In addition, a vigorous search of the mesorectum was performed to identify as many lymph nodes as possible and all identified lymph nodes were submitted entirely for microscopic evaluation. For the evaluation of tumor response, Dworak grading system (12)
was used by two gastrointestinal pathologists at Istanbul Medical Faculty, Department of Gastrointestinal Pathology. Pathologic response was evaluated using Total Regression Inhibitors,research,lifescience,medical Score (TRG), where TRG IV indicates no viable cancer cells and TRG 0 indicates no downgrading. Acellular pools of residual mucin in specimens were considered to represent completely eradicated tumor. Follow-up Patients were followed up routinely at 3-month intervals for the first 2 years after the operation and at 6-month intervals during next years. A local recurrence was defined as a radiologically demonstrated Inhibitors,research,lifescience,medical or a biopsy proven tumor within pelvis or perineum. Disease-free survival (DFS) and overall survival (OSS) were defined as the time from initiation of chemotherapy to the first evidence of relapse or death. Inhibitors,research,lifescience,medical Statistical analysis Statistical analysis was performed using SPSS software version 16.0 (SPSS, Chicago, IL). Kaplan-Meier method was used to analyze survival and the differences in survival probabilities were assessed using log-rank test. Mann-Whitney U, chi-square and Fisher’s exact tests were used, where applicable.
Statistical significance was set at 0.05. learn more Results Patient characteristics Between January 2002 and December 2007, 170 eligible patients were enrolled in the trial. Baseline characteristic and clinical outcomes of the patients are shown in Table 1. Groups were similar with regard to patient Inhibitors,research,lifescience,medical characteristics. Seventeen patients (9 patients from group A and 8 patients from group B) were withdrawn from the study due to following reasons: intestinal obstruction (2 patients), M1 identified at surgery (5 pts), patient preferred local excision (2 pts), frozen pelvis found at operation (5 pts), progression during
treatment (3 pts). Table 1 Patient characteristics Inhibitors,research,lifescience,medical and clinical outcomes Clinical outcomes Lateral and distal surgical margin positivity was present in 11 and 3 patients, respectively. The two groups did not differ with regard to lateral surgical margin positivity and pathological tumor regression rate. Local recurrence occurred in 9 (11.8%) and 8 (10, 3%) patients in Group A and Group B, respectively. Local recurrence rate was significantly higher Metalloexopeptidase among patients with surgical margin positivity (either lateral or distal) compared to patients with negative margins (28.5% vs. 9.3%, P=0.02). Group A and Group B had similar 5-year overall survival (76.5% vs. 74.2%, P=0.60) (Figure 1A) and disease free survival rates (73.2% vs. 70.5%, P=0.80) (Figure 1B). Overall survival was better in patients with negative surgical margins (78.8% vs. 53.0%, P=0.04) (Figure 1C). In addition, local recurrence was associated with worse survival (37.7% vs. 80.3%, P<0.