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A phase II evaluation of AMG 102 (rilotumumab) in the treatment of persistent or
recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: a
Gynecologic Oncology Group study
#MMPMID24361733
Martin LP
; Sill M
; Shahin MS
; Powell M
; DiSilvestro P
; Landrum LM
; Gaillard SL
; Goodheart MJ
; Hoffman J
; Schilder RJ
Gynecol Oncol
2014[Mar]; 132
(3
): 526-30
PMID24361733
show ga
OBJECTIVE: This open-label, multi-institutional phase II trial evaluated activity
and safety of rilotumumab (AMG 102), a monoclonal antibody that targets HGF
(hepatocyte growth factor), the ligand for the MET receptor, in women with
recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal
cancer. PATIENTS AND METHODS: Women were eligible for treatment with rilotumumab
if they had measurable disease, a performance status of 0, 1 or 2, previously
received platinum-based therapy with a progression-free interval of <12 months or
a second recurrence, and adequate bone marrow and organ function. Patients
received rilotumumab 20mg/kg IV every 14 days until evidence of unacceptable
toxicity or disease progression. The study utilized co-dual primary endpoints of
tumor response and six-month PFS to assess the efficacy of rilotumumab. Secondary
endpoints included the frequency and severity of adverse events and the duration
of progression-free and overall survival. RESULTS: Thirty-one women enrolled and
received rilotumumab. All were eligible for analysis. One patient achieved a
complete response (3.2%; 90% CI 0.2-14%), and two women had 6-month PFS (6.5%;
90% CI 1.1-19%). Most adverse events were grade 1 or 2, with no grade 4 adverse
events. Grade 3 adverse events were gastrointestinal (4), metabolic (3) anemia
(3), a thromboembolic event (1), ventricular tachycardia (1), hypotension during
infusion (1) and fatigue (1). The study was stopped after the first stage of
accrual. CONCLUSION: Rilotumumab was well-tolerated, but had limited activity.
The level of activity does not warrant further evaluation of rilotumumab as a
single agent in patients with ovarian cancer.
|Adult
[MESH]
|Aged
[MESH]
|Aged, 80 and over
[MESH]
|Antibodies, Monoclonal, Humanized
[MESH]
|Antibodies, Monoclonal/*therapeutic use
[MESH]
|Carcinoma, Ovarian Epithelial
[MESH]
|Disease-Free Survival
[MESH]
|Fallopian Tube Neoplasms/*drug therapy
[MESH]
|Female
[MESH]
|Humans
[MESH]
|Middle Aged
[MESH]
|Neoplasm Recurrence, Local/*drug therapy
[MESH]
|Neoplasms, Glandular and Epithelial/*drug therapy
[MESH]
free
free
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