Phase II trial of oxaliplatin combined with leucovorin and fluorouracil for recurrent/metastatic biliary tract carcinoma

Jae Yun Lim, Hei Cheul Jeung, Hee Sun Mun, DongKi Lee, Yong Han Paik, Se Joon Lee, Dong Sup Yoon, Jae Yong Cho

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Biliary tract carcinoma is often diagnosed at an advanced stage, and there is currently no established palliative standard of care. This phase II study investigated the efficacy and safety of combination chemotherapy of oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) in biliary tract carcinoma. Patients with unresectable or recurrent biliary tract carcinoma were enrolled, including pretreated and chemotherapy-naive patients. Treatment consisted of intravenous oxaliplatin (100g mg/m, day 1) followed by leucovorin (100g mg/m, day 1) and 5-FU (1000g mg/m, days 1 and 2). Treatment was repeated every 3 weeks. The efficacy and safety of the treatment were determined. Twenty-eight patients were evaluable, and a total of 166 cycles were administered (median five cycles). One complete response (3.6%) and five partial responses (17.9%) were noted, with a response rate of 21.5% [95% confidence interval (CI): 6.2g-36.7], according to Response Evaluation Criteria in Solid Tumors criteria. The median time to progression and overall survival was 3.5 months (95% CI: 2.7g-4.3) and 10.0 months (95% CI: 7.2g-12.8), respectively. The 1-year survival rate was 17.8%. Grade 3/4 neutropenia and thrombocytopenia were recorded in 18 and 4% of the patients, respectively. No treatment-related death was observed. Oxaliplatin in combination with leucovorin and 5-FU should be considered a feasible chemotherapy regimen for patients with recurrent/metastatic biliary tract carcinoma.

Original languageEnglish
Pages (from-to)631-635
Number of pages5
JournalAnti-Cancer Drugs
Volume19
Issue number6
DOIs
Publication statusPublished - 2008 Jul 1

Fingerprint

oxaliplatin
Leucovorin
Biliary Tract
Fluorouracil
Carcinoma
Confidence Intervals
Safety
Drug Therapy
Standard of Care
Combination Drug Therapy
Neutropenia
Palliative Care
Therapeutics
Survival Rate

All Science Journal Classification (ASJC) codes

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

Cite this

Lim, Jae Yun ; Jeung, Hei Cheul ; Mun, Hee Sun ; Lee, DongKi ; Paik, Yong Han ; Lee, Se Joon ; Yoon, Dong Sup ; Cho, Jae Yong. / Phase II trial of oxaliplatin combined with leucovorin and fluorouracil for recurrent/metastatic biliary tract carcinoma. In: Anti-Cancer Drugs. 2008 ; Vol. 19, No. 6. pp. 631-635.
@article{aef6826798f64c98aed3fc820df27245,
title = "Phase II trial of oxaliplatin combined with leucovorin and fluorouracil for recurrent/metastatic biliary tract carcinoma",
abstract = "Biliary tract carcinoma is often diagnosed at an advanced stage, and there is currently no established palliative standard of care. This phase II study investigated the efficacy and safety of combination chemotherapy of oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) in biliary tract carcinoma. Patients with unresectable or recurrent biliary tract carcinoma were enrolled, including pretreated and chemotherapy-naive patients. Treatment consisted of intravenous oxaliplatin (100g mg/m, day 1) followed by leucovorin (100g mg/m, day 1) and 5-FU (1000g mg/m, days 1 and 2). Treatment was repeated every 3 weeks. The efficacy and safety of the treatment were determined. Twenty-eight patients were evaluable, and a total of 166 cycles were administered (median five cycles). One complete response (3.6{\%}) and five partial responses (17.9{\%}) were noted, with a response rate of 21.5{\%} [95{\%} confidence interval (CI): 6.2g-36.7], according to Response Evaluation Criteria in Solid Tumors criteria. The median time to progression and overall survival was 3.5 months (95{\%} CI: 2.7g-4.3) and 10.0 months (95{\%} CI: 7.2g-12.8), respectively. The 1-year survival rate was 17.8{\%}. Grade 3/4 neutropenia and thrombocytopenia were recorded in 18 and 4{\%} of the patients, respectively. No treatment-related death was observed. Oxaliplatin in combination with leucovorin and 5-FU should be considered a feasible chemotherapy regimen for patients with recurrent/metastatic biliary tract carcinoma.",
author = "Lim, {Jae Yun} and Jeung, {Hei Cheul} and Mun, {Hee Sun} and DongKi Lee and Paik, {Yong Han} and Lee, {Se Joon} and Yoon, {Dong Sup} and Cho, {Jae Yong}",
year = "2008",
month = "7",
day = "1",
doi = "10.1097/CAD.0b013e3283017f94",
language = "English",
volume = "19",
pages = "631--635",
journal = "Anti-Cancer Drugs",
issn = "0959-4973",
publisher = "Lippincott Williams and Wilkins",
number = "6",

}

Phase II trial of oxaliplatin combined with leucovorin and fluorouracil for recurrent/metastatic biliary tract carcinoma. / Lim, Jae Yun; Jeung, Hei Cheul; Mun, Hee Sun; Lee, DongKi; Paik, Yong Han; Lee, Se Joon; Yoon, Dong Sup; Cho, Jae Yong.

In: Anti-Cancer Drugs, Vol. 19, No. 6, 01.07.2008, p. 631-635.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Phase II trial of oxaliplatin combined with leucovorin and fluorouracil for recurrent/metastatic biliary tract carcinoma

AU - Lim, Jae Yun

AU - Jeung, Hei Cheul

AU - Mun, Hee Sun

AU - Lee, DongKi

AU - Paik, Yong Han

AU - Lee, Se Joon

AU - Yoon, Dong Sup

AU - Cho, Jae Yong

PY - 2008/7/1

Y1 - 2008/7/1

N2 - Biliary tract carcinoma is often diagnosed at an advanced stage, and there is currently no established palliative standard of care. This phase II study investigated the efficacy and safety of combination chemotherapy of oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) in biliary tract carcinoma. Patients with unresectable or recurrent biliary tract carcinoma were enrolled, including pretreated and chemotherapy-naive patients. Treatment consisted of intravenous oxaliplatin (100g mg/m, day 1) followed by leucovorin (100g mg/m, day 1) and 5-FU (1000g mg/m, days 1 and 2). Treatment was repeated every 3 weeks. The efficacy and safety of the treatment were determined. Twenty-eight patients were evaluable, and a total of 166 cycles were administered (median five cycles). One complete response (3.6%) and five partial responses (17.9%) were noted, with a response rate of 21.5% [95% confidence interval (CI): 6.2g-36.7], according to Response Evaluation Criteria in Solid Tumors criteria. The median time to progression and overall survival was 3.5 months (95% CI: 2.7g-4.3) and 10.0 months (95% CI: 7.2g-12.8), respectively. The 1-year survival rate was 17.8%. Grade 3/4 neutropenia and thrombocytopenia were recorded in 18 and 4% of the patients, respectively. No treatment-related death was observed. Oxaliplatin in combination with leucovorin and 5-FU should be considered a feasible chemotherapy regimen for patients with recurrent/metastatic biliary tract carcinoma.

AB - Biliary tract carcinoma is often diagnosed at an advanced stage, and there is currently no established palliative standard of care. This phase II study investigated the efficacy and safety of combination chemotherapy of oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) in biliary tract carcinoma. Patients with unresectable or recurrent biliary tract carcinoma were enrolled, including pretreated and chemotherapy-naive patients. Treatment consisted of intravenous oxaliplatin (100g mg/m, day 1) followed by leucovorin (100g mg/m, day 1) and 5-FU (1000g mg/m, days 1 and 2). Treatment was repeated every 3 weeks. The efficacy and safety of the treatment were determined. Twenty-eight patients were evaluable, and a total of 166 cycles were administered (median five cycles). One complete response (3.6%) and five partial responses (17.9%) were noted, with a response rate of 21.5% [95% confidence interval (CI): 6.2g-36.7], according to Response Evaluation Criteria in Solid Tumors criteria. The median time to progression and overall survival was 3.5 months (95% CI: 2.7g-4.3) and 10.0 months (95% CI: 7.2g-12.8), respectively. The 1-year survival rate was 17.8%. Grade 3/4 neutropenia and thrombocytopenia were recorded in 18 and 4% of the patients, respectively. No treatment-related death was observed. Oxaliplatin in combination with leucovorin and 5-FU should be considered a feasible chemotherapy regimen for patients with recurrent/metastatic biliary tract carcinoma.

UR - http://www.scopus.com/inward/record.url?scp=53749107653&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=53749107653&partnerID=8YFLogxK

U2 - 10.1097/CAD.0b013e3283017f94

DO - 10.1097/CAD.0b013e3283017f94

M3 - Article

C2 - 18525323

AN - SCOPUS:53749107653

VL - 19

SP - 631

EP - 635

JO - Anti-Cancer Drugs

JF - Anti-Cancer Drugs

SN - 0959-4973

IS - 6

ER -