Format

Send to

Choose Destination
See comment in PubMed Commons below
Br J Cancer. 2014 Jul 29;111(3):430-6. doi: 10.1038/bjc.2014.343. Epub 2014 Jun 24.

Phase II study of gemcitabine, oxaliplatin in combination with panitumumab in KRAS wild-type unresectable or metastatic biliary tract and gallbladder cancer.

Author information

1
Division of Hematology/Oncology, James P. Wilmot Cancer Center, University of Rochester, Rochester, NY, USA.
2
Division of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.
3
Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
4
Biostatistics Center, Massachusetts General Hospital, Boston, MA, USA.
5
Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.
6
Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY, USA.
7
Department of Public Health Sciences, University of Rochester Medical Center, Rochester, NY, USA.
8
Department of Pathology, Massachusetts General Hospital, Boston, MA, USA.

Abstract

BACKGROUND:

Current data suggest that platinum-based combination therapy is the standard first-line treatment for biliary tract cancer. EGFR inhibition has proven beneficial across a number of gastrointestinal malignancies; and has shown specific advantages among KRAS wild-type genetic subtypes of colon cancer. We report the combination of panitumumab with gemcitabine (GEM) and oxaliplatin (OX) as first-line therapy for KRAS wild-type biliary tract cancer.

METHODS:

Patients with histologically confirmed, previously untreated, unresectable or metastatic KRAS wild-type biliary tract or gallbladder adenocarcinoma with ECOG performance status 0-2 were treated with panitumumab 6 mg kg(-1), GEM 1000 mg m(-2) (10 mg m(-2) min(-1)) and OX 85 mg m(-2) on days 1 and 15 of each 28-day cycle. The primary objective was to determine the objective response rate by RECIST criteria v.1.1. Secondary objectives were to evaluate toxicity, progression-free survival (PFS), and overall survival.

RESULTS:

Thirty-one patients received at least one cycle of treatment across three institutions, 28 had measurable disease. Response rate was 45% and disease control rate was 90%. Median PFS was 10.6 months (95% CI 5-24 months) and median overall survival 20.3 months (95% CI 9-25 months). The most common grade 3/4 adverse events were anaemia 26%, leukopenia 23%, fatigue 23%, neuropathy 16% and rash 10%.

CONCLUSIONS:

The combination of gemcitabine, oxaliplatin and panitumumab in KRAS wild type metastatic biliary tract cancer showed encouraging efficacy, additional efforts of genetic stratification and targeted therapy is warranted in biliary tract cancer.

PMID:
24960403
PMCID:
PMC4119993
DOI:
10.1038/bjc.2014.343
[Indexed for MEDLINE]
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Nature Publishing Group Icon for PubMed Central
    Loading ...
    Support Center