Abstract
BackgroundLaparoscopic surgery, fast-track perioperative treatment and XELOX chemotherapy are effective strategies for shortening the duration of hospital stay for cancer patients. This trial aimed to clarify the safety and efficacy of the fast-track multidisciplinary treatment (FTMDT) model compared to conventional surgery combined with chemotherapy in Chinese colorectal cancer patients.MethodsThis trial was a prospective randomized controlled study with a 2 × 2 balanced factorial design and was conducted at six hospitals. Patients in group 1 (FTMDT) received fast-track perioperative treatment and XELOX adjuvant chemotherapy. Patients in group 2 (conventional treatment) received conventional perioperative treatment and mFOLFOX6 adjuvant chemotherapy. Subgroups 1a and 2a had laparoscopic surgery and subgroups 1b and 2b had open surgery. The primary endpoint was total length of hospital stay during treatment.ResultsA total of 374 patients were randomly assigned to the four subgroups, and 342 patients were finally analyzed, including 87 patients in subgroup 1a, 85 in subgroup 1b, 86 in subgroup 2a, and 84 in subgroup 2b. The total hospital stay of group 1 was shorter than that of group 2 [13 days, (IQR, 11–17 days) vs. 23.5 days (IQR, 15–42 days), P = 0.0001]. Compared to group 2, group 1 had lower surgical costs, fewer in-hospital complications and faster recovery (all P < 0.05). Subgroup 1a showed faster surgical recovery than that of subgroup 1b (all P < 0.05). There was no difference in 5-year overall survival between groups 1 and 2 [87.1% (95% CI, 80.7–91.5%) vs. 87.1% (95% CI, 80.8–91.4%), P = 0.7420].ConclusionsThe FTMDT model, which integrates laparoscopic surgery, fast-track treatment, and XELOX chemotherapy, was the superior model for enhancing the recovery of Chinese patients with colorectal cancer.Trial registrationClinicalTrials.gov: NCT01080547, registered on March 4, 2010.
Highlights
Laparoscopic surgery, fast-track perioperative treatment and Adjuvant chemotherapy with capecitabine and oxaliplatin (XELOX) chemotherapy are effective strategies for shortening the duration of hospital stay for cancer patients
Four Chinese prospective studies have reported that fast-track surgery effectively accelerates early recovery and reduces the postoperative hospital stay for colorectal cancer patients [9,10,11,12]
Eligible patients were randomized (1:1: 1:1) to receive either laparoscopic fast-track surgery followed by XELOX, open fast-track surgery followed by XELOX, laparoscopic conventional surgery followed by FOLFOX, or open conventional surgery followed by FOLFOX
Summary
Laparoscopic surgery, fast-track perioperative treatment and XELOX chemotherapy are effective strategies for shortening the duration of hospital stay for cancer patients. Two European clinical trials, “EnROL” and “LAFA”, have shown that fast-track surgery is safe and effective for colorectal cancer patients [7, 8]. In both trials, fasttrack laparoscopic surgery was the best choice in terms of postoperative hospital stay. Four Chinese prospective studies have reported that fast-track surgery effectively accelerates early recovery and reduces the postoperative hospital stay for colorectal cancer patients [9,10,11,12]. Some procedures in the LAFA and EnROL trials were considered by Chinese surgeons to be radical and were difficult to comply with
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