Survival and recurrence rates were not significantly different between patients with low rectal cancer who were treated with either local or total mesorectal excision, according to the results from a 5-year follow-up after a prospective randomized open-label phase 3 trial published in The Lancet Gastroenterology and Hepatology.
Adult patients with T2 or T3 low rectal cancer (≤8 cm from the anal verge, maximum tumor size 4 cm, and up to 3 nodes) who were good responders to chemoradiotherapy (residual tumor size ≤2 cm after long-course fluorouracil-based chemotherapy, 50 Gy in 25 fractions of 2 Gy, 5 days per week for 5 weeks) were randomly assigned to local (n=74) or total mesorectal (n=71) excision groups. The trial was performed at 15 centers in France between 2007 and 2012 and patients were followed up after a median of 60 months.
The 5-year local recurrence was the same (n=5) for both groups (7%; 95% CI, 3%-16%; P =.60). The recurrent tumor types were reported as ypT0 (n=2), ypT1 (n=3), yPT2 (n=2), ypT3 (n=1), and 2 patients did not undergo additional surgery. Macroscopic removal of the cancer was possible in 70% of the local recurrences.
The study investigators reported no significant difference between the groups in oncologic outcomes. Between the local vs total excision groups the rates of metastatic disease (18%; 95% CI, 11%-30% vs 19%; 95% CI, 11%-31%, respectively; P =.73), overall survival (84%; 95% CI, 73%-91% vs 82%; 95% CI, 71%-90%, respectively; P =.85), and cancer-specific mortality (7%; 95% CI, 3%-17% vs 10%; 95% CI, 5%-20%, respectively; P =.53) were similar.
A study limitation is that only patients who had a positive clinical and pathologic response to neoadjuvant treatment were included and the results may not be representative of the general patient population with low rectal cancer.
Based on these results, the investigators concluded that local excision was an adequate treatment in patients with low rectal cancer who had a good response to chemoradiotherapy, indicating that rectal preservation should be practiced in this patient population.
Rullier E, Vendrely V, Asselineau J, et al. Organ preservation with chemoradiotherapy plus local excision for rectal cancer: 5-year results of the GRECCAR 2 randomised trial [published online February 7, 2020]. Lancet Gastroenterol Hepatol. doi:10.1016/ S2468-1253(19)30410-8