title: Phase II study of preoperative chemoradiotherapy (CRT) with irinotecan plus S-1 in locally advanced rectal cancer.
abstract: OBJECTIVE
  The aim of this study is to evaluate the efficacy and safety of preoperative radiation therapy combined with S-1 and irinotecan (SI) in LARC.
  
  
  METHODS
  Patients were considered LARC if they had a T3/T4 lesion or node positive. Weekly doses of 40 mg/m(2) irinotecan were intravenously administered once per week during weeks 1-5 of radiotherapy. S-1 (70 mg/m(2)) was given from Monday to Friday in all weeks of radiotherapy. 3-D conformal radiotherapy was given at daily fractions of 1.8Gy for 5days for a total dose of 50.4 (45+5.4)Gy. Surgery was performed 4-6 weeks following the completion of chemoradiation.
  
  
  RESULTS
  Between June 2006 and November 2007, 43 pts were enrolled. The stage was: cT3 24 patients, cT4 6 patients; 28 patients were cN+. Forty-one patients completed the chemoradiation and 42 patients underwent operation: a low anterior resection was performed in 36 patients, a total colectomy in 1 patient, and an abdominal perineal resection in 5 patients. T downstaging was observed in 50%; 23 N+ patients became N- (55%). The complete pathological response was observed in 9 patients (21%). The 3-year locoregional failure rate, distant failure rate, disease-free survival, and overall survival were 9.5%, 18.6%, 72.1%, and 94.3%, respectively. Only three patients experienced G3 diarrhea; one had G3 sepsis and two had septic shock. Hematological toxicity (G3-G4) was observed in five patients.
  
  
  CONCLUSIONS
  This study demonstrated the efficacy of preoperative CRT with S-1 and irinotecan with 21% of complete response. However, prompt recognition and management of infection is needed to use it in patients with locally advanced rectal cancer.
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, Republic of Korea.
authors.forename: Sang Joon
authors.initials: SJ
authors.lastname: Shin
authors.forename: Nam Kyu
authors.initials: NK
authors.lastname: Kim
authors.forename: Ki Chang
authors.initials: KC
authors.lastname: Keum
authors.forename: Ho Geun
authors.initials: HG
authors.lastname: Kim
authors.forename: Jun Seok
authors.initials: JS
authors.lastname: Im
authors.forename: Hye Jin
authors.initials: HJ
authors.lastname: Choi
authors.forename: Seung Hyuk
authors.initials: SH
authors.lastname: Baik
authors.forename: Jae Hee
authors.initials: JH
authors.lastname: Choen
authors.forename: Hei-Cheul
authors.initials: HC
authors.lastname: Jeung
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Rha
authors.forename: Jae Kyung
authors.initials: JK
authors.lastname: Roh
authors.forename: Hyun Cheol
authors.initials: HC
authors.lastname: Chung
authors.forename: Joong Bae
authors.initials: JB
authors.lastname: Ahn
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage; D012004:Rectal Neoplasms / Q000401:mortality / Q000628:therapy*; D005641:Tegafur / Q000008:administration & dosage
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000077146:Irinotecan; D002166:Camptothecin