Fast track multidiscipline treatment versus conventional treatment for colorectal cancer: The results of a prospective randomized controlled study (FTMDT trial).

Abstract

743 Background: Fast Track Multi-Discipline Treatment (FTMDT) integrates fast-track perioperative treatment (laparoscopic or open surgery) plus XELOX adjuvant chemotherapy for colorectal cancer (CRC). This study aimed to verify the effects of FTMDT model and to clarify the value of laparoscopic surgery in fast-track perioperative treatment. Methods: The study (NCT01080547) was a prospective randomized controlled multi-centers study. Group I (FTMDT) received fast-track treatment plus XELOX chemotherapy (Group Ia received laparoscopic surgery and Group Ib received open surgery). Group II (conventional treatment, CT) received conventional treatment plus mFOLFOX6 chemotherapy (Group IIa received laparoscopic surgery and Group IIb received open surgery). The primary endpoint was total hospital stays during treatment. The secondary endpoints included surgical complications, chemotherapy related adverse events, quality of life and hospitalization costs. Results: Between April 2010 and June 2014, 374 patients were enrolled and 342 patients were finally analyzed. The total hospital stays were shorter in FTMDT than CT (median 13 days vs. 23.5 days, P= 0.0001) but similar between Group Ia and Group Ib (median 13 days vs. 14 days, P= 0.1951). The postoperative hospital stays were shorter in FTMDT than CT (median 6 days vs. 9 days, P= 0.0001) but similar between Group Ia and Group Ib (median 6 days vs. 6 days, P= 0.2160). Resume of flatus and defecation was earlier in FTMDT ( P< 0.05) and Group Ia was the earliest. The in-hospital complication rate was lower in FTMDT (6.40% vs. 14.71%, P= 0.014) but similar between Group Ia and Group Ib. The surgery cost of Group Ib was the lowest ( P< 0.05). The rate of chemotherapy related adverse events was similar between FTMDT and CT( P> 0.05). The EORTC QLQ-C30 physical functioning and fatigue in one week postoperative were better in FTMDT than CT( P< 0.05). Conclusions: FTMDT model enhanced the postoperative recovery of CRC patients. On the premise of fast-track perioperative treatment, laparoscopic surgery showed minor advantage over open surgery which had economic advantages. Clinical trial information: NCT01080547.