title: Raltitrexed plus gemcitabine (TOMGEM) in advanced pancreatic cancer. Results of a Belgian multicentre phase II study.
abstract: OBJECTIVE
  This multicenter phase II study was designed to determine the activity and tolerance of gemcitabine and raltitrexed in advanced pancreatic adenocarcinoma.
  
  
  METHODS
  Thirty-three chemonaive patients with measurable disease received the TOMGEM regimen consisting of Raltitrexed 3 mg/m(2) in 15 min followed by Gemcitabine 1,000 mg/m(2) in 30 min on day 1, Gemcitabine alone 1,000 mg/m(2) on day 8 and repeated on day 21.
  
  
  RESULTS
  Thirty-three patients (median age: 62; locally advanced/metastatic disease: 5/28) were enrolled; the total number of cycles administered was 173 (median: 4). There were 10 partial response (confirmed), 2 stable disease (SD) >/=24 weeks, 7 SD <24 weeks, and 14 progressive disease for a response rate of 30.3% (95% CI: 14-46%); a clinical benefit was observed in 8/30 patients assessed (30%); median duration of response was 9.1 months. National Cancer Institute Common Toxicity Criteria grade III or IV neutropenia/thrombocytopenia were observed in 42 and 12% of the patients, respectively. Relevant nonhematological toxicities (grade III-IV) were rare although one toxic death was observed. Median time to progression was 2.8 months; one-year survival was 21%; median survival was 4.7 months.
  
  
  CONCLUSIONS
  Our data suggest that the combination of raltitrexed/gemcitabine is a very convenient regimen with an acceptable toxicity, and is active in advanced pancreatic cancer.
authors.affiliation: Erasme University Hospital, Brussels, Belgium. jvlaethe@ulb.ac.be
authors.forename: J-L
authors.initials: JL
authors.lastname: Van Laethem
authors.forename: Ph
authors.initials: P
authors.lastname: Van Maele
authors.forename: C
authors.initials: C
authors.lastname: Verslype
authors.forename: M
authors.initials: M
authors.lastname: Polus
authors.forename: A
authors.initials: A
authors.lastname: Demols
authors.forename: Gh
authors.initials: G
authors.lastname: Houbiers
authors.forename: P
authors.initials: P
authors.lastname: Caenepeel
authors.forename: A
authors.initials: A
authors.lastname: Leleux
authors.forename: R R
authors.initials: RR
authors.lastname: Vermaut
authors.forename: E
authors.initials: E
authors.lastname: Van Cutsem
authors.forename: M
authors.initials: M
authors.lastname: Peeters
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001530:Belgium; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011799:Quinazolines / Q000008:administration & dosage; D016019:Survival Analysis; D013876:Thiophenes / Q000008:administration & dosage; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D011799:Quinazolines; D013876:Thiophenes; D003841:Deoxycytidine; C068874:raltitrexed; D000093542:Gemcitabine