Docetaxel Improves Survival in Node-Positive Early-Stage Breast Cancer Patients

August 1, 2002

Women with early-stage breast cancer treated with a docetaxel (Taxotere)-based regimen after surgery had a 32% less chance of developing disease recurrence than did women receiving one of the most effective adjuvant treatments currently available. Results from the Breast Cancer International Research Group (BCIRG) trial 001, the first phase III trial to evaluate docetaxel after breast surgery, were presented at the recent annual meeting of the American Society of Clinical Oncology (ASCO) by the BCIRG.

Women with early-stage breast cancer treated with adocetaxel (Taxotere)-based regimen after surgery had a 32% less chance ofdeveloping disease recurrence than did women receiving one of the most effectiveadjuvant treatments currently available. Results from the Breast CancerInternational Research Group (BCIRG) trial 001, the first phase III trial toevaluate docetaxel after breast surgery, were presented at the recent annualmeeting of the American Society of Clinical Oncology (ASCO) by the BCIRG.

Benefits Favor One Group

In the analysis of the study, women were divided into two groups—those withone to three positive lymph nodes and those with four or more. The mostsignificant benefit from the use of docetaxel was seen in women with one tothree positive lymph nodes. Among these women, treatment with docetaxel reducedthe risk of relapse by 50% and the mortality rate by 54%. Women with one tothree positive lymph nodes account for 60% to 70% of all women worldwide withnode-positive early-stage breast cancer.

"The superior results observed with the docetaxel-based regimen indicatethat it can potentially cure more women than one of the best chemotherapies wehave," said Jean-Marc Nabholtz, MD, chairman of the BCIRG, study chairman,professor of medicine at the University of California at Los Angeles (UCLA), anddirector of the Cancer Therapy Development Program at the Jonsson ComprehensiveCancer Center at UCLA. "Although early, these results should be consideredwhen choosing therapy for a large number of women with early breastcancer."

Study Demographics

The BCIRG 001 study was designed to determine whether docetaxel would alsobenefit women with early-stage disease. After surgery, study participantsreceived either the TAC regimen (docetaxel, doxorubicin [Adriamycin],cyclophosphamide [Cytoxan, Neosar]) or the standard FAC regimen (fluorouracil,doxorubicin, cyclophosphamide). Of the 1,491 women enrolled in the study, 745were randomized to the TAC arm and 746 to the FAC arm.

Nearly 3 years after treatment, study results show that 82% of patients inthe TAC arm and 74% in the FAC arm were alive and disease-free. For thosetreated with TAC, this represents a significant improvement in disease-freesurvival and a 32% reduction in the risk of recurrence (P = .0011)compared to those treated with FAC. In addition, women in the TAC arm had nearlya 50% less chance of developing a metastatic relapse.

The majority of study participants (54%) were younger than age 50 years, 56%were premenopausal, 62% had one to three cancerous lymph nodes, 69% werehormone-receptor-positive, 60% had tumors larger than 2 cm, and 20% hadHER2-positive tumors. The benefit from TAC was observed regardless ofhormone-receptor or HER2-receptor status.

"While still early, the results of this study are promising for reducingrecurrence of breast cancer among early-stage patients," said Susan Braun,president and chief executive officer of the Susan G. Komen Breast CancerFoundation. "Perhaps more importantly, though, they highlight theimportance of patient participation in clinical research trials and theextraordinary potential of global cooperation of breast cancer researchers toidentify new and more effective treatments. The Komen Foundation stronglysupports educating patients and physicians about the scientific benefits, aswell as the high quality of patient care, associated with well-designed clinicaltrials."

The study compared an equal number of treatment cycles for both treatmentgroups, and more than 90% of patients in both treatment groups received all sixcycles of treatment.

Adverse Effects

The TAC regimen was associated with a higher incidence of febrile neutropeniacompared with the FAC arm (24% vs 2%). However, no patients in either arm diedof an infection due to treatment.

Severe (grade 3/4) infections occurred rarely with both treatments (2.8% vs1.3%). Severe adverse events, which developed in more than 5% of patients in theFAC arm, included nausea (9%), vomiting (7%), and fatigue/asthenia (5%), and inthe TAC arm, fatigue/asthenia (11%) and stomatitis (7%).

"These early results are important for two reasons," said Dr.Nabholtz. "They represent a new, and possibly very large, advance in thechoice of chemotherapy for many women, but they also may indicate a very goodregimen for future combination with new therapies coming from biologicalresearch."