Docetaxel, oxaliplatin and capecitabine (TEX regimen) in patients with metastatic gastric or gastro-esophageal cancer: results of a multicenter phase I/II study
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Docetaxel, oxaliplatin and capecitabine (TEX regimen) in patients with metastatic gastric or gastro-esophageal cancer: results of a multicenter phase I/II study. / 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.
in: ACTA ONCOL, Jahrgang 53, Nr. 3, 03.2014, S. 392-8.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - Docetaxel, oxaliplatin and capecitabine (TEX regimen) in patients with metastatic gastric or gastro-esophageal cancer: results of a multicenter phase I/II study
AU - Stein, Alexander
AU - Arnold, Dirk
AU - Thuss-Patience, Peter C
AU - Moehler, Markus
AU - Grothe, Wilfried
AU - Seufferlein, Thomas
AU - Reinacher-Schick, Anke
AU - Geissler, Michael
AU - Hofheinz, Ralf-Dieter
AU - Schmoll, Hans-Joachim
PY - 2014/3
Y1 - 2014/3
N2 - 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.
AB - 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.
KW - Adult
KW - Aged
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Deoxycytidine
KW - Disease-Free Survival
KW - Esophageal Neoplasms
KW - Female
KW - Fluorouracil
KW - Humans
KW - Male
KW - Middle Aged
KW - Organoplatinum Compounds
KW - Stomach Neoplasms
KW - Taxoids
KW - Treatment Outcome
U2 - 10.3109/0284186X.2013.833346
DO - 10.3109/0284186X.2013.833346
M3 - SCORING: Journal article
C2 - 24024696
VL - 53
SP - 392
EP - 398
JO - ACTA ONCOL
JF - ACTA ONCOL
SN - 0284-186X
IS - 3
ER -