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

作者：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

来源：Acta Oncologica, 2014, 53(3): 392-398.

DOI：10.3109/0284186X.2013.833346

Three drug taxane-based regimens have shown activity in patients with metastatic or locally advanced gastric or gastroesophageal 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 3/4 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.

• 出版日期2014-3