Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer: A Korean Cancer Study Group phase II trial

Joung Soon Jang, Ho Yeong Lim, In Gyu Hwang, Hong Suk Song, Naechoon Yoo, Soyoung Yoon, Yeul Hong Kim, Eunsik Park, Jae Ho Byun, Myung Ah Lee, Suk Joong Oh, Kyung Hee Lee, Bong Seog Kim, Sang Cheul Oh, Sam Yong Kim, Sang Jae Lee

Research output: Contribution to journalArticle

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Abstract

Purpose: Chemotherapy represents a palliative treatment, with poor response rates and a median survival of less than 6 months in patients with biliary tract cancers (BTCs). The aim of this study was to evaluate the efficacy and safety of the combination chemotherapy with gemcitabine and oxaliplatin (GEMOX) in patients with BTCs including gall bladder cancer. Methods: We carried out a nationwide multicenter phase II study evaluated the efficacy and safety of GEMOX as first-line therapy in patients with advanced BTCs. Eligible patients with previously untreated locally advanced or metastatic BTCs received gemcitabine 1,000 mg/m2 (day 1 and 8) and oxaliplatin 100 mg/m2 (day 1), every 3 weeks. Results: Fifty-three patients were evaluated, 60% had cholangiocarcinoma and the remaining 40% gall bladder cancer; the objective response rate was 18.9% (10/53 patients including 1 Complete response) [14.9%; 95% confidence interval (CI), 7.4-25.7%] in the treated population. Stable disease were observed in 27/53 (50.9%) patients, disease control rate was achieved in 69.8% of all patients. Median progression-free survival was 4.8 months (3.1-6.5, 95% CI) and median overall survival was 8.3 months (5.8-10.8, 95% CI). Grade 3/4 toxicities included neutropenia (33.9% of patients) and thrombocytopenia (7.6%). Conclusions: The GEMOX regimen demonstrated a modest antitumor activity and is well tolerated in patients with advanced BTCs.

Original languageEnglish
Pages (from-to)641-647
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Volume65
Issue number4
DOIs
Publication statusPublished - 2010 Mar 1

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oxaliplatin
gemcitabine
Biliary Tract Neoplasms
Gallbladder Neoplasms
Chemotherapy
Disease control
Neoplasms
Toxicity
Confidence Intervals
Safety

Keywords

  • Biliary tract cancers
  • Chemotherapy
  • Gemcitabine
  • Oxaliplatin

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pharmacology
  • Pharmacology (medical)
  • Toxicology

Cite this

Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer : A Korean Cancer Study Group phase II trial. / Jang, Joung Soon; Lim, Ho Yeong; Hwang, In Gyu; Song, Hong Suk; Yoo, Naechoon; Yoon, Soyoung; Kim, Yeul Hong; Park, Eunsik; Byun, Jae Ho; Lee, Myung Ah; Oh, Suk Joong; Lee, Kyung Hee; Kim, Bong Seog; Oh, Sang Cheul; Kim, Sam Yong; Lee, Sang Jae.

In: Cancer Chemotherapy and Pharmacology, Vol. 65, No. 4, 01.03.2010, p. 641-647.

Research output: Contribution to journalArticle

Jang, JS, Lim, HY, Hwang, IG, Song, HS, Yoo, N, Yoon, S, Kim, YH, Park, E, Byun, JH, Lee, MA, Oh, SJ, Lee, KH, Kim, BS, Oh, SC, Kim, SY & Lee, SJ 2010, 'Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer: A Korean Cancer Study Group phase II trial', Cancer Chemotherapy and Pharmacology, vol. 65, no. 4, pp. 641-647. https://doi.org/10.1007/s00280-009-1069-7
Jang, Joung Soon ; Lim, Ho Yeong ; Hwang, In Gyu ; Song, Hong Suk ; Yoo, Naechoon ; Yoon, Soyoung ; Kim, Yeul Hong ; Park, Eunsik ; Byun, Jae Ho ; Lee, Myung Ah ; Oh, Suk Joong ; Lee, Kyung Hee ; Kim, Bong Seog ; Oh, Sang Cheul ; Kim, Sam Yong ; Lee, Sang Jae. / Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer : A Korean Cancer Study Group phase II trial. In: Cancer Chemotherapy and Pharmacology. 2010 ; Vol. 65, No. 4. pp. 641-647.
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abstract = "Purpose: Chemotherapy represents a palliative treatment, with poor response rates and a median survival of less than 6 months in patients with biliary tract cancers (BTCs). The aim of this study was to evaluate the efficacy and safety of the combination chemotherapy with gemcitabine and oxaliplatin (GEMOX) in patients with BTCs including gall bladder cancer. Methods: We carried out a nationwide multicenter phase II study evaluated the efficacy and safety of GEMOX as first-line therapy in patients with advanced BTCs. Eligible patients with previously untreated locally advanced or metastatic BTCs received gemcitabine 1,000 mg/m2 (day 1 and 8) and oxaliplatin 100 mg/m2 (day 1), every 3 weeks. Results: Fifty-three patients were evaluated, 60{\%} had cholangiocarcinoma and the remaining 40{\%} gall bladder cancer; the objective response rate was 18.9{\%} (10/53 patients including 1 Complete response) [14.9{\%}; 95{\%} confidence interval (CI), 7.4-25.7{\%}] in the treated population. Stable disease were observed in 27/53 (50.9{\%}) patients, disease control rate was achieved in 69.8{\%} of all patients. Median progression-free survival was 4.8 months (3.1-6.5, 95{\%} CI) and median overall survival was 8.3 months (5.8-10.8, 95{\%} CI). Grade 3/4 toxicities included neutropenia (33.9{\%} of patients) and thrombocytopenia (7.6{\%}). Conclusions: The GEMOX regimen demonstrated a modest antitumor activity and is well tolerated in patients with advanced BTCs.",
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T1 - Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer

T2 - A Korean Cancer Study Group phase II trial

AU - Jang, Joung Soon

AU - Lim, Ho Yeong

AU - Hwang, In Gyu

AU - Song, Hong Suk

AU - Yoo, Naechoon

AU - Yoon, Soyoung

AU - Kim, Yeul Hong

AU - Park, Eunsik

AU - Byun, Jae Ho

AU - Lee, Myung Ah

AU - Oh, Suk Joong

AU - Lee, Kyung Hee

AU - Kim, Bong Seog

AU - Oh, Sang Cheul

AU - Kim, Sam Yong

AU - Lee, Sang Jae

PY - 2010/3/1

Y1 - 2010/3/1

N2 - Purpose: Chemotherapy represents a palliative treatment, with poor response rates and a median survival of less than 6 months in patients with biliary tract cancers (BTCs). The aim of this study was to evaluate the efficacy and safety of the combination chemotherapy with gemcitabine and oxaliplatin (GEMOX) in patients with BTCs including gall bladder cancer. Methods: We carried out a nationwide multicenter phase II study evaluated the efficacy and safety of GEMOX as first-line therapy in patients with advanced BTCs. Eligible patients with previously untreated locally advanced or metastatic BTCs received gemcitabine 1,000 mg/m2 (day 1 and 8) and oxaliplatin 100 mg/m2 (day 1), every 3 weeks. Results: Fifty-three patients were evaluated, 60% had cholangiocarcinoma and the remaining 40% gall bladder cancer; the objective response rate was 18.9% (10/53 patients including 1 Complete response) [14.9%; 95% confidence interval (CI), 7.4-25.7%] in the treated population. Stable disease were observed in 27/53 (50.9%) patients, disease control rate was achieved in 69.8% of all patients. Median progression-free survival was 4.8 months (3.1-6.5, 95% CI) and median overall survival was 8.3 months (5.8-10.8, 95% CI). Grade 3/4 toxicities included neutropenia (33.9% of patients) and thrombocytopenia (7.6%). Conclusions: The GEMOX regimen demonstrated a modest antitumor activity and is well tolerated in patients with advanced BTCs.

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KW - Biliary tract cancers

KW - Chemotherapy

KW - Gemcitabine

KW - Oxaliplatin

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