First Line Gemcitabine/Pazopanib in Locally Advanced and/or Metastatic Biliary Tract Carcinoma. A Hellenic Cooperative Oncology Group Phase II Study.


Journal

Anticancer research
ISSN: 1791-7530
Titre abrégé: Anticancer Res
Pays: Greece
ID NLM: 8102988

Informations de publication

Date de publication:
Feb 2020
Historique:
received: 10 12 2019
revised: 19 12 2019
accepted: 20 12 2019
entrez: 5 2 2020
pubmed: 6 2 2020
medline: 20 3 2020
Statut: ppublish

Résumé

The efficacy of gemcitabine-based chemotherapy in locally advanced/metastatic biliary tract carcinoma is limited. The aim of this trial was to assess the activity of a novel gemcitabine-pazopanib combination in such patients. In this phase II, multicenter trial, patients with histologically/cytologically confirmed biliary tract carcinoma, previously untreated for advanced disease, received 1000 mg/m A total of 29 patients (median age; 69 years) were enrolled between June 2013 and March 2018. The ORR was 13.8% in the intent-to-treat and 19.1% in the per protocol population. The median progression-free and overall survival were 6.3 and 10.4 months, respectively. The low response rate precludes further testing of the combination in patients with biliary tract carcinoma.

Sections du résumé

BACKGROUND/AIM OBJECTIVE
The efficacy of gemcitabine-based chemotherapy in locally advanced/metastatic biliary tract carcinoma is limited. The aim of this trial was to assess the activity of a novel gemcitabine-pazopanib combination in such patients.
PATIENTS AND METHODS METHODS
In this phase II, multicenter trial, patients with histologically/cytologically confirmed biliary tract carcinoma, previously untreated for advanced disease, received 1000 mg/m
RESULTS RESULTS
A total of 29 patients (median age; 69 years) were enrolled between June 2013 and March 2018. The ORR was 13.8% in the intent-to-treat and 19.1% in the per protocol population. The median progression-free and overall survival were 6.3 and 10.4 months, respectively.
CONCLUSION CONCLUSIONS
The low response rate precludes further testing of the combination in patients with biliary tract carcinoma.

Identifiants

pubmed: 32014937
pii: 40/2/929
doi: 10.21873/anticanres.14026
doi:

Substances chimiques

Indazoles 0
Pyrimidines 0
Sulfonamides 0
Deoxycytidine 0W860991D6
pazopanib 7RN5DR86CK
Gemcitabine 0

Types de publication

Clinical Trial, Phase II Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

929-938

Informations de copyright

Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Auteurs

Joseph Sgouros (J)

Third Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece josephsgouros@yahoo.co.uk.

Gerasimos Aravantinos (G)

Second Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece.

Georgia-Angeliki Koliou (GA)

Section of Biostatistics, Hellenic Cooperative Oncology Group, Data Office, Athens, Greece.

George Pentheroudakis (G)

Department of Medical Oncology, Medical School, University of Ioannina, Ioannina, Greece.
Society for Study of Clonal Heterogeneity of Neoplasia (EMEKEN), Ioannina, Greece.

Flora Zagouri (F)

Department of Clinical Therapeutics, Alexandra Hospital, National and Kapodistrian University of Athens School of Medicine, Athens, Greece.

Amanda Psyrri (A)

Section of Medical Oncology, Department of Internal Medicine, Attikon University Hospital, Faculty of Medicine, National and Kapodistrian University of Athens School of Medicine, Athens, Greece.

Dimitra Ioanna Lampropoulou (DI)

Second Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece.

Stamatina Demiri (S)

Second Department of Internal Medicine, Agios Savvas Cancer Hospital, Athens, Greece.

Dimitrios Pectasides (D)

Oncology Section, Second Department of Internal Medicine, Hippokration Hospital, Athens, Greece.

Evangelia Razis (E)

Third Department of Medical Oncology, Hygeia Hospital, Athens, Greece.

George Fountzilas (G)

Laboratory of Molecular Oncology, Hellenic Foundation for Cancer Research/Aristotle University of Thessaloniki, Thessaloniki, Greece.
Aristotle University of Thessaloniki, Thessaloniki, Greece.
German Oncology Center, Limassol, Cyprus.

Epaminontas Samantas (E)

Third Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece.

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Classifications MeSH