However, greater pathological regression grade (TRG III-IV) did not provide any overall survival benefit (Figure 1E). Similarly, receiving adjuvant
treatment did not improve survival (77.4% vs. 75.4%, P=0.62). Figure 1 Survival functions. (A,B) Overall survival and disease free survival curves for patients receiving surgery after 4 weeks versus 8 weeks after Inhibitors,research,lifescience,medical neoadjuvant treatment, respectively. Overall survival curves for patients with or without surgical margin positivity … Complications Neoadjuvant chemoradiotherapy complications Twenty percent dose reduction in preoperative chemotherapy was required in 12 (15.7%) and 14 (18.8%) patients from Group A and Group B, respectively. Only two patients required interruption of radiotherapy (for one week). Neoadjuvant chemoradiotherapy related complications
are listed in Table 2. Table 2 Neoadjuvant chemoradiotherapy complications Adjuvant chemotherapy complications Patients in 4-week group received 93.5% of planned postoperative chemotherapy Inhibitors,research,lifescience,medical cycles, whereas the corresponding figure was 92.5% in the 8-week group. Adjuvant chemotherapy grade III-IV complications were as follows: diarrhea, Inhibitors,research,lifescience,medical 7%; nausea/vomiting, 10%; Kinase Inhibitor Library stomatitis, 10%; leukopenia, 5%; decrease in Hb, 5%; angina, 2%; cerebrovascular accident, 1%; catheter infection, 2%; ileus, 2%. Dose reduction was required in 22% of the patients receiving adjuvant chemotherapy. Surgical complications There were two early postoperative deaths (one from each group). Surgical complications are shown in Table 3. Table 3 Surgical Inhibitors,research,lifescience,medical complications Long-term complications In the long-term, renal complications due to local recurrences were seen in 7 patients (4.5%) and a nephrostomy
tube was placed in all of them. Discussion This study was the first prospective randomized study conducted with rectum cancer patients to test the effect of the interval between preoperative neoadjuvant chemoradiotherapy and surgery Inhibitors,research,lifescience,medical on both pathological response to chemoradiotherapy and long-term outcomes including local recurrence and survival. A difference between long-interval (8 weeks) and short interval (4 weeks) groups could not be found in any of the parameters tested. To date, several studies with varying methodology Oxygenase and sample size have examined the effects of neoadjuvant radiotherapy/chemoradiotherapy-surgery interval on treatment outcomes (Table 4) (6,8-10). An important issue to address is to show whether delaying surgery results in better pathological response in the tumor bed where most relapses occur. The second important question to answer is whether potential benefits of delaying surgery results in low recurrence rates or long-term survival gain. Studies that have examined these hypotheses are relatively scarce in number with conflicting results.