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 language | English |
|---|---|
| Pages (from-to) | 47-52 |
| Number of pages | 6 |
| Journal | Cancer Chemotherapy and Pharmacology |
| Volume | 61 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2008 Jan 1 |
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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 journal › Article
}
TY - JOUR
T1 - Phase II trial of gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas
AU - Lee, Jeeyun
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
PY - 2008/1/1
Y1 - 2008/1/1
N2 - 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.
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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U2 - 10.1007/s00280-007-0444-5
DO - 10.1007/s00280-007-0444-5
M3 - Article
VL - 61
SP - 47
EP - 52
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
SN - 0344-5704
IS - 1
ER -