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Abstract
Three drug taxane-based regimens have shown activity in patients with metastatic or locally advanced gastric or gastro-esophageal cancer (GC/GEC). Limited tolerability of these regimens warrants treatment modification, particularly in regard of the proven equivalence of oxaliplatin and cisplatin as well as capecitabine and 5FU. Thus, a regimen with docetaxel (T), oxaliplatin (E) and capecitabine (X) was established and evaluated. Methods. Patients with metastatic or locally advanced GC/GEC, adequate organ function, ECOG PS 0–2 were enrolled. TEX regimen was administered as defined by the phase I trial with T 35 mg/m2 and E 70 mg/m2 on days (d) 1, 8 and X 800 mg/m2 bid on d 1–14 every 22 days. Primary endpoint was progression free survival (PFS) rate after 6 months. Results. Altogether 70 patients (15 phase I; 55 phase II) were eligible for analysis. Results of the phase II part were as follows: most common grade toxicities diarrhea (30%), nausea/vomiting and infections, PFS rate after 6 months 56.3%, response rate 43%, median PFS 6.9 and overall survival 13 months, respectively. Conclusion. The TEX regimen show similar efficacy compared to other infusional 5FU-based taxane and platinum containing triplets, but the reduced tolerability, in particular grade 3 diarrhea, limits the feasibility.
Acknowledgments
We want to thank all patients who participated in this trial, all institutions who included patients, and all the staff engaged in this study, especially the study team at the Koordinationszentrum Klinische Studien Halle.
Declaration of interest: The trial was supported by Roche and Sanofi-Aventis. The trial was supported by Roche and Sanofi -Aventis. AS, HJS and PCT-P received honoraria and research grants from Roche and Sanofi Aventis. MM received honoraria from Roche and Sanofi Aventis. RDH, DA received honoraria from Roche and Sanofi Aventis and research grants from Roche. The other authors have declared no conflicts of interest.