Multicenter phase II study of oral capecitabine plus irinotecan as first-line chemotherapy in advanced colorectal cancer: a Korean Cancer Study Group trial |
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Authors: | Kim Tae Won,Kang Won Ki,Chang Heung Moon,Park Joon Oh,Ryoo Baek Yeol,Ahn Jin Seok,Zang Dae Young,Lee Kyung Hee,Kang Yoon Koo,Kim Sung Rok,Kim Hoon-Kyo Korean Cancer Study Group |
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Affiliation: | a Section of Oncology, Department of Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Koreab Division of Hematology-Oncology, Department of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Koreac Division of Hematology and Oncology, Department of Internal Medicine, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Science, Seoul, Koread Department of Internal Medicine, Hallym University College of Medicine, Hallym Sacred Heart Hospital, Anyang, Koreae Division of Hematology-Oncology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Koreaf Department of Internal Medicine, Inje University College of Medicine, Sanggye Paik Hospital, Seoul, Koreag Department of Internal Medicine, The Catholic University College of Medicine, St Vincent's Hospital, Suwon, Korea |
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Abstract: | A phase II study was conducted to assess the efficacy and tolerability of capecitabine in combination with irinotecan (CAPIRI) in advanced colorectal cancer. Forty-seven patients with previously untreated metastatic or unresectable colorectal adenocarcinoma received capecitabine 1000 mg/m2 twice daily on days 2-15 and intravenous irinotecan 100 mg/m2 on days 1 and 8, every 21 days. A total of 268 cycles of chemotherapy (median 6: range 1-11) were administered. According to an intent-to-treat analysis, the overall response rate was 49% (95% CI, 35-63%). Median time to progression and overall survival were 7.5 months (95% CI, 4.8-10.2) and 19.5 months (95% CI, 15.7-23.8), respectively. The most common grade 3/4 adverse events were diarrhea (24%) and neutropenia (11%). There were no treatment-related deaths. These results indicate that CAPIRI has comparable activity and tolerability to FOLFIRI as first-line treatment for advanced colorectal cancer. |
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