• BJU international · Oct 2011

    Clinical Trial

    Co-administration of intravesical bacillus Calmette-Guérin and interferon α-2B as first line in treating superficial transitional cell carcinoma of the urinary bladder.

    • Shouki Bazarbashi, Hussein Soudy, Mahmoud Abdelsalam, Ali Al-Jubran, Saad Akhtar, Muhammad Memon, Muhammad Aslam, Said Kattan, and Mohamed Shoukri.
    • Section of Medical Oncology, King Faisal Specialist Hospital and Research Centre, Riyadh, Kingdom of Saudi Arabia.
    • BJU Int. 2011 Oct 1; 108 (7): 1115-8.

    Objective• To evaluate the efficacy and toxicity of the combination of bacillus Calmette-Guérin (BCG) and interferon α-2B (IFNα-2B) in treating superficial bladder cancer (SBC). The mentioned combination has shown synergism in pre-clinical studies.Patients And Methods• The present study is a single-arm, open-label, single-institution prospective trial. Patients with Ta, T1 or in situ carcinoma and no previous intravesical therapy were included between July 2002 and June 2009. • Patients were treated with weekly intravesical instillation of 27 mg of BCG mixed with 10 million units (MU) of IFNα-2B for six consecutive weeks followed by 3-weekly booster instillations at 3 months if there was no recurrence. • The primary endpoint was disease recurrence. Secondary endpoints were disease progression and toxicity. • Patients were followed-up with cystoscopy and urine cytology every 3 months.Results• In all, 50 patients were included. • At a median follow-up of 55.8 months, 31 (62%) patients were recurrence-free. • Progression to muscle invasion occurred in two (4%) and metastasis occurred in two (4%) patients. • Treatment was well tolerated, with grade III dysuria and frequency occurring in 18 and 14% of patients, respectively, and with 74% of patients being able to complete the maintenance dosage.Conclusion• The combination of BCG and IFNα-2B in the patient population with SBC has similar efficacy and toxicity to BCG monotherapy.© 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.

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