Imperial College London
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Professor Hani Gabra

Faculty of Medicine, Department of Surgery & Cancer

Emeritus Professor of Medical Oncology
 
 
 
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Contact

 

h.gabra Website

 
 
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Assistant

 

Ms Sophie Lions +44 (0)20 7594 2792

 
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Location

 

Garry Weston CentreCancer CentreHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Ledermann:2009,
author = {Ledermann, JA and Rustin, GJ and Hackshaw, A and Kaye, SB and Jayson, G and Gabra, H and James, LE and Bell, S and Temple, G},
journal = {J Clin Oncol},
title = {A randomized phase II placebo-controlled trial using maintenance therapy to evaluate the vascular targeting agent BIBF 1120 following treatment of relapsed ovarian cancer (OC).},
url = {http://www.ncbi.nlm.nih.gov/pubmed/27962444},
volume = {27},
year = {2009}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - 5501 Background: BIBF 1120 is a new targeted therapeutic agent for maintenance therapy in OC. It is a unique triple angiokinase inhibitor, targeting 3 receptor classes involved in the formation of blood vessels (VEGFR, PDGFR, and FGFR). METHODS: Continuous BIBF 1120 (250 mg, oral, twice daily) for up to 9 months (mo) was compared with placebo in a novel application of a randomized double-blind trial in pts who responded to their last (at least second line) chemotherapy. The primary endpoint, progression-free survival at 36 weeks, was confirmed by CT assessment, performed at 12-week intervals. RESULTS: 84 pts were randomized (44 BIBF 1120; 40 placebo), mean age 60y (range 27-76). All had responded according to GCIG criteria. Treatment-free interval before prior chemotherapy was <6 mo for 41% and 6-12 mo for 59% of pts. Median treatment duration was 116 days (d), range, 2-281d (BIBF 1120) and 101 d, 2-239d (placebo). Five BIBF 1120 pts completed 9 mo of treatment vs 0 placebo pts. The 36-wk PFS rates (95% confidence interval [CI]) were 15.6% (3.8, 27.3) for BIBF 1120 and 2.9% (0.0, 8.4) for placebo. Although the trial was not powered for a direct comparison, the PFS hazard ratio was 0.68 (95% CI: 0.42, 1.09). Median time to RECIST progression (mo) was 4.8 for BIBF 1120, and 2.8 for placebo. There were no deaths during treatment. Grade 3 and 4 adverse events (AE) were seen in 54 and 7% (BIBF 1120) and 25 and 3% (placebo) of pts. Expected gastrointestinal toxicities occurred slightly more frequently in the BIBF 1120 arm (16 vs 10%, all gd 3; no gd 4 events). Elevated liver enzymes occurred in 43% (BIBF 1120) vs. 6.3% (placebo). CONCLUSIONS: Our trial suggests that maintenance BIBF 1120 could delay disease progression in OC pts who had previously responded to chemotherapy. A large phase III trial is needed to confirm the efficacy of this drug. [Table: see text].
AU  - Ledermann,JA
AU  - Rustin,GJ
AU  - Hackshaw,A
AU  - Kaye,SB
AU  - Jayson,G
AU  - Gabra,H
AU  - James,LE
AU  - Bell,S
AU  - Temple,G
PY  - 2009///
TI  - A randomized phase II placebo-controlled trial using maintenance therapy to evaluate the vascular targeting agent BIBF 1120 following treatment of relapsed ovarian cancer (OC).
T2  - J Clin Oncol
UR  - http://www.ncbi.nlm.nih.gov/pubmed/27962444
VL  - 27
ER  -
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