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

JOSEPH SGOUROS; GERASIMOS ARAVANTINOS; GEORGIA-ANGELIKI KOLIOU; GEORGE PENTHEROUDAKIS; FLORA ZAGOURI; AMANDA PSYRRI; DIMITRA IOANNA LAMPROPOULOU; STAMATINA DEMIRI; DIMITRIOS PECTASIDES; EVANGELIA RAZIS; GEORGE FOUNTZILAS; EPAMINONTAS SAMANTAS

doi:10.21873/anticanres.14026

Abstract

Background/Aim: 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: In this phase II, multicenter trial, patients with histologically/cytologically confirmed biliary tract carcinoma, previously untreated for advanced disease, received 1000 mg/m² of gemcitabine on days 1 and 8 every 21 days and 800 mg of pazopanib once daily continuously for 8 cycles, followed by pazopanib maintenance. The primary endpoint was objective response rate (ORR). 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: The low response rate precludes further testing of the combination in patients with biliary tract carcinoma.

Footnotes

Authors' Contributions
Conceptualization: JS, GP, ES; Formal analysis: GAK; Resources: JS, GA, GP, FZ, AP, DL, MD, DP, ER, GF, ES; Writing – original draft preparation: JS, GAK, GF, ES; Writing – review and editing: All Authors.
Conflicts of Interest
Gerasimos Aravantinos: Advisory Boards: Novartis, BMS, Roche Hellas, Astra Zeneca, Sanofi, Amgen, Genesis Pharma, Merck, Pfizer; George Pentheroudakis: Advisory Role: Roche, Amgen, Merck, Astra-Zeneca, BMS, MSD, Lilly. Research Funding: Boehringer, Merck, Amgen, Astra-Zeneca, Roche, Enorasis, BMS, Lilly. Institutional financial support for clinical trials or contracted research: Boehringer, Merck, Amgen, Astra-Zeneca; Amanda Psyrri: Consultation Fees: Amgen, Merck Serono, Roche, BMS. AstraZeneca, MSD. Honoraria: Amgen, Merck Serono, Roche, BMS, AstraZeneca, MSD. Research funds BMS Kura; Dimitrios Pectasides: Advisory Role: Roche, MSD, Astellas. Honoraria: Roche, MSD, Astellas; Evangelia Razis: Consulting or Advisory Role: AstraZeneca, Bristol-Myers Squibb, Pfizer; Research Funding: Novartis, Demo Pharmaceutical, EORTC, Radius Pharmaceuticals, Tesaro, Parexel, Anabiosis Pharmaceuticals. Travel: Sanofi, Ipsen, Genesis Pharmaceuticals, LEO Pharma, Merck, Roche, Genekor; George Fountzilas: Advisory Board of Pfizer, Sanofi and Roche. Honoraria from Astra-Zeneca; Epaminontas Samantas: Advisory Board of Merck, MSD, Asta-Zeneca, Roche, Amgen and Genesis.

Received December 10, 2019.
Revision received December 19, 2019.
Accepted December 20, 2019.

View Full Text

This article requires a subscription to view the full text. If you have a subscription you may use the login form below to view the article. Access to this article can also be purchased.