Do patients with advanced urothelial carcinoma benefit from weekly paclitaxel chemotherapy? A GETUG phase II study.
BACKGROUND
There is no standard second-line chemotherapy for patients who relapse with advanced urothelial carcinoma. A GETUG phase II clinical trial was designed to evaluate the response rate and the palliative clinical benefit of weekly paclitaxel.


METHODS
Paclitaxel (80 mg/m2, 1 hour) was administered on day 1, 8, and 15 (28-day course) to 45 patients. The primary endpoint was disease control rate (objective response and stable disease). Response rate was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria; quality of life (QOL) assessment used FACT-B1 and FACT-Taxane questionnaires.


RESULTS
Characteristics of the patients were: M/F, 36/9; mean age, 64 years; performance status (PS) 0-1, 82%; metastatic disease, 93%; gemcitabine/platinum first-line chemotherapy, 89%; median number of cycles, 2. Grade 3/4 toxicity was uncommon. The disease control rate was 47%. One patient achieved a complete response, 3 a partial response (objective response, 9%) and 17 (38%) a stable disease. Median time to progression or death were 3 and 7 months. Among the 21 patients with controlled disease, 10% displayed QOL improvement, and 14% decreased their analgesic consumption.


CONCLUSIONS
Weekly paclitaxel is associated with limited objective response but a high rate of stabilization; QOL assessment indicates that a small group of patients might experience a clinical benefit.
Joly
Florence
F
Département d'oncologie Médicale, Centre François, Baclesse, France. f.joly@baclesse.fr
Houédé
Nadine
N
Noal
Sabine
S
Chevreau
Christine
C
Priou
Frank
F
Chinet-Charrot
Paule
P
Rolland
Frédéric
F
Fléchon
Aude
A
Henry-Amar
Michel
M
Culine
Stéphane
S
D000368:Aged; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000523:psychology
D017239:Paclitaxel