Efficacy and safety of trastuzumab in combination with oxaliplatin and fluorouracil-based chemotherapy for patients with HER2-positive metastatic gastric and gastro-oesophageal junction adenocarcinoma patients: a retrospective study.

Abstract

BACKGROUND:

Trastuzumab with 5-fluorouracil (5-FU) and cisplatin offers prolonged survival in patients with HER2-overexpressing advanced gastric cancer (AGC) and advanced gastro-oesophageal junction cancer (AGOJ). Oxaliplatin in combination with intravenous 5-FU plus leucovorin (LV; modified [m]FOLFOX6) or capecitabine (XELOX) improves tolerability compared with 5-FU/cisplatin regimen. There are few data available on the efficacy and safety of trastuzumab-oxaliplatin-based chemotherapy in previously untreated HER2-positive AGC and AGOJ patients.

METHODS:

Clinical data were retrospectively analysed in patients receiving trastuzumab plus mFOLFOX6 or XELOX as first-line therapy between July 2009 and December 2012. Eligible patients had histologically proven AGC or AGOJ, HER2 overexpression, and no prior chemotherapy for metastatic disease.

RESULTS:

Thirty-four patients met the eligibility criteria. Median age was 63 years, 79% of patients had ECOG PS score of 0-1, and all had metastatic disease. Median duration of treatment was 7.5 months. Overall response rate was 41% (95% CI: 25-56). Median progression-free survival and overall survival were 9.0 months (95% CI: 5.6-12) and 17.3 months (95% CI: 13.5-32.3), respectively. Tolerability was acceptable. The most frequent grade 3-4 toxicities were neutropenia (8.8%) and neuropathy (17.6%).

CONCLUSION:

mFOLFOX6-trastuzumab combination is an efficient regimen with an acceptable safety profile for AGC and AGOJ patients. These results warrant further prospective study.

• Authors: Émilie Soularue, Romain Cohen, Christophe Tournigand, Aziz Zaanan, Christophe Louvet, Jean-Baptiste Bachet, Olivia Hentic, Emmanuelle Samalin, Benoist Chibaudel, Aimery de Gramont, Thierry André, for GERCOR
• Journal: Bulletin du cancer (Bull Cancer) Vol. 102 Issue 4 Pg. 324-31 (Apr 2015) ISSN: 1769-6917 [Electronic] France
• PMID: 25744576 (Publication Type: Journal Article, Multicenter Study)
• Copyright: Copyright © 2015 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

Chemical References

• Antibodies, Monoclonal, Humanized
• Organoplatinum Compounds
• Oxaloacetates
• Deoxycytidine
• Capecitabine
• ERBB2 protein, human
• Receptor, ErbB-2
• Trastuzumab
• Leucovorin
• Fluorouracil

Topics

• Adenocarcinoma (drug therapy, metabolism, mortality, pathology)
• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal, Humanized (administration & dosage, adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Capecitabine
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Esophageal Neoplasms (chemistry, drug therapy, metabolism, mortality)
• Esophagogastric Junction
• Female
• Fluorouracil (administration & dosage, adverse effects, analogs & derivatives)
• Humans
• Leucovorin (adverse effects)
• Male
• Middle Aged
• Organoplatinum Compounds (adverse effects)
• Oxaloacetates
• Receptor, ErbB-2 (metabolism)
• Retrospective Studies
• Stomach Neoplasms (chemistry, drug therapy, metabolism, mortality)
• Trastuzumab