title: Randomized phase II study of sequential docetaxel and irinotecan with 5-fluorouracil/folinic acid (leucovorin) in patients with advanced gastric cancer: the GATAC trial.
abstract: BACKGROUND
  The optimal chemotherapy in patients with advanced gastric carcinoma (GC) is yet to be determined. We compared sequential administration of docetaxel and irinotecan, both in combination with infused 5-fluorouracil/leucovorin (5-Fu/Lv), and randomly assigned patients to start with either of the two.
  
  
  METHODS
  Patients with previously untreated locally advanced or metastatic GC and with measurable lesions (response evaluation criteria in solid tumors; RECIST) were randomly assigned to start with docetaxel 45 mg/m(2) (arm T) or irinotecan 180 mg/m(2) (arm C) with bolus/44-h infusion of 5-Fu/Lv (day 1 every 2 weeks). After four courses, there was a prescheduled crossover to the alternative regimen for four additional courses.
  
  
  RESULTS
  Eighty-one patients were randomized and 78 started treatment. Complete and partial responses were seen in 31 (40%) patients after 8 weeks and in 32 (41%) after 16 weeks, with similar results in both study arms. The median overall survival (OS) was 11.5 and 10.6 months in arms T and C, respectively (P = 0.3). The two schedules were feasible and did not differ in the overall rate of severe adverse events (SAEs).
  
  
  CONCLUSIONS
  This is the first randomized comparison of two of the newer cytostatic drugs in GC therapy. No differences favoring either arm T or arm C were found with respect to response rate, OS, or toxicity. The median OS of 11 months indicates that sequential administration of the two combinations is effective and is similar to triple combinations. Thus, comparable efficacy to platinum combinations appears to be obtained with newer, less toxic regimens when given sequentially.
authors.affiliation: Department of Oncology, Karolinska University Hospital at Södersjukhus, Sjukhusbacken 10, SE-118 83, Stockholm, Sweden.
authors.forename: Michael
authors.initials: M
authors.lastname: Gubanski
authors.forename: Anders
authors.initials: A
authors.lastname: Johnsson
authors.forename: Eva
authors.initials: E
authors.lastname: Fernebro
authors.forename: Lianna
authors.initials: L
authors.lastname: Kadar
authors.forename: Ingegerd
authors.initials: I
authors.lastname: Karlberg
authors.forename: Petra
authors.initials: P
authors.lastname: Flygare
authors.forename: Ake
authors.initials: A
authors.lastname: Berglund
authors.forename: Bengt
authors.initials: B
authors.lastname: Glimelius
authors.forename: Pehr A
authors.initials: PA
authors.lastname: Lind
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D013223:Statistics as Topic; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D013997:Time Factors; D014803:Vitamin B Complex / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D043823:Taxoids; D014803:Vitamin B Complex; D000077143:Docetaxel; D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin
references.citation: World J Gastroenterol. 2006 Jan 14;12(2):204-13
references.pmid: 16482619
references.citation: Ann Oncol. 1997 Feb;8(2):163-8
references.pmid: 9093725
references.citation: Ann Oncol. 2004 Dec;15(12):1773-81
references.pmid: 15550582
references.citation: Ann Oncol. 2001 Jan;12(1):47-51
references.pmid: 11249048
references.citation: Br J Cancer. 1994 Aug;70(2):380-3
references.pmid: 7914428
references.citation: Med Oncol. 1996 Jun;13(2):87-93
references.pmid: 9013471
references.citation: Gastric Cancer. 2002;5(3):142-7
references.pmid: 12378340
references.citation: N Engl J Med. 2008 Jan 3;358(1):36-46
references.pmid: 18172173
references.citation: Acta Oncol. 2001;40(2-3):309-26
references.pmid: 11441938
references.citation: Br J Cancer. 2005 Jun 20;92(12):2122-8
references.pmid: 15942629
references.citation: Cancer Treat Rep. 1979 Nov-Dec;63(11-12):1727-33
references.pmid: 526911
references.citation: Cochrane Database Syst Rev. 2005 Apr 18;(2):CD004064
references.pmid: 15846694
references.citation: Cancer Chemother Pharmacol. 2001 May;47(5):380-4
references.pmid: 11391851
references.citation: J Clin Oncol. 1997 Jan;15(1):261-7
references.pmid: 8996151
references.citation: Med Oncol. 2007;24(2):137-46
references.pmid: 17848736
references.citation: Ann Oncol. 2003;14 Suppl 2:ii41-4
references.pmid: 12810457
references.citation: Ann Oncol. 2000 Mar;11(3):301-6
references.pmid: 10811496
references.citation: Cancer. 2002 Feb 1;94(3):641-6
references.pmid: 11857295
references.citation: Am J Clin Oncol. 2000 Aug;23(4):341-4
references.pmid: 10955859
references.citation: J Clin Oncol. 2007 Aug 1;25(22):3205-9
references.pmid: 17664467
references.citation: J Clin Oncol. 1999 Jan;17(1):319-23
references.pmid: 10458249
references.citation: Ann Oncol. 2008 Aug;19(8):1450-1457
references.pmid: 18558665
references.citation: Lancet Oncol. 2008 Mar;9(3):215-21
references.pmid: 18282805
references.citation: J Clin Oncol. 2006 Nov 1;24(31):4991-7
references.pmid: 17075117