Maintenance Bacillus Calmette-Guerin Immunotherapy For TaG3 Or T1G3 And/or Carcinoma In Situ Transitional Cell Carcinoma Of The Bladder

Main Category: Urology / Nephrology
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 13 Apr 2008 - 0:00 PDT

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UroToday.com - On behalf of the Spanish CUETO study group, Dr. Martinez-Pineiro presented multicenter data on a new BCG schedule with the intent to lower toxicity. Patients in the study had TaG3 or T1G3 transitional cell carcinoma of the bladder and/or carcinoma in situ. Within 3 weeks following biopsy of carcinoma in situ and resection of any stage Ta or T1 transitional cell tumors, 398 patients were started on a 6-week induction course of 81 mg intravesical Connaught BCG. Patients were randomized by central computer to receive BCG maintenance therapy (n=202) or no BCG maintenance therapy (n=196). Maintenance therapy consisted of one intravesical BCG instillation every 3 months from initiation of induction therapy during 3 years (12 instillations). All patients were followed for adverse effects of treatment, recurrence, disease worsening and survival.

Twenty patients discontinued treatment in the maintenance arm versus 6 in the no maintenance arm. Mean follow-up was 33.5 months; 33.2 months for the no maintenance arm and 33.7 months for the maintenance arm. Estimated mean recurrence-free survival was 58.9 months in the no maintenance and 62.1 months in the maintenance arm (p=0.1118). Estimated mean time for worsening-free survival, defined as no evidence of progression including pathological stage T2 disease or greater, or need for cystectomy, systemic chemotherapy or radiation therapy, is 73.5 months in the no maintenance and 73.5 months in the maintenance arm (p=0.33). Neither the median time to recurrence nor the median time for worsening-free survival has been reached yet. 65 patients (33.1%) in the no maintenance arm experienced tumor recurrence versus 57 patients (28.4%) in the maintenance arm. Thirty patients (15.3%) in the no maintenance arm showed tumor progression versus 25 patients (12.4%) in the maintenance arm.

He summarized that compared to standard induction therapy, maintenance BCG immunotherapy with the present regime was not beneficial in patients with carcinoma in situ and/or TaG3 or T1G3 bladder cancer at a mean follow-up of 33.5 months. Mean recurrence-free survival time and time to tumor progression was similar in both arms.

Presented by: L. Martizez-Pineiro, MD, et al at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

Reported by UroToday.com Contributing Editor Christopher P. Evans, MD, FACS

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