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Paclitaxel Is Dose Escalated in Combination Regimen

Paclitaxel Is Dose Escalated in Combination Regimen

DUARTE, Calif—Researchers at the City of Hope National Medical Center are in the process of updating their high-dose chemotherapy regimens for high-risk breast cancer patients to include paclitaxel (Taxol), George Somlo, MD, said in a poster presentation at the San Antonio Breast Cancer Symposium.

The researchers are conducting a phase I study to define the maximum-tolerated dose of a regimen of doxorubicin, cyclophosphamide, and paclitaxel with stem cell support. Paclitaxel has been shown to be more effective than etoposide, which it replaces, Dr. Somlo said.

The regimen consists of 96 hours of continuous infusion doxorubicin at 165 mg/m², followed by cyclophosphamide at 100 mg/kg, followed by a 24-hour infusion of paclitaxel in a dose-escalating scheme.

The investigators are nearing the sixth dose level of paclitaxel. "We are presently accruing patients at 525 mg/m² of Taxol as continuous infusion," Dr. Somlo said in an interview.

So far, side effects have been tolerable. "The main side effect is mucositis, which is not more pronounced than what we have seen with our previous regimens," Dr. Somlo said, "although it does require both IV narcotics and nutritional support in the majority of patients."

To date, the researchers have enrolled 21 patients, and the study is ongoing at an accrual rate of about three patients per month. Eligible patients are those with high-risk breast cancer (stage II with 10 or more involved lymph nodes, or stage IIIA and IIIB) or those with responsive stage IV breast cancer.

"It is obviously too early to say anything about the results," Dr. Somlo noted.

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