Improvements in disease-free survival reported with adjuvant dose-dense chemotherapy.(breast cancer)

2003 JAN 9 - (NewsRx.com & NewsRx.net) -- New data from a large phase III study of 2005 women with node-positive breast cancer show that when Taxol (paclitaxel) (T) is given with standard chemotherapy, doxorubicin (A) and cyclophosphamide (C), in a 2-weekly dose-densei regimen the rate of recurrence is significantly reduced by 26% (p=0.010) and the rate of death is reduced by 31% (p=0.013), compared to standard 3-weekly administration, with an acceptable toxicity profile.

The results of the study are reported for the first time at the 25th Annual San Antonio Breast Cancer Symposium.

"Chemotherapy treatment is very difficult for patients, both physically and mentally. To be able to complete adjuvant treatment faster with the hope for better long-term survival is a huge boost for breast cancer patients," said Dr. Marc Citron, clinical professor of medicine, Albert Einstein College of Medicine, New York City, the principal investigator of the study. "The dose-dense treatment approach used in this study allows patients to receive their chemotherapy doses on time, giving them the best opportunity to recover and continue with their everyday lives."

Based on positive results from previous studies (CALGB 9344, Hudis et al.) AC plus Taxol became standard adjuvant therapy in the USA and investigators of CALGB 9741 used this foundation to determine if additional improvements in treatment outcome could be gained through varying the schedule and dose-density of Taxol. CALGB 9741 was designed to compare concurrent AC-T vs. sequential A-T-C either in a 2-weekly dose-dense schedule or in a 3-weekly conventional schedule in women with axillary node-positive operable breast cancer. The cumulative dose of treatment in each of the arms was identical, Taxol (175 mg/m[superscript]2), doxorubicin (60 mg/m[superscript]2) and cyclophosphamide (600 mg/m[superscript]2).

Two thousand five patients were randomized into four study arms and received either A-T-C for 36 weeks (arm 1); A-T-C for 24 weeks (arm 2); AC-T for 24 weeks (arm 3); AC-T for 16 weeks (arm 4).

In addition, all patients receiving chemotherapy in the dose-dense arms (arms 2 and 4) received Neupogen (filgrastim) prophylactically to boost their production of infection-fighting white blood cells. Researchers found that the women in the dose-dense arms of the study who were given Neupogen were less prone to infection than those who did not receive Neupogen.

Grade 4 granulocytopenia was ...