Abstract
Background
Trastuzumab has been approved for use in combination with fluoropyrimidine plus cisplatin
for the treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced
gastric cancer (AGC). Although capecitabine plus oxaliplatin (XELOX) is a standard
first-line regimen for AGC, combination trastuzumab plus XELOX has not been studied.
Methods
Patients with metastatic or unresectable HER2-positive AGC were diagnosed by either
HER2 immunohistochemistry (IHC) 3+ or IHC 2+/fluorescence in-situ hybridisation (FISH)+ received intravenous trastuzumab (8 mg/kg for first cycle and 6 mg/kg for subsequent cycles on day 1) plus oral capecitabine (1000 mg/m2 twice daily on days 1–14) and intravenous oxaliplatin (130 mg/m2 on day 1), every 3 weeks. The primary end-point was the objective response rate, and secondary end-points
included progression-free survival (PFS), overall survival (OS) and toxicity profiles.
Results
Fifty-five HER2-positive AGC patients were enrolled between August 2011 and February
2013. The median age was 57 years (range = 29–74). The confirmed objective response rate was 67% (95% confidence interval (CI) = 54–80%). After a median follow-up period of 13.8 months (range = 6.1–23.9), the median PFS and OS were 9.8 months (95% CI = 7.0–12.6) and 21.0 months (95% CI = 6.4–35.7), respectively. Frequently encountered grade 3–4 toxicities included neutropenia
(18%), anaemia (11%), and peripheral neuropathy (11%). There was a treatment-related
death caused by severe diarrhoea and complicated sepsis.
Conclusion
Combination of trastuzumab and XELOX is well tolerated and highly effective in patients
with HER2-positive AGC.
Keywords
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Article info
Publication history
Published online: February 03, 2015
Accepted:
December 29,
2014
Received in revised form:
December 10,
2014
Received:
October 1,
2014
Identification
Copyright
© 2015 Elsevier Ltd. Published by Elsevier Inc. All rights reserved.
