According to the results of a phase II clinical trial published in the journal Cancer, the chemotherapy combination P-HDFL (cisplatin, high-dose 5-fluorouracil, and leucovorin) reduced or eliminated detectable cancer in 63% of patients with metastatic urothelial cancer. There were few serious toxic effects.
Urothelial cancer develops in the lining of the urinary tract. These cancers most commonly involve the bladder, but may also develop in the part of the kidney known as the renal pelvis, the ureters (the tubes that connect the kidneys to the bladder), or the urethra (the tube that empties urine from the bladder).
Among patients with metastatic urothelial cancer (cancer that has spread beyond the urinary tract to other sites in the body), treatment often involves a combination of chemotherapy drugs. One commonly used chemotherapy regimen is M-VAC (methotrexate, vinblastine, doxorubicin, and cisplatin).
Though the commonly used chemotherapy regimens reduce or eliminate detectable cancer is some patients, they can produce severe toxic effects. Researchers therefore continue to explore effective but less toxic treatment alternatives.
To evaluate the safety and effectiveness of the chemotherapy combination P-HDFL (cisplatin, high-dose 5-fluorouracil, and leucovorin), researchers in Taiwan conducted a phase II clinical trial among 35 patients with metastatic urothelial cancer. Twenty-one patients had cancer of the bladder, nine patients had cancer of the renal pelvis or ureter, and five subjects had cancer of both the bladder and the renal pelvis or ureter. Median patient age was 71 years. All patients were treated with four-week cycles of P-HDFL.
- 32 of the 35 patients received at least two cycles of P-HDFL.
- 28% of these patients experienced a complete disappearance of detectable cancer.
- 34% experienced a partial disappearance of detectable cancer.
- Overall survival was 12.3 months.
- Survival without cancer progression was 10.5 months.
- Severe (grade 3 or grade 4) toxic effects of treatment were rare. Severe nausea developed in three patients, severe vomiting developed in two patients, severe diarrhea developed in two patients, and low white blood cell levels developed in one patient.
The researchers concluded that the chemotherapy regimen P-HDFL produces a treatment response in some patients with metastatic urothelial cancer, with few serious toxic effects. They note that these characteristics may make this regimen particularly appropriate for patients in poor health. The researchers recommend clinical trials to directly compare P-HDFL with the chemotherapy regimens that are generally used for metastatic urothelial cancer.
Reference: Lin C-C, Hsu C-H, Huang C-Y et al. Weekly Cisplatin plus Infusional High-Dose 5-Fluorouracil and Leucovorin (P-HDFL) for Metastatic Urothelial Cancer. Cancer. 2006;106:1269-75.
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