title: Disease Control, Survival, and Toxicity Outcome After Intensified Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer: A Single-Institution Experience.
abstract: OBJECTIVE
  To report the long-term follow-up data and determine the toxicity rate concerning patients with locally advanced rectal cancer (LARC) treated with an intensified neoadjuvant treatment regimen.
  
  
  METHODS
  Patients with histologically proven stage II to III adenocarcinoma of the rectum were included and treated with a trimodal approach. Intensified neoadjuvant treatment (chemoradiotherapy [CRT]) consisted of radiotherapy (total dose 50.4/54 Gy) and concomitant oxaliplatin (50 mg/m(2)/week) and 5-fluorouracil (200 mg/m(2)/5 daily continuous infusion). Surgery was planned 7 to 9 weeks after the end of CRT. Adjuvant chemotherapy was recommended in those patients with lymph node metastasis at diagnosis.
  
  
  RESULTS
  One hundred patients (median age, 64 years) were eligible. Overall, the 5-year overall survival and disease-free survival (DFS) were 76.4% and 74.5%, respectively. CRT was well tolerated, with only 17% grade 3/4 acute toxicity. Twenty-four patients (24%) had a pathologic complete response (pCR), and only 1 patient had perioperative metastasis. The 5-year DFS were 95.7% and 66.7% for pCR and no-pCR tumor histology, respectively (P = .0275).
  
  
  CONCLUSIONS
  Although oxaliplatin is not considered to be a standard treatment, the high 5-year rate of overall survival and DFS, the low severe toxicity rates, and the effective benefit on pCR and perioperative metastasis support an intensified treatment regimen for LARC.
authors.affiliation: Department of Radiotherapy, Policlinico Umberto I "Sapienza" University of Rome, Rome, Italy. Electronic address: fradefelice@hotmail.it.
authors.forename: Francesca
authors.initials: F
authors.lastname: De Felice
authors.affiliation: Department of Radiotherapy, Policlinico Umberto I "Sapienza" University of Rome, Rome, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Musio
authors.affiliation: Department of Radiotherapy, Policlinico Umberto I "Sapienza" University of Rome, Rome, Italy.
authors.forename: Anna Lisa
authors.initials: AL
authors.lastname: Magnante
authors.affiliation: Department of Radiotherapy, Policlinico Umberto I "Sapienza" University of Rome, Rome, Italy.
authors.forename: Nadia
authors.initials: N
authors.lastname: Bulzonetti
authors.affiliation: Department of Radiotherapy, Policlinico Umberto I "Sapienza" University of Rome, Rome, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Benevento
authors.affiliation: Department of Radiotherapy, Policlinico Umberto I "Sapienza" University of Rome, Rome, Italy.
authors.forename: Rossella
authors.initials: R
authors.lastname: Caiazzo
authors.affiliation: Department of Radiotherapy, Policlinico Umberto I "Sapienza" University of Rome, Rome, Italy; Spencer-Lorillard Foundation, Rome, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Tombolini
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000628:therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D059186:Chemoradiotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods*; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects / Q000379:methods*; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D016016:Proportional Hazards Models; D012004:Rectal Neoplasms / Q000401:mortality / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D005472:Fluorouracil
keywords: Neoadjuvant treatment; Oxaliplatin; Pre-operative treatment; Radiation; pCR