colon or rectal cancer, different pT3 categories showed neither a statistically significant influence on survival nor the occurrence of local or distant recurrence in univariate and multivariate analyses; however, higher pT3 subgroups had a significant influence on lymph node involvement and vessel invasion in patients with rectal cancer. CONCLUSIONS: Subdivision of pT3 tumors in colon cancer based on depth of infiltration does not provide additional information about prognosis. In rectal cancer, T3 substages were associated with lymph node involvement; however, we could not demonstrate an impact on recurrence or survival.

Solitary giant splenic metastasis in a patient with metachronous gastric cancers.

Splenic metastases from solid tumors are uncommon. They may be observed in a context of multivisceral dissemination or as a solitary lesion. We report the case of an 80-year-old woman with a history of two metachronous gastric cancers treated with distal gastrectomy and resection of the gastric remnant within a period of 15 years, who presented with a huge splenic tumor mass three years after the second operation. Splenectomy was performed. The resection specimens showed a well-circumscribed solid lesion measuring 15 cm in the largest diameter. Histology revealed metastatic gastric cancer. The differential diagnosis and clinical significance of this rare condition is discussed.

Risk factors for anastomotic leakage after resection for rectal cancer.

BACKGROUND: Controversy still exists concerning the impact of patient and tumor characteristics on anastomotic dehiscence after resection for rectal cancer. METHODS: Between January 1986 and July 2006, 472 patients underwent curative rectal resection. Patient and tumor characteristics, details of treatment, and postoperative results were recorded prospectively. Univariate and multivariate analysis were applied to identify risk factors for anastomotic leakage. RESULTS: In our patients, the anastomotic leak rate was 10.4% (49 of 472 patients), and mortality was 2.2% (1 of 49 patients). In univariate analysis, tumor diameter and absence of a protective stoma were associated with increased anastomotic leak rate, whereas American Society of Anesthesiologists (ASA) score and tumor localization showed borderline significance. In multivariate analysis, tumor diameter, tumor localization, and absence of a protective stoma were significantly associated with anastomotic leakage. CONCLUSIONS: Patients with large and low lying rectal tumors are at high risk for anastomotic leakage. A protective stoma significantly decreases the rate of clinical leaks and subsequent reoperation after low anterior resection.

Rectal cancer delivery of radiotherapy in adequate time and with adequate dose is influenced by treatment center, treatment schedule, and gender and is prognostic parameter for local control: results of study CAO/ARO/AIO-94.

PURPOSE: The impact of the delivery of radiotherapy (RT) on treatment results in rectal cancer patients is unknown. METHODS AND MATERIALS: The data from 788 patients with rectal cancer treated within the German CAO/AIO/ARO-94 phase III trial were analyzed concerning the impact of the delivery of RT (adequate RT: minimal radiation RT dose delivered, 4300 cGy for neoadjuvant RT or 4700 cGy for adjuvant RT; completion of RT in <44 days for neoadjuvant RT or <49 days for adjuvant RT) in different centers on the locoregional recurrence rate (LRR) and disease-free survival (DFS) at 5 years. The LRR, DFS, and delivery of RT were analyzed as endpoints in multivariate analysis. RESULTS: A significant difference was found between the centers and the delivery of RT. The overall delivery of RT was a prognostic factor for the LRR (no RT, 29.6% +/- 7.8%; inadequate RT, 21.2% +/- 5.6%; adequate RT, 6.8% +/- 1.4%; p = 0.0001) and DFS (no RT, 55.1% +/- 9.1%; inadequate RT, 57.4% +/- 6.3%; adequate RT, 69.1% +/- 2.3%; p = 0.02). Postoperatively, delivery of RT was a prognostic factor for LRR on multivariate analysis (together with pathologic stage) but not for DFS (independent parameters, pathologic stage and age). Preoperatively, on multivariate analysis, pathologic stage, but not delivery of RT, was an independent prognostic parameter for LRR and DFS (together with adequate chemotherapy). On multivariate analysis, the treatment center, treatment schedule (neoadjuvant vs. adjuvant RT), and gender were prognostic parameters for adequate RT. CONCLUSION: Delivery of RT should be regarded as a prognostic factor for LRR in rectal cancer and is influenced by the treatment center, treatment schedule, and patient gender.

Impact of blood transfusions on recurrence and survival after rectal cancer surgery.

PURPOSE: This study was designed to determine whether type or number of blood units transfused affected short-term and long-term outcome in patients undergoing surgery for rectal cancer. The number of perioperative blood units is associated with postoperative mortality and overall survival by some authors. In addition, allogenic perioperative blood transfusion has been postulated to produce host immunosuppression and has been reported to result in adverse outcome in patients with colorectal cancer. Autologous blood transfusion might improve results compared with allogenic transfusion. METHODS: Clinical outcome for 597 patients undergoing surgery for rectal cancer was analyzed according to their transfusion status. Results for type (autologous or allogenic) and number of blood units transfused were recorded. RESULTS: Blood transfusion was associated with increased postoperative mortality at 60 days. Patients who received > 3 units had a postoperative mortality of 6 percent compared with 1 percent for patients who received 1 to 3 units and 0 percent for patients who did not require transfusions. No difference was found between patients who received autologous or allogenic blood. Blood transfusions were also associated with impaired overall survival in a univariate analysis, but this finding was not confirmed in the multivariate analysis. The number or type of blood units transfused did not influence oncologic results. Local recurrence rates, distant metastases rates, and disease-free survival were not influenced by transfusion in our patients. CONCLUSIONS: Increased numbers of blood units were associated with postoperative mortality. However, there is no reason, with respect to cancer recurrence or disease-free survival, to use a program of transfusion with autologous blood in patients undergoing surgery for rectal cancer.

Long-term results of early gastric cancer accomplished in a European institution by Japanese-type radical resection.

BACKGROUND: Long-term survival following Japanese-type radical surgery for 130 consecutively performed early gastric cancers (EGC) in a single Austrian institution between January 1, 1984 and May 31, 1998 was analyzed in terms of long-term survival, postoperative morbidity, and mortality.METHODS: Extended D2 lymphadenectomy as defined by the JRSGC was performed in 129 patients with EGC. The surgical process was consistent as nearly all patients were operated on by only two surgeons. Overall survival and factors influencing survival were analyzed with particular regard to the depth of tumor infiltration, histological type, tumor grading, Lauren classification, tumor diameter, macroscopic appearance, localization, and lymph node involvement.RESULTS: Of 678 gastric cancer patients surgically treated in the mentioned period, 130 patients (19.2%) were qualified as EGC. In 70 patients the tumor was limited to the mucosa and in 60 patients the tumor had not yet invaded the submucosa. The percentage of patients with positive lymph nodes increased from 2.9% with mucosal invasion to 21.7% with submucosal tumor involvement. The overall 5- and 10-year observed survival rate, postoperative mortality not excluded, was 74.6% and 62.1%, respectively, and 91.1% and 91.1%, respectively, when calculated as tumor specific. The 5- and 10-year observed survival rate of tumors limited to the mucosa was 77.2% and 72.1%, respectively, and 98.1% and 98.1%, respectively, when calculated as tumor specific. The respective values for submucosal invasion were 71.6% and 51.7%, and 82.7% and 82.7%. Postoperative complications occurred in 17 patients (13.1%) and postoperative hospital mortality totaled 1.5% (2/130). In multivariate analysis, only lymph node metastases were found to have independent prognostic influence on survival ( P < 0.001; hazard ratio, 8.25).CONCLUSION: Japanese-type radical lymph node dissection for EGC in a European surgical institution yielded long-term survival nearly identical to that reported repeatedly by Japanese authors. Postoperative morbidity and mortality was not sacrificed by our comparatively radical surgical approach.