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

38 Citations (Scopus)

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 1 2008

Fingerprint

Transitional Cell Carcinoma
Carcinoma
Confidence Intervals
Hypernatremia
Lymphopenia
Proteasome Inhibitors
Poisons
Neuralgia
Therapeutics
Combination Drug Therapy
Dehydration
Hyperglycemia
Disease-Free Survival
Vomiting
Fatigue
Anemia
Bortezomib
Neoplasm Metastasis
Safety
Drug Therapy

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

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. / Phase II study of bortezomib in patients with previously treated advanced urothelial tract transitional cell carcinoma : CALGB 90207. In: Annals of Oncology. 2008 ; Vol. 19, No. 5. pp. 946-950.
@article{786f84b45ce744e1b1f73305e7a55444,
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.",
author = "Rosenberg, {J. E.} and S. Halabi and Sanford, {B. L.} and Himelstein, {A. L.} and Atkins, {J. N.} and Hohl, {R. J.} and F. Millard and Bajorin, {D. F.} and Small, {E. J.}",
year = "2008",
month = "5",
day = "1",
doi = "10.1093/annonc/mdm600",
language = "English (US)",
volume = "19",
pages = "946--950",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "Oxford University Press",
number = "5",

}

Rosenberg, JE, Halabi, S, Sanford, BL, Himelstein, AL, Atkins, JN, Hohl, RJ, Millard, F, Bajorin, DF & Small, EJ 2008, 'Phase II study of bortezomib in patients with previously treated advanced urothelial tract transitional cell carcinoma: CALGB 90207', Annals of Oncology, vol. 19, no. 5, pp. 946-950. https://doi.org/10.1093/annonc/mdm600

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

In: Annals of Oncology, Vol. 19, No. 5, 01.05.2008, p. 946-950.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Phase II study of bortezomib in patients with previously treated advanced urothelial tract transitional cell carcinoma

T2 - CALGB 90207

AU - Rosenberg, J. E.

AU - Halabi, S.

AU - Sanford, B. L.

AU - Himelstein, A. L.

AU - Atkins, J. N.

AU - Hohl, R. J.

AU - Millard, F.

AU - Bajorin, D. F.

AU - Small, E. J.

PY - 2008/5/1

Y1 - 2008/5/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=43049129660&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=43049129660&partnerID=8YFLogxK

U2 - 10.1093/annonc/mdm600

DO - 10.1093/annonc/mdm600

M3 - Article

C2 - 18272914

AN - SCOPUS:43049129660

VL - 19

SP - 946

EP - 950

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

IS - 5

ER -