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Title: Docetaxel a Safe Choice for Elderly Breast Cancer Patients: Presented at ESMO

"Docetaxel a Safe Choice for Elderly Breast Cancer Patients: Presented at ESMO"

By Charlene Laino VIENNA, AUSTRIA -- November 2, 2004 -- Docetaxel is a safe drug for older women with metastatic breast cancer who have a good performance status, according to an analysis of 4 phase 3 studies. Chief investigator Arti Hurria, MD, medical oncologist, breast cancer medicine service, Memorial Sloan-Kettering Cancer Center, New York, New York, United States, said that the study was conducted to help fill the void of data on the use of chemotherapy in elderly patients. Dr. Hurria presented the analysis here on October 31st at the 29th European Society for Medical Oncology Congress, and pooled data from 4 studies of docetaxel with similar study populations.* In the studies, a total of 777 patients were randomised to 100 mg/m[² of docetaxel every 3 weeks; 81% were under 65 years.

The median number of treatment cycles (range 5 to 7) across studies and age groups was similar, and the median relative dose intensities were similar in younger and older patients, Dr. Hurria said.

Results show that progressive disease was the major reason for patients withdrawing from treatment, he said. In contrast, adverse events caused 11% to 24% of patients under 65 years and 17% to 34% of older patients to leave the studies, Dr. Hurria reported.

In general, the safety profile of the regimen was similar for both age groups, with 13% of patients under 65 reporting grade 3/4 febrile neutropaenia, compared with 12% of older patients. Grade 3/4 neutropaenia was observed in 94% of younger patients versus 93% of older patients.

Of the common toxicities, the largest difference was in the incidence of grade 3/4 anorexia, seen in 11% of older patients, compared with 5% of younger patients (P =.01), Dr. Hurria said.

"Overall, the safety profile of 100 mg/m² of docetaxel every 3 weeks for metastatic breast cancer is similar in women 65 years and older to that in younger patients," he concluded. He added, however, that the safety of the regimen in patients older than 75 years could not be assessed fully due to the small number of patients enrolled.

References
· TAX 303: Chan S, et al. Prospective randomised trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol. 1999;17:2341-2354
· TAX 304: Nabholtz J-M, et al. Prospective randomised trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. J Clin Oncol. 1999;17:1413-1424
· TAX 311: Jones S, et al. Phase 3 comparison of docetaxel and paclitaxel in patients with metastatic breast cancer. Presented at 26th Annual San Antonio Breast Cancer Symposium; December 3-6, 2003; San Antonio, Texas. Abstract 10.
· TAX 313: Mouridsen H, et al. Phase 3 study of docetaxel 100 versus 75 versus 60 mg/m² as second-line chemotherapy in advanced breast cancer. Presented at 25th Annual San Antonio Breast Cancer Symposium; December 11-14, 2002; San Antonio, Texas. Poster 327.

[Presentation title: Safety Profile of Docetaxel in Patients (Pts) >/=65 Years of Age With Metastatic Breast Cancer (MBC): Analysis of Four Phase III Studies. Poster 176P]

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