1. A phase II study single agent of aflibercept (VEGF Trap) in patients with recurrent or metastatic gynecologic carcinosarcomas and uterine leiomyosarcoma. A trial of the Princess Margaret Hospital, Chicago and California Cancer Phase II Consortia.
- Author
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Mackay HJ, Buckanovich RJ, Hirte H, Correa R, Hoskins P, Biagi J, Martin LP, Fleming GF, Morgan R, Wang L, Polintan R, and Oza AM
- Subjects
- Adult, Aged, Antineoplastic Agents adverse effects, California, Carcinosarcoma mortality, Chicago, Disease-Free Survival, Drug Administration Schedule, Female, Genital Neoplasms, Female mortality, Humans, Kaplan-Meier Estimate, Leiomyosarcoma mortality, Middle Aged, Receptors, Vascular Endothelial Growth Factor, Recombinant Fusion Proteins adverse effects, Treatment Outcome, Antineoplastic Agents therapeutic use, Carcinosarcoma drug therapy, Genital Neoplasms, Female drug therapy, Leiomyosarcoma drug therapy, Recombinant Fusion Proteins therapeutic use
- Abstract
Objective: The aim of this multi-institutional non randomized phase II trial was to determine the efficacy and safety of single agent aflibercept (VEGF Trap), a recombinant fusion protein that blocks multiple vascular endothelial growth factor isoforms, in women with gynecologic soft tissue sarcoma., Methods: Patients were enrolled in two cohorts each with Simon two stage designs: uterine leiomyosarcoma and carcinosarcoma of endometrial, ovarian or fallopian tube origin. Eligibility criteria included ≤2 prior lines of chemotherapy for metastatic disease and ECOG performance status of ≤2. Aflibercept 4mg/kg was administered intravenously on day 1 of a 14 day cycle. Primary endpoints were objective response and disease stabilization (Progression Free Survival (PFS) at 6 months)., Results: 41 patients with uterine leiomyosarcoma and 22 patients with carcinosarcoma (19 uterine, 3 ovarian) were enrolled on study. In the leiomyosarcoma cohort, eleven (27%) patients had stable disease (SD), 4 with SD lasting at least 24 weeks. The 6 month PFS was 17%, with median time to progression (TTP) of 1.8 (95% CI:1.6-2.1) months. In the carcinosarcoma cohort, two (9%) patients had SD, one lasting >24 weeks, median TTP was 1.6 months (95%CI: 1.1-1.7) No partial responses were observed in patients from either cohort. Grade 3 or more aflibercept related toxicity was uncommon and included hypertension, fatigue, headache and abdominal pain., Conclusions: Single agent aflibercept has modest activity in patients with uterine leiomyosarcoma and minimal activity in women with carcinosarcoma., (Copyright © 2011 Elsevier Inc. All rights reserved.)
- Published
- 2012
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