Organ preservation constitutes a paradigm shift in the management of patients with rectal cancer. One of the main reasons for exploring organ preservation strategies is the potential to preserve anorectal function, thus avoiding the need for permanent colostomy and maintaining quality of life (QoL) 1 . Deteriorations in several parameters of bowel function -including urgency, frequency, incontinence and bowel movement clusteringcan occur with variable frequency in patients with rectal cancer who receive low anterior resection after neoadjuvant chemoradiotherapy (CRT). The number of clinical trials examining organ preservation strategies such as nonoperative management (NOM) or local excision (LE) only after CRT in patients with rectal cancer is progressively increasing 1 . Habr-Gama and colleagues were the first to implement a selective NOM approach in patients with resectable rectal cancers with a clinical complete response (cCR) following CRT 2 . Since this initial study,

489 Background: The study tested whether preoperative 5x5 Gy and consolidation chemotherapy is more locally efficacious than standard preoperative chemoradiation in “unresectable” cancer (ClinicalTrials.gov NCT00833131). Methods: Patients with fixed cT3 or cT4 rectal cancer without distant metastases were randomized either to 5x5 Gy and 3 courses of FOLFOX4 after one week rest (experimental group) or to 50.4 Gy delivered in 28 fractions given simultaneously with a 5-Fu bolus, leucovorin and oxaliplatin (control group). For the second study part, oxaliplatin was delivered to the two groups at the discretion of the participating centre. Both groups underwent surgery about 12 weeks after starting radiation and about 6 weeks after neoadjuvant treatment. Results: 515 patients were eligible for analysis; 261 in the experimental group and 254 in the control group. Acute toxicity of neoadjuvant treatment was recorded in 74% of patients in the experimental group and in 83% in the control group, p = 0.007; the rate of patients with grade 3+ toxicity was identical in the two groups - 24%. R0 resection rates (primary endpoint) and pathological complete response rates were respectively in the experimental group and in the control group 77% vs. 71% (p = 0.081) and 16% vs. 11.5% (p = 0.19). Median follow-up was 35 months. At 3 years, rates of overall survival, disease-free survival and cumulative incidence of local failure were respectively in the experimental group and in the control 73% vs. 64.5%, p = 0.055; 53% vs. 52%, p = 0.74 and 22% vs. 21%, p = 0.82. Conclusions: The trial showed no difference in local efficacy between preoperative 5x5 Gy with consolidation chemotherapy and standard preoperative chemoradiation. The trend towards improved overall survival, lower toxicity, lower cost and convenience favors 5x5 Gy with consolidation chemotherapy. Clinical trial information: NCT00833131.

Background. Distal intramural spread is present within 1 cm from visible tumor in a substantial proportion of patients. Therefore, C1 cm of distal bowel clearance is recommended as minimally acceptable. However, clinical results are contradictory in answering the question of whether this rule is valid. The aim of this review was to evaluate whether in patients undergoing anterior resection, a distal bowel gross margin of \1 cm jeopardizes oncologic safety. Methods. A systematic review of the literature identified 17 studies showing results in relation to margins of approximately \1 cm (948 patients) versus [1 cm (4626 patients); five studies in relation to a margin of B5 mm (173 patients) versus [5 mm (1277 patients), and five studies showing results in a margin of B2 mm (73 patients). In most studies, pre-or postoperative radiation was provided. Results. A multifactorial process was identified resulting in selection of favorable tumors for anterior resection with the short bowel margin and unfavorable tumors for abdominoperineal resection or for anterior resection with the long margin. In total, the local recurrence rate was 1.0% higher in the \1-cm margin group compared to the [1-cm margin group (95% confidence interval [CI] -0.6 to 2.7; P = 0.175). The corresponding figures for B5 mm cutoff point were 1.7% (95% CI -1.9 to 5.3; P = 0.375). The pooled local recurrence rate in patients having B2 mm margin was 2.7% (95% CI 0 to 6.4). Conclusions. In the selected group of patients, \1 cm margin did not jeopardize oncologic safety.

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The interim analysis revealed no major differences in acute toxicity and local efficacy between the two evaluated strategies.