Finn-HER Studies

[Joe]

Short Course of Adjuvant Trastuzumab With Chemotherapy Has Good Long-Term Safety and Efficacy for HER2-Positive Breast Cancer: Presented at SGBCC

By Mary Wessling

ST. GALLEN, Switzerland -- March 13, 2009 -- Women assigned to a regimen of docetaxel plus 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) had better distant disease-free survival and also tended to have more favourable overall survival than those assigned to vinorelbine, according to a 5-year update of the Finland Herceptin (FinHer) trial.

Lead investigator Heikki Joensuu, MD, Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland, presented the findings here on March 12 at the St. Gallen Oncology Conferences: Primary Therapy of Early Breast Cancer International Conference (SGBCC).

The study aimed to compare the safety and efficacy of docetaxel as adjuvant treatment of breast cancer and to determine the efficacy of a short adjuvant course of trastuzumab with chemotherapy. A second aim was to study the effect of combining trastuzumab with chemotherapy.

The study population consisted of 1,010 breast cancer patients aged 65 years or younger treated at 17 centres in Finland.

Patients were randomised to 5 years of treatment with 1 of 2 treatments: 3 cycles of 3-weekly docetaxel 100 mg/m2 (amended later to 80 mg/m2 due to neutropenia) or to vinorelbine 25 mg/m2 on days 1, 8, and 15 of the 21-day cycle. Both treatment arms were also treated with 3 cycles of FEC and were followed for a median of 62 months.

To evaluate the effect of combining trastuzumab with chemotherapy, a subset of 232 women with HER2 gene amplification was further randomised to receive 9 weekly infusions of trastuzumab at an initial infusion dose of 4 mg/kg and 2 mg/kg thereafter in combination with their chemotherapy.

Radiotherapy was given after chemotherapy according to each institution's guidelines.

Baseline characteristics of the groups were balanced, except that larger tumours (>20 mm in diameter) were more common in the docetaxel group than in the vinorelbine group (59.4% vs 53.3%) and axillary nodal metastases were more frequent in the trastuzumab group than in the control group (89.7% vs 78.4%).

Women treated with the docetaxel regimen had more favourable distant disease-free survival (DDFS) than those in the vinorelbine group (hazard ratio [HR] = 0.66) and also overall survival (HR = 0.70).

Results of the exploratory analyses showed that addition of trastuzumab to docetaxel and FEC produced better overall results, with improved DDFS compared with controls (HR = 0.32, P = .029) and as compared with for vinorelbine, trastuzumab, and FEC (HR = 0.31, P = .020).

Only 9.3% of those patients were diagnosed with distant metastases compared with 18.8% of controls.

In the HER2-positive subset, the HR for distant recurrence or death without known cancer recurrence was 0.65 (0.57 after adjustment for the presence of axillary nodal metastases).

Overall mortality was also improved by adding trastuzumab to the docetaxel treatment regimen (HR = 0.42) and favoured the vinorelbine plus trastuzumab regimen as well (HR = 0.33).

Median left ventricular ejection fraction did not change during the 5-year follow-up. Serious adverse events were few; 1 woman treated with trastuzumab and 2 controls were diagnosed with heart failure.

[Presentation title: Update of the FINHER Trial Based on 5 Years of Follow-Up. Abstract S24]



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Joe

[Donna]

I have been waiting for this report since my herceptin was stopped at 7 months due to heart problems. This is such welcome news, thanks so much for posting this!

Donna

P.S. Thanks so much Joe for all you do for us at her2!