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Combination of Intravesical Chemotherapy and Bacillus Calmette – Guerin Versus Bacillus Calmette – Guerin Monotherapy in Intermediate- and High-risk Nonmuscle Invasive Bladder Cancer

View Article: PubMed Central - PubMed

ABSTRACT

Urothelial carcinoma of the bladder has become a major cause of morbidity, mortality, and health-related costs. There is still no standard instillation therapy against bladder cancer. A meta-analysis was conducted to evaluate the efficacy and toxicity of adding chemotherapy to Bacillus Calmette–Guerin (BCG) in intermediate- and high-risk nonmuscle invasive bladder cancer (NMIBC).

All randomized controlled trials (RCTs) that evaluated the efficacy of combination therapy and BCG monotherapy for intermediate- and high-risk NMIBC were comprehensively searched. Relevant databases, including PubMed, Embase, Cochrane Central Register of Controlled trials databases, and American Society of Clinical Oncology (http://www.asco.org/ASCO), the clinical trial registration website (ClinicalTrials.gov), and relevant trials from the references of selected studies were searched from initial state up to June 6, 2015. Random-effects model was used to estimate hazard ratios (HRs) statistics. All statistical analyses were performed by STATA (version 13.0, College Station, TX).

Seven studies, including 1373 patients with intermediate- and high-risk NMIBC, were identified. For disease-free survival, the pooled HRs from all studies was 0.69 (95% confidence interval [CI], 0.48–1.00; P = 0.048). The disease-free survival benefit was more apparent among patients with intermediate-risk NMIBC (P = 0.002) or Ta/T1 with/without carcinoma in situ (P < 0.01). In subgroup analysis, a significant reduction in recurrence was found in studies that explored the influence of a perioperative single dose instillation compared with delayed BCG monotherapy (HR = 0.60; 95% CI, 0.38–0.92; P = 0.021). No significant difference was found for progression-free survival (HR = 0.78; 95% CI, 0.43–1.44; P = 0.435).

Patients with intermediate- and high-risk NMIBC who underwent combination therapy achieved lower rates of recurrence than those who underwent BCG therapy alone. No difference in progression-free survival was found between the 2 different therapy schedules. Better efficacy for a perioperative single dose instillation compared with delayed BCG monotherapy was found in this meta-analysis.

No MeSH data available.


Related in: MedlinePlus

A, Forest plots of disease-free survival for different tumor stages. B, Different tumor risks. HR = hazard ratio, CI = confidence interval.
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Figure 4: A, Forest plots of disease-free survival for different tumor stages. B, Different tumor risks. HR = hazard ratio, CI = confidence interval.

Mentions: The subgroup analyses were shown in Figures 4 and 5. The heterogeneity was explained by the tumor stage. Patients with Ta/T1 with (or without) the CIS stage benefited from combination therapy (HR = 0.54; 95% CI, 0.44–0.67; P = 0, heterogeneity P = 0.889, I2 = 0%, Figure 4), whereas patients with CIS alone did not gain any benefit from combination therapy (HR = 1.20; 95% CI, 0.79–1.81; P = 0.395, Figure 4). Carcinoma in situ is different from the Ta/T1 stage. Patients treated with BCG + MMC did not exhibit a significant difference compared with patients treated with BCG alone in terms of DFS (HR = 0.75; 95% CI, 0.49–1.16; P = 0.198, Figure 5), but there was a significant difference in DFS between BCG + epirubicin combination therapy and BCG monotherapy (HR = 0.52; 95% CI, 0.30–0.88; P = 0.015, Figure 5). The combination therapy had a more significant effect on reducing the recurrence rate of intermediate-risk NMIBC (HR = 0.6; 95% CI, 0.44–0.83; P = 0.002, Figure 4), but did not have a significant benefit for high-risk NMIBC (HR = 0.72; 95% CI, 0.43–1.21; P = 0.215, Figure 4).


Combination of Intravesical Chemotherapy and Bacillus Calmette – Guerin Versus Bacillus Calmette – Guerin Monotherapy in Intermediate- and High-risk Nonmuscle Invasive Bladder Cancer
A, Forest plots of disease-free survival for different tumor stages. B, Different tumor risks. HR = hazard ratio, CI = confidence interval.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4998288&req=5

Figure 4: A, Forest plots of disease-free survival for different tumor stages. B, Different tumor risks. HR = hazard ratio, CI = confidence interval.
Mentions: The subgroup analyses were shown in Figures 4 and 5. The heterogeneity was explained by the tumor stage. Patients with Ta/T1 with (or without) the CIS stage benefited from combination therapy (HR = 0.54; 95% CI, 0.44–0.67; P = 0, heterogeneity P = 0.889, I2 = 0%, Figure 4), whereas patients with CIS alone did not gain any benefit from combination therapy (HR = 1.20; 95% CI, 0.79–1.81; P = 0.395, Figure 4). Carcinoma in situ is different from the Ta/T1 stage. Patients treated with BCG + MMC did not exhibit a significant difference compared with patients treated with BCG alone in terms of DFS (HR = 0.75; 95% CI, 0.49–1.16; P = 0.198, Figure 5), but there was a significant difference in DFS between BCG + epirubicin combination therapy and BCG monotherapy (HR = 0.52; 95% CI, 0.30–0.88; P = 0.015, Figure 5). The combination therapy had a more significant effect on reducing the recurrence rate of intermediate-risk NMIBC (HR = 0.6; 95% CI, 0.44–0.83; P = 0.002, Figure 4), but did not have a significant benefit for high-risk NMIBC (HR = 0.72; 95% CI, 0.43–1.21; P = 0.215, Figure 4).

View Article: PubMed Central - PubMed

ABSTRACT

Urothelial carcinoma of the bladder has become a major cause of morbidity, mortality, and health-related costs. There is still no standard instillation therapy against bladder cancer. A meta-analysis was conducted to evaluate the efficacy and toxicity of adding chemotherapy to Bacillus Calmette–Guerin (BCG) in intermediate- and high-risk nonmuscle invasive bladder cancer (NMIBC).

All randomized controlled trials (RCTs) that evaluated the efficacy of combination therapy and BCG monotherapy for intermediate- and high-risk NMIBC were comprehensively searched. Relevant databases, including PubMed, Embase, Cochrane Central Register of Controlled trials databases, and American Society of Clinical Oncology (http://www.asco.org/ASCO), the clinical trial registration website (ClinicalTrials.gov), and relevant trials from the references of selected studies were searched from initial state up to June 6, 2015. Random-effects model was used to estimate hazard ratios (HRs) statistics. All statistical analyses were performed by STATA (version 13.0, College Station, TX).

Seven studies, including 1373 patients with intermediate- and high-risk NMIBC, were identified. For disease-free survival, the pooled HRs from all studies was 0.69 (95% confidence interval [CI], 0.48–1.00; P = 0.048). The disease-free survival benefit was more apparent among patients with intermediate-risk NMIBC (P = 0.002) or Ta/T1 with/without carcinoma in situ (P < 0.01). In subgroup analysis, a significant reduction in recurrence was found in studies that explored the influence of a perioperative single dose instillation compared with delayed BCG monotherapy (HR = 0.60; 95% CI, 0.38–0.92; P = 0.021). No significant difference was found for progression-free survival (HR = 0.78; 95% CI, 0.43–1.44; P = 0.435).

Patients with intermediate- and high-risk NMIBC who underwent combination therapy achieved lower rates of recurrence than those who underwent BCG therapy alone. No difference in progression-free survival was found between the 2 different therapy schedules. Better efficacy for a perioperative single dose instillation compared with delayed BCG monotherapy was found in this meta-analysis.

No MeSH data available.


Related in: MedlinePlus