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Clinical Trial
. 2012 Jul 24;107(3):435-41.
doi: 10.1038/bjc.2012.286. Epub 2012 Jul 5.

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

A Roy  1 , 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
Affiliations
Clinical Trial

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

A Roy et al. Br J Cancer. .

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.

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Figures

Figure 1
Figure 1
Consort diagram. Total analysed for primary endpoint=85 (ITT), 65 (PPP). Total analysed for safety=85. Abbreviations: DF=docetaxel plus 5-fluorouracil; DI=docetaxel plus irinotecan; ITT=intention-to-treat; PPP=per protocol population; LFT=liver function test.
Figure 2
Figure 2
Kaplan–Meier curve of overall survival in the ITT population. Abbreviations: DF=docetaxel plus 5-fluorouracil; DI=docetaxel plus irinotecan; ITT=intention-to-treat population.
See this image and copyright information in PMC

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