膀胱上皮内癌に対するBCG40mg6回膀胱腔内注入療法の検討

Abstract

膀胱上皮内癌(CIS)に対するBCG 40mg・6回膀胱内注入療法を検討した.対象は, 膀胱CISと診断された43例(男性35例, 女性8例・平均67.5歳)で, Primary CIS(13例)とSecondary CIS(30例)に分けて評価し, BCGは40mgを週1回, 計6回連続膀胱内注入とした.その結果, 1)成績はPrimary CISでCR 11例(84.6%), NC 2例, Secondary CISで各々25例(83.3%), 5例であった.2)CR持続期間中央値はPrimary CIS 29ヵ月, Secondary CIS 36ヵ月, 非再発率は12ヵ月で97.2%, 36ヵ月で70.7%であった.3)CR例で膀胱内再発11例, 尿管癌1例を認め, BCG再投与(5例), TUR-Bt(6例), 腎尿管全摘術(1例)施行で現在も再発・転移を認めていない.4)NC7例中5例は再度BCG6回投与でCRとなり, 他の1例は膀胱全摘術施行, 1例は陰性化せず来院しなくなった.5)副作用は膀胱刺激症状21例(48.8%), 膿尿20例(46.5%), 肉眼的血尿8例(18.6%), 発熱4例(9.3%)を認めた

We performed a study to evaluate the usefulness of intravesical Bacillus Calmette-Guerin (BCG: Tokyo 172 strain) instillation on carcinoma in situ (CIS) of the bladder. Between 1998 and 2003, 43 patients were treated for CIS of the bladder with a median follow-up period of 45 months (range: 12 to 69 months). The patients (35 males and 8 females) ranged in age from 45 to 89 years (average: 67.5 years). They underwent intravesical instillation of 40 mg of BCG once a week for 6 weeks. A complete response (CR) was achieved in 83.7% of the patients. Among these patients, 97.2% and 70.7% remained recurrence-free during follow up for one year and three years, respectively. The median duration of CR was 31.5 months. Although total cystectomy was performed on 1 patient, none of the patients died of bladder cancer. Adverse effects included bladder irritability in 48.8%, pyuria in 46.5%, gross hematuria in 18.6%, and fever (temperature over 37.5 degrees C) in 9.3%. No clinically significant side effects were observed. These results indicate that intravesical instillation of BCG at a dose of 40 mg given 6 times was as effective as the routine dose of 80 mg, and could decrease systemic adverse effects such as high fever.