| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 3945259 | Gynecologic Oncology | 2012 | 5 Pages |
ObjectiveThe 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.MethodsPatients 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 4 mg/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).Results41 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.ConclusionsSingle agent aflibercept has modest activity in patients with uterine leiomyosarcoma and minimal activity in women with carcinosarcoma.
► In this study we investigate the efficacy of the anti-angiogenic aflibercept in 2 groups of women with uterine sarcoma. ► Single agent aflibercept has minimal activity in women with recurrent or metastatic carcinosarcoma. ► Single agent aflibercept has modest activity (stable disease rate 27%) in women with metastatic or recurrent uterine leiomyosarcoma.
