Adult urologyProspective Trial of Ifosfamide, Paclitaxel, and Cisplatin in Patients with Advanced Non-transitional Cell Carcinoma of the Urothelial Tract
Section snippets
Patient Population
To be eligible for this study, all patients were required to have measurable or evaluable non-TCC of the urothelial tract. Measurable disease included unresectable or metastatic urothelial tract tumors that were bi-dimensionally measurable on x-ray, cross-sectional imaging, or physical examination. Evaluable disease was restricted to unresectable bladder tumors that could be evaluated for response by cystoscopy and examination under anesthesia. Pathologic confirmation was required at Memorial
Patient Characteristics
The patient characteristics are detailed in Table 2. Twenty patients were enrolled from February 1997 to September 2004. Of these 20 patients, 11 had adenocarcinoma, 8 had squamous cell carcinoma, and 1 had small cell carcinoma. Of the 11 patients with adenocarcinoma, 6 had tumors of urachal origin. Of the 20 patients, 14 had metastatic disease (70%) and 6 had unresectable primary tumors. Although the median age of those enrolled was 57 years, 35% of the patients were 50 years old or older at
Comment
To our knowledge, this is the first prospective trial exploring the use of a specific chemotherapy regimen for the treatment of patients with advanced/metastatic (nonbilharzial) non-TCC of the bladder. The results of this study have demonstrated the safety and activity of ITP in patients with squamous cell carcinoma, small cell carcinoma, and adenocarcinoma of the urothelial tract. Furthermore, our results have revealed that long-term disease-free survival is possible in a select subgroup of
Conclusions
Larger trials are desirable to confirm, and improve on, our results. However, even in the cooperative group setting, trials in patients with rare malignancies are difficult to complete, taking several years to accrue a small number of patients. Innovative collaborative efforts are likely needed, such as those proved successful in the study of other rare malignancies,13 to make meaningful advances in the management of non-TCCs of the urothelial tract. Currently, in the absence of a prospective
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2023, Cancer Treatment and Research CommunicationsCitation Excerpt :However, Galsky et al. conducted a prospective phase II trial of ifosfamide, paclitaxel, and cisplatin in advanced non-UC histologies including 8 patients with SCC. Two of these patients achieved radiographic CR, one had stable disease (SD), and 5 had progressive disease (PD) as their best clinical response; median OS was 8.9 months [28]. In advanced bilharzial SCC, a phase II study of gemcitabine and cisplatin yielded an objective response rate (ORR) of 55% including 8 (24%) CRs and 10 (30%) PRs [29].
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D. F. Bajorin has been a paid consultant and received research funding in the past from Bristol-Myers Squibb.