TY - JOUR
T1 - Docetaxel combined with irinotecan or 5-fluorouracil in patients with advanced oesophago-gastric cancer
T2 - A randomised phase II study
AU - Roy, Amitesh
AU - Cunningham, David
AU - Hawkins, Robert
AU - Sörbye, Halfdan
AU - Adenis, Antoine
AU - Barcelo, Jose
AU - Lopez-Vivanco, Guillermo
AU - Adler, Guido
AU - Canon, Jean-Luc
AU - Lofts, Fiona
AU - Castanon, Carmen
AU - Fonseca, Emilio
AU - Rixe, Olivier
AU - Aparicio, Jorge
AU - Cassinello, Javier
AU - Nicolson, Marianne
AU - Mousseau, Mireille
AU - Schalhorn, Andreas
AU - D'Hondt, Lionel
AU - Kerger, Joseph
AU - Hossfeld, Dieter
AU - Garcia Giron, Carlos
AU - Rodriguez, R.
AU - Schoffski, Patrick
AU - Misset, Jean-Louis
PY - 2012/7/24
Y1 - 2012/7/24
N2 - Background: Docetaxel and irinotecan chemotherapy have shown good efficacy in the treatment of advanced oesophago-gastric cancer. This randomised phase II study evaluated the efficacy and toxicity profile of two non-platinum docetaxel-based doublet regimens in advanced oesophago-gastric cancer.Methods:Chemotherapy-nave patients with advanced oesophago-gastric cancer were randomised to receive either 3-weekly DI (docetaxel 60 mg m2 plus irinotecan 250 mg m2 (Day 1)) or 3-weekly DF (docetaxel 85 mg m2 (Day 1) followed by 5-fluorouracil 750 mg m2 per day as a continuous infusion (Days 1-5)).Results:A total of 85 patients received DI (n42) or DF (n43). The primary endpoint was overall response rate (ORR). The ORR and time to progression (TTP) in the evaluable population (n65) were 37.5% (DI) vs 33.3% (DF), and 4.2 months vs 4.4 months, respectively. In the intent-to-treat population, the observed ORR, TTP and median overall survival were similar between the two groups. Grade 3-4 neutropenia, febrile neutropenia and diarrhoea were more frequent in the DI arm as compared with the DF arm (83.3% vs 69.8%, 40.5% vs 18.6%, and 42.9% vs 16.3%, respectively).Conclusion: Both docetaxel-based doublet regimens show comparable efficacy; however, the DF regimen was associated with a better toxicity profile and is an alternative treatment option for patients in whom platinum-based regimens are unsuitable.
AB - Background: Docetaxel and irinotecan chemotherapy have shown good efficacy in the treatment of advanced oesophago-gastric cancer. This randomised phase II study evaluated the efficacy and toxicity profile of two non-platinum docetaxel-based doublet regimens in advanced oesophago-gastric cancer.Methods:Chemotherapy-nave patients with advanced oesophago-gastric cancer were randomised to receive either 3-weekly DI (docetaxel 60 mg m2 plus irinotecan 250 mg m2 (Day 1)) or 3-weekly DF (docetaxel 85 mg m2 (Day 1) followed by 5-fluorouracil 750 mg m2 per day as a continuous infusion (Days 1-5)).Results:A total of 85 patients received DI (n42) or DF (n43). The primary endpoint was overall response rate (ORR). The ORR and time to progression (TTP) in the evaluable population (n65) were 37.5% (DI) vs 33.3% (DF), and 4.2 months vs 4.4 months, respectively. In the intent-to-treat population, the observed ORR, TTP and median overall survival were similar between the two groups. Grade 3-4 neutropenia, febrile neutropenia and diarrhoea were more frequent in the DI arm as compared with the DF arm (83.3% vs 69.8%, 40.5% vs 18.6%, and 42.9% vs 16.3%, respectively).Conclusion: Both docetaxel-based doublet regimens show comparable efficacy; however, the DF regimen was associated with a better toxicity profile and is an alternative treatment option for patients in whom platinum-based regimens are unsuitable.
KW - 5-fluorouracil
KW - docetaxel
KW - irinotecan
KW - oesophago-gastric cancer
UR - http://www.scopus.com/inward/record.url?scp=84864371155&partnerID=8YFLogxK
U2 - 10.1038/bjc.2012.286
DO - 10.1038/bjc.2012.286
M3 - Article
VL - 107
SP - 435
EP - 441
JO - British Journal of Cancer
JF - British Journal of Cancer
SN - 0007-0920
IS - 3
ER -