Methods
All patients treated for rectal cancer with an oncological resection in our institution between January 2000 and December 2009 were included into this retrospective study after identification by the pathological data base. The term rectum carcinoma was applied to adenocacinomas located at a distance from 0 to 16 cm from the anal verge measured by rectoscopy. The cancer was located in either the lower (0- < 6 cm), middle (6- < 12 cm) or upper (12–16 cm) rectum. Patients' records were analyzed under special consideration of neoadjuvant treatment, type of operation and perioperative complications.
According to German guidelines, there was an indication for neoadjuvant RCT for T3, T4 and/or nodal positive tumors of the lower and middle third of the rectum. In the upper third of the rectum, the only indication for neoadjuvant treatment was a T4 cancer. In our facility, the majority of neoadjuvant treated patients received an intensified neoadjuvant radiochemotherapy, which changed within the observation period. From January 2000 to January 2002 patients received a combination of a continuous infusion 5-FU (250 mg/m per day) over 31 days, seven weekly applications of irinotecan (40 mg/m) and a local radiation five days a week with a single dose of 1.8 Gy adding up to 50.4 Gy (last three doses were reduced). From February 2002 5-FU was substituted by a daily intake of Capecitabine with a single dose between 1000 and 1650 mg/m. Doses of radiation were no longer reduced and reached a cumulative dose of 55.8 Gy. Oxaliplatin had been applied instead of Irinotecan in eight patients.
The type of surgery depended on localization of the tumor, preoperative stool incontinence and general condition of the patient. Generally, patients received a total mesorectal excision (TME) for all cancers located between 0 and 12 cm and a partial mesorectal excision (PME) for all cancers located higher than 12 cm. All anastomoses were performed by double stapling technique. Postoperatively, in case of unusual elevation of CRP or white blood cell count, clinical symptoms as well as suspicious drain secretion, diagnostics were performed to determine an anastomotic leakage by rectal digital examination, water soluble contrast study, endoscopy or ct-scan. If any of the diagnostic tools showed an anastomotic leakage it was documented as such regardless of the clinical consequences (stage I-III).
After identifying all patients with a rectal adenocarcinoma, we eliminated all patients receiving a short term radiation (5×5 Gy), conventional neoadjuvant radiochemotherapy and all patients having complications during the intensified neoadjuvant treatment (11 patients) or having another malignancy in their history (5 patients). Thereafter, the study population was divided into patients with intensified neoadjuvant RCT and without any neoadjuvant treatment. There were 106 patients eligible to the intensified neoadjuvant RCT group. After that, 106 patients of the not neoadjuvant treated group were matched in decreasing preference by tumor height, discontinuous resection/exstirpation, T-category of the TNM-system, diverting stoma and UICC stage (Figure 1). Of these 106 patients, 27 patients received a combination of 5FU, Irinotecan and 50.4 Gy; 9 patients received a combination of Capecitabine, Irinotecan and 50.4 Gy; 20 patients received a combination of 5FU, Irinotecan and 55.8 Gy; 42 patients received a combination of Capecitabine, Irinotecan and 55.8 Gy; 8 patients received a combination of 5FU, Oxaliplatin and 50.4 Gy.
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Figure 1.
This flow chart shows the matching of the patients and the reasons of exclusions from the study.
The study was approved by the Medical Ethical Committee of Rostock University.
Statistical Analysis
Statistical analysis was performed using Statistical Package for Social Science (SPSS) version 15.0. Statistical analysis was done using Pearson's chi-square test or Fisher's exact test.