title: Pre-operative radiochemotherapy with raltitrexed for resectable locally-advanced rectal cancer: a phase II study.
abstract: BACKGROUND
  The aim of the study was to evaluate the response to and toxicity of pre-operative radiochemotherapy containing raltitrexed (Tomudex) for resectable rectal adenocarcinoma.
  
  
  METHODS
  From November 2000 to June 2002, 18 consecutive patients staged T3 NO0N+ were treated with pre-operative chemotherapy (3 mg/m2 of raltitrexed on days 1, 19, 38) and concurrent radiotherapy (RT) (50.4 Gy) in 6 weeks, followed by radical surgery within 8 weeks.
  
  
  RESULTS
  The treatment compliance was high. No major acute toxicity was reported. Concerning late toxicity, genitourinary adverse effects were prevalent. A complete response was observed in one patient (6%), partial response in eight (47%), stable disease in seven (41%) and progression in one case. Three-year actuarial disease-free and overall survival rates were 37% and 87.5%, respectively.
  
  
  CONCLUSIONS
  Raltitrexed did not increase the pathological response rate compared with the rates obtained with use of preoperative RT alone and reported in the literature. Acute morbidity was low and acceptable, while late toxicity was considerable, prevalently concerning sexual dysfunction and urinary complications.
authors.affiliation: Division of Radiation Oncology, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy. cristina.leonardi@ieo.it
authors.forename: Maria Cristina
authors.initials: MC
authors.lastname: Leonardi
authors.forename: Maria Giulia
authors.initials: MG
authors.lastname: Zampino
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Luca
authors.forename: Barbara Alicja
authors.initials: BA
authors.lastname: Jereczek-Fossa
authors.forename: Elena
authors.initials: E
authors.lastname: Petazzi
authors.forename: Brunilda
authors.initials: B
authors.lastname: Tatani
authors.forename: Roberta
authors.initials: R
authors.lastname: Lazzari
authors.forename: Roberto
authors.initials: R
authors.lastname: Biffi
authors.forename: Katia
authors.initials: K
authors.lastname: Lorizzo
authors.forename: Elena
authors.initials: E
authors.lastname: Magni
authors.forename: Diego
authors.initials: D
authors.lastname: Scanniffio
authors.forename: Franco
authors.initials: F
authors.lastname: Orsi
authors.forename: Guido
authors.initials: G
authors.lastname: Bonomo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Petralia
authors.forename: Cristina
authors.initials: C
authors.lastname: Trovato
authors.forename: Cristiano
authors.initials: C
authors.lastname: Crosta
authors.forename: Bruno
authors.initials: B
authors.lastname: Andreoni
authors.forename: Roberto
authors.initials: R
authors.lastname: Orecchia
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011300:Preoperative Care; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000964:Antimetabolites, Antineoplastic; D011799:Quinazolines; D013876:Thiophenes; C068874:raltitrexed