title: Long-term follow-up of preoperative pelvic radiation therapy and concomitant boost irradiation in locally advanced rectal cancer patients: a multi-institutional phase II study (KROG 04-01).
abstract: OBJECTIVE
  To perform a prospective phase II study to investigate the efficacy and safety of preoperative pelvic radiation therapy and concomitant small-field boost irradiation with 5-fluorouracil and leucovorin for 5 weeks in locally advanced rectal cancer patients.
  
  
  METHODS
  Sixty-nine patients with locally advanced, nonmetastatic, mid-to-lower rectal cancer were prospectively enrolled. They had received preoperative chemoradiation therapy and total mesorectal excision. Pelvic radiation therapy of 43.2 Gy in 24 fractions plus concomitant boost radiation therapy of 7.2 Gy in 12 fractions was delivered to the pelvis and tumor bed for 5 weeks. Two cycles of 5-fluorouracil and leucovorin were administered for 3 days in the first and fifth week of radiation therapy. The pathologic response, survival outcome, and treatment toxicity were evaluated for the study endpoints.
  
  
  RESULTS
  Of 69 patients, 8 (11.6%) had a pathologically complete response. Downstaging rates were 40.5% for T classification and 68.1% for N classification. At the median follow-up of 69 months, 36 patients have been followed up for more than 5 years. The 5-year disease-free survival (DFS) and overall survival rates were 66.0% and 75.3%, respectively. Higher pathologic T (P=.045) and N (P=.032) classification were significant adverse prognostic factors for DFS, and high-grade histology was an adverse prognostic factor for both DFS (P=.025) and overall survival (P=.031) on the multivariate analysis. Fifteen patients (21.7%) experienced grade 3 or 4 acute toxicity, and 7 patients (10.1%) had long-term toxicity.
  
  
  CONCLUSIONS
  Preoperative pelvic radiation therapy with concomitant boost irradiation with 5-fluorouracil and leucovorin for 5 weeks showed acceptable acute and long-term toxicities. However, the benefit of concomitant small-field boost irradiation for 5 weeks in rectal cancer patients was not demonstrated beyond conventional irradiation for 6 weeks in terms of tumor response and survival.
authors.affiliation: Department of Radiation Oncology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Jong Hoon
authors.initials: JH
authors.lastname: Lee
authors.forename: Dae Yong
authors.initials: DY
authors.lastname: Kim
authors.forename: Taek-Keun
authors.initials: TK
authors.lastname: Nam
authors.forename: Sei-Chul
authors.initials: SC
authors.lastname: Yoon
authors.forename: Doo Seok
authors.initials: DS
authors.lastname: Lee
authors.forename: Ji Won
authors.initials: JW
authors.lastname: Park
authors.forename: Jae Hwan
authors.initials: JH
authors.lastname: Oh
authors.forename: Hee Jin
authors.initials: HJ
authors.lastname: Chang
authors.forename: Mee Sun
authors.initials: MS
authors.lastname: Yoon
authors.forename: Jae-Uk
authors.initials: JU
authors.lastname: Jeong
authors.forename: Hong Seok
authors.initials: HS
authors.lastname: Jang
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D010388:Pelvis; D011300:Preoperative Care / Q000379:methods*; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods; D012004:Rectal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D012074:Remission Induction / Q000379:methods; D015996:Survival Rate
chemical_list: D000964:Antimetabolites, Antineoplastic; D002955:Leucovorin; D005472:Fluorouracil