DOCETAXEL AND TRASTUZUMAB IMPROVES SURVIVAL IN EARLY BREAST CANCER

NEW YORK (Reuters Health) Nov 19 - In women with node-positive or high-risk node-negative early breast cancer, disease-free survival was better when docetaxel was substituted for vinorelbine as an adjuvant therapy to fluorouracil, epirubicin and cyclophosphamide (FEC).

The large Finnish study also found that a short course of trastuzumab given alongside the docetaxel was effective and safe, particularly in terms of cardiac toxicity.

As reported in an online publication November 2 in the Journal of Clinical Oncology by Dr. Heikki Joensuu of Helsinki University and colleagues, the phase III trial involved 1,010 women no older than 65 (median age 50.9) who entered the study no more than 12 weeks after mastectomy or breast-conserving surgery.

The majority of participants had HER2-negative cancer and were randomized to treatment with either docetaxel/FEC or vinorelbine/FEC. The 232 women with HER2-positive disease were further randomized to receive or not receive trastuzumab.

The median follow-up was 62 months. Overall, women who received docetaxel had better distant disease-free survival than those treated with vinorelbine (P = 0.010) and also were less likely to have recurrence of breast cancer or develop cancer of the other breast.

Patients treated with trastuzumab also tended to have better overall survival than those who only received chemotherapy. Specifically, 19.1% of patients who received trastuzumab were diagnosed with distant recurrence or died without known cancer recurrence, versus 26.7% of those who did not receive trastuzumab (P = 0.12).

Furthermore, 10.4% of trastuzumab-treated patients died, compared with 18.1% of women with HER2-positive disease who did not receive the drug.

Distant disease-free survival was also better with trastuzumab than without, and better in those who received trastuzumab with docetaxel/FEC than in those treated with trastuzumab plus vinorelbine/FEC.

According to the report and an accompanying editorial, at least two additional studies of trastuzumab are under way. One compares docetaxel, nine weeks of trastuzumab and FEC to the same regimen but with trastuzumab continued for a total of 12 months. The other involves a large cohort of women with stage I breast cancer who receive 12 weeks of paclitaxel and trastuzumab, followed by maintenance trastuz