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Gemcitabine and oxaliplatin combination as first-line treatment for advanced pancreatic cancer: a multicenter phase II study
Authors:Kyung Hee Lee  Min Kyoung Kim  Yeol Hong Kim  Baek Yeol Ryoo  Ho Yeong Lim  Hong Suk Song  Hoon Kyo Kim  Myung Ah Lee  Seock Ah Im  Heung Moon Chang  Jae Yong Cho  Dae Young Zang  Bong Seog Kim  Jun Suk Kim
Affiliation:1. Division of Hemato-Oncology, College of Medicine, Yeungnam University, Daegu, South Korea
2. Division of Hemato-Oncology, College of Medicine, Korea University, Anam Hospital, Seoul, South Korea
3. Division of Hemato-Oncology, College of Medicine, Korea Cancer Center Hospital, Seoul, South Korea
4. Division of Hemato-Oncology, College of Medicine, Samsung Medical Center, Seoul, South Korea
5. Division of Hemato-Oncology, College of Medicine, Keimyung University, Dongsan Medical Center, Daegu, South Korea
6. Division of Hemato-Oncology, College of Medicine, Catholic University, St. Vincent Hospital, Seoul, South Korea
7. Division of Hemato-Oncology, College of Medicine, Kangnam St. Mary’s Hospital, Seoul, South Korea
8. Division of Hemato-Oncology, College of Medicine, Seoul National University Hospital, Seoul, South Korea
9. Division of Hemato-Oncology, College of Medicine, Asan Medical Center, Seoul, South Korea
10. Division of Hemato-Oncology, College of Medicine, Youngdong Severance Hospital, Seoul, South Korea
11. Division of Hemato-Oncology, College of Medicine, Hallym Sacred Heart Hospital, Seoul, South Korea
12. Division of Hemato-Oncology, College of Medicine, Seoul Veterans Hospital, Seoul, South Korea
13. Division of Hemato-Oncology, College of Medicine, Korea University, Guro Hospital, 80 Guro-Dong, Guro-Gu, Seoul, 152-703, South Korea
Abstract:Purpose  Gemcitabine is the only drug approved for single-agent therapy in advanced pancreatic carcinoma (APC). Gemcitabine-based combination chemotherapy has not yet shown promising results. Methods  This multicenter phase II study enrolled previously untreated patients with locally advanced and/or metastatic pancreatic adenocarcinoma. Patients received 1,000 mg/m2 gemcitabine, 100-min infusion, day 1 and 100 mg/m2 oxaliplatin, 2-h infusion, day 2; q2w. The primary end point was response rate (RR). Results  Thirteen study centers enrolled 48 eligible patients of which 44 were evaluable. The RR, median overall survival, and median time to progression were 18.2%, 9.4 and 5.6 months, respectively. Sixteen patients (36.4%) experienced clinical benefit. The global quality of life scores improved by 11.71. Grade 3/4 peripheral sensory neuropathy was noted (2.1%), while the most common hematologic toxicity was anemia (grade 3/4, 6.3%). Conclusions  Gemcitabine and oxaliplatin combination chemotherapy showed a promising activity in APC patients and was well tolerated.
Keywords:Advanced pancreatic cancer  Combination chemotherapy  Gemcitabine  GEMOX  Oxaliplatin
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