title: Complete response to neoadjuvant chemoradiation for rectal cancer does not influence survival.
abstract: BACKGROUND
  Up to 30% of patients with locally advanced rectal cancer have a complete clinical or pathologic response to neoadjuvant chemoradiation. This study analyzes complete clinical and pathologic responders among a large group of rectal cancer patients treated with neoadjuvant chemoradiation.
  
  
  METHODS
  From 1987 to 2000, 141 consecutive patients with biopsy-proven, locally advanced rectal cancer were treated with preoperative 5-fluorouracil-based chemotherapy and radiation. Clinical restaging after treatment consisted of proctoscopic examination and often computed tomography scan. One hundred forty patients then underwent operative resection, with results tracked in a database. Standard statistical methods were used to examine the outcomes of those patients with complete clinical or pathologic responses.
  
  
  RESULTS
  No demographic differences were detected between either clinical complete and clinical partial responders or pathologic complete and pathologic partial responders. The positive predictive value of clinical restaging was 60%, and accuracy was 82%. By use of the Kaplan-Meier life table analysis, clinical complete responders had no advantage in local recurrence, disease-free survival, or overall survival rates when compared with clinical partial responders. Pathologic complete responders also had no recurrence or survival advantage when compared with pathologic partial responders. Of the 34 pathologic T0 tumors, 4 (13%) had lymph node metastases.
  
  
  CONCLUSIONS
  Clinical assessment of complete response to neoadjuvant chemoradiation is unreliable. Micrometastatic disease persists in a proportion of patients despite pathologic complete response. Observation or local excision for patients thought to be complete responders should be undertaken with caution.
authors.affiliation: Department of Surgery, Duke University Medical Center, Durham, North Carolina 27710, USA.
authors.forename: M W
authors.initials: MW
authors.lastname: Onaitis
authors.forename: R B
authors.initials: RB
authors.lastname: Noone
authors.forename: R
authors.initials: R
authors.lastname: Fields
authors.forename: H
authors.initials: H
authors.lastname: Hurwitz
authors.forename: M
authors.initials: M
authors.lastname: Morse
authors.forename: P
authors.initials: P
authors.lastname: Jowell
authors.forename: K
authors.initials: K
authors.lastname: McGrath
authors.forename: C
authors.initials: C
authors.lastname: Lee
authors.forename: M S
authors.initials: MS
authors.lastname: Anscher
authors.forename: B
authors.initials: B
authors.lastname: Clary
authors.forename: C
authors.initials: C
authors.lastname: Mantyh
authors.forename: T N
authors.initials: TN
authors.lastname: Pappas
authors.forename: K
authors.initials: K
authors.lastname: Ludwig
authors.forename: H F
authors.initials: HF
authors.lastname: Seigler
authors.forename: D S
authors.initials: DS
authors.lastname: Tyler
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003082:Colectomy / Q000379:methods; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D018365:Neoplasm, Residual; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D015996:Survival Rate
chemical_list: D002945:Cisplatin; D005472:Fluorouracil