Local excision after preoperative chemoradiotherapy for rectal cancer: results of a multicenter phase II clinical trial

Maria Antonietta Gambacorta, Vincenzo Valentini, Claudio Coco, Salvatore Pucciarelli, Antonino De Paoli, Mario Guerrieri, Giuseppe La Torre, Isacco Maretto, Francesco De Marchi, Giovanna Mantello, Vincenzo Canzonieri, Donato Nitti

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116 Citazioni (Scopus)

Abstract

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.
Lingua originaleEnglish
pagine (da-a)1349-56-1356
RivistaDISEASES OF THE COLON & RECTUM
Volume56
DOI
Stato di pubblicazionePubblicato - 2013

Keywords

  • Adenocarcinoma
  • Adult
  • Aged
  • Aged, 80 and over
  • Chemoradiotherapy
  • Digestive System Surgical Procedures
  • Disease-Free Survival
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neoadjuvant Therapy
  • Neoplasm Recurrence, Local
  • Rectal Neoplasms
  • Treatment Outcome

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