title: Complications, functional outcome and quality of life after intensive preoperative chemoradiotherapy for rectal cancer.
abstract: OBJECTIVE
  To investigate early and late complications in 44 patients with locally advanced mid-low rectal cancer enrolled in a phase I-II study, who had received an aggressive chemoradiation treatment (50.4Gy/28F; 5-FU continuous infusion and weekly Oxaliplatin) followed by total mesorectal excision and 5-FU based postoperative chemotherapy. The aim of the present study is also to evaluate functional outcome and quality of life (QoL) in a sub-group of 22 patients.
  
  
  METHODS
  Standardized forms for early and late surgical complications were completed for all patients. Anorectal function and QoL were also investigated in 22 patients who underwent surgery in the same surgical unit, using the fecal incontinence scoring system (FIS) and EORTC-QLQ-CR38 questionnaires, compiled before and after radiotherapy and at least 8 months after surgery. The differences over time in scores were analyzed using repeated measure ANOVA.
  
  
  RESULTS
  The median age of patients (25 males and 19 females) was 58 (range: 34-73) years. A low anterior resection was performed in 39 cases, radical resection in 41, and 12 patients had a pathological complete response. There were no operative deaths; 4 and 9 patients required re-operation for early and late complications, respectively. FIS score did not present a significant worsening over time. According to data in the EORTC-QLQ-CR38 questionnaire, a significant improvement over time was found only for "future perspective".
  
  
  CONCLUSIONS
  Our findings seem to indicate that this aggressive 5-FU-Oxalipaltin-based treatment implies no impairment of QoL and anorectal function, even if a high rate of late major complications was observed. Studies on larger series are required to confirm these results.
authors.affiliation: Clinica Chirurgica II, Dipartimento di Scienze Oncologiche e Chirurgiche, Policlinico Università di Padova, Policlinico, VI piano, Via Giustiniani 2, 35128 Padova, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Urso
authors.forename: S
authors.initials: S
authors.lastname: Serpentini
authors.forename: S
authors.initials: S
authors.lastname: Pucciarelli
authors.forename: G L
authors.initials: GL
authors.lastname: De Salvo
authors.forename: M L
authors.initials: ML
authors.lastname: Friso
authors.forename: G
authors.initials: G
authors.lastname: Fabris
authors.forename: S
authors.initials: S
authors.lastname: Lonardi
authors.forename: B
authors.initials: B
authors.lastname: Ferraro
authors.forename: A
authors.initials: A
authors.lastname: Bruttocao
authors.forename: C
authors.initials: C
authors.lastname: Aschele
authors.forename: D
authors.initials: D
authors.lastname: Nitti
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005242:Fecal Incontinence / Q000209:etiology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D011183:Postoperative Complications; D011788:Quality of Life; D012004:Rectal Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery*; D012007:Rectum / Q000601:surgery; D011795:Surveys and Questionnaires
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D005472:Fluorouracil