Phase II study of bortezomib in patients with previously treated advanced urothelial tract transitional cell carcinoma: CALGB 90207

J. E. Rosenberg, S. Halabi, B. L. Sanford, A. L. Himelstein, J. N. Atkins, R. J. Hohl, F. Millard, D. F. Bajorin, E. J. Small

Research output: Contribution to journalArticle

40 Scopus citations

Abstract

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 andmethods: 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.

Original languageEnglish (US)
Pages (from-to)946-950
Number of pages5
JournalAnnals of Oncology
Volume19
Issue number5
DOIs
StatePublished - May 2008

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

Fingerprint Dive into the research topics of 'Phase II study of bortezomib in patients with previously treated advanced urothelial tract transitional cell carcinoma: CALGB 90207'. Together they form a unique fingerprint.

  • Cite this

    Rosenberg, J. E., Halabi, S., Sanford, B. L., Himelstein, A. L., Atkins, J. N., Hohl, R. J., Millard, F., Bajorin, D. F., & Small, E. J. (2008). Phase II study of bortezomib in patients with previously treated advanced urothelial tract transitional cell carcinoma: CALGB 90207. Annals of Oncology, 19(5), 946-950. https://doi.org/10.1093/annonc/mdm600