Diseases of the Colon & Rectum

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Diseases of the Colon & Rectum:
doi: 10.1097/DCR.0b013e3182a2303e
Original Contributions: Colorectal/Anal Neoplasia

Local Excision After Preoperative Chemoradiotherapy for Rectal Cancer: Results of a Multicenter Phase II Clinical Trial

Pucciarelli, Salvatore M.D.1; De Paoli, Antonino M.D.2; Guerrieri, Mario M.D.3; La Torre, Giuseppe M.D.4; Maretto, Isacco M.D.1; De Marchi, Francesco M.D.5; Mantello, Giovanna M.D.6; Gambacorta, Maria Antonietta M.D.7; Canzonieri, Vincenzo M.D.8; Nitti, Donato M.D.1; Valentini, Vincenzo M.D.7; Coco, Claudio M.D.9

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BACKGROUND: Transanal local excision has been suggested as an attractive approach for patients with rectal cancer who show a major clinical response after preoperative chemoradiotherapy.

OBJECTIVE: To evaluate the impact of transanal local excision on the local recurrence of rectal cancer in patients who had a major clinical response after preoperative chemoradiotherapy.

DESIGN: Sequential 2-stage phase II study for early efficacy.

SETTING: Multicenter study.

PATIENTS: Patients with clinical T3 or low-lying T2 rectal adenocarcinoma that showed a major clinical response after a preoperative chemoradiotherapy. Eligible patients underwent a full-thickness transanal local excision. According to their histopathology, the patients staged as ypT0-1 were observed, while the remaining patients were recommended to undergo a subsequent total mesorectal excision.

MAIN OUTCOME MEASURES: A local recurrence rate of ≤5% was set as a successful rate for stopping the trial early after the first stage.

RESULTS: The study group included 63 patients. Before chemoradiotherapy, patients were staged as clinical T3 (n = 42) and T2 (n = 21). After the local excision, 43 patients fulfilled the criteria to be observed with no further treatment. Nine of the remaining 20 patients for whom a subsequent total mesorectal excision was recommended refused surgery. Two of these patients who refused surgery had intraluminal local recurrence; both had a ypT2 tumor and underwent salvage surgery. The estimated cumulative 3-year overall survival, disease-free survival and local disease-free survival were 91.5% (95% CI: 75.9–97.2), 91.0% (95% CI: 77.0–96.6) and 96.9% (95% CI: 80.3–99.5), respectively.

LIMITATIONS: The time of follow-up is still short and the sample size is limited.

CONCLUSIONS: Our data suggest that local excision is a good option for patients with a major clinical response after chemoradiotherapy. A longer period of follow-up is required to confirm these findings.

© 2013 The American Society of Colon and Rectal Surgeons


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