title: Results of neoadjuvant short-course radiation therapy followed by transanal endoscopic microsurgery for t1-t2 n0 extraperitoneal rectal cancer.
abstract: OBJECTIVE
  This study was undertaken to assess the short-term outcomes of neoadjuvant short-course radiation therapy (SCRT) followed by transanal endoscopic microsurgery (TEM) for T1-T2 N0 extraperitoneal rectal cancer. Recent studies suggest that neoadjuvant radiation therapy followed by TEM is safe and has results similar to those with abdominal rectal resection for the treatment of extraperitoneal early rectal cancer.
  
  
  METHODS
  We planned a prospective pilot study including 25 consecutive patients with extraperitoneal T1-T2 N0 M0 rectal adenocarcinoma undergoing SCRT followed by TEM 4 to 10 weeks later (SCRT-TEM). Safety, efficacy, and acceptability of this treatment modality were compared with historical groups of patients with similar rectal cancer stage and treated with long-course radiation therapy (LCRT) followed by TEM (LCRT-TEM), TEM alone, or laparoscopic rectal resection with total mesorectal excision (TME) at our institution.
  
  
  RESULTS
  The study was interrupted after 14 patients underwent SCRT of 25 Gy in 5 fractions followed by TEM. Median time between SCRT and TEM was 7 weeks (range: 4-10 weeks). Although no preoperative complications occurred, rectal suture dehiscence was observed in 7 patients (50%) at 4 weeks follow-up, associated with an enterocutaneous fistula in the sacral area in 2 cases. One patient required a colostomy. Quality of life at 1-month follow-up, according to European Organization for Research and Treatment of Cancer QLQ-C30 survey score, was significantly worse in SCRT-TEM patients than in LCRT-TEM patients (P=.0277) or TEM patients (P=.0004), whereas no differences were observed with TME patients (P=.604). At a median follow-up of 10 months (range: 6-26 months), we observed 1 (7%) local recurrence at 6 months that was treated with abdominoperineal resection.
  
  
  CONCLUSIONS
  SCRT followed by TEM for T1-T2 N0 rectal cancer is burdened by a high rate of painful dehiscence of the suture line and enterocutaneous fistula, compared to TEM alone and TEM following LCRT, which forced us to stop the study.
authors.affiliation: General Surgery I, Department of Surgical Sciences, University of Torino, Torino, Italy. Electronic address: alberto.arezzo@unito.it.
authors.forename: Alberto
authors.initials: A
authors.lastname: Arezzo
authors.affiliation: General Surgery I, Department of Surgical Sciences, University of Torino, Torino, Italy.
authors.forename: Simone
authors.initials: S
authors.lastname: Arolfo
authors.affiliation: General Surgery I, Department of Surgical Sciences, University of Torino, Torino, Italy.
authors.forename: Marco Ettore
authors.initials: ME
authors.lastname: Allaix
authors.affiliation: Radiation Oncology, Department of Oncology, University of Torino, Torino, Italy.
authors.forename: Fernando
authors.initials: F
authors.lastname: Munoz
authors.affiliation: Pathology Unit, Department of Medical Sciences, University of Torino, Torino, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Cassoni
authors.affiliation: Clinical Epidemiology Unit, Piedmont Reference Centre for Epidemiology and Cancer Prevention, City of Health and Science Hospital of Torino, Torino, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Monagheddu
authors.affiliation: Radiation Oncology, Department of Oncology, University of Torino, Torino, Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Ricardi
authors.affiliation: Clinical Epidemiology Unit, Piedmont Reference Centre for Epidemiology and Cancer Prevention, City of Health and Science Hospital of Torino, Torino, Italy.
authors.forename: Giovannino
authors.initials: G
authors.lastname: Ciccone
authors.affiliation: General Surgery I, Department of Surgical Sciences, University of Torino, Torino, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Morino
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016099:Endoscopy, Gastrointestinal; D005260:Female; D006801:Humans; D007412:Intestinal Fistula / Q000209:etiology*; D010535:Laparoscopy; D008297:Male; D008866:Microsurgery / Q000009:adverse effects* / Q000379:methods; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects* / Q000379:methods; D009364:Neoplasm Recurrence, Local; D017699:Pelvic Pain / Q000209:etiology; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods; D012004:Rectal Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery*; D018709:Statistics, Nonparametric; D013529:Surgical Wound Dehiscence / Q000209:etiology*