As recently reported in Lancet Oncology by Martijn H.G.M. van der Pas, MD, of VU University Medical Center, Amsterdam, and colleagues, the phase III COLOR II trial has shown that laparoscopic surgery can produce similar safety outcomes, resection margins, and completeness of resection compared with open surgery in patients with rectal cancer, with laparoscopic surgery being associated with improved recovery.1 Results for locoregional recurrence, the primary endpoint of the trial, are expected by the end of 2013.
Study Details
Between January 2004 and May 2010, 1,044 evaluable patients aged 18 years or older with rectal cancer within 15 cm from the anal verge without evidence of distant metastases were randomly assigned to laparoscopic surgery (n = 699) or open surgery (n = 345). Patients with rectal cancer invading adjacent tissues or organs, T4 tumors, or T3 tumors within 2 mm of the endopelvic fascia were excluded from the study. Analysis of outcomes was by modified intention to treat, excluding patients with postrandomization exclusion criteria and for whom data were not available.
For the laparoscopic group and the open surgery group: 64% and 61% were male; mean ages were 67 and 66 years; 23%, 57%, 19%, and < 1% and 19%, 62%, 18%, and < 1% were in American Society of Anesthesiologists categories I, II, III, and IV, respectively; mean body mass index was 26.1 and 26.5 kg/m2; tumor locations were lower, middle, and upper rectum in 29%, 39%, and 32% and in 27%, 39%, and 34%, respectively; clinical stages were I, II, and III in 30%, 31%, and 38% and in 29%, 33%, and 38%, respectively; 59% and 58% had received preoperative radiotherapy; and 32% and 34% had received preoperative chemotherapy.
The distribution of procedures performed was similar in the laparoscopic and open surgery groups, including resection with partial (10% and 10%) or total (60% and 67%) mesorectal excision and abdominoperineal resection (29% and 23%). Hartmann procedures were performed in 5% and 7% of patients, and 35% and 38% of patients with an anastomosis had diverting ileostomies; of those with ileostomies, 33% and 38% were in the upper rectum, 49% and 54% were in the middle rectum, and 17% and 15% were in the lower rectum. Laparoscopic procedures were converted to open surgery in 17% of patients in the laparoscopic surgery group (intraoperatively in 16%).
Short-term Outcomes
Laparoscopic procedures took significantly longer than open procedures (median, 240 vs 188 minutes; P < .0001) but were associated with significantly reduced blood loss (median, 200 mL vs 400 mL; P < .0001). There were no significant differences between groups with regard to intraoperative complications except for nerve injury, which occurred in none of the patients in the laparoscopic surgery group and in three patients in the open surgery group (P = .036). There were no significant differences between groups with regard to analgesic drug use on days 1 to 3, except for greater use of epidural medication in the open surgery group on days 2 (64% vs 51%, P = .0003) and 3 (38% vs 30%, P = .007).
Bowel function returned significantly sooner after surgery in the laparoscopic surgery group (median, 2.0 vs 3.0 days; P < .0001). There was no difference between groups with regard to overall rate of postoperative complications (40% and 37%) or with regard to rates of cardiac complications, anastomotic leak, respiratory complications, abscess, wound infection, or ileus. Reintervention occurred in 16% of the laparoscopic surgery group and 15% of the open surgery group.
Hospital stay was significantly reduced by 1 day in the laparoscopic surgery group (median 8.0 vs 9.0 days, P = .036). There was no difference between the two groups in 28-day mortality (1% vs 2%, P = .409).
Pathology Outcomes
With regard to pathology, resection was macroscopically complete in 88% of the laparoscopic surgery group and 92% of the open surgery group (P = .250). Incomplete resections occurred in patients in both groups, with incomplete resection specimens being more commonly from the upper rectum in the laparoscopic surgery group (1% vs <1%, P = .026). There was no difference in proportion of patients (10% and 10%) with positive circumferential resection margins (< 2 mm); positive circumferential resection margins were more likely to be from the middle rectum in the laparoscopic surgery group (10% vs 3%, P = .068) and significantly more likely to be from the lower rectum in the open surgery group (22% vs 9%, P = .014). Neither median circumferential resection margin (1 cm in both groups) nor median tumor distance to distal resection margin (3 cm in both groups) differed between groups.
There was no difference between groups with regard to number of harvested lymph nodes, pathology stage of tumors, or proportions of patients with no residual tumor after preoperative radiation or chemoradiation therapy.
The authors noted that the findings of the study are not applicable to all patients with rectal cancer, since patients with T3 cancer within 2 mm from the endopelvic fascia or T4 cancers were excluded.
They concluded, “[I]n selected patients treated by skilled surgeons, laparoscopic resection of rectal cancer provided oncologic radicality, using the pathology report as a proxy, similar to open surgery. In-hospital recovery after laparoscopic surgery was better than after open surgery. Long-term follow-up to assess local recurrence and survival is necessary to ascertain oncological safety of laparoscopic resection in patients with rectal cancer.” ■
Disclosure: Funding for the study was provided by Ethicon End-Surgery Europe, Swedish Cancer Foundation, West Gothia Region, Sahlgrenska University Hospital. The authors reported no potential conflicts of interest.
Reference
1. van der Pas MHG, Haglind E, Cuesta MA, et al: Laparoscopic versus open surgery for rectal cancer (COLOR II): Short-term outcomes of a randomized, phase 3 trial. Lancet Oncol 14:210-218, 2013.
