Jimenez-Cruz J F, Vera-Donoso C D, Leiva O, Pamplona M, Rioja-Sanz L A, Martinez-Lasierra M, Flores N, Unda M
Department of Urology, La Fe Hospital, Valencia, Spain.
Urology. 1997 Oct;50(4):529-35. doi: 10.1016/S0090-4295(97)00303-8.
To estimate and compare recurrence rates, index of recurrence, and disease-free interval in patients with superficial recurrent bladder cancer receiving bacille Calmette-Guérin (BCG) or interferon (IFN) for immunoprophylaxis.
One hundred twenty-two patients with recurrent superficial Stage pT1, grade 1 to 3 tumors were enrolled in a randomized, prospective, multicenter trial with two treatment arms of endovesical immunoprophylaxis: 150 mg of BCG versus 54 MU of recombinant IFN-alpha-2a. Administration was weekly during the first month, biweekly for 2 months, and monthly for 9 months. Both groups were similar with regard to tumor stage, grade, size, and number.
Sixty-one patients were evaluable in the BCG group and 49 in the IFN group. Tumors recurred in 34 (69.4%) of 49 patients in the IFN group (890 months of follow-up) and in 24 (39.3%) of 61 in the BCG group (1272 months of follow-up). The total number of recurrences (28 for BCG, 47 for IFN), disease-free interval (mean 19.3 months for BCG, 15.3 months for IFN), and index of recurrence (2.2 for BCG, 5.5 for IFN) were statistically significant (P = 0.001) in favor of BCG. Progression to invasive carcinoma was similar in both study arms. Neither systemic nor local side effects were seen in the IFN group. However, the previously reported toxicity of BCG was confirmed.
According to our trial, BCG remains the most efficacious agent for immunoprophylaxis of recurrent superficial bladder tumors.
评估并比较接受卡介苗（BCG）或干扰素（IFN）进行免疫预防的浅表性复发性膀胱癌患者的复发率、复发指数和无病生存期。
122例复发性浅表性pT1期、1至3级肿瘤患者参与了一项随机、前瞻性、多中心试验，该试验有两个膀胱内免疫预防治疗组：150mg卡介苗与54MU重组干扰素-α-2a。给药方式为第一个月每周一次，接下来两个月每两周一次，之后九个月每月一次。两组在肿瘤分期、分级、大小和数量方面相似。
卡介苗组有61例患者可评估，干扰素组有49例。干扰素组49例患者中有34例（69.4%）复发（随访890个月），卡介苗组61例中有24例（39.3%）复发（随访1272个月）。复发总数（卡介苗组28例，干扰素组47例）、无病生存期（卡介苗组平均19.3个月，干扰素组平均15.3个月）和复发指数（卡介苗组2.2，干扰素组5.5）在统计学上有显著差异（P = 0.001），支持卡介苗。两个研究组进展为浸润性癌的情况相似。干扰素组未观察到全身或局部副作用。然而，卡介苗先前报道的毒性得到了证实。
根据我们的试验，卡介苗仍然是复发性浅表性膀胱肿瘤免疫预防最有效的药物。
