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Randomized phase II study of sequential docetaxel and irinotecan with 5-fluorouracil/folinic acid (leucovorin) in patients with advanced gastric cancer: the GATAC trial

Gubanski, Michael; Johnsson, Anders LU ; Fernebro, Eva LU ; Kadar, Lianna LU ; Karlberg, Ingegerd; Flygare, Petra; Berglund, Ake; Glimelius, Bengt and Lind, Pehr A. (2010) In Gastric Cancer 13(3). p.155-161
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 m (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 pre-scheduled crossover to the alternative regimen for four additional courses. Results.... (More)
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 m (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 pre-scheduled 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). Conclusion. 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. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Docetaxel, Irinotecan, treatment, Sequential, Chemotherapy, Gastric cancer, Palliative treatment
in
Gastric Cancer
volume
13
issue
3
pages
155 - 161
publisher
Springer
external identifiers
  • wos:000284961300003
  • scopus:77957933128
ISSN
1436-3291
DOI
10.1007/s10120-010-0553-4
language
English
LU publication?
yes
id
fad93a87-240c-46f6-9132-3cb5d53a97b6 (old id 1773758)
date added to LUP
2011-02-02 14:51:19
date last changed
2018-05-29 09:53:36
@article{fad93a87-240c-46f6-9132-3cb5d53a97b6,
  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 m (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 pre-scheduled 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). Conclusion. 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.},
  author       = {Gubanski, Michael and Johnsson, Anders and Fernebro, Eva and Kadar, Lianna and Karlberg, Ingegerd and Flygare, Petra and Berglund, Ake and Glimelius, Bengt and Lind, Pehr A.},
  issn         = {1436-3291},
  keyword      = {Docetaxel,Irinotecan,treatment,Sequential,Chemotherapy,Gastric cancer,Palliative treatment},
  language     = {eng},
  number       = {3},
  pages        = {155--161},
  publisher    = {Springer},
  series       = {Gastric Cancer},
  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},
  url          = {http://dx.doi.org/10.1007/s10120-010-0553-4},
  volume       = {13},
  year         = {2010},
}