Biweekly cisplatin and gemcitabine in patients with advanced biliary tract cancer

Daniel Ahn, Josh Reardon, Chul W. Ahn, Manojkumar Bupathi, Sameh Mikhail, Christina Sing Ying Wu, Tanios Bekaii-Saab

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Treatment with cisplatin and gemcitabine demonstrates a survival benefit in patients with advanced biliary tract cancer (ABTC). However, the weekly administration can add significant toxicities that may prohibit prolonged treatment. Based on previous studies, we implemented a modified biweekly regimen of GC in an attempt to optimize the prescribed regimen with an improved toxicity profile, added convenience to patients while maintaining efficacy. Patients with ABTC were treated with fixed dose rate (FDR) gemcitabine (1,000 mg/m2/min) and cisplatin 20 mg/m2 on days 1 and 15 of every 28-day cycle. Patients received treatment until time of progression, death, or discontinuation due to intolerance. Collected data included demographics, clinico-pathologic features, toxicities, and survival. Kaplan-Meier curves were used to calculate the median overall survival (OS) and progression free survival (PFS). The study included 107 evaluable pts with unresectable ABTC who received the biweekly regimen. Sites of tumor included gallbladder (21.5%), ampullary (3.7%), and bile duct (74.8%). Median number of cycles was 6 (1–27). Median PFS was 8.34 (6.74, 9.23) months and median OS was 10.32 (9.10, 11.43) months. Most common grade ≥3 adverse events included neutropenia (11%), fatigue (10%), and thrombocytopenia (6.4%). Biweekly FDR GC in ABTC is associated with a more favorable toxicity profile while maintaining efficacy similar to that observed in prior clinical trials. Minimal toxicities were observed despite a prolonged course for many patients. Further prospective trials should consider evaluating the role of biweekly GC regimen in ABTC, including a potentially more favorable platform in novel experimental strategies.

Original languageEnglish (US)
Pages (from-to)1671-1675
Number of pages5
JournalInternational Journal of Cancer
Volume142
Issue number8
DOIs
StatePublished - Apr 15 2018

Fingerprint

gemcitabine
Biliary Tract Neoplasms
Cisplatin
Survival
Disease-Free Survival
Bile Ducts
Gallbladder
Neutropenia
Thrombocytopenia
Fatigue
Therapeutics
Demography
Clinical Trials

Keywords

  • biliary tract cancer
  • cisplatin
  • efficacious
  • gemcitabine
  • improved toxicity profile
  • modified regimen

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Biweekly cisplatin and gemcitabine in patients with advanced biliary tract cancer. / Ahn, Daniel; Reardon, Josh; Ahn, Chul W.; Bupathi, Manojkumar; Mikhail, Sameh; Wu, Christina Sing Ying; Bekaii-Saab, Tanios.

In: International Journal of Cancer, Vol. 142, No. 8, 15.04.2018, p. 1671-1675.

Research output: Contribution to journalArticle

Ahn, Daniel ; Reardon, Josh ; Ahn, Chul W. ; Bupathi, Manojkumar ; Mikhail, Sameh ; Wu, Christina Sing Ying ; Bekaii-Saab, Tanios. / Biweekly cisplatin and gemcitabine in patients with advanced biliary tract cancer. In: International Journal of Cancer. 2018 ; Vol. 142, No. 8. pp. 1671-1675.
@article{fa8e48ac0c8448d2bf7d2e54c70e5a3c,
title = "Biweekly cisplatin and gemcitabine in patients with advanced biliary tract cancer",
abstract = "Treatment with cisplatin and gemcitabine demonstrates a survival benefit in patients with advanced biliary tract cancer (ABTC). However, the weekly administration can add significant toxicities that may prohibit prolonged treatment. Based on previous studies, we implemented a modified biweekly regimen of GC in an attempt to optimize the prescribed regimen with an improved toxicity profile, added convenience to patients while maintaining efficacy. Patients with ABTC were treated with fixed dose rate (FDR) gemcitabine (1,000 mg/m2/min) and cisplatin 20 mg/m2 on days 1 and 15 of every 28-day cycle. Patients received treatment until time of progression, death, or discontinuation due to intolerance. Collected data included demographics, clinico-pathologic features, toxicities, and survival. Kaplan-Meier curves were used to calculate the median overall survival (OS) and progression free survival (PFS). The study included 107 evaluable pts with unresectable ABTC who received the biweekly regimen. Sites of tumor included gallbladder (21.5{\%}), ampullary (3.7{\%}), and bile duct (74.8{\%}). Median number of cycles was 6 (1–27). Median PFS was 8.34 (6.74, 9.23) months and median OS was 10.32 (9.10, 11.43) months. Most common grade ≥3 adverse events included neutropenia (11{\%}), fatigue (10{\%}), and thrombocytopenia (6.4{\%}). Biweekly FDR GC in ABTC is associated with a more favorable toxicity profile while maintaining efficacy similar to that observed in prior clinical trials. Minimal toxicities were observed despite a prolonged course for many patients. Further prospective trials should consider evaluating the role of biweekly GC regimen in ABTC, including a potentially more favorable platform in novel experimental strategies.",
keywords = "biliary tract cancer, cisplatin, efficacious, gemcitabine, improved toxicity profile, modified regimen",
author = "Daniel Ahn and Josh Reardon and Ahn, {Chul W.} and Manojkumar Bupathi and Sameh Mikhail and Wu, {Christina Sing Ying} and Tanios Bekaii-Saab",
year = "2018",
month = "4",
day = "15",
doi = "10.1002/ijc.31144",
language = "English (US)",
volume = "142",
pages = "1671--1675",
journal = "International Journal of Cancer",
issn = "0020-7136",
publisher = "Wiley-Liss Inc.",
number = "8",

}

TY - JOUR

T1 - Biweekly cisplatin and gemcitabine in patients with advanced biliary tract cancer

AU - Ahn, Daniel

AU - Reardon, Josh

AU - Ahn, Chul W.

AU - Bupathi, Manojkumar

AU - Mikhail, Sameh

AU - Wu, Christina Sing Ying

AU - Bekaii-Saab, Tanios

PY - 2018/4/15

Y1 - 2018/4/15

N2 - Treatment with cisplatin and gemcitabine demonstrates a survival benefit in patients with advanced biliary tract cancer (ABTC). However, the weekly administration can add significant toxicities that may prohibit prolonged treatment. Based on previous studies, we implemented a modified biweekly regimen of GC in an attempt to optimize the prescribed regimen with an improved toxicity profile, added convenience to patients while maintaining efficacy. Patients with ABTC were treated with fixed dose rate (FDR) gemcitabine (1,000 mg/m2/min) and cisplatin 20 mg/m2 on days 1 and 15 of every 28-day cycle. Patients received treatment until time of progression, death, or discontinuation due to intolerance. Collected data included demographics, clinico-pathologic features, toxicities, and survival. Kaplan-Meier curves were used to calculate the median overall survival (OS) and progression free survival (PFS). The study included 107 evaluable pts with unresectable ABTC who received the biweekly regimen. Sites of tumor included gallbladder (21.5%), ampullary (3.7%), and bile duct (74.8%). Median number of cycles was 6 (1–27). Median PFS was 8.34 (6.74, 9.23) months and median OS was 10.32 (9.10, 11.43) months. Most common grade ≥3 adverse events included neutropenia (11%), fatigue (10%), and thrombocytopenia (6.4%). Biweekly FDR GC in ABTC is associated with a more favorable toxicity profile while maintaining efficacy similar to that observed in prior clinical trials. Minimal toxicities were observed despite a prolonged course for many patients. Further prospective trials should consider evaluating the role of biweekly GC regimen in ABTC, including a potentially more favorable platform in novel experimental strategies.

AB - Treatment with cisplatin and gemcitabine demonstrates a survival benefit in patients with advanced biliary tract cancer (ABTC). However, the weekly administration can add significant toxicities that may prohibit prolonged treatment. Based on previous studies, we implemented a modified biweekly regimen of GC in an attempt to optimize the prescribed regimen with an improved toxicity profile, added convenience to patients while maintaining efficacy. Patients with ABTC were treated with fixed dose rate (FDR) gemcitabine (1,000 mg/m2/min) and cisplatin 20 mg/m2 on days 1 and 15 of every 28-day cycle. Patients received treatment until time of progression, death, or discontinuation due to intolerance. Collected data included demographics, clinico-pathologic features, toxicities, and survival. Kaplan-Meier curves were used to calculate the median overall survival (OS) and progression free survival (PFS). The study included 107 evaluable pts with unresectable ABTC who received the biweekly regimen. Sites of tumor included gallbladder (21.5%), ampullary (3.7%), and bile duct (74.8%). Median number of cycles was 6 (1–27). Median PFS was 8.34 (6.74, 9.23) months and median OS was 10.32 (9.10, 11.43) months. Most common grade ≥3 adverse events included neutropenia (11%), fatigue (10%), and thrombocytopenia (6.4%). Biweekly FDR GC in ABTC is associated with a more favorable toxicity profile while maintaining efficacy similar to that observed in prior clinical trials. Minimal toxicities were observed despite a prolonged course for many patients. Further prospective trials should consider evaluating the role of biweekly GC regimen in ABTC, including a potentially more favorable platform in novel experimental strategies.

KW - biliary tract cancer

KW - cisplatin

KW - efficacious

KW - gemcitabine

KW - improved toxicity profile

KW - modified regimen

UR - http://www.scopus.com/inward/record.url?scp=85034223441&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85034223441&partnerID=8YFLogxK

U2 - 10.1002/ijc.31144

DO - 10.1002/ijc.31144

M3 - Article

C2 - 29114851

AN - SCOPUS:85034223441

VL - 142

SP - 1671

EP - 1675

JO - International Journal of Cancer

JF - International Journal of Cancer

SN - 0020-7136

IS - 8

ER -