Bacillus Calmette-Guérin with or without interferon α-2b and megadose versus recommended daily allowance vitamins during induction and maintenance intravesical treatment of nonmuscle invasive bladder cancer
Copyright © 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved..
PURPOSE: In a multicenter, prospectively randomized study we evaluated bacillus Calmette-Guérin alone vs bacillus Calmette-Guérin plus interferon α-2b and megadose vitamins vs recommended daily allowance vitamins during induction and maintenance intravesical therapy in the treatment of nonmuscle invasive bladder cancer.
MATERIALS AND METHODS: Patients who were bacillus Calmette-Guérin naïve with carcinoma in situ, Ta or T1 urothelial cancer were randomized to receive intravesical bacillus Calmette-Guérin or bacillus Calmette-Guérin plus interferon α-2b. Patients were further randomized to receive a recommended daily allowance or megadose vitamin preparation. Induction bacillus Calmette-Guérin treatment was given weekly for 6 weeks, and patients who were recurrence-free received maintenance treatment at 4, 7, 13, 19, 25 and 37 months. Patients were followed with quarterly cystoscopy for 2 years, then semiannually through year 4 and then annually. The primary end point was biopsy confirmed tumor recurrence or positive cytology.
RESULTS: A total of 670 patients were accrued and randomized. At 24-month median followup recurrence-free survival was similar in all groups with 63% in the bacillus Calmette-Guérin with recommended daily allowance vitamins group, 59% in bacillus Calmette-Guérin with megadose vitamins, 55% in bacillus Calmette-Guérin/interferon α-2b with recommended daily allowance vitamins and 61% in bacillus Calmette-Guérin/interferon α-2b with megadose vitamins (p >0.05). The addition of interferon α-2b was associated with a more frequent incidence of fever (11% vs 5%) and constitutional symptoms (18% vs 11%) vs bacillus Calmette-Guérin alone (p <0.05).
CONCLUSIONS: Interferon α-2b added to bacillus Calmette-Guérin induction and maintenance intravesical therapy did not decrease tumor recurrence in bacillus Calmette-Guérin naïve cases, but was associated with increased fever and constitutional symptoms. No difference in time to recurrence was present in patients receiving recommended daily allowance vs high dose vitamins.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2010 |
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| Erschienen: |
2010 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:184 |
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| Enthalten in: |
The Journal of urology - 184(2010), 5 vom: 15. Nov., Seite 1915-9 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Nepple, Kenneth G [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 02.11.2010 Date Revised 30.03.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.juro.2010.06.147 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM201618303 |
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| 024 | 7 | |a 10.1016/j.juro.2010.06.147 |2 doi | |
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| 041 | |a eng | ||
| 100 | 1 | |a Nepple, Kenneth G |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Bacillus Calmette-Guérin with or without interferon α-2b and megadose versus recommended daily allowance vitamins during induction and maintenance intravesical treatment of nonmuscle invasive bladder cancer |
| 264 | 1 | |c 2010 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 02.11.2010 | ||
| 500 | |a Date Revised 30.03.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a PURPOSE: In a multicenter, prospectively randomized study we evaluated bacillus Calmette-Guérin alone vs bacillus Calmette-Guérin plus interferon α-2b and megadose vitamins vs recommended daily allowance vitamins during induction and maintenance intravesical therapy in the treatment of nonmuscle invasive bladder cancer | ||
| 520 | |a MATERIALS AND METHODS: Patients who were bacillus Calmette-Guérin naïve with carcinoma in situ, Ta or T1 urothelial cancer were randomized to receive intravesical bacillus Calmette-Guérin or bacillus Calmette-Guérin plus interferon α-2b. Patients were further randomized to receive a recommended daily allowance or megadose vitamin preparation. Induction bacillus Calmette-Guérin treatment was given weekly for 6 weeks, and patients who were recurrence-free received maintenance treatment at 4, 7, 13, 19, 25 and 37 months. Patients were followed with quarterly cystoscopy for 2 years, then semiannually through year 4 and then annually. The primary end point was biopsy confirmed tumor recurrence or positive cytology | ||
| 520 | |a RESULTS: A total of 670 patients were accrued and randomized. At 24-month median followup recurrence-free survival was similar in all groups with 63% in the bacillus Calmette-Guérin with recommended daily allowance vitamins group, 59% in bacillus Calmette-Guérin with megadose vitamins, 55% in bacillus Calmette-Guérin/interferon α-2b with recommended daily allowance vitamins and 61% in bacillus Calmette-Guérin/interferon α-2b with megadose vitamins (p >0.05). The addition of interferon α-2b was associated with a more frequent incidence of fever (11% vs 5%) and constitutional symptoms (18% vs 11%) vs bacillus Calmette-Guérin alone (p <0.05) | ||
| 520 | |a CONCLUSIONS: Interferon α-2b added to bacillus Calmette-Guérin induction and maintenance intravesical therapy did not decrease tumor recurrence in bacillus Calmette-Guérin naïve cases, but was associated with increased fever and constitutional symptoms. No difference in time to recurrence was present in patients receiving recommended daily allowance vs high dose vitamins | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Adjuvants, Immunologic |2 NLM | |
| 650 | 7 | |a Antineoplastic Agents |2 NLM | |
| 650 | 7 | |a BCG Vaccine |2 NLM | |
| 650 | 7 | |a Interferon alpha-2 |2 NLM | |
| 650 | 7 | |a Interferon-alpha |2 NLM | |
| 650 | 7 | |a Recombinant Proteins |2 NLM | |
| 650 | 7 | |a Vitamins |2 NLM | |
| 700 | 1 | |a Lightfoot, Andrew J |e verfasserin |4 aut | |
| 700 | 1 | |a Rosevear, Henry M |e verfasserin |4 aut | |
| 700 | 1 | |a O'Donnell, Michael A |e verfasserin |4 aut | |
| 700 | 1 | |a Lamm, Donald L |e verfasserin |4 aut | |
| 700 | 0 | |a Bladder Cancer Genitourinary Oncology Study Group |e verfasserin |4 aut | |
| 700 | 1 | |a Alter, L |e investigator |4 oth | |
| 700 | 1 | |a Beccia, D |e investigator |4 oth | |
| 700 | 1 | |a Bergreen, P |e investigator |4 oth | |
| 700 | 1 | |a Bilhartz, D |e investigator |4 oth | |
| 700 | 1 | |a Bodie, B |e investigator |4 oth | |
| 700 | 1 | |a Bogache, W |e investigator |4 oth | |
| 700 | 1 | |a Bohl, R |e investigator |4 oth | |
| 700 | 1 | |a Ching, V |e investigator |4 oth | |
| 700 | 1 | |a Chow, S |e investigator |4 oth | |
| 700 | 1 | |a Chu, F |e investigator |4 oth | |
| 700 | 1 | |a Clark, P |e investigator |4 oth | |
| 700 | 1 | |a Cohen, S |e investigator |4 oth | |
| 700 | 1 | |a Craig, M |e investigator |4 oth | |
| 700 | 1 | |a Danella, J |e investigator |4 oth | |
| 700 | 1 | |a Davis, J |e investigator |4 oth | |
| 700 | 1 | |a Dineen, M |e investigator |4 oth | |
| 700 | 1 | |a Dresner, S |e investigator |4 oth | |
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| 700 | 1 | |a Evans, R |e investigator |4 oth | |
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| 700 | 1 | |a Freedman, S |e investigator |4 oth | |
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| 700 | 1 | |a Goldfischer, E |e investigator |4 oth | |
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| 700 | 1 | |a Holcomb, F |e investigator |4 oth | |
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| 700 | 1 | |a Kabler, R |e investigator |4 oth | |
| 700 | 1 | |a Kandzari, S |e investigator |4 oth | |
| 700 | 1 | |a Keane, T |e investigator |4 oth | |
| 700 | 1 | |a Keeler, L |c 3rd |e investigator |4 oth | |
| 700 | 1 | |a Kerfoot, W |e investigator |4 oth | |
| 700 | 1 | |a Klein, F |e investigator |4 oth | |
| 700 | 1 | |a Kotler, M |e investigator |4 oth | |
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| 700 | 1 | |a Mangubat, M |e investigator |4 oth | |
| 700 | 1 | |a McCammon, K |e investigator |4 oth | |
| 700 | 1 | |a McCurdy, M |e investigator |4 oth | |
| 700 | 1 | |a Messing, E |e investigator |4 oth | |
| 700 | 1 | |a Metzger, C |e investigator |4 oth | |
| 700 | 1 | |a Monnig, W |e investigator |4 oth | |
| 700 | 1 | |a Oselinsky, D |e investigator |4 oth | |
| 700 | 1 | |a Pewitt, E |e investigator |4 oth | |
| 700 | 1 | |a Phillips, N |e investigator |4 oth | |
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| 700 | 1 | |a Williams, R |e investigator |4 oth | |
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