Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial.

BACKGROUND: Laparoscopic surgery as an alternative to open surgery in patients with rectal cancer has not yet been shown to be oncologically safe. The aim in the COlorectal cancer Laparoscopic or Open Resection (COLOR II) trial was to compare laparoscopic and open surgery in patients with rectal cancer. METHODS: A non-inferiority phase 3 trial was undertaken at 30 centres and hospitals in eight countries. Patients (aged ≥18 years) with rectal cancer within 15 cm from the anal verge without evidence of distant metastases were randomly assigned to either laparoscopic or open surgery in a 2:1 ratio, stratified by centre, location of tumour, and preoperative radiotherapy. The study was not masked. Secondary (short-term) outcomes-including operative findings, complications, mortality, and results at pathological examination-are reported here. Analysis was by modified intention to treat, excluding those patients with post-randomisation exclusion criteria and for whom data were not available. This study is registered with ClinicalTrials.gov, number NCT00297791. FINDINGS: The study was undertaken between Jan 20, 2004, and May 4, 2010. 1103 patients were randomly assigned to the laparoscopic (n=739) and open surgery groups (n=364), and 1044 were eligible for analyses (699 and 345, respectively). Patients in the laparoscopic surgery group lost less blood than did those in the open surgery group (median 200 mL [IQR 100-400] vs 400 mL [200-700], p<0·0001); however, laparoscopic procedures took longer (240 min [184-300] vs 188 min [150-240]; p<0·0001). In the laparoscopic surgery group, bowel function returned sooner (2·0 days [1·0-3·0] vs 3·0 days [2·0-4·0]; p<0·0001) and hospital stay was shorter (8·0 days [6·0-13·0] vs 9·0 days [7·0-14·0]; p=0·036). Macroscopically, completeness of the resection was not different between groups (589 [88%] of 666 vs 303 [92%] of 331; p=0·250). Positive circumferential resection margin (<2 mm) was noted in 56 (10%) of 588 patients in the laparoscopic surgery group and 30 (10%) of 300 in the open surgery group (p=0·850). Median tumour distance to distal resection margin did not differ significantly between the groups (3·0 cm [IQR 2·0-4·8] vs 3·0 cm [1·8-5·0], respectively; p=0·676). In the laparoscopic and open surgery groups, morbidity (278 [40%] of 697 vs 128 [37%] of 345, respectively; p=0·424) and mortality (eight [1%] of 699 vs six [2%] of 345, respectively; p=0·409) within 28 days after surgery were similar. INTERPRETATION: In selected patients with rectal cancer treated by skilled surgeons, laparoscopic surgery resulted in similar safety, resection margins, and completeness of resection to that of open surgery, and recovery was improved after laparoscopic surgery. Results for the primary endpoint-locoregional recurrence-are expected by the end of 2013. FUNDING: Ethicon Endo-Surgery Europe, Swedish Cancer Foundation, West Gothia Region, Sahlgrenska University Hospital.

Sentinel-lymph-node procedure in colon and rectal cancer: a systematic review and meta-analysis.

BACKGROUND: No consensus exists on the validity of the sentinel-lymph-node procedure for assessment of nodal status in patients with colorectal cancer. We aimed to assess the diagnostic performance of this procedure. METHODS: We searched Embase and PubMed databases for studies published before March 20, 2010. Eligible studies had a prospective design, a sample size of at least 20 patients, and reported the rate of sentinel-lymph-node positivity. Individual patient data were requested for localisation and T-stage stratification. A subset of reports with high methodological quality was selected and analysed. FINDINGS: We identified 52 eligible studies, which included 3767 sentinel-lymph-node procedures (2961 [78·6%] colon and 806 [21·4%] rectal carcinomas). Most tumours 2339 (62·1%) were stage T3 or T4. 1887 (50·1%) of patients were male, 1880 (49·9%) female. Mean overall weighted-detection rate was 0·94 (95% CI 0·92-0·95), at a pooled sensitivity of 0·76 (0·72-0·80) with limited heterogeneity (χ(2)=286·08, degrees of freedom=51; p=0·003). A mean weighted upstaging of 0·15 (95% CI 0·12-0·19) was noted. Individual patient data were available from 19 studies that included 1168 patients. Analysis of these data showed no significant difference in sensitivity between colon (0·86 [95% CI 0·83-0·90]) and rectal cancer (0·82 [0·77-0·88]; p=0·23). Also, there was no dependency of sensitivity on T stage for both colon (pT1: 0·79 [95% CI 0·73-0·84], pT2: 0·76 [0·62-0·90], pT3: 0·73 [0·59-0·87], pT4: 0·73 [0·53-0·93]) and rectal cancer (T1 or T2: 0·81 [0·52-0·94] vs T3 or T4: 0·80 [0·51-0·93]). The subgroup of eight studies with high methodological quality showed a mean detection rate of 0·96 (95% CI 0·90-0·99) for colonic tumours and 0·95 (0·75-0·99) for rectal tumours, and a mean sensitivity of 0·90 (95% CI 0·86-0·93) for colonic tumours and 0·82 (0·60-0·93) for rectal tumours. INTERPRETATION: The sentinel-lymph-node procedure shows a low sensitivity, regardless of T stage, localisation, or pathological technique. For every patient diagnosed with colon or rectal cancer without clinical evidence of lymph-node involvement or metastatic disease, this procedure in addition to conventional resection should be considered, since the prognostic information provided by this technique could be clinically significant. FUNDING: Cancer Center Amsterdam Foundation, Amsterdam, Netherlands.