Risk of subsequent tumour recurrence and stage progression in bacille Calmette‐Guérin relapsing non‐muscle‐invasive bladder cancer

• Published in: BJU international Vol. 110; no. 11b; pp. E508 - E513
• Main Authors: Matsumoto, Kazuhiro, Kikuchi, Eiji, Shirakawa, Hiroshi, Hayakawa, Nozomi, Tanaka, Nobuyuki, Ninomiya, Akiharu, Miyajima, Akira, Nakamura, So, Oya, Mototsugu
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.12.2012; Wiley Subscription Services, Inc
• Subjects: Adjuvants, Immunologic - administration & dosage; Administration, Intravesical; Adult; Aged; Aged, 80 and over; bacille Calmette‐Guérin; BCG failure; BCG relapsing; BCG Vaccine - administration & dosage; Bladder cancer; Carcinoma, Transitional Cell - drug therapy; Carcinoma, Transitional Cell - pathology; Disease Progression; Disease-Free Survival; Female; Humans; Incidence; Instillation, Drug; Japan - epidemiology; Male; Middle Aged; Neoplasm Invasiveness; Neoplasm Recurrence, Local - epidemiology; Neoplasm Recurrence, Local - pathology; Neoplasm Staging; non‐muscle‐invasive bladder cancer; Risk Factors; stage progression; Treatment Outcome; tumour recurrence; Urinary Bladder Neoplasms - drug therapy; Urinary Bladder Neoplasms - pathology; Japan
• ISSN: 1464-4096; 1464-410X; 1464-410X
• DOI: 10.1111/j.1464-410X.2012.11194.x

Study Type – Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? So far, few previous reports have analysed the risk factors for tumour recurrence and stage progression with a special focus on BCG‐relapsing disease, defined as the recurrence after achieving a disease‐free status by initial BCG instillations for 6 months. There are no guidelines outlining a specific treatment strategy for BCG‐relapsing disease, although many BCG failure cases are attributable to BCG‐relapsing disease. In this study, additional BCG instillation was shown to decrease the subsequent tumour recurrence rate against BCG‐relapsing tumours with intermediate pathological risk features; however, a BCG‐relapsing tumour with a pathologically high risk was a significant risk factor for both subsequent tumour recurrence and stage progression. This information might identify a therapeutic strategy for BCG‐relapsing tumours. OBJECTIVE •  To investigate the risk of subsequent tumour recurrence and stage progression in bacillus Calmette‐Guérin (BCG)‐relapsing non‐muscle‐invasive bladder cancer, defined as recurrence after achieving a disease‐free status for 6 months. PATIENTS AND METHODS •  A total of 183 patients with BCG‐relapsing tumours were treated with conservative therapy between 1985 and 2008 at our three institutions. •  We analysed the association between their clinicopathological parameters and subsequent tumour recurrence or stage progression. RESULTS •  Additional induction courses of BCG or anticancer drug (mitomycin C or epirubicin) instillations were performed in 119 patients and 24 patients, respectively. The remaining 40 patients did not undergo any adjuvant therapy. •  Multivariate analysis showed that a relapsing tumour with a pathologically high risk (defined as tumours with G3 and/or pT1 and/or concomitant carcinoma in situ) was a significant risk factor for subsequent tumour recurrence (P= 0.002; hazard ratio [HR] 2.15). Additional BCG instillation significantly decreased the subsequent tumour recurrence rate (P < 0.001; HR 0.41). •  Multivariate analysis also showed that a relapsing tumour with a pathologically high risk was also significantly associated with stage progression (P < 0.001; HR 8.05). CONCLUSIONS •  An additional course of BCG instillation might be effective in patients with BCG‐relapsing tumours with pathologically intermediate risk. •  Nevertheless, some patients with high‐risk pathological features developed subsequent stage progression. Such patients should be followed up closely and counselled on the need for aggressive therapeutic options, such as radical cystectomy.