Stricker P, Pryor K, Nicholson T, Goldstein D, Golovsky D, Ferguson R, Nash P, Ehsman S, Rumma J, Mammen G, Penny R
Department of Urology, St. Vincent's Hospital, University of New South Wales, Sydney, Australia.
Urology. 1996 Dec;48(6):957-61; discussion 961-2. doi: 10.1016/s0090-4295(96)00375-5.
Bacillus Calmette-Guérin (BCG) and interferon alpha-2b (IFN alpha 2b) have been used individually for the treatment of bladder cancer. We used a low dose of BCG combined with IFN alpha 2b to determine the safety and to assess the efficacy of this combination therapy.
A study of 12 patients with superficial bladder cancer evaluated the safety and efficacy of a combination of low-dose BCG and IFN alpha 2b, given weekly for 6 weeks. Three patients were assigned to each of four groups in which 60 mg of BCG was combined with 10, 30, 60, or 100 x 10(6) IU of IFN alpha 2b.
The combination BCG/IFN alpha 2b therapy was well tolerated, with adverse effects being mild to moderate and resolved at the end of treatment. At 12 months post-treatment there has been no tumor progression. Two patients with previous multifocal transitional cell carcinoma have had solitary recurrences. One patient has had recurrent carcinoma in situ.
This preliminary study found combination BCG/IFN alpha 2b induction therapy to be safe and well tolerated. These early results show a high response rate, but efficacy can only be determined with Phase II and III studies.
卡介苗（BCG）和干扰素α-2b（IFNα2b）已分别用于膀胱癌的治疗。我们使用低剂量的BCG联合IFNα2b来确定这种联合治疗的安全性并评估其疗效。
一项针对12例浅表性膀胱癌患者的研究评估了低剂量BCG与IFNα2b联合使用的安全性和疗效，每周给药一次，共6周。12例患者被分为四组，每组3例，分别接受60mg BCG与10、30、60或100×10⁶IU IFNα2b的联合治疗。
BCG/IFNα2b联合治疗耐受性良好，不良反应为轻至中度，治疗结束时症状消失。治疗后12个月无肿瘤进展。两名既往有多灶性移行细胞癌的患者出现了单发复发。一名患者出现原位癌复发。
这项初步研究发现BCG/IFNα2b诱导治疗安全且耐受性良好。这些早期结果显示出较高的缓解率，但疗效仍需通过II期和III期研究来确定。
