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  • Title: Docetaxel, oxaliplatin and capecitabine (TEX regimen) in patients with metastatic gastric or gastro-esophageal cancer: results of a multicenter phase I/II study.
    Author: Stein A, Arnold D, Thuss-Patience PC, Moehler M, Grothe W, Seufferlein T, Reinacher-Schick A, Geissler M, Hofheinz RD, Schmoll HJ.
    Journal: Acta Oncol; 2014 Mar; 53(3):392-8. PubMed ID: 24024696.
    Abstract:
    UNLABELLED: 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/m(2) and E 70 mg/m(2) on days (d) 1, 8 and X 800 mg/m(2) 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.
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