Docetaxel combined with irinotecan or 5-fluorouracil in patients with advanced oesophago-gastric cancer: a randomised phase II study.

Abstract

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-naïve patients with advanced oesophago-gastric cancer were randomised to receive either 3-weekly DI (docetaxel 60 mg m(-2) plus irinotecan 250 mg m(-2) (Day 1)) or 3-weekly DF (docetaxel 85 mg m(-2) (Day 1) followed by 5-fluorouracil 750 mg m(-2) per day as a continuous infusion (Days 1-5)).

RESULTS:

A total of 85 patients received DI (n=42) or DF (n=43). The primary endpoint was overall response rate (ORR). The ORR and time to progression (TTP) in the evaluable population (n=65) 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.

• Authors: A Roy, D Cunningham, R Hawkins, H Sörbye, A Adenis, J-R Barcelo, G Lopez-Vivanco, G Adler, J-L Canon, F Lofts, C Castanon, E Fonseca, O Rixe, J Aparicio, J Cassinello, M Nicolson, M Mousseau, A Schalhorn, L D'Hondt, J Kerger, D K Hossfeld, C Garcia Giron, R Rodriguez, P Schoffski, J-L Misset
• Journal: British journal of cancer (Br J Cancer) Vol. 107 Issue 3 Pg. 435-41 (Jul 24 2012) ISSN: 1532-1827 [Electronic] England
• PMID: 22767144 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2012 Cancer Research UK

Chemical References

• Taxoids
• Docetaxel
• Irinotecan
• Fluorouracil
• Camptothecin

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Camptothecin (administration & dosage, analogs & derivatives)
• Disease Progression
• Docetaxel
• Esophageal Neoplasms (drug therapy)
• Female
• Fluorouracil (administration & dosage)
• Humans
• Irinotecan
• Male
• Middle Aged
• Stomach Neoplasms (drug therapy)
• Taxoids (administration & dosage)