Paclitaxel-based second-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 the expression of tumor cell motility factor gp78hAMFR correlates with tumor progression in patients with bladder carcinoma. This study was initiated 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 influence of paclitaxel, carboplatin, and an antimotility factor (acellular pertussis vaccine [APV]) in 18 patients with cisplatin- and methotrexate-resistant metastatic bladder carcinoma. Intramuscular injection of APV 3 times in the first week, on Days 1, 4, and 7, was followed by paclitaxel 135 mg/m2 and carboplatin 400 mg/m2. After an interval 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 patients had objective responses (2 had complete remissions and 2 had partial remissions). After a median number of 2.5 cycles, side effects did not exceed World Health Organization Grade 4.


CONCLUSIONS
The results of this clinical Phase II study demonstrate that the combination of paclitaxel-based therapy causes complete remissions previously not obtained 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.
Otto
T
T
Clinic of Urology, University of Essen Medical School, Germany.
Bex
A
A
Krege
S
S
Walz
P H
PH
Rübben
H
H
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D010567:Pertussis Vaccine / Q000627:therapeutic use*; D012074:Remission Induction; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
D010567:Pertussis Vaccine; D016190:Carboplatin; D017239:Paclitaxel