Weekly paclitaxel and carboplatin against advanced transitional cell cancer after failure of a platinum-based regimen.
OBJECTIVE
Weekly administration of paclitaxel plus carboplatin is hypothesized to be an effective second-line treatment for advanced transitional cell cancer after failure of platinum-based regimen. In this phase 2 trial, we tested this hypothesis.


METHODS
Patients with advanced transitional cell cancer who showed evidence of progressive or recurrent disease after methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) therapy were eligible for this study. Weekly paclitaxel (80mg/m(2)) and carboplatin (AUC 2) were administered on days 1, 8, 15, 22, 29, and 36; the cycle was repeated every 7 wk until disease progression or intolerable toxicity (maximum 18 doses).


RESULTS
Thirty-five patients entered this study. Among the 31 patients who were assessable, 10 had an objective response (overall response rate: 32.3%, 95% confidence interval, 15.8-48.7%). The median progression-free survival (PFS) and median survival times were 3.7 and 7.9 mo, respectively. Among the 22 patients who received prior MVAC therapy for metastatic disease, 36% had an objective response; their median PFS and median survival times were 4.3 and 7.9 mo, respectively; neither survival time significantly differed from the survival time of those who received prior MVAC as adjuvant setting. Toxicities were mild except one toxic death due to neutropenic sepsis.


CONCLUSIONS
Weekly paclitaxel plus carboplatin was a manageable, active second-line treatment for advanced transitional cell cancer after failure of platinum-based therapy.
Kouno
Tsutomu
T
Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan. tkouno@ncc.go.jp
Ando
Masashi
M
Yonemori
Kan
K
Matsumoto
Koji
K
Shimizu
Chikako
C
Katsumata
Noriyuki
N
Komiyama
Motokiyo
M
Okajima
Eijiro
E
Matsuoka
Naoki
N
Fujimoto
Hiroyuki
H
Fujiwara
Yasuhiro
Y
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D016190:Carboplatin / Q000008:administration & dosage; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000401:mortality; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality; D007682:Kidney Pelvis; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D018579:Patient Selection; D017671:Platinum Compounds / Q000627:therapeutic use; D016019:Survival Analysis; D017741:Survivors; D017211:Treatment Failure; D014523:Urethral Neoplasms / Q000188:drug therapy* / Q000401:mortality; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality
D017671:Platinum Compounds; D016190:Carboplatin; D017239:Paclitaxel