Phase II study of bortezomib in patients with previously treated advanced urothelial tract transitional cell carcinoma: CALGB 90207 Journal Article
| Authors: | 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. |
| Article Title: | Phase II study of bortezomib in patients with previously treated advanced urothelial tract transitional cell carcinoma: CALGB 90207 |
| 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. © The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. |
| Keywords: | clinical article; controlled study; survival rate; treatment failure; overall survival; clinical trial; constipation; drug tolerability; fatigue; salvage therapy; cisplatin; advanced cancer; diarrhea; drug dose reduction; drug efficacy; drug safety; hypertension; side effect; treatment duration; antineoplastic agents; gemcitabine; paclitaxel; neurotoxicity; follow-up studies; lymph node metastasis; anorexia; carboplatin; edema; bortezomib; proteasome; proteasome inhibitor; controlled clinical trial; infection; multiple cycle treatment; phase 2 clinical trial; sensory neuropathy; boronic acids; protease inhibitors; pyrazines; anemia; blood toxicity; esophagitis; mucosa inflammation; nausea; stomatitis; thrombocytopenia; vomiting; antineoplastic combined chemotherapy protocols; dehydration; creatinine blood level; drug resistance, neoplasm; bladder cancer; docetaxel; alanine aminotransferase blood level; arthralgia; aspartate aminotransferase blood level; asthenia; dizziness; dyspnea; febrile neutropenia; hyperglycemia; lymphocytopenia; confidence interval; chemotherapy induced emesis; dysphagia; gastrointestinal toxicity; hyperkalemia; hypoalbuminemia; hypokalemia; hyponatremia; malaise; odynophagia; survival time; urologic neoplasms; disease severity; disease progression; drug response; gefitinib; urothelial carcinoma; muscle weakness; visceral metastasis; alkaline phosphatase blood level; carcinoma, transitional cell; hiccup; lethargy; transitional cell carcinoma; neuropathic pain; metabolic disorder; musculoskeletal disease; hypertriglyceridemia; mood disorder; soft tissue disease; hypernatremia; hypocalcemia; abdominal distension; hematologic diseases; gastrointestinal diseases; bloating; ps-341; response time |
| Journal Title: | Annals of Oncology |
| Volume: | 19 |
| Issue: | 5 |
| ISSN: | 0923-7534 |
| Publisher: | Oxford University Press |
| Date Published: | 2008-05-01 |
| Start Page: | 946 |
| End Page: | 950 |
| Language: | English |
| DOI: | 10.1093/annonc/mdm600 |
| PUBMED: | 18272914 |
| PROVIDER: | scopus |
| PMCID: | PMC5815560 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 14" - "Export Date: 17 November 2011" - "CODEN: ANONE" - "Source: Scopus" |
