Min-Hee Ryu1, Changhoon Yoo1, Jong Gwang Kim2, Baek-Yeol Ryoo1, Young Soo Park3, Sook Ryun Park1, Hye-Suk Han4, Ik Joo Chung5, Eun-Kee Song6, Kyung Hee Lee7, Seok Yun Kang8, Yoon-Koo Kang9. 1. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. 2. Department of Oncology/Hematology, Kyungpook National University Medical Center, Daegu, South Korea. 3. Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. 4. Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, South Korea. 5. Department of Internal Medicine, Chonnam National University Medical School, Gwangju, South Korea. 6. Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, South Korea. 7. Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu, South Korea. 8. Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea. 9. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Electronic address: ykkang@amc.seoul.kr.
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 (8mg/m(2) for first cycle and 6mg/m(2) for subsequent cycles on day 1) plus oral capecitabine (1000mg/m(2) twice daily on days 1-14) and intravenous oxaliplatin (130mg/m(2) 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 57years (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.
BACKGROUND:Trastuzumab has been approved for use in combination with fluoropyrimidine plus cisplatin for the treatment of humanepidermal 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 (8mg/m(2) for first cycle and 6mg/m(2) for subsequent cycles on day 1) plus oral capecitabine (1000mg/m(2) twice daily on days 1-14) and intravenous oxaliplatin (130mg/m(2) 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 57years (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.
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