title: Pemetrexed in combination with oxaliplatin as a first-line therapy for advanced gastric cancer: a multi-institutional phase II study.
abstract: BACKGROUND
  This clinical trial assessed the efficacy of pemetrexed combined with oxaliplatin (PEMOX) in patients with advanced gastric cancer (AGC).
  
  
  METHODS
  Forty-four patients with untreated AGC were enrolled to evaluate response rate (RR). Patients received pemetrexed (500 mg/m(2)) with vitamin supplementation and oxaliplatin (120 mg/m(2)) every 21 days for six cycles or until disease progression occurred.
  
  
  RESULTS
  Median age was 62 years (range 26-76). The majority of patients (93%) had metastatic disease. Sixteen of the 44 patients achieved confirmed response [RR 36%; 95% confidence interval (CI) 22% to 52%]; four complete responses and 12 partial responses (complete and partial responses according to the RECIST guidelines are the confirmed-responses observed in the study population). Median time to tumor progression (TTP) was 6.2 months (95% CI 4.3-7.5) and median survival was 10.8 months (95% CI 7.7-17.2). A total of 220 cycles were administered, with a median of six cycles. Most common grade 3/4 toxic effects were neutropenia in 41% of patients (19% of cycles) and thrombocytopenia in 11% of patients (4% of cycles). Treatment delays or dose reductions for toxicity occurred in 10% and 5% of cycles, respectively.
  
  
  CONCLUSIONS
  PEMOX is active and well tolerated in AGC. RR, TTP, and survival were comparable to those achieved in studies using different 5-fluorouracil (5-FU)-oxaliplatin combinations, without the inconvenience of prolonged 5-FU schedules.
authors.affiliation: Medical Oncology Unit 2, Foundation IRCCS National Tumour Institute, Milan, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Celio
authors.forename: C N
authors.initials: CN
authors.lastname: Sternberg
authors.forename: R
authors.initials: R
authors.lastname: Labianca
authors.forename: I
authors.initials: I
authors.lastname: La Torre
authors.forename: V
authors.initials: V
authors.lastname: Amoroso
authors.forename: C
authors.initials: C
authors.lastname: Barone
authors.forename: G
authors.initials: G
authors.lastname: Pinotti
authors.forename: S
authors.initials: S
authors.lastname: Cascinu
authors.forename: F
authors.initials: F
authors.lastname: Di Costanzo
authors.forename: G L
authors.initials: GL
authors.lastname: Cetto
authors.forename: E
authors.initials: E
authors.lastname: Bajetta
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D005260:Female; D005971:Glutamates / Q000008:administration & dosage; D006147:Guanine / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D000068437:Pemetrexed; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary
chemical_list: D005971:Glutamates; D009944:Organoplatinum Compounds; D000068437:Pemetrexed; D000077150:Oxaliplatin; D006147:Guanine