title: Combination of Intravesical Chemotherapy and Bacillus Calmette-Guerin Versus Bacillus Calmette-Guerin Monotherapy in Intermediate- and High-risk Nonmuscle Invasive Bladder Cancer: A Systematic Review and Meta-analysis.
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.
authors.affiliation: From the Department of Urology, Qilu Hospital of Shandong University (JC, SC, YY, YZ, FC, BS); Department of Endocrinology and Metabolism, Shandong Provincial Hospital affiliated to Shandong University (WW); Department of Radiation Oncology, Qilu Hospital of Shandong University (PC); and Department of Neurology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, People's Republic of China (YG).
authors.forename: Jianfeng
authors.initials: J
authors.lastname: Cui
authors.forename: Wenbo
authors.initials: W
authors.lastname: Wang
authors.forename: Shouzhen
authors.initials: S
authors.lastname: Chen
authors.forename: Pengxiang
authors.initials: P
authors.lastname: Chen
authors.forename: Yue
authors.initials: Y
authors.lastname: Yang
authors.forename: Yunliang
authors.initials: Y
authors.lastname: Guo
authors.forename: Yaofeng
authors.initials: Y
authors.lastname: Zhu
authors.forename: Fan
authors.initials: F
authors.lastname: Chen
authors.forename: Benkang
authors.initials: B
authors.lastname: Shi
mesh_terms: D000283:Administration, Intravesical; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001500:BCG Vaccine / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D001500:BCG Vaccine
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