表在性膀胱腫瘍に対するピラルビシン(Pirarubicin:THP)による術前膀胱内注入療法の検討

Abstract

原発性表在性膀胱腫瘍で移行上皮癌の症例63例を, ピラルビシン(THP)注入群30例と対照群33例に無作為に分け, 経尿道的膀胱腫瘍切除術(TUR)前膀胱内注入療法の効果について比較検討した.その結果, THP注入群中1例でCRを得た.Kaplan-Meier法による再発率の検討では, THP注入群で再発抑制傾向を認め, 腫瘍径1cm以上の例(THP注入群16例, 対照群20例)では, THP注入群は非再発期間が有意に長かった.単発症例(THP注入群13例, 対照群11例)では, THP注入群は再発期間が長い傾向を認めた.異型度別ではgrade 1とgrade 2の症例(THP注入群24例, 対照群26例)ではTHP注入群で再発抑制期間が長い傾向を認めた.以上より, THP注入療法は径1cm以上, 単発症例, grade 1とgrade 2の腫瘍では再発予防の効果があると考えられた

A prospective randomized study was conducted to evaluate the efficacy of prophylactic intravesical instillation of pirarubicin (THP) prior to transurethral resection (TUR) of superficial bladder cancer. A total of 63 patients were randomized into two groups, the THP group and the control group. In the THP group, 30 mg of THP dissolved in 50 ml saline was administered 4 times intravesically for 4 consecutive days before TUR. In the control group, no instillation was performed before TUR. The patients were followed by cystoscopy and urinary cytology every 3 months. The non-recurrence rates in the THP group and control group were 54.1% versus 37.6% at 1 year and 40.4% versus 26.8% at 2 years, respectively (P = 0.086). Time to recurrence for tumors larger than 1 cm was significantly longer in the THP group (P = 0.0137). Time to recurrence for single and grade 1+2 tumors tended to be longer in the THP group (P = 0.09, P = 0.079). No significant adverse effects were observed in any patient. Our findings suggest that intravesical THP instillation prior to TUR would be effective for patients with single, low grade lesions larger than 1 cm of superficial bladder cancer.