Prospective trial of ifosfamide, paclitaxel, and cisplatin in patients with advanced non-transitional cell carcinoma of the urothelial tract Journal Article


Authors: Galsky, M. D.; Iasonos, A.; Mironov, S.; Scattergood, J.; Donat, S. M.; Bochner, B. H.; Herr, H. W.; Russo, P.; Boyle, M. G.; Bajorin, D. F.
Article Title: Prospective trial of ifosfamide, paclitaxel, and cisplatin in patients with advanced non-transitional cell carcinoma of the urothelial tract
Abstract: Objectives: Non-transitional cell carcinomas account for 5% to 10% of urothelial tract tumors and are each characterized by unique demographics, risk factors, and patterns of spread. A unifying feature of these malignancies is their aggressive course and poor outcome with standard chemotherapeutic regimens. Given the rarity of these tumors, no prospective data are available to guide management. Methods: Patients with unresectable/metastatic adenocarcinoma or squamous cell, small cell, sarcomatoid, or poorly differentiated carcinoma of the urothelial tract were eligible for enrollment. Treatment consisted of paclitaxel 200 mg/m2 intravenously on day 1, cisplatin 70 mg/m2 intravenously on day 1, ifosfamide 1500 mg/m2 intravenously on days 1 to 3 plus mesna. Granulocyte colony-stimulating factor was administered with each cycle. The treatment was started again every 3 to 4 weeks for a maximum of six cycles. Results: A total of 20 patients were enrolled. They had the following histologic types: adenocarcinoma in 11, squamous cell carcinoma in 8, and small cell carcinoma in 1. Patients received a median of four cycles (range one to six). The treatment was generally well tolerated, and the toxicity was predominantly hematologic. Overall, 7 (35%) of 20 patients (95% confidence interval 15% to 59%) achieved a major response (3 partial and 4 complete). The median survival for patients with adenocarcinoma was 24.8 months (95% confidence interval 10.2 to 32.3), and for those with squamous cell carcinoma it was 8.9 months (95% confidence interval 5.4 to not yet reached). Conclusions: The results of our study have shown that this regimen (ifosfamide, paclitaxel, and cisplatin) is active in patients with advanced non-transitional cell carcinoma of the urothelial tract. To our knowledge, this is the first prospective study of a chemotherapeutic regimen in this patient population. © 2007 Elsevier Inc. All rights reserved.
Keywords: adult; cancer survival; clinical article; treatment outcome; aged; aged, 80 and over; disease-free survival; middle aged; survival rate; clinical trial; disease course; drug tolerability; neutropenia; squamous cell carcinoma; carcinoma, squamous cell; cisplatin; advanced cancer; cancer combination chemotherapy; diarrhea; drug dose reduction; paclitaxel; cancer patient; neurotoxicity; follow-up studies; neoplasm staging; prospective study; prospective studies; adenocarcinoma; demography; multiple cycle treatment; anemia; blood toxicity; mucosa inflammation; nausea; neuropathy; stomatitis; thrombocytopenia; vomiting; antineoplastic combined chemotherapy protocols; drug administration schedule; odds ratio; combination chemotherapy; kidney failure; dose-response relationship, drug; risk factor; ifosfamide; risk assessment; drug hypersensitivity; febrile neutropenia; confidence intervals; confusion; urologic neoplasms; urothelium; biopsy, needle; neoplasm invasiveness; seizure; mesna; recombinant granulocyte colony stimulating factor; neurologic disease; urinary tract carcinoma; small cell carcinoma; carcinoma, small cell
Journal Title: Urology
Volume: 69
Issue: 2
ISSN: 0090-4295
Publisher: Elsevier Science, Inc.  
Date Published: 2007-02-01
Start Page: 255
End Page: 259
Language: English
DOI: 10.1016/j.urology.2006.10.029
PUBMED: 17320659
PROVIDER: scopus
DOI/URL:
Notes: --- - "Cited By (since 1996): 4" - "Export Date: 17 November 2011" - "CODEN: URGYA" - "Source: Scopus"
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MSK Authors
  1. Matthew Galsky
    28 Galsky
  2. Paul Russo
    457 Russo
  3. Dean Bajorin
    416 Bajorin
  4. Sherri M Donat
    135 Donat
  5. Svetlana Mironov
    37 Mironov
  6. Alexia Elia Iasonos
    182 Iasonos
  7. Bernard Bochner
    327 Bochner
  8. Harry W Herr
    407 Herr
  9. Mary G Boyle
    29 Boyle