膀胱上皮内癌に対する初回BCG注入療法及び残存・再発例に対する再注入療法(セカンドコースBCG療法)について膀胱温存の立場から検討を行った.初回BCG注入療法を行った膀胱上皮内癌104症例(男92例, 女12例)を対象に, 原則的に週1回の注入を計6回行い, 治療効果判定は治療開始3ヵ月後の膀胱鏡検査及び尿細胞診又は膀胱洗浄液細胞診により行った.3ヵ月後にCRが得られなかった残存例や再発例のうちBCG再注入療法を行ったのは23例で, ゲムシタビン膀胱内注入療法を行って効果判定できたのは4症例で, 隆起性病変を伴わなかったのは33例であった.平均観察期間は66.4ヵ月, 中央値は42.2ヵ月であった.3ヵ月での治療効果判定では104例中94例(90.4%)はCRが得られたが, そのうち22例が平均21.1ヵ月, 中央値14.1ヵ月で再発をきたした.初回BCG注入療法後の非再発率は5年で67.2%, 10年で60.4%であった.BCG再注入療法の22例(95.6%)にCRが得られたが, 8例が平均24.9ヵ月で再発をきたした.BCG再注入療法後の非再発率は5年で55.9%, 10年で27.9%であった.ゲムシタビン膀胱内注入療法を行った4例は全て男性で, 3例にCRが得られた.全体では進展例は16例に見られたThree months after an initial 6-week course ofintravesical bacillus Calmette-Guerin (BCG) given between January 1990 and March 2005, 94 (90%) out of 104 patients with carcinoma in situ (CIS) of the bladder achieved a complete response (CR). The 5- and 10-year recurrence-free rates were 67 and 60%, respectively (median follow-up 42 months). Three months after a second course ofintravesical BCG given to 23 patients who failed the initial induction course for CIS was evaluated. Of these, 96% achieved a CR, and the 5- and 10-year recurrence-free rates were 56 and 28%, respectively (median follow-up 23 months). Only one patient who received a second course of BCG therapy showed disease progression. Two of the 4 patients with BCG-refractory CIS of the bladder achieved CR after intravesical gemcitabine therapy and maintained a tumor-free status beyond 6 months. Five of the 16 patients showing disease progression had upper urinary tract cancer, 4 had recurrent or muscle invasive bladder cancer, 6 had prostatic involvement of CIS, and one patient had urethral recurrence. Three of the 16 patients died. Bladder preservation was achieved in 97 of the 104 patients, although 7 patients ultimately underwent radical cystectomy and urinary diversion for aggressive disease. In conclusion, some patients may be managed safely by repeated endoscopic resection and intravesical therapy with cystectomy postponed until objective evidence of progression exists
