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The role of paclitaxel in the therapy of bladder cancer
1Division of Hematology/Oncology, Indiana University Medical Center, Indianapolis, USA.
Abstract:
Although significant strides have been made in the development of effective chemotherapy for metastatic bladder cancer, those benefits have plateaued and prompted a search for new, active agents. The most active of a new generation of investigational agents is paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ). The only single-agent phase II trial to date, which used paclitaxel at a dose of 250 mg/m2 by 24-hour infusion every 3 weeks, resulted in a 42% response rate and a 27% complete response rate in previously untreated patients. With granulocyte colony-stimulating factor support, this therapy was well tolerated, with fewer than 10% of patients developing neurtropenic fever during therapy. Paclitaxel's potential as a radiation sensitizer and its relatively low renal excretion make it an attractive agent for use in patients with urothelial carcinoma. The goal of ongoing and planned clinical trials will be to (1) identify potential paclitaxel-containing combination regimens, (2) define the optimal dose and schedule of administration in patients with bladder cancer, and (3) define the activity of paclitaxel in previously treated patients.
Insights
Paclitaxel shows promise for metastatic bladder cancer, achieving a 42% response rate in a Phase II trial. This chemotherapy agent was well-tolerated, offering a new option for urothelial carcinoma treatment.
Area of Science:
- Oncology
- Pharmacology
Background:
- Chemotherapy benefits for metastatic bladder cancer have plateaued, necessitating novel therapeutic agents.
- Paclitaxel represents a new generation of investigational agents with significant activity.
Purpose of the Study:
- To evaluate the efficacy and tolerability of paclitaxel as a single agent in patients with metastatic bladder cancer.
- To explore paclitaxel's potential as a radiation sensitizer and its suitability for urothelial carcinoma treatment.
Main Methods:
- A single-agent Phase II trial administered paclitaxel at 250 mg/m2 via 24-hour infusion every 3 weeks.
- Granulocyte colony-stimulating factor support was utilized to mitigate toxicity.
Main Results:
- The trial demonstrated a 42% overall response rate and a 27% complete response rate in previously untreated patients.
- Fewer than 10% of patients experienced neutropenic fever, indicating good tolerability with supportive care.
Conclusions:
- Paclitaxel is an active and well-tolerated agent for metastatic bladder cancer, particularly in previously untreated patients.
- Its properties suggest potential for combination regimens and use in urothelial carcinoma, warranting further clinical investigation.