A phase II study of sorafenib in advanced uterine carcinoma/carcinosarcoma: a trial of the Chicago, PMH, and California Phase II Consortia.
Gynecol Oncol
; 117(1): 37-40, 2010 Apr.
Article
em En
| MEDLINE
| ID: mdl-20117828
ABSTRACT
OBJECTIVES:
To determine the efficacy and safety of single agent sorafenib, an oral multi-targeted tyrosine kinase inhibitor, in patients with advanced uterine carcinoma and carcinosarcoma.METHODS:
This multi-institutional non-randomized phase II trial enrolled two cohorts patients with uterine carcinoma (cohort A) and uterine carcinosarcoma (cohort B). Eligibility criteria included measurable disease, 0-1 prior chemotherapy regimens, and ECOG performance statusRESULTS:
Fifty-six patients (40 with carcinoma, 16 with carcinosarcoma) were enrolled between March 2005 and August 2007. Two (5%) patients with uterine carcinoma had a partial response (PR) and 17 (42.5%) achieved stable disease (SD). Five had SD lasting at least 4 months. The 6-month progression-free survival rate for patients with carcinoma was 29%, and the median overall survival was 11.4 months. No patients with carcinosarcoma had an objective response. Four (25%) had SD, and one had SD lasting 18 months. The 6-month progression-free survival rate was 13%, and the median overall survival was 5.0 months. Grade 3/4 drug related toxicities included hypertension (13%), hand-foot syndrome (13%), hypophosphatemia (7%), anemia (5%), rash (5%), diarrhea (5%), thrombosis (5%), fatigue (5%) and bleeding (5%).CONCLUSION:
Sorafenib had minimal activity in patients with uterine carcinoma. Predictive factors for potential benefit are needed.
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Piridinas
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Neoplasias Uterinas
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Benzenossulfonatos
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Carcinoma
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Carcinossarcoma
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Antineoplásicos
Tipo de estudo:
Clinical_trials
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Prognostic_studies
Limite:
Adult
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Aged
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Aged80
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
Gynecol Oncol
Ano de publicação:
2010
Tipo de documento:
Article
País de afiliação:
Estados Unidos