Capecitabine combined with gemcitabine (CapGem) as first-line treatment in patients with advanced/metastatic biliary tract carcinoma

Jae Yong Cho, Yong Han Paik, Yoon Soo Chang, Se Joon Lee, DongKi Lee, Si Young Song, Jae Bock Chung, Mi Suk Park, Jeong Sik Yu, Dong Sup Yoon

Research output: Contribution to journalArticle

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Abstract

BACKGROUND. Biliary tract carcinoma is an aggressive cancer, with median survival rarely exceeding 6 months. There is currently no established palliative standard of care. A Phase II trial was conducted to study a combination of oral capecitabine and gemcitabine (CapGem) as first-line therapy in patients with advanced and/or metastatic biliary carcinoma. METHODS. Patients with unresectable or metastatic intrahepatic or extrahepatic biliary duct carcinoma and gallbladder carcinoma were enrolled. Eligible patients had histologically or cytologically confirmed, measurable adenocarcinoma and had not received prior therapy with capecitabine or gemcitabine. Treatment consisted of intravenous (i.v.) gemcitabine (1000 mg/m2 on Days 1 and 8) plus oral capecitabine (650 mg/m2 twice daily on Days 1-14) every 3 weeks for up to 6 cycles. Tumor response, survival, and safety were determined. RESULTS. A total of 44 patients were evaluable. Primary tumor sites were: intrahepatic (n = 14) and extrahepatic biliary duct (n = 16); gallbladder (n = 7); and ampulla (n = 7). Fourteen (32%) patients had a partial response and 15 (34%) patients had stable disease. Median time to disease progression and overall survival were 6.0 (range, 3.8-8.1) and 14 (range, 11.4-16.6) months, respectively. The 1-year survival rate was 58%. No Grade 4 adverse events were seen. Transient Grade 3 neutropenia/thrombocytopenia and manageable (almost invariably Grade 2) nausea, diarrhea, and hand-foot syndrome were the most common adverse events. CONCLUSIONS. CapGem is an active and well tolerated first-line combination chemotherapy regimen for patients with advanced/metastatic biliary tract carcinoma that offers a convenient home-based therapy.

Original languageEnglish
Pages (from-to)2753-2758
Number of pages6
JournalCancer
Volume104
Issue number12
DOIs
Publication statusPublished - 2005 Dec 15

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gemcitabine
Biliary Tract
Carcinoma
Gallbladder
Therapeutics
Survival
Hand-Foot Syndrome
Neoplasms
Standard of Care
Capecitabine
Combination Drug Therapy
Neutropenia
Palliative Care
Nausea
Disease Progression
Diarrhea
Adenocarcinoma
Survival Rate

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Cho, Jae Yong ; Paik, Yong Han ; Chang, Yoon Soo ; Lee, Se Joon ; Lee, DongKi ; Song, Si Young ; Chung, Jae Bock ; Park, Mi Suk ; Yu, Jeong Sik ; Yoon, Dong Sup. / Capecitabine combined with gemcitabine (CapGem) as first-line treatment in patients with advanced/metastatic biliary tract carcinoma. In: Cancer. 2005 ; Vol. 104, No. 12. pp. 2753-2758.
@article{ea54ddf15d9f427c8df4d8c1f798a340,
title = "Capecitabine combined with gemcitabine (CapGem) as first-line treatment in patients with advanced/metastatic biliary tract carcinoma",
abstract = "BACKGROUND. Biliary tract carcinoma is an aggressive cancer, with median survival rarely exceeding 6 months. There is currently no established palliative standard of care. A Phase II trial was conducted to study a combination of oral capecitabine and gemcitabine (CapGem) as first-line therapy in patients with advanced and/or metastatic biliary carcinoma. METHODS. Patients with unresectable or metastatic intrahepatic or extrahepatic biliary duct carcinoma and gallbladder carcinoma were enrolled. Eligible patients had histologically or cytologically confirmed, measurable adenocarcinoma and had not received prior therapy with capecitabine or gemcitabine. Treatment consisted of intravenous (i.v.) gemcitabine (1000 mg/m2 on Days 1 and 8) plus oral capecitabine (650 mg/m2 twice daily on Days 1-14) every 3 weeks for up to 6 cycles. Tumor response, survival, and safety were determined. RESULTS. A total of 44 patients were evaluable. Primary tumor sites were: intrahepatic (n = 14) and extrahepatic biliary duct (n = 16); gallbladder (n = 7); and ampulla (n = 7). Fourteen (32{\%}) patients had a partial response and 15 (34{\%}) patients had stable disease. Median time to disease progression and overall survival were 6.0 (range, 3.8-8.1) and 14 (range, 11.4-16.6) months, respectively. The 1-year survival rate was 58{\%}. No Grade 4 adverse events were seen. Transient Grade 3 neutropenia/thrombocytopenia and manageable (almost invariably Grade 2) nausea, diarrhea, and hand-foot syndrome were the most common adverse events. CONCLUSIONS. CapGem is an active and well tolerated first-line combination chemotherapy regimen for patients with advanced/metastatic biliary tract carcinoma that offers a convenient home-based therapy.",
author = "Cho, {Jae Yong} and Paik, {Yong Han} and Chang, {Yoon Soo} and Lee, {Se Joon} and DongKi Lee and Song, {Si Young} and Chung, {Jae Bock} and Park, {Mi Suk} and Yu, {Jeong Sik} and Yoon, {Dong Sup}",
year = "2005",
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Cho, JY, Paik, YH, Chang, YS, Lee, SJ, Lee, D, Song, SY, Chung, JB, Park, MS, Yu, JS & Yoon, DS 2005, 'Capecitabine combined with gemcitabine (CapGem) as first-line treatment in patients with advanced/metastatic biliary tract carcinoma', Cancer, vol. 104, no. 12, pp. 2753-2758. https://doi.org/10.1002/cncr.21591

Capecitabine combined with gemcitabine (CapGem) as first-line treatment in patients with advanced/metastatic biliary tract carcinoma. / Cho, Jae Yong; Paik, Yong Han; Chang, Yoon Soo; Lee, Se Joon; Lee, DongKi; Song, Si Young; Chung, Jae Bock; Park, Mi Suk; Yu, Jeong Sik; Yoon, Dong Sup.

In: Cancer, Vol. 104, No. 12, 15.12.2005, p. 2753-2758.

Research output: Contribution to journalArticle

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T1 - Capecitabine combined with gemcitabine (CapGem) as first-line treatment in patients with advanced/metastatic biliary tract carcinoma

AU - Cho, Jae Yong

AU - Paik, Yong Han

AU - Chang, Yoon Soo

AU - Lee, Se Joon

AU - Lee, DongKi

AU - Song, Si Young

AU - Chung, Jae Bock

AU - Park, Mi Suk

AU - Yu, Jeong Sik

AU - Yoon, Dong Sup

PY - 2005/12/15

Y1 - 2005/12/15

N2 - BACKGROUND. Biliary tract carcinoma is an aggressive cancer, with median survival rarely exceeding 6 months. There is currently no established palliative standard of care. A Phase II trial was conducted to study a combination of oral capecitabine and gemcitabine (CapGem) as first-line therapy in patients with advanced and/or metastatic biliary carcinoma. METHODS. Patients with unresectable or metastatic intrahepatic or extrahepatic biliary duct carcinoma and gallbladder carcinoma were enrolled. Eligible patients had histologically or cytologically confirmed, measurable adenocarcinoma and had not received prior therapy with capecitabine or gemcitabine. Treatment consisted of intravenous (i.v.) gemcitabine (1000 mg/m2 on Days 1 and 8) plus oral capecitabine (650 mg/m2 twice daily on Days 1-14) every 3 weeks for up to 6 cycles. Tumor response, survival, and safety were determined. RESULTS. A total of 44 patients were evaluable. Primary tumor sites were: intrahepatic (n = 14) and extrahepatic biliary duct (n = 16); gallbladder (n = 7); and ampulla (n = 7). Fourteen (32%) patients had a partial response and 15 (34%) patients had stable disease. Median time to disease progression and overall survival were 6.0 (range, 3.8-8.1) and 14 (range, 11.4-16.6) months, respectively. The 1-year survival rate was 58%. No Grade 4 adverse events were seen. Transient Grade 3 neutropenia/thrombocytopenia and manageable (almost invariably Grade 2) nausea, diarrhea, and hand-foot syndrome were the most common adverse events. CONCLUSIONS. CapGem is an active and well tolerated first-line combination chemotherapy regimen for patients with advanced/metastatic biliary tract carcinoma that offers a convenient home-based therapy.

AB - BACKGROUND. Biliary tract carcinoma is an aggressive cancer, with median survival rarely exceeding 6 months. There is currently no established palliative standard of care. A Phase II trial was conducted to study a combination of oral capecitabine and gemcitabine (CapGem) as first-line therapy in patients with advanced and/or metastatic biliary carcinoma. METHODS. Patients with unresectable or metastatic intrahepatic or extrahepatic biliary duct carcinoma and gallbladder carcinoma were enrolled. Eligible patients had histologically or cytologically confirmed, measurable adenocarcinoma and had not received prior therapy with capecitabine or gemcitabine. Treatment consisted of intravenous (i.v.) gemcitabine (1000 mg/m2 on Days 1 and 8) plus oral capecitabine (650 mg/m2 twice daily on Days 1-14) every 3 weeks for up to 6 cycles. Tumor response, survival, and safety were determined. RESULTS. A total of 44 patients were evaluable. Primary tumor sites were: intrahepatic (n = 14) and extrahepatic biliary duct (n = 16); gallbladder (n = 7); and ampulla (n = 7). Fourteen (32%) patients had a partial response and 15 (34%) patients had stable disease. Median time to disease progression and overall survival were 6.0 (range, 3.8-8.1) and 14 (range, 11.4-16.6) months, respectively. The 1-year survival rate was 58%. No Grade 4 adverse events were seen. Transient Grade 3 neutropenia/thrombocytopenia and manageable (almost invariably Grade 2) nausea, diarrhea, and hand-foot syndrome were the most common adverse events. CONCLUSIONS. CapGem is an active and well tolerated first-line combination chemotherapy regimen for patients with advanced/metastatic biliary tract carcinoma that offers a convenient home-based therapy.

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