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INTRAVESICULAR IMMUNOTHERAPY WITH BCG VACCINE AND INTERFERON-αα2B FOR NON-INVASIVE CARCINOMA OF THE URINARY BLADDER: RESULTS OF PROSPECTIVE RANDOMIZED STUDY

Oncourology

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Title INTRAVESICULAR IMMUNOTHERAPY WITH BCG VACCINE AND INTERFERON-αα2B FOR NON-INVASIVE CARCINOMA OF THE URINARY BLADDER: RESULTS OF PROSPECTIVE RANDOMIZED STUDY
ВНУТРИПУЗЫРНАЯ ИММУНОТЕРАПИЯ ВАКЦИНОЙ БЦЖ И ИНТЕРФЕРОНОМ-Α2B ПРИ НЕИНВАЗИВНОМ РАКЕ МОЧЕВОГО ПУЗЫРЯ: РЕЗУЛЬТАТЫ ПРОСПЕКТИВНОГО РАНДОМИЗИРОВАННОГО ИССЛЕДОВАНИЯ
 
Creator A. Minich A.; N.N. Aleksandrov Republican Research-and-Production Center of Oncology and Medical Radiology, Minsk
O. Sukonko G.; N.N. Aleksandrov Republican Research-and-Production Center of Oncology and Medical Radiology, Minsk
A. Rolevich A.; N.N. Aleksandrov Republican Research-and-Production Center of Oncology and Medical Radiology, Minsk
А. Минич А.; ГУ РНПЦ онкологии и медицинской радиологии им. Н.Н. Александрова, Минск
О. Суконко Г.; ГУ РНПЦ онкологии и медицинской радиологии им. Н.Н. Александрова, Минск
А. Ролевич И.; ГУ РНПЦ онкологии и медицинской радиологии им. Н.Н. Александрова, Минск
 
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Description Background: Both bacillus Calmette-Gue’rin (BCG) and interferon-alpha (IFN-α) are active against urinary bladder cancer. In this studywe evaluate the therapeutic efficacy and toxicity of combined intravesical BCG plus IFN-α for treating non-invasive bladder cancer.Subjects and methods: A total of 149 patients (mean age 63.2 years) were enrolled for the study. The inclusion criteria were histologically verifiednon-invasive transitional cell carcinoma with intermediate and high risks of recurrence and progression. After transurethral tumor resection, all thepatients were randomized in three groups. Group 1 (n=60) was treated with a 6-week course of BCG, 125 mg, starting 14 to 21 days after TUR, Group2 (n=60) patients received 6-week instillations of BCG, 125 mg, plus IFN-α, 6 million units, Group 3 patients (n = 29) had 4-month courses ofintravesical IFN-α, 6 million units, twice daily during 3 consecutive days. A response was assessed by cystoscopy every 3 months after treatment.Results: A median follow-up of 30.9 months revealed recurrences in 26 (43.3%) patients in the BCG group, 8 (13.3%) patients in the BCG + IFN-αgroup and 18 (62.1%) patients in the IFN-α group. Progression to muscle invasion occurred in 12% and 7% in Groups 1 and 3, respectively, withno progression in Group 2 patients. Three-year relapse-free survival was higher in the BCG+IFN group (78.5% versus 62.6 and 40.2% in theBCG and IFN-α groups, respectively). There was no significant difference between the BCG groups in relapse-free survival. Monotherapy withIFN-α showed a significantly lower response rate than did BCG therapies (p = 0.007). Adverse reactions were observed in 25, 116, and 6.9% ofpatients from Groups 1, 2 and 3, respectively. Toxicity-related withdrawal and treatment delay were similar in both BCG groups. Comparison ofthe rate of adverse reactions revealed a significant difference between the BCG + IFN-α and BCG groups (p = 0.025). The respective rates ofmoderate-to-severe adverse reactions caused by treatment were 6.7 and 21.7% in the BCG+IFN-α and BCG groups, respectively (p = 0.013).Conclusions: Full-dose intravesical BCG plus IFN-α appears to be much effective than BCG and IFN-α monotherapies despite that there isno significant difference in this study. IFN-α monotherapy showed the lowest complication rate but a lower response rate than those withBCG therapies (p = 0.007). The co-administration of BCG and IFN-α displayed a significantly less complication rate and severe adversereactions (p = 0.025 and p = 0.013, respectively). Longer follow-up is required to validate these findings. 
Внутрипузырная иммунотерапия вакциной БЦЖ и интерфероном-α2b при неинвазивном раке мочевого пузыря: результаты проспективного рандомизированного исследования
 
Publisher "PH "ABV-Press"", LLC
 
Contributor —
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Date 2014-07-31
 
Type info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
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Format application/pdf
 
Identifier http://oncourology.abvpress.ru/index.php/oncur/article/view/190
 
Source Oncourology; № 1 (2009); 34-39
Онкоурология; № 1 (2009); 34-39
1726-9776
 
Language rus
 
Relation http://oncourology.abvpress.ru/index.php/oncur/article/view/190/205
 
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