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

Tony S.K. Mok, Tsai Shen Yang, Yee Chao, Cheng Hsu Wang, Mei Ching Liu, Yoon Koo Kang, Won Ki Kang, Jun Suk Kim, Yajie Wang, Thomas Leung

Research output: Contribution to journalArticle

Abstract

Aim: Hepatocellular carcinoma (HCC) is one of the most commonly fatal malignancies in Asia but treatment options are limited. Methods: 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/m2 every 3 weeks followed by capecitabine 1000 mg/m2 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. Results: 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. Conclusion: Combination therapy with irinotecan and capecitabine has limited efficacy in the treatment of advanced-stage HCC. Further investigation of this combination is not warranted.

Original languageEnglish
Pages (from-to)95-100
Number of pages6
JournalAsia-Pacific Journal of Clinical Oncology
Volume5
Issue number2
DOIs
Publication statusPublished - 2009 Jun 16

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irinotecan
Hepatocellular Carcinoma
Drug Therapy
Safety
Neoplasms
Survival
Therapeutics
Neutropenia
Bilirubin
Anemia
Diarrhea
Capecitabine

Keywords

  • Capecitabine
  • Hepatocellular carcinoma
  • Irinotecan
  • Phase II trial

ASJC Scopus subject areas

  • Oncology

Cite this

Phase II study of irinotecan in combination with capecitabine as a first-line chemotherapy in Asian patients with inoperable hepatocellular carcinoma. / Mok, Tony S.K.; Yang, Tsai Shen; Chao, Yee; Wang, Cheng Hsu; Liu, Mei Ching; Kang, Yoon Koo; Kang, Won Ki; Kim, Jun Suk; Wang, Yajie; Leung, Thomas.

In: Asia-Pacific Journal of Clinical Oncology, Vol. 5, No. 2, 16.06.2009, p. 95-100.

Research output: Contribution to journalArticle

Mok, Tony S.K. ; Yang, Tsai Shen ; Chao, Yee ; Wang, Cheng Hsu ; Liu, Mei Ching ; Kang, Yoon Koo ; Kang, Won Ki ; Kim, Jun Suk ; Wang, Yajie ; Leung, Thomas. / Phase II study of irinotecan in combination with capecitabine as a first-line chemotherapy in Asian patients with inoperable hepatocellular carcinoma. In: Asia-Pacific Journal of Clinical Oncology. 2009 ; Vol. 5, No. 2. pp. 95-100.
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abstract = "Aim: Hepatocellular carcinoma (HCC) is one of the most commonly fatal malignancies in Asia but treatment options are limited. Methods: 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/m2 every 3 weeks followed by capecitabine 1000 mg/m2 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. Results: 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. Conclusion: 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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T1 - Phase II study of irinotecan in combination with capecitabine as a first-line chemotherapy in Asian patients with inoperable hepatocellular carcinoma

AU - Mok, Tony S.K.

AU - Yang, Tsai Shen

AU - Chao, Yee

AU - Wang, Cheng Hsu

AU - Liu, Mei Ching

AU - Kang, Yoon Koo

AU - Kang, Won Ki

AU - Kim, Jun Suk

AU - Wang, Yajie

AU - Leung, Thomas

PY - 2009/6/16

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N2 - Aim: Hepatocellular carcinoma (HCC) is one of the most commonly fatal malignancies in Asia but treatment options are limited. Methods: 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/m2 every 3 weeks followed by capecitabine 1000 mg/m2 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. Results: 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. Conclusion: Combination therapy with irinotecan and capecitabine has limited efficacy in the treatment of advanced-stage HCC. Further investigation of this combination is not warranted.

AB - Aim: Hepatocellular carcinoma (HCC) is one of the most commonly fatal malignancies in Asia but treatment options are limited. Methods: 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/m2 every 3 weeks followed by capecitabine 1000 mg/m2 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. Results: 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. Conclusion: Combination therapy with irinotecan and capecitabine has limited efficacy in the treatment of advanced-stage HCC. Further investigation of this combination is not warranted.

KW - Capecitabine

KW - Hepatocellular carcinoma

KW - Irinotecan

KW - Phase II trial

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