Docetaxel, oxaliplatin and capecitabine (TEX regimen) in patients with metastatic gastric or gastro-esophageal cancer: Results of a multicenter phase I/II study. (March 2014)

• Record Type: Journal Article
• Authors: Stein, Alexander; Arnold, Dirk; Thuss-Patience, Peter C.; Moehler, Markus; Grothe, Wilfried; Seufferlein, Thomas; Reinacher-Schick, Anke; Geissler, Michael; Hofheinz, Ralf-Dieter; Schmoll, Hans-Joachim
• Is Part Of: Acta oncologica. Volume 53:Number 3(2014)
• Page Start: 392
• Page End: 398
• Publication Date: 2014-03
• Subjects: Oncology -- Periodicals; Cancer -- Treatment -- Periodicals; 616.992
• DOI: 10.3109/0284186X.2013.833346
• Languages: English
• ISSNs: 0284-186X

Abstract

<abstract> <title>Abstract</title> <p>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. <italic>Methods.</italic> 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. <italic>Results.</italic> 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. <italic>Conclusion</italic>. 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.</p> </abstract>