Phase II study of bortezomib in patients with previously treated advanced urothelial tract transitional cell carcinoma: CALGB 90207.
Journal Article (Journal Article;Multicenter Study)
BACKGROUND: There is no standard second-line treatment for advanced urothelial carcinoma (UC). Response rates to second-line chemotherapy for advanced UC are low and response duration is short. Bortezomib is a proteasome inhibitor with preclinical activity against UC. PATIENTS AND METHODS: Treatment consisted of bortezomib 1.3 mg/m(2) i.v. twice weekly for two consecutive weeks, followed by a 1-week break. The primary end point was objective response rate (complete response + partial response) by Response Evaluation Criteria in Solid Tumors criteria. Secondary end points included safety, toxicity, and progression-free and overall survival. RESULTS: In all, 25 patients with advanced UC previously treated with combination chemotherapy were enrolled in a multi-institutional single-arm trial from December 2003 through April 2005. Only 29% of patients had node-only metastases. Grade 3/4 drug-related toxic effects included thrombocytopenia (4%), anemia (8%), lymphopenia (8%), sensory neuropathy (6%), hyperglycemia (4%), hypernatremia (4%), fatigue (4%), neuropathic pain (6%), dehydration (4%), and vomiting (4%). No objective responses were observed [95% confidence interval (CI) = 0-12]. The median time to progression was 1.4 months (95% CI = 1.1-2.0 months), and the median survival time was 5.7 months (95% CI = 3.6-8.4 months). There were no treatment-related deaths. CONCLUSION: Although bortezomib is well tolerated, it does not have antitumor activity as second-line therapy in UC.
Full Text
Duke Authors
Cited Authors
- Rosenberg, JE; Halabi, S; Sanford, BL; Himelstein, AL; Atkins, JN; Hohl, RJ; Millard, F; Bajorin, DF; Small, EJ; Cancer and Leukemia Group B,
Published Date
- May 2008
Published In
Volume / Issue
- 19 / 5
Start / End Page
- 946 - 950
PubMed ID
- 18272914
Pubmed Central ID
- 18272914
Electronic International Standard Serial Number (EISSN)
- 1569-8041
Digital Object Identifier (DOI)
- 10.1093/annonc/mdm600
Language
- eng
Conference Location
- England