Journal article
Safety and Efficacy of Intravesical Bacillus Calmette-Guerin Plus Interferon alpha -2b Therapy for Nonmuscle Invasive Bladder Cancer in Patients With Prosthetic Devices
The Journal of urology, Vol.184(5), pp.1920-1924
11/01/2010
DOI: 10.1016/j.juro.2010.06.149
PMID: 20846678
Abstract
Patients with bladder cancer who have prosthetic devices, such as a cardiac pacemaker, artificial heart valve or orthopedic hardware, and who undergo intravesical bacillus Calmette-Guerin therapy are theoretically at higher risk for complications, including bacterial seeding of pacemaker wires or orthopedic hardware, and at further risk for infective endocarditis. We assessed the safety and efficacy of bacillus Calmette-Guerin plus interferon alpha -2b therapy in patients with nonmuscle invasive bladder cancer and a pacemaker, artificial heart valve or orthopedic hardware. Materials and Methods: We evaluated 1,045 patients with nonmuscle invasive bladder cancer enrolled in a multicenter American phase II trial of bacillus Calmette-Guerin plus interferon alpha -2b therapy, including 143 with a prosthetic device (pacemaker in 87, artificial heart valve in 13 and orthopedic hardware in 43). Weekly physician toxicity assessments and standard adverse effect reporting were done. Results: No patient had infective endocarditis or hardware infection. One patient with a pacemaker, 2 with orthopedic hardware and none with an artificial heart valve required treatment cessation for fever greater than 102.5F. All defervesced within 24 hours and had no long-term sequelae. Due to intolerable, nonlife threatening side effects 12 patients with a pacemaker, 2 with orthopedic hardware and 1 with an artificial heart valve stopped treatment. Of the remaining patients with a prosthesis 99 and 24 stopped treatment due to intolerable, nonlife threatening and serious side effects, respectively. Conclusions: Patients with a pacemaker, artificial heart valve or orthopedic hardware were no more likely than the general population to have infection or fever, or discontinue treatment due to side effects. These patients should not be excluded from intravesical bacillus Calmette-Guerin plus interferon alpha -2b therapy for nonmuscle invasive bladder cancer.
Details
- Title: Subtitle
- Safety and Efficacy of Intravesical Bacillus Calmette-Guerin Plus Interferon alpha -2b Therapy for Nonmuscle Invasive Bladder Cancer in Patients With Prosthetic Devices
- Creators
- Henry M RosevearAndrew J LightfootKenneth G NeppleMichael A O'Donnell
- Resource Type
- Journal article
- Publication Details
- The Journal of urology, Vol.184(5), pp.1920-1924
- DOI
- 10.1016/j.juro.2010.06.149
- PMID
- 20846678
- ISSN
- 0022-5347
- eISSN
- 1527-3792
- Language
- English
- Date published
- 11/01/2010
- Academic Unit
- Urology
- Record Identifier
- 9984051762702771
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