A multi-institutional phase II trial of gemcitabine plus paclitaxel in patients with locally advanced or metastatic urothelial cancer

被引:46
作者
Kaufman, DS
Carducci, MA
Kuzel, TM
Todd, MB
Oh, WK
Smith, MR
Ye, ZS
Nicol, SJ
Stadle, WM [1 ]
机构
[1] Univ Chicago, Chicago, IL 60637 USA
[2] Lilly Res Labs, Indianapolis, IN USA
[3] Dana Farber Canc Inst, Boston, MA 02115 USA
[4] Canc Inst New Jersey, New Brunswick, NJ USA
[5] Northwestern Univ, Sch Med, Evanston, IL 60208 USA
[6] Johns Hopkins Oncol Ctr, Baltimore, MD USA
[7] Massachusetts Gen Hosp, Boston, MA 02114 USA
关键词
urothelial cancer; bladder cancer; clinical trial; gemcitabine; paclitaxel;
D O I
10.1016/j.urolonc.2004.01.002
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
The purpose of the study was to evaluate response and survival in patients with metastatic urothelial cancer treated with combination gemcitabine and paclitaxel administered on a biweekly schedule at doses of 3000 mg/m(2) and 150 mg/m(2), respectively. Patients with adequate organ function and performance status were accrued through 7 institutions, stratified by prior therapy status, and treated as noted. Response was evaluated by 1979 bi-dimensional World Health Organization (WHO) criteria. Of 55 eligible patients, 17 had a partial and 5 had a complete response rate for an overall response rate of 40% (27-54%). One complete response and one partial response were observed in the 6 previously treated patients. Overall median survival was 11.8 months (11.9 months in the chemonaive cohort). Grade 3 or 4 myelosuppression occurred in 56%, but only 4 serious infections were observed. We conclude that because of a lower than expected complete response rate. even when corrected for prognostic groupings, this regimen is not recommended for routine use in patients with metastatic urothelial cancer. Insufficient patients with poor renal function or prior therapy were accrued to reach conclusions regarding its utility in these subgroups. (C) 2004 Elsevier Inc. All rights reserved.
引用
收藏
页码:393 / 397
页数:5
相关论文
共 17 条
[1]   Long-term survival in metastatic transitional-cell carcinoma and prognostic factors predicting outcome of therapy [J].
Bajorin, DF ;
Dodd, PM ;
Mazumdar, M ;
Fazzari, M ;
McCaffrey, JA ;
Scher, HI ;
Herr, H ;
Higgins, G ;
Boyle, MG .
JOURNAL OF CLINICAL ONCOLOGY, 1999, 17 (10) :3173-3181
[2]   Phase I study of paclitaxel and day 1/day 8 gemcitabine in patients with solid malignancies [J].
Fleming, DR ;
Glisson, SD ;
Bhupalam, L ;
Michelson, GD ;
Goldsmith, GH ;
LaRocca, RV .
AMERICAN JOURNAL OF CLINICAL ONCOLOGY-CANCER CLINICAL TRIALS, 2000, 23 (04) :349-352
[3]   A phase I-II study of gemcitabine and paclitaxel in advanced non-small-cell lung cancer patients [J].
Giaccone, G ;
Smit, EF ;
van Meerbeeck, JP ;
Splinter, T ;
Golding, RP ;
Pinedo, HM ;
Laan, D ;
van Tinteren, H ;
Postmus, PE .
ANNALS OF ONCOLOGY, 2000, 11 (01) :109-112
[4]   Phase II trial of gemcitabine plus cisplatin in patients with metastatic urothelial cancer [J].
Kaufman, D ;
Raghavan, D ;
Carducci, M ;
Levine, EG ;
Murphy, B ;
Aisner, J ;
Kuzel, T ;
Nicol, S ;
Oh, W ;
Stadler, W .
JOURNAL OF CLINICAL ONCOLOGY, 2000, 18 (09) :1921-1927
[5]   Paclitaxel and gemcitabine chemotherapy for advanced transitional-cell carcinoma of the urothelial tract: A phase II trial of the Minnie Pearl Cancer Research Network [J].
Meluch, AA ;
Greco, FA ;
Burris, HA ;
O'Rourke, T ;
Ortega, G ;
Steis, RG ;
Morrissey, LH ;
Johnson, V ;
Hainsworth, JD .
JOURNAL OF CLINICAL ONCOLOGY, 2001, 19 (12) :3018-3024
[6]   Gemcitabine plus cisplatin, an active regimen in advanced urothelial cancer: A phase II trial of the National Cancer Institute of Canada clinical trials group [J].
Moore, MJ ;
Winquist, EW ;
Murray, N ;
Tannock, IF ;
Huan, S ;
Bennett, K ;
Walsh, W ;
Seymour, L .
JOURNAL OF CLINICAL ONCOLOGY, 1999, 17 (09) :2876-2881
[7]   SIGNIFICANT ACTIVITY OF PACLITAXEL IN ADVANCED TRANSITIONAL-CELL CARCINOMA OF THE UROTHELIUM - A PHASE-II TRIAL OF THE EASTERN-COOPERATIVE-ONCOLOGY-GROUP [J].
ROTH, BJ ;
DREICER, R ;
EINHORN, LH ;
NEUBERG, D ;
JOHNSON, DH ;
SMITH, JL ;
HUDES, GR ;
SCHULTZ, SM ;
LOEHRER, PJ .
JOURNAL OF CLINICAL ONCOLOGY, 1994, 12 (11) :2264-2270
[8]   Phase I trial of paclitaxel and gemcitabine administered every two weeks in patients with refractory solid tumors [J].
Rothenberg, ML ;
Sharma, A ;
Weiss, GR ;
Villalona-Calero, MA ;
Eckardt, JR ;
Aylesworth, C ;
Kraynak, MA ;
Rinaldi, DA ;
Rodriguez, GI ;
Burris, HA ;
Eckhardt, SG ;
Stephens, CD ;
Forral, K ;
Nicol, SJ ;
Von Hoff', DD .
ANNALS OF ONCOLOGY, 1998, 9 (07) :733-738
[9]   Long-term follow-up of a phase III intergroup study of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: A cooperative group study [J].
Saxman, SB ;
Propert, KJ ;
Einhorn, LH ;
Crawford, ED ;
Tannock, I ;
Raghavan, D ;
Loehrer, PJ ;
Trump, D .
JOURNAL OF CLINICAL ONCOLOGY, 1997, 15 (07) :2564-2569
[10]   Long-term survival in phase II trials of gemcitabine plus cisplatin for advanced transitional cell cancer [J].
Stadler, WM ;
Hayden, A ;
von der Maase, H ;
Roychowdhury, D ;
Dogliotti, L ;
Seymour, L ;
Kaufmann, D ;
Moore, M .
UROLOGIC ONCOLOGY, 2002, 7 (04) :153-157