Phase II trial of gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas

Jeeyun Lee, Tae You Kim, Myung Ah Lee, Myung Ju Ahn, Hoon Kyo Kim, Ho Yeong Lim, Nam Su Lee, Byung Joo Park, Jun Suk Kim

Research output: Contribution to journalArticle

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Abstract

Objectives: The aim of this phase II study was to evaluate the response rate to gemcitabine combined with cisplatin in patients with locally advanced, metastatic or recurrent biliary tract cancer who had received no prior chemotherapy. Methods: The treatment consisted of cisplatin 70 mg/m2 in intravenous infusion followed by gemcitabine 1,250 mg/m2 in 30-min intravenous infusion on days 1 and 8, repeated every 3 weeks until disease progression, unacceptable toxicity, patient's refusal or up to 8 cycles. Results: Thirty-nine patients with advanced biliary cancer were enrolled between March 2003 and August 2003. Fourteen patients (40%) had gall bladder cancer and 20 patients (57%) had cholangiocarcinoma. Thirty-two patients (91%) had metastatic disease at study entry with liver being the most commonly involved site of metastasis. About 84.5 and 94.2% of the initially planned dose were administered for gemcitabine and cisplatin, respectively. In the ITT population (n = 35), six partial responses were observed for an objective response rate of 17.1% (95% CI; 4.7-29.6%). Ten patients (28.6%) had stable disease, 16 (45.7%) progressed, and three (8.6%) were not evaluable. For the 35 patients in the ITT population, the median overall survival time was 8.6 months (95% CI; 6.1-10.4 months). The median time to disease progression was 3.2 months (95% CI; 2.3-4.9 months) and the median time to treatment failure was 3.1 months (95% CI; 1.9-4.1 months). Among the six tumor responders, the median duration of tumor response was 7.3 months (95% CI; 5.6-11.0 months). The most common grade 3/4 maximum toxicities were nausea (3.4%) and vomiting (2.7%). Conclusion: The combination chemotherapy with gemcitabine and cisplatin in this trial demonstrated moderate antitumor activity with favorable toxicity profile.

Original languageEnglish
Pages (from-to)47-52
Number of pages6
JournalCancer Chemotherapy and Pharmacology
Volume61
Issue number1
DOIs
Publication statusPublished - 2008 Jan 1

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gemcitabine
Biliary Tract
Cisplatin
Carcinoma
Toxicity
Chemotherapy
Tumors
Biliary Tract Neoplasms
Intravenous Infusions
Liver
Disease Progression
Gallbladder Neoplasms
Cholangiocarcinoma
Combination Drug Therapy
Treatment Failure
Nausea
Population
Vomiting
Neoplasms

ASJC Scopus subject areas

  • Cancer Research
  • Pharmacology
  • Oncology

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Phase II trial of gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas. / Lee, Jeeyun; Kim, Tae You; Lee, Myung Ah; Ahn, Myung Ju; Kim, Hoon Kyo; Lim, Ho Yeong; Lee, Nam Su; Park, Byung Joo; Kim, Jun Suk.

In: Cancer Chemotherapy and Pharmacology, Vol. 61, No. 1, 01.01.2008, p. 47-52.

Research output: Contribution to journalArticle

Lee, Jeeyun ; Kim, Tae You ; Lee, Myung Ah ; Ahn, Myung Ju ; Kim, Hoon Kyo ; Lim, Ho Yeong ; Lee, Nam Su ; Park, Byung Joo ; Kim, Jun Suk. / Phase II trial of gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas. In: Cancer Chemotherapy and Pharmacology. 2008 ; Vol. 61, No. 1. pp. 47-52.
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abstract = "Objectives: The aim of this phase II study was to evaluate the response rate to gemcitabine combined with cisplatin in patients with locally advanced, metastatic or recurrent biliary tract cancer who had received no prior chemotherapy. Methods: The treatment consisted of cisplatin 70 mg/m2 in intravenous infusion followed by gemcitabine 1,250 mg/m2 in 30-min intravenous infusion on days 1 and 8, repeated every 3 weeks until disease progression, unacceptable toxicity, patient's refusal or up to 8 cycles. Results: Thirty-nine patients with advanced biliary cancer were enrolled between March 2003 and August 2003. Fourteen patients (40{\%}) had gall bladder cancer and 20 patients (57{\%}) had cholangiocarcinoma. Thirty-two patients (91{\%}) had metastatic disease at study entry with liver being the most commonly involved site of metastasis. About 84.5 and 94.2{\%} of the initially planned dose were administered for gemcitabine and cisplatin, respectively. In the ITT population (n = 35), six partial responses were observed for an objective response rate of 17.1{\%} (95{\%} CI; 4.7-29.6{\%}). Ten patients (28.6{\%}) had stable disease, 16 (45.7{\%}) progressed, and three (8.6{\%}) were not evaluable. For the 35 patients in the ITT population, the median overall survival time was 8.6 months (95{\%} CI; 6.1-10.4 months). The median time to disease progression was 3.2 months (95{\%} CI; 2.3-4.9 months) and the median time to treatment failure was 3.1 months (95{\%} CI; 1.9-4.1 months). Among the six tumor responders, the median duration of tumor response was 7.3 months (95{\%} CI; 5.6-11.0 months). The most common grade 3/4 maximum toxicities were nausea (3.4{\%}) and vomiting (2.7{\%}). Conclusion: The combination chemotherapy with gemcitabine and cisplatin in this trial demonstrated moderate antitumor activity with favorable toxicity profile.",
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AU - Kim, Tae You

AU - Lee, Myung Ah

AU - Ahn, Myung Ju

AU - Kim, Hoon Kyo

AU - Lim, Ho Yeong

AU - Lee, Nam Su

AU - Park, Byung Joo

AU - Kim, Jun Suk

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AB - Objectives: The aim of this phase II study was to evaluate the response rate to gemcitabine combined with cisplatin in patients with locally advanced, metastatic or recurrent biliary tract cancer who had received no prior chemotherapy. Methods: The treatment consisted of cisplatin 70 mg/m2 in intravenous infusion followed by gemcitabine 1,250 mg/m2 in 30-min intravenous infusion on days 1 and 8, repeated every 3 weeks until disease progression, unacceptable toxicity, patient's refusal or up to 8 cycles. Results: Thirty-nine patients with advanced biliary cancer were enrolled between March 2003 and August 2003. Fourteen patients (40%) had gall bladder cancer and 20 patients (57%) had cholangiocarcinoma. Thirty-two patients (91%) had metastatic disease at study entry with liver being the most commonly involved site of metastasis. About 84.5 and 94.2% of the initially planned dose were administered for gemcitabine and cisplatin, respectively. In the ITT population (n = 35), six partial responses were observed for an objective response rate of 17.1% (95% CI; 4.7-29.6%). Ten patients (28.6%) had stable disease, 16 (45.7%) progressed, and three (8.6%) were not evaluable. For the 35 patients in the ITT population, the median overall survival time was 8.6 months (95% CI; 6.1-10.4 months). The median time to disease progression was 3.2 months (95% CI; 2.3-4.9 months) and the median time to treatment failure was 3.1 months (95% CI; 1.9-4.1 months). Among the six tumor responders, the median duration of tumor response was 7.3 months (95% CI; 5.6-11.0 months). The most common grade 3/4 maximum toxicities were nausea (3.4%) and vomiting (2.7%). Conclusion: The combination chemotherapy with gemcitabine and cisplatin in this trial demonstrated moderate antitumor activity with favorable toxicity profile.

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