The aim: to compare disease-free survival time (DFS) in high-risk non-muscle-invasive bladder cancer patients treated with adjuvant hyperthermic intravesical chemotherapy and standard BCG therapy. Materials and methods: patients were divided into 2 groups. Group 1 (control) included patients who received adjuvant therapy after TURB with BCG vaccine (BCG therapy group; n=50), group 2 (study group) included patients (HIVEC® therapy group; n=46 ), who received adjuvant intravesical chemotherapy using a Combat BRS HIVEC® device for local hyperthermia. Results: median follow-up was 23 months (range 4 - 36). Tumor recurrence was reported in 19 patients receiving intravesical BCG therapy and in 8 patients receiving intravesical hyperthermic chemotherapy. The incidence of DFS in patients receiving chemohyperthermy was statistically higher than in patients receiving BCG therapy (log-rank test result: p=0.029). Conclusions: The method of hyperthermic intravesical chemotherapy significantly increased the 2-year disease-free survival rate - 82.6 % versus 62 % BCG therapy group (p=0.025). Its use in the future will allow increasing the frequency of organ-preserving treatment of patients with primary and recurrent muscular-non-invasive bladder tumors
Introduction Expression level of the cell proliferation marker Ki-67 correlates with the degree of differentiation of tumor cells and stage in primary patients with non-muscle-invasive bladder cancer (NMIBC), but the marker is currently not used in assessing the efficacy of adjuvant intravesical therapy and risk stratification in patients with recurrent bladder tumors. Material and methods A retroprospective study included 107 patients with high-risk NMIBC; the patients were divided into 2 groups. The first group included patients who received adjuvant therapy after transurethral resection of the bladder using the Bacillus Calmette-Guérin (BCG) vaccine (BCG therapy group; n = 54), the second group consisted of patients who received hyperthermic intravesical chemotherapy (HIVEC ® therapy group; n = 53) using the device for local hyperthermia Combat BRS HIVEC ® . Results Tumor recurrences were recorded in 21 (39%) patients receiving intravesical BCG therapy and in 9 (17%) patients after intravesical hyperthermic chemotherapy (p = 0.012). The expression level of Ki-67 in primary tumors did not differ; in recurrent tumors it was significantly different in both groups (32.05 ±13.80 vs 11.00 ± 6.86). The frequency of recurrence-free survival (RFS) in patients receiving chemohyperthermia was significantly higher than in patients after the BCG therapy (log-rank test result: p = 0.048). Conclusions Assessment of Ki-67 expression in recurrent tumors can be a criterion for the effectiveness of intravesical bladder-preserving treatment. The use of hyperthermic chemotherapy can reduce the number of radical cystectomies in a separate group of patients with NMIBC.
Objective. Comparative estimation of quality of life in patients with a high-risk musculo-noninvasive cancer of the bladder was accomplished while conduction of adjuvant intrabladder hyperthermic chemotherapy and immunotherapy with BCG vaccine. Маterials and methods. Depending on kind of treatment, the patients were distributed into two groups: Group I - 44 patients, to whom adjuvant intrabladder immunotherapy with BCG vaccine was applied, and Group II - 41 patients, to whom intrabladder chemotherapy was conducted, using the system for local hyperthermy Combat BRS. Results. The data from the patients interviewed, using EORTC QLQ-30 questionnaires, confirmed better quality of life in patients of Group II, who obtained intrabladder hyperthermic chemotherapy, peculiarly in accordance to indices of physical status, social adaptation and intoxication. In accordance to data of the patients’ interviewed with the help of FACT-BL questionnaire, also better results were obtained in patients of Group II in accordance to the social and functional well-being status, the urination quality and values of indices of the «Cancer of the Bladder» scale. Conclusion. Higher quality of life was noted in patients of Group II, who obtained intrabladder hyperthermic chemotherapy. The lower quality of life in patients of Group I, who obtained immunotherapy with BCG vaccine, was connected with multiple side effects and enhanced toxicity of this therapy, accordingly.
Cur rently, the search for additional organ-sparing methods of intravesical therapy for non-muscular-invasive bladder cancer (NMIBC) is actively continuing, which could become an effective alternative to standard treatment using the Bacillus Calmette-Guérin (BCG) vaccine. The aim of this work was to analyze the safety profile and long-term results of treatment of patients with the high-risk non-muscular-invasive bladder cancer who received adjuvant intravesical chemotherapy using the Combat BRS HIVEC® device for local hyperthermia (HIVEC® therapy group; n=53) in comparison with patients who received adjuvant therapy after transurethral resection of bladder performed with the Bacillus Calmette-Guérin vaccine (BCG therapy group; n=54). As a result, the median follow-up was 30 months (range 7-36). According to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0, the most relevant side effects in HIVEC®/BCG therapy groups were adverse events grade 1-2: fever – 1%/8%; dysuria – 9%/13%; bladder spasms – 7%/12%; hematuria – 3%/4% and urinary tract infection – 3%/10%. Tumor recurrence was reported in 23 patients receiving intravesical BCG therapy and in 10 patients receiving intravesical hyperthermic chemotherapy (42.6% versus 18.9%, p=0.008). Tumor progression was recorded in 11 patients receiving intravesical BCG therapy and in 4 patients receiving intravesical hyperthermic chemotherapy (20.4% versus 7.5%, p=0.046). The study allows us to conclude that the method of hyperthermic intravesical chemotherapy has a better safety profile compared to intravesical Bacillus Calmette–Guérin vaccine therapy, while such indicators of oncological efficacy as 3-year recurrence-free survival and the incidence of progression were better in the HIVEC® therapy group.
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