PMID- 25538178
OWN - NLM
STAT- MEDLINE
DCOM- 20160818
LR  - 20221207
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Linking)
VI  - 26
IP  - 3
DP  - 2015 Mar
TI  - A randomized, multicenter, phase II study of vandetanib monotherapy versus 
      vandetanib in combination with gemcitabine versus gemcitabine plus placebo in 
      subjects with advanced biliary tract cancer: the VanGogh study.
PG  - 542-7
LID - 10.1093/annonc/mdu576 [doi]
AB  - BACKGROUND: The management of biliary tract cancers (BTCs) is complex due to 
      limited data on the optimal therapeutic approach. This phase II multicenter study 
      evaluated the efficacy and tolerability of vandetanib monotherapy compared with 
      vandetanib plus gemcitabine or gemcitabine plus placebo in patients with advanced 
      BTC. PATIENTS AND METHODS: Patients were randomized in a 1 : 1 : 1 ratio to three 
      treatment groups: vandetanib 300 mg monotherapy (V), vandetanib 100 mg plus 
      gemcitabine (V/G), gemcitabine plus placebo (G/P). Vandetanib (300 mg or 100 mg) 
      or placebo was given in single oral daily doses. Gemcitabine 1000 mg/m(2) was 
      i.v. infused on day 1 and day 8 of each 21-day cycle. The primary end point was 
      progression-free survival (PFS). Secondary end points were: objective response 
      rate (ORR), disease control rate, overall survival, duration of response, 
      performance status and safety outcomes. RESULTS: A total of 173 patients (mean 
      age 63.6 years) were recruited at 19 centers across Italy. Median (95% confidence 
      intervals) PFS (days) were 105 (72-155), 114 (91-193) and 148 (71-225), 
      respectively, for the V, V/G and G/P treatment groups, with no statistical 
      difference among them (P = 0.18). No statistical difference between treatments 
      was observed for secondary end points, except ORR, which slightly favored the V/G 
      combination over other treatments. The proportion of patients reporting adverse 
      events (AEs) was similar for the three groups (96.6% in V arm, 91.4% in the V/G 
      arm and 89.3% in the G/P arm). CONCLUSIONS: Vandetanib treatment did not improve 
      PFS in patients with advanced BTC. The safety profile of vandetanib did not show 
      any additional AEs or worsening of already known AEs. CLINICAL TRIAL NUMBER: 
      NCT00753675.
CI  - (c) The Author 2014. Published by Oxford University Press on behalf of the European 
      Society for Medical Oncology. All rights reserved. For permissions, please email: 
      journals.permissions@oup.com.
FAU - Santoro, A
AU  - Santoro A
AD  - Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical 
      and Research Center, Milan armando.santoro@cancercenter.humanitas.it.
FAU - Gebbia, V
AU  - Gebbia V
AD  - Department of Medical Oncology, Nursing Home 'La Maddalena', Palermo.
FAU - Pressiani, T
AU  - Pressiani T
AD  - Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical 
      and Research Center, Milan.
FAU - Testa, A
AU  - Testa A
AD  - Department of Medical Oncology, Nursing Home 'La Maddalena', Palermo.
FAU - Personeni, N
AU  - Personeni N
AD  - Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical 
      and Research Center, Milan.
FAU - Arrivas Bajardi, E
AU  - Arrivas Bajardi E
AD  - Department of Medical Oncology, Nursing Home 'La Maddalena', Palermo.
FAU - Foa, P
AU  - Foa P
AD  - Department of Medical Oncology, 'San Paolo' University Hospital, Milan.
FAU - Buonadonna, A
AU  - Buonadonna A
AD  - Oncology Referral Center, IRCCS, Aviano.
FAU - Bencardino, K
AU  - Bencardino K
AD  - Niguarda Cancer Center, Ospedale Niguarda Ca' Granda, Milan.
FAU - Barone, C
AU  - Barone C
AD  - Department of Medical Oncology, Universita Cattolica del S. Cuore, Rome.
FAU - Ferrari, D
AU  - Ferrari D
AD  - Department of Medical Oncology, 'San Paolo' University Hospital, Milan.
FAU - Zaniboni, A
AU  - Zaniboni A
AD  - Department of Oncology, 'Poliambulanza' Foundation, Brescia.
FAU - Tronconi, M C
AU  - Tronconi MC
AD  - Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical 
      and Research Center, Milan.
FAU - Carteni, G
AU  - Carteni G
AD  - Department of Oncology, Cardarelli Hospital, Naples.
FAU - Milella, M
AU  - Milella M
AD  - Medical Oncology A, Regina Elena National Cancer Institute, Rome.
FAU - Comandone, A
AU  - Comandone A
AD  - Department of Oncology, Gradenigo Hospital, Turin.
FAU - Ferrari, S
AU  - Ferrari S
AD  - Oncology Unit, AstraZeneca, Basiglio, Italy.
FAU - Rimassa, L
AU  - Rimassa L
AD  - Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical 
      and Research Center, Milan.
LA  - eng
SI  - ClinicalTrials.gov/NCT00753675
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20141223
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Piperidines)
RN  - 0 (Quinazolines)
RN  - 0W860991D6 (Deoxycytidine)
RN  - YO460OQ37K (vandetanib)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage
MH  - Biliary Tract Neoplasms/*diagnosis/*drug therapy
MH  - Deoxycytidine/administration & dosage/*analogs & derivatives
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Piperidines/*administration & dosage
MH  - Quinazolines/*administration & dosage
MH  - Gemcitabine
OTO - NOTNLM
OT  - advanced biliary tract cancer
OT  - gemcitabine
OT  - vandetanib
EDAT- 2014/12/30 06:00
MHDA- 2016/08/19 06:00
CRDT- 2014/12/25 06:00
PHST- 2014/12/25 06:00 [entrez]
PHST- 2014/12/30 06:00 [pubmed]
PHST- 2016/08/19 06:00 [medline]
AID - S0923-7534(19)31431-0 [pii]
AID - 10.1093/annonc/mdu576 [doi]
PST - ppublish
SO  - Ann Oncol. 2015 Mar;26(3):542-7. doi: 10.1093/annonc/mdu576. Epub 2014 Dec 23.