A phase II study of sorafenib in advanced uterine carcinoma/carcinosarcoma: a trial of the Chicago, PMH, and California Phase II Consortia.

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 status <or=2. Sorafenib at a dose of 400 mg was administered orally twice daily. A cycle was defined as 28 days. Objective tumor response was the primary endpoint and was assessed following every two cycles.

RESULTS:

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.

• Authors: Halla S Nimeiri, Amit M Oza, Robert J Morgan, Dezheng Huo, Laurie Elit, James A Knost, James L Wade 3rd, Edem Agamah, Everett E Vokes, Gini F Fleming
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 117 Issue 1 Pg. 37-40 (Apr 2010) ISSN: 1095-6859 [Electronic] United States
• PMID: 20117828 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: Copyright 2010 Elsevier Inc. All rights reserved.

Chemical References

• Antineoplastic Agents
• Benzenesulfonates
• Phenylurea Compounds
• Pyridines
• Niacinamide
• Sorafenib

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents (adverse effects, therapeutic use)
• Benzenesulfonates (adverse effects, therapeutic use)
• Carcinoma (drug therapy)
• Carcinosarcoma (drug therapy)
• Disease-Free Survival
• Female
• Humans
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy)
• Niacinamide (analogs & derivatives)
• Phenylurea Compounds
• Pyridines (adverse effects, therapeutic use)
• Sorafenib
• Survival Rate
• Uterine Neoplasms (drug therapy)