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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

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/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.

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: Gastric cancer, Trastuzumab, Capecitabine, Oxaliplatin, HER2.

Footnotes

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.