Annals of Oncology Advance Access published online on February 13, 2008
Annals of Oncology, doi:10.1093/annonc/mdm600
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Phase II study of bortezomib in patients with previously treated advanced urothelial tract transitional cell carcinoma: CALGB 90207
1 Division of Hematology and Oncology, University of California, San Francisco Cancer Center, San Francisco, CA
2 Department of Biostatistics and Bioinformatics and Cancer and Leukemia Group B (CALGB) Statistical Center, Duke University Medical Center, Durham, NC
3 Helen F. Graham Cancer Center, Newark, DE
4 Southeast Cancer Control Consortium, Winston-Salem, NC
5 Department of Internal Medicine, University of Iowa, Iowa City, IA
6 Department of Internal Medicine, University of Iowa, Iowa City, IA
7 Department of Medicine, UCSD Moores Cancer Center, La Jolla, CA
8 Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY
* Correspondence to: Dr J. E. Rosenberg, UCSF Cancer Center, 1600 Divisadero Street, Box 1711, San Francisco, CA 94115, USA. Tel: +1-415-353-7095; Fax: +1-415-353-7779; E-mail: jrosenbe{at}medicine.ucsf.edu
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/m2 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 Reponse 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.
bladder cancer, bortezomib, proteasome, PS-341, salvage therapy, urothelial carcinoma
Received for publication September 27, 2007. Revision received December 4, 2007. Accepted for publication December 17, 2007.
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