title: Does preoperative radiotherapy with postoperative chemotherapy increase acute side-effects and postoperative complications of total mesorectal excision? Report of the randomized Finnish rectal cancer trial.
abstract: OBJECTIVE
  In a randomized trial the effect of short-term preoperative radiotherapy and postoperative chemotherapy was studied in patients undergoing total mesorectal excision (TME) for clinically resectable rectal cancer. The primary endpoint was overall survival. The secondary endpoints published herein were the incidence of postoperative complications and adverse events with perioperative adjuvant therapy.
  
  
  METHODS
  In 1995-2002, 278 eligible patients with stage II and stage III rectal cancer were randomly assigned to TME alone (surgery group) or to preoperative 25 Gy radio-therapy in 5 fractions and postoperative 5-fluorouracil and leucovorin chemotherapy in addition (RT+CT group).
  
  
  RESULTS
  Anastomotic leakage rate did not significantly differ between the surgery and the RT + CT group, 20.6% vs. 27.4%. Postoperative infections (15.5 vs. 26.2%, p = 0.037) and perineal wound dehiscence (15.9 vs. 38.5%, p = 0.045) were more common after radiotherapy. Grade 3-5 adverse events were uncommon with preoperative radiotherapy (one, 0.7% with reversible lumbar plexopathy) and postoperative chemotherapy (hematologic in 10.8%, with one septic death, and gastrointestinal in 4.8%).
  
  
  CONCLUSIONS
  Perioperative adjuvant therapy was generally well tolerated and did not lead to an increase in serious surgical complications. Wound infections and perineal wound dehiscence were more common in irradiated patients.
authors.affiliation: Department of Surgery, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: S
authors.initials: S
authors.lastname: Salmenkylä
authors.forename: M
authors.initials: M
authors.lastname: Kouri
authors.forename: P
authors.initials: P
authors.lastname: Österlund
authors.forename: E
authors.initials: E
authors.lastname: Pukkala
authors.forename: P
authors.initials: P
authors.lastname: Luukkonen
authors.forename: M
authors.initials: M
authors.lastname: Hyöty
authors.forename: M
authors.initials: M
authors.lastname: Pääkkönen
authors.forename: J
authors.initials: J
authors.lastname: Mäkelä
authors.forename: H
authors.initials: H
authors.lastname: Mustonen
authors.forename: H J
authors.initials: HJ
authors.lastname: Järvinen
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000628:therapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D019583:Dose Fractionation, Radiation; D005260:Female; D005387:Finland; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology*; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant; D012004:Rectal Neoplasms / Q000401:mortality / Q000628:therapy*; D012007:Rectum / Q000601:surgery*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D002955:Leucovorin; D005472:Fluorouracil