Source: Kardiologiia  |  Posted 7 years ago

By Paula Moyer

PARIS, FRANCE -- February 16, 2004 -- A dose-dense treatment consisting of docetaxel (Taxotere) and doxorubicin (Adriamycin) appears to increase the rate of disease-free survival to 5 years or more in patients with stage II and III breast cancer, say researchers.

"This therapy combination is safe and effective in the treatment of locally advanced breast cancer," according to principal investigator Peter J. Mencel, MD. On the basis of these findings, he and his co-investigators recommend examining the potential of this treatment strategy for these stages of breast cancer in prospective, randomised trials. Dr. Mencel, medical director of the Jersey Shore Cancer Center in Neptune, NJ, United States, presented the study findings here February 11th at the 15th International Congress of Anti-Cancer Therapy.

The investigative team was interested in the potential of these 2 agents against locally advanced breast cancer because of promising investigations regarding their activity against early breast disease. They recruited 18 patients with large tumours and 2 to 10 axillary lymph nodes with metastatic disease.

The treatment consisted of 100 mg/m2 of docetaxel administered every 2 weeks for 4 cycles, followed by 75 mg/m2 of doxorubicin on the same schedule. The patients received granulocyte colony stimulating factor (G-CSF) after every chemotherapy dose and underwent radiation therapy according to criteria established by the Radiation Therapy Oncology Group.

Among the patients, 83% have survived disease-free. The longest follow up has been 69 months, and the longest disease-free survival has been 69 months. One patient died with metastatic disease 33 months after completing chemotherapy. Two patients progressed to stage IV disease, 1 at 19 months after treatment and the other at 29 months. Both are alive and are being treated for recurrence, noted Dr. Mencel.

The investigators documented all haematologic adverse events and subcategorised severe events, which were defined as grade 3-4. Among 10 patients who received 80 chemotherapy cycles, the investigators documented neutropaenia in 13.7% of the cycles; the investigators noted that all of the patients experienced severe neutropaenia in at least one cycle. The investigators also reported that anaemia occurred in 64.9% of the cycles and severe anaemia occurred in 6 patients and in 5.1% of the cycles. Thrombocytopaenia developed in 11.6% of the cycles, with severe thrombocytopaenia developing in 1 patient and 2.4% of cycles. Dr. Mencel reported that when the anaemic patients were treated with epoetin-alfa, the severity of their anaemia decreased, and they were less likely to need transfusions. Transfusions were required in 5% of the cycles, and in 4 patients.

Two patients had mild oncolysis-related side effects. The investigators reported that no cardiac events have occurred in any of the patients. They concluded that any chronic toxicities associated with the treatment regimen appeared to be self-limited, and that no patients have been lost to follow up.

[Study title: "83% Disease-Free Survival 5 ? After Treatment With Adjuvant Dose-Dense Sequential Docetaxel and Doxorubicin for Stage II and III Breast Cancer." Abstract P11]