You are here
Multicenter phase II study of trastuzumab in combination with capecitabine and oxaliplatin for advanced gastric cancer
European Journal of Cancer, Volume 51, Issue 4, March 2015, Pages 482 - 488
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.
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/m2 for first cycle and 6 mg/m2 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.
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.
Combination of trastuzumab and XELOX is well tolerated and highly effective in patients with HER2-positive AGC.
Keywords: Gastric cancer, Trastuzumab, Capecitabine, Oxaliplatin, HER2.
a Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
b Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
c Department of Oncology/Hematology, Kyungpook National University Medical Center, Daegu, South Korea
d Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, South Korea
e Department of Internal Medicine, Chonnam National University Medical School, Gwangju, South Korea
f Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, South Korea
g Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu, South Korea
h Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea
⁎ Corresponding author at: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 138-736, South Korea. Tel.: +82 2 3010 3230; fax: +82 2 3010 8772.
1 M.-H. Ryu and C. Yoo contributed equally and should be considered co-first authors.
© 2015 Elsevier Ltd, All rights reserved.