Treatment of patients with transitional-cell carcinoma of the urothelial tract with ifosfamide, paclitaxel, and cisplatin: A phase II trial Journal Article

  

Authors:	Bajorin, D. F.; McCaffrey, J. A.; Hilton, S.; Mazumdar, M.; Kelly, W. K.; Scher, H. I.; Spicer, J.; Herr, H.; Higgins, G.
Article Title:	Treatment of patients with transitional-cell carcinoma of the urothelial tract with ifosfamide, paclitaxel, and cisplatin: A phase II trial
Abstract:	Purpose: A phase II trial of ifosfamide, paclitaxel, and cisplatin (ITP) was conducted in previously untreated patients with advanced transitional- cell carcinoma (TCC) to assess its efficacy and toxicity. Patients and Methods: Thirty patients with metastatic or unresectable TCC were treated with ifosfamide 1.5 g/m2/d for 3 days with paclitaxel 200 mg/m2 over 3 hours and cisplatin 70 mg/m2 on day 1 of each 28-day treatment cycle. Therapy was continued for a maximum of six cycles. Prophylactic hematopoietic growth factor (recombinant human granulocyte colony-stimulating factor [rhG- CSF]) was given on days 6 to 17 of each cycle, Results: Twenty-three of 29 assessable patients (79%; 95% confidence interval [CI], 60% to 92%) demonstrated a major response (six complete [CR] and 17 partial [PR]) with response durations that ranged from 5 to 24+ months. Five patients with T4 bladder primary tumors had a major response, two with pathologic CR. At a median follow-up duration of 17.9 months, nine (31%) patients remain disease- free (range, 10+ to 24+). Hematologic toxicity included anemia, thrombocytopenia, and neutropenia; febrile neutropenia was observed in 17% of patients and 4% of cycles. No grade 4 nonhematologic toxicity was observed. Grade 3 nonhematologic toxicity included alopecia, allergy (3%), renal insufficiency (13%), and neuropathy (10%). Dose reductions or drug omissions were necessary for adverse events in seven (23%) patients. Conclusion: ITP is an active, well-tolerated regimen in previously untreated patients with TCC of the urothelial tract. Further study of this regimen in patients with both TCC and non-transitional-cell urothelial tumors is ongoing.
Keywords:	adult; clinical article; treatment outcome; aged; aged, 80 and over; middle aged; survival rate; clinical trial; neutropenia; cisplatin; cancer combination chemotherapy; drug efficacy; paclitaxel; phase 2 clinical trial; anemia; allergy; blood toxicity; neuropathy; thrombocytopenia; antineoplastic combined chemotherapy protocols; dexamethasone; clinical protocol; kidney failure; ifosfamide; urologic neoplasms; taxoids; mesna; recombinant granulocyte colony stimulating factor; carcinoma, transitional cell; bladder carcinoma; alopecia; transitional cell carcinoma; mannitol; urinary tract carcinoma; intravenous drug administration; oral drug administration; diphenhydramine; cimetidine; granulocyte colony stimulating factor, recombinant; subcutaneous drug administration; humans; human; male; female; priority journal; article
Journal Title:	Journal of Clinical Oncology
Volume:	16
Issue:	8
ISSN:	0732-183X
Publisher:	American Society of Clinical Oncology
Date Published:	1998-08-01
Start Page:	2722
End Page:	2727
Language:	English
PUBMED:	9704723
PROVIDER:	scopus
DOI:	10.1200/JCO.1998.16.8.2722
DOI/URL:	https://www.scopus.com/inward/record.uri?eid=2-s2.0-0031903265&partnerID=40&md5=8909cac7ed42d984e8ca52d869e06cd9
Notes:	Article -- Export Date: 12 December 2016 -- Source: Scopus

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