| Long-term outcomes of a randomized controlled trial comparing thermochemotherapy with mitomycin-C alone as adjuvant treatment for non-muscle-invasive bladder cancer (NMIBC). | |
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MedLine Citation:
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PMID: 21029314 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: • To present long-term efficacy data of intravesical thermochemotherapy vs chemotherapy alone with mitomycin-C (MMC) randomly administered to patients with non-muscle-invasive bladder cancer (NMIBC) as an adjuvant treatment after complete transurethral resection. PATIENTS AND METHODS: • In all, 83 patients with intermediate-/high-risk NMIBC, following complete transurethral resection, were randomly assigned to receive either intravesical thermochemotherapy by means of Synergo® (Medical Enterprises, Amsterdam, The Netherlands) or intravesical chemotherapy alone, for prophylaxis of tumour recurrence. • Two doses of MMC (20 mg dissolved in 50 mL distilled water administered throughout two consecutive sessions) was used as the chemotherapeutic agent in both arms. • In all, 75 patients completed the original study (35 of 42 in the treatment arm, 40 of 41 in the control arm), whose results at minimum 2-year follow-up have already been published. • Recently, the files of these patients have been updated for long-term outcome definition. Data on general health, follow-up examinations, tumour relapse or progression, and cause of death were collected and analysed. RESULTS: • Updated complete data collection was available for 65/75 (87%) of the original patients. • The median follow-up for tumour-free patients was 91 months. The 10-year disease-free survival rate for thermochemotherapy and chemotherapy alone were 53% and 15%, respectively (P < 0.001). • An intent-to-treat analysis performed to overcome the potential bias introduced by the asymmetrical discontinuation rate still showed a significant advantage of the active treatment over the control treatment. Bladder preservation rates for thermochemotherapy and chemotherapy alone were 86% and 79%, respectively. CONCLUSION: • This is the first analysis of long-term follow-up of patients treated with intravesical thermochemotherapy. The high rate (53%) of patients who were tumour-free 10 years after treatment completion, as well as the high rate (86%) of bladder preservation, confirms the efficacy of this adjuvant approach for NMIBC at long-term follow-up, even in patients with multiple tumours. |
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Authors:
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Renzo Colombo; Andrea Salonia; Zvi Leib; Michele Pavone-Macaluso; Dov Engelstein |
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Publication Detail:
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Type: Comparative Study; Journal Article; Randomized Controlled Trial Date: 2010-10-04 |
Journal Detail:
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Title: BJU international Volume: 107 ISSN: 1464-410X ISO Abbreviation: BJU Int. Publication Date: 2011 Mar |
Date Detail:
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Created Date: 2011-03-11 Completed Date: 2011-05-03 Revised Date: 2011-06-10 |
Medline Journal Info:
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Nlm Unique ID: 100886721 Medline TA: BJU Int Country: England |
Other Details:
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Languages: eng Pagination: 912-8 Citation Subset: IM |
Copyright Information:
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© 2010 THE AUTHORS. BJU INTERNATIONAL © 2010 BJU INTERNATIONAL. |
Affiliation:
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Department of Urology, University Vita-Salute San-Raffaele, Milan, Italy. colombo.renzo@hsr.it |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Intravesical Aged Antibiotics, Antineoplastic / therapeutic use* Chemotherapy, Adjuvant Epidemiologic Methods Female Humans Hyperthermia, Induced / methods* Male Middle Aged Mitomycin / therapeutic use* Neoplasm Invasiveness Treatment Outcome Urinary Bladder Neoplasms / drug therapy* |
| Chemical | |
Reg. No./Substance:
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0/Antibiotics, Antineoplastic; 50-07-7/Mitomycin |
| Comments/Corrections | |
Comment In:
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BJU Int. 2011 May;107(10):1685; author reply 1685-6
[PMID:
21518420
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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