title: Neoadjuvant conformal chemoradiation with induction chemotherapy for rectal adenocarcinoma. A prospective observational study.
abstract: OBJECTIVE
  The purpose of this prospective observational study was to evaluate the rate and the prognostic factors for down-staging and complete response for rectal adenocarcinoma after induction chemotherapy and neoadjuvant chemoradiation followed by surgery, and to analyze the rate of sphincter-saving surgery.
  
  
  METHODS
  We included from March 2011 to October 2013 a number of 88 patients hospitalized with locally advanced rectal adenocarcinoma in the Prof. Dr. Ion Chiricuta Institute of Oncology, Cluj. The treatment schedule included 2-4 cycles of Oxaliplatin plus a fluoropyrimidine followed by concomitant chemoradiation with a dose of 50 Gy in 25 fractions combined with a fluoropyrimidine monotherapy.
  
  
  RESULTS
  The rate of T down-staging was 49.4% (40/81 evaluable patients). Independent prognostic factors for T down-staging were: age >57 years (p<0.01), cN0 (p<0.01), distance from anal verge >5 cm (p<0.01), initial CEA <6.2 ng/ml (p<0.01), higher number of chemotherapy cycles with Oxaliplatin (pROC=0.05) and protraction of radiotherapy of >35 days (p<0.01). Nine patients from 81 (11.1%) presented complete response (7 pathological and 2 clinical); the independent prognostic factors were stage cT2 versus cT3-4 (p<0.01), initial tumor size ≤3.5 cm and distance from anal verge >5 cm (p=0.03). Sixty-eight patients (79.1%) underwent radical surgery and among them 35 patients (51.5 %) had a sphincter saving procedure.
  
  
  CONCLUSIONS
  Induction chemotherapy with neoadjuvant chemoradiation produced important down-staging in rectal adenocarcinoma. Independent prognostic factors for T down-staging were: age, cN0, distance from anal verge, initial CEA, the number of Oxaliplatin cycles and duration of radiotherapy; for complete response: cT2, initial tumor size and distance from the anal verge.
authors.affiliation: University of Medicine and Pharmacy Iuliu Haţieganu;Institute of Oncology Prof. Dr. Ion Chiricuţa,Cluj-Napoca, Romania. fekete.zsolt@umfcluj.ro.
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Fekete
authors.affiliation: Institute of Oncology Prof. Dr. Ion Chiricuţa, Cluj-Napoca, Romania.
authors.forename: Alina-Simona
authors.initials: AS
authors.lastname: Muntean
authors.affiliation: Institute of Oncology Prof. Dr. Ion Chiricuţa, Cluj-Napoca, Romania.
authors.forename: Ştefan
authors.initials: Ş
authors.lastname: Hica
authors.affiliation: Institute of Oncology Prof. Dr. Ion Chiricuţa; Scandia Imagistica, Cluj-Napoca, Romania.
authors.forename: Alin
authors.initials: A
authors.lastname: Rancea
authors.affiliation: Institute of Oncology Prof. Dr. Ion Chiricuţa, Cluj-Napoca, Romania.
authors.forename: Liliana
authors.initials: L
authors.lastname: Resiga
authors.affiliation: University of Medicine and Pharmacy Iuliu Haţieganu;Scandia Imagistica, Cluj-Napoca, Romania.
authors.forename: Csaba
authors.initials: C
authors.lastname: Csutak
authors.affiliation: Institute of Oncology Prof. Dr. Ion Chiricuţa, Cluj-Napoca, Romania.
authors.forename: Nicolae
authors.initials: N
authors.lastname: Todor
authors.affiliation: University of Medicine and Pharmacy Iuliu Haţieganu;Institute of Oncology Prof. Dr. Ion Chiricuţa,Cluj-Napoca, Romania.
authors.forename: Viorica Magdalena
authors.initials: VM
authors.lastname: Nagy
mesh_terms: D000230:Adenocarcinoma / Q000175:diagnosis / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood; D018395:CA-19-9 Antigen / Q000097:blood; D002272:Carcinoembryonic Antigen / Q000378:metabolism; D059186:Chemoradiotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy / Q000009:adverse effects / Q000379:methods; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects / Q000379:methods; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D011379:Prognosis; D012004:Rectal Neoplasms / Q000175:diagnosis / Q000473:pathology / Q000601:surgery / Q000628:therapy*
chemical_list: D014408:Biomarkers, Tumor; D018395:CA-19-9 Antigen; D002272:Carcinoembryonic Antigen; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin