Use of intravesical valrubicin in clinical practice for treatment of nonmuscle-invasive bladder cancer, including carcinoma of the bladder
Objectives: The objective was to conduct a US multicenter, retrospective medical record study examining the effectiveness, safety, and patterns of use of valrubicin for treatment of nonmuscle-invasive bladder cancer (NMIBC) by clinicians since the 2009 reintroduction of valrubicin. Methods: Patients...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2014-10-01
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| Series: | Therapeutic Advances in Urology |
| Online Access: | https://doi.org/10.1177/1756287214541798 |
| _version_ | 1818113598719787008 |
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| author | Michael S. Cookson Sam S. Chang Christine Lihou Thomas Li Samira Q. Harper Zhihui Lang Ronald F. Tutrone |
| author_facet | Michael S. Cookson Sam S. Chang Christine Lihou Thomas Li Samira Q. Harper Zhihui Lang Ronald F. Tutrone |
| author_sort | Michael S. Cookson |
| collection | DOAJ |
| description | Objectives: The objective was to conduct a US multicenter, retrospective medical record study examining the effectiveness, safety, and patterns of use of valrubicin for treatment of nonmuscle-invasive bladder cancer (NMIBC) by clinicians since the 2009 reintroduction of valrubicin. Methods: Patients ≥ 18 years with NMIBC who received had one or more instillations of valrubicin (October 2009– September 2011) were eligible. The primary endpoint was event-free survival (EFS). Safety and tolerability were also assessed. Results: The medical records of 113 patients met the inclusion criteria; 100 patients (88.5%) completed valrubicin treatment. The median age was 75 years (range 42–95 years). The median NMIBC duration was 31 months since diagnosis: 51.3% (58/113) had carcinoma in situ (CIS) alone, and 31.9% (36/113) had unspecified NMIBC. Most patients, 94.7% (107/113), had more than three valrubicin instillations and 70.8% (80/113) completed a full course. The EFS rate (95% confidence interval) was 51.6% (40.9–61.3%), 30.4% (20.4–41.1%), and 16.4% (7.9–27.5%) at 3, 6, and 12 months, respectively. Median time to an event was 3.5 (2.5–4.0) months after the first valrubicin instillation. Local adverse reactions (LARs) were experienced by 49.6% (56/113) of patients; most LARs were mild (93.6%). The most frequent LARs were hematuria, pollakiuria, micturition urgency, bladder spasm, and dysuria. In total, 4.4% (5/113) of patients discontinued valrubicin because of adverse events or LARs. Conclusions: Data from the present retrospective study are consistent with previous prospective clinical trials that demonstrated valrubicin effectiveness and tolerability for select patients with CIS, before considering cystectomy. Additional prospective studies are warranted to evaluate valrubicin safety and efficacy in the broader patient population with NMIBC. |
| first_indexed | 2024-12-11T03:37:23Z |
| format | Article |
| id | doaj.art-ff586a2b1ed54437a93ba451fce2b9bd |
| institution | Directory Open Access Journal |
| issn | 1756-2872 1756-2880 |
| language | English |
| last_indexed | 2024-12-11T03:37:23Z |
| publishDate | 2014-10-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Urology |
| spelling | doaj.art-ff586a2b1ed54437a93ba451fce2b9bd2022-12-22T01:22:12ZengSAGE PublishingTherapeutic Advances in Urology1756-28721756-28802014-10-01610.1177/1756287214541798Use of intravesical valrubicin in clinical practice for treatment of nonmuscle-invasive bladder cancer, including carcinoma of the bladderMichael S. CooksonSam S. ChangChristine LihouThomas LiSamira Q. HarperZhihui LangRonald F. TutroneObjectives: The objective was to conduct a US multicenter, retrospective medical record study examining the effectiveness, safety, and patterns of use of valrubicin for treatment of nonmuscle-invasive bladder cancer (NMIBC) by clinicians since the 2009 reintroduction of valrubicin. Methods: Patients ≥ 18 years with NMIBC who received had one or more instillations of valrubicin (October 2009– September 2011) were eligible. The primary endpoint was event-free survival (EFS). Safety and tolerability were also assessed. Results: The medical records of 113 patients met the inclusion criteria; 100 patients (88.5%) completed valrubicin treatment. The median age was 75 years (range 42–95 years). The median NMIBC duration was 31 months since diagnosis: 51.3% (58/113) had carcinoma in situ (CIS) alone, and 31.9% (36/113) had unspecified NMIBC. Most patients, 94.7% (107/113), had more than three valrubicin instillations and 70.8% (80/113) completed a full course. The EFS rate (95% confidence interval) was 51.6% (40.9–61.3%), 30.4% (20.4–41.1%), and 16.4% (7.9–27.5%) at 3, 6, and 12 months, respectively. Median time to an event was 3.5 (2.5–4.0) months after the first valrubicin instillation. Local adverse reactions (LARs) were experienced by 49.6% (56/113) of patients; most LARs were mild (93.6%). The most frequent LARs were hematuria, pollakiuria, micturition urgency, bladder spasm, and dysuria. In total, 4.4% (5/113) of patients discontinued valrubicin because of adverse events or LARs. Conclusions: Data from the present retrospective study are consistent with previous prospective clinical trials that demonstrated valrubicin effectiveness and tolerability for select patients with CIS, before considering cystectomy. Additional prospective studies are warranted to evaluate valrubicin safety and efficacy in the broader patient population with NMIBC.https://doi.org/10.1177/1756287214541798 |
| spellingShingle | Michael S. Cookson Sam S. Chang Christine Lihou Thomas Li Samira Q. Harper Zhihui Lang Ronald F. Tutrone Use of intravesical valrubicin in clinical practice for treatment of nonmuscle-invasive bladder cancer, including carcinoma of the bladder Therapeutic Advances in Urology |
| title | Use of intravesical valrubicin in clinical practice for treatment of nonmuscle-invasive bladder cancer, including carcinoma of the bladder |
| title_full | Use of intravesical valrubicin in clinical practice for treatment of nonmuscle-invasive bladder cancer, including carcinoma of the bladder |
| title_fullStr | Use of intravesical valrubicin in clinical practice for treatment of nonmuscle-invasive bladder cancer, including carcinoma of the bladder |
| title_full_unstemmed | Use of intravesical valrubicin in clinical practice for treatment of nonmuscle-invasive bladder cancer, including carcinoma of the bladder |
| title_short | Use of intravesical valrubicin in clinical practice for treatment of nonmuscle-invasive bladder cancer, including carcinoma of the bladder |
| title_sort | use of intravesical valrubicin in clinical practice for treatment of nonmuscle invasive bladder cancer including carcinoma of the bladder |
| url | https://doi.org/10.1177/1756287214541798 |
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