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Phase II study of irinotecan in combination with capecitabine as a first-line chemotherapy in Asian patients with inoperable hepatocellular carcinoma

Authors
Mok, TonyYang, Tsai-ShenChao, YeeWang, Cheng-HsuLiu, Mei-ChingKang, Yoon KooKang, Won KiKim, Jun SukWang, YajieLeung, Thomas
Issue Date
Jun-2009
Publisher
WILEY-BLACKWELL
Keywords
capecitabine; hepatocellular carcinoma; irinotecan; phase II trial
Citation
ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, v.5, no.2, pp.95 - 100
Indexed
SCIE
SCOPUS
Journal Title
ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY
Volume
5
Number
2
Start Page
95
End Page
100
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/119931
DOI
10.1111/j.1743-7563.2009.01198.x
ISSN
1743-7555
Abstract
Hepatocellular carcinoma (HCC) is one of the most commonly fatal malignancies in Asia but treatment options are limited. This multinational, nonrandomized phase II trial using the combination of irinotecan (Campto or CPT-11) and capecitabine (Xeloda) was conducted to determine efficacy and safety of this combination in Asian patients with advanced inoperable HCC. The starting dose was irinotecan 200 mg/m(2) every 3 weeks followed by capecitabine 1000 mg/m(2) orally twice daily for 14 days followed by a 7-day rest. The primary endpoint was tumor response rate, based on response evaluation criteria in solid tumors criteria. Secondary objectives included the safety and tolerability of the treatment combination, time to progression, duration of overall response, tumor growth control rate (complete response, partial response plus stable disease) and overall survival. Of the 63 recruited patients, 47 were evaluable. Of these, three (6.4%) achieved a partial response (lasting 2.2, 3.4 and 8.0 months, respectively). The median overall survival was 4.5 months. Grade 4 diarrhea was reported in four patients. Hematologic grade 4 laboratory abnormalities observed in patients while on study treatment included neutropenia (5.2%) and anemia (1.7%). Seven patients (12.1%) had grade 4 elevations in their total bilirubin. Both irinotecan and capecitabine were generally well tolerated, with manageable and reversible toxicities. Combination therapy with irinotecan and capecitabine has limited efficacy in the treatment of advanced-stage HCC. Further investigation of this combination is not warranted.
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