Lam John S, Benson Mitchell C, O'Donnell Michael A, Sawczuk Alexandra, Gavazzi Anna, Wechsler Michael H, Sawczuk Ihor S
Department of Urology, Columbia University College of Physicians and Surgeons, New York, NY, USA
Urol Oncol. 2003 Sep-Oct;21(5):354-60. doi: 10.1016/s1078-1439(03)00012-7.
Bacillus Calmette-Guérin (BCG) and interferon-alpha2B (IFN-alpha2B) have both been individually used for the intravesical treatment of superficial bladder cancer. We report our experience on the therapeutic efficacy and toxicity of combined intravesical BCG plus IFN-alpha2B for treating superficial bladder cancer, including patients failing previous BCG therapy. Thirty-two patients with superficial bladder cancer underwent 6 weekly treatments with full-, one-third, or one-tenth-dose of BCG plus 50 or 100 MU of IFN-alpha2B based on prior BCG exposure and tolerance. Patients with no evidence of disease proceeded onto maintenance therapy of 3 weekly treatments at 3 months followed by 2 additional maintenance cycles given 6 months apart. Response was assessed by cystoscopy/biopsy every 3 months after treatment. Before BCG plus IFN-alpha2B treatment, 20 patients (63%) had previously failed intravesical BCG therapy, 27 (84%) had aggressive disease (stage T1, grade 3, or carcinoma in situ), 27 (84%) had recurrent disease, 14 (44%) had multifocal disease, and 6 (19%) had disease of over 4 years duration. At median follow-up of 22 months, 21 patients (66%) remain disease-free and 11 patients (34%) had disease-recurrence. Nineteen of 32 patients (59%) were disease-free after the initial induction cycle. Six of 11 patients 55% ultimately failing combination therapy did so at the first 3 to 4 month evaluation. Four of 7 patients (57%) benefited from salvage re-induction therapy. Of the 20 patients previously treated with BCG, 12 patients (60%) remain disease-free. Combination BCG plus IFN-alpha2B intravesical therapy was well tolerated. Combination intravesical BCG plus IFN-alpha2B is an effective and tolerable alternative for patients with superficial bladder cancer, including those patients in whom intravesical BCG therapy had previously failed. Benefits of this combination therapy may include potentially less morbidity, improved clinical efficacy, and in the long term, fewer patients undergoing radical therapy. However, radical treatment options should be pursued for early failures of this combination regimen in those patients with risk factors for recurrence and progression.
卡介苗（BCG）和干扰素-α2B（IFN-α2B）均已单独用于浅表性膀胱癌的膀胱内治疗。我们报告了联合膀胱内注射BCG加IFN-α2B治疗浅表性膀胱癌的疗效和毒性方面的经验，包括既往BCG治疗失败的患者。32例浅表性膀胱癌患者根据既往BCG暴露情况和耐受性，接受了为期6周的全剂量、三分之一剂量或十分之一剂量的BCG加50或100 MU IFN-α2B的治疗。无疾病证据的患者在3个月时开始进行为期3周的维持治疗，随后每隔6个月再进行2个维持周期的治疗。治疗后每3个月通过膀胱镜检查/活检评估反应。在BCG加IFN-α2B治疗前，20例患者（63%）既往膀胱内BCG治疗失败，27例患者（84%）患有侵袭性疾病（T1期、3级或原位癌），27例患者（84%）患有复发性疾病，14例患者（44%）患有多灶性疾病，6例患者（19%）患有病程超过4年的疾病。在中位随访22个月时，21例患者（66%）无疾病复发，11例患者（34%）疾病复发。32例患者中有19例（59%）在初始诱导周期后无疾病复发。在最终联合治疗失败的11例患者中有6例（55%）在最初3至4个月的评估时失败。7例患者中有4例（57%）从挽救性再诱导治疗中获益。在既往接受BCG治疗的20例患者中，12例患者（60%）无疾病复发。联合BCG加IFN-α2B膀胱内治疗耐受性良好。联合膀胱内BCG加IFN-α2B对浅表性膀胱癌患者是一种有效且耐受性良好的替代治疗方法，包括那些既往膀胱内BCG治疗失败的患者。这种联合治疗的益处可能包括潜在的更低发病率、提高临床疗效，从长远来看，接受根治性治疗的患者更少。然而，对于有复发和进展风险因素的患者，如果这种联合方案早期失败，应采取根治性治疗方案。
