PACLITAXEL-BASED 2ND-LINE THERAPY FOR PATIENTS WITH ADVANCED CHEMOTHERAPY-RESISTANT BLADDER-CARCINOMA (M1) - A CLINICAL-PHASE-II STUDY

BACKGROUND. In a previous clinical trial, the authors disclosed that t he expression of tumor cell motility factor gp78hAMFR correlates with tumor progression in patients with bladder carcinoma. This study was i nitiated to evaluate whether the combination of cytostatic drugs with an antimotility factor has an effect on chemotherapy-resistant bladder carcinoma. METHODS. In a Phase II trial, the authors evaluated the in fluence of paclitaxel, carboplatin, and an antimotility factor (acellu lar pertussis Vaccine [APV]) in 18 patients with cisplatin- and methot rexate-resistant metastatic bladder carcinoma. Intramuscular injection of APV 3 times in the first week, on Days 1, 4, and 7, was followed b y paclitaxel 135 mg/m(2) and carboplatin. 400 mg/m(2). After an interv al of 1 week APV was given again on Days 15 and 19. Each cycle lasted 3 weeks. On Day 22 the cycle was repeated. RESULTS. Four of 18 patient s had objective responses (2 had complete remissions and 2 had partial remissions). After a median number of 2.5 cycles, side effects did no t exceed World Health Organization Grade 4. CONCLUSIONS. The results o f this clinical Phase II study demonstrate that the combination of pac litaxel-based therapy causes complete remissions previously not obtain ed with second-line chemotherapy, although no conclusions can be drawn as to the effectiveness of the individual substances. Further trials have to be evaluated with regard to the individual components. (C) 199 7 American Cancer Society.