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Rupali · 12-12-2005, 02:37 PM

Trastuzumab significantly improves DFS in HER2-overexpressing, node-negative or node-positive breast cancer

By Claire Sowerbutt

December 09, 2005

Trastuzumab has been found to significantly improve disease-free survival (DFS) in patients with human epidermal growth factor receptor 2 (HER2)-overexpressing, node-negative or node-positive breast cancer. This finding was presented as part of the interim analysis of the HERA study by Richard D. Gelber, PhD, with the Harvard School of Public Health in Boston, Massachusetts, during the 28th Annual San Antonio Breast Cancer Symposium.

HERA is a large, multinational, multicenter, randomized, 3-arm trial designed to assess the comparative efficacies of 1 or 2 years of adjuvant treatment with trastuzumab vs observation in patients with HER2 positive breast cancer. Participants must have undergone surgery and completed a minimum of 4 cycles of an acceptable (neo) adjuvant chemotherapy regimen.

The study enrolled 5000 patients over a 3-year period. The primary efficacy endpoint was DFS, with 1 interim efficacy analysis conducted this April after the required 475 events had been met. Approximately one half of the patients were younger than 50 years of age. Approximately 94% of patients received chemotherapy containing an anthracycline, and 25% received taxane plus anthracycline therapy. Dr. Gelber reported that there was a significant improvement in DFS for patients who received 1 year of trastuzumab compared with thos patients randomized to observation alone. DFS at 2 years was 85.8% for the trastuzumab cohort and 77.4% for the observation arm, equivalent to a 46% reduction in the risk of a disease event (hazard ratio, 0.54; 95% confidence interval: 0.43-0.67; P < .001).

“With respect to the types of events reported, it was primarily distant events that were reduced with trastuzumab, but we still have a problem with central nervous system relapses,” Dr. Gelber explained. Specifically, while distant events were reduced from 9.1% with observation to 5.0% with trastuzumab, the proportion of those events affecting the central nervous system was similar between the 2 groups.

Data were also presented on the annual hazard rates for the first 1.5 years of the study. These analyses show a 14% to 15% risk for recurrence in the observation group compared with a 7%-8% risk for recurrence with trastuzumab. Dr. Gelber explained that, according to their calculations, “even if beyond this point both treatment groups have exactly the same risk of recurrence, and we continue to follow them for at least another 4 years, there’s less than a 20% chance that the statistical significance in the HERA trial would disappear.” He concluded that “in terms of reducing the risk of early events, these results are solid.”

An increase in cardiac events was reported in the trastuzumab treatment arm, although most of these have been clinically manageable. Specifically, 10 patients in the trastuzumab group have suffered from congestive heart failure, compared with no patients in the observation arm (P < .01). However, no cardiac-related deaths have been reported in the trastuzumab group.

Reference

Hera Study Team. Trastuzumab (H: Herceptin) following adjuvant chemotherapy (CT) significantly improves disease-free survival (DFS) in early breast cancer (BC) with HER2 overexpression: the HERA Trial. Program and abstracts of the 28th Annual San Antonio Breast Cancer Symposium; December 8-11, 2005; San Antonio, Texas. Abstract 11.

12-12-2005, 02:37 PM	#9
Rupali Senior Member Join Date: Dec 2005 Posts: 148	Trastuzumab significantly improves DFS in HER2-overexpressing, node-negative or node-positive breast cancer By Claire Sowerbutt December 09, 2005 Trastuzumab has been found to significantly improve disease-free survival (DFS) in patients with human epidermal growth factor receptor 2 (HER2)-overexpressing, node-negative or node-positive breast cancer. This finding was presented as part of the interim analysis of the HERA study by Richard D. Gelber, PhD, with the Harvard School of Public Health in Boston, Massachusetts, during the 28th Annual San Antonio Breast Cancer Symposium. HERA is a large, multinational, multicenter, randomized, 3-arm trial designed to assess the comparative efficacies of 1 or 2 years of adjuvant treatment with trastuzumab vs observation in patients with HER2 positive breast cancer. Participants must have undergone surgery and completed a minimum of 4 cycles of an acceptable (neo) adjuvant chemotherapy regimen. The study enrolled 5000 patients over a 3-year period. The primary efficacy endpoint was DFS, with 1 interim efficacy analysis conducted this April after the required 475 events had been met. Approximately one half of the patients were younger than 50 years of age. Approximately 94% of patients received chemotherapy containing an anthracycline, and 25% received taxane plus anthracycline therapy. Dr. Gelber reported that there was a significant improvement in DFS for patients who received 1 year of trastuzumab compared with thos patients randomized to observation alone. DFS at 2 years was 85.8% for the trastuzumab cohort and 77.4% for the observation arm, equivalent to a 46% reduction in the risk of a disease event (hazard ratio, 0.54; 95% confidence interval: 0.43-0.67; P < .001). “With respect to the types of events reported, it was primarily distant events that were reduced with trastuzumab, but we still have a problem with central nervous system relapses,” Dr. Gelber explained. Specifically, while distant events were reduced from 9.1% with observation to 5.0% with trastuzumab, the proportion of those events affecting the central nervous system was similar between the 2 groups. Data were also presented on the annual hazard rates for the first 1.5 years of the study. These analyses show a 14% to 15% risk for recurrence in the observation group compared with a 7%-8% risk for recurrence with trastuzumab. Dr. Gelber explained that, according to their calculations, “even if beyond this point both treatment groups have exactly the same risk of recurrence, and we continue to follow them for at least another 4 years, there’s less than a 20% chance that the statistical significance in the HERA trial would disappear.” He concluded that “in terms of reducing the risk of early events, these results are solid.” An increase in cardiac events was reported in the trastuzumab treatment arm, although most of these have been clinically manageable. Specifically, 10 patients in the trastuzumab group have suffered from congestive heart failure, compared with no patients in the observation arm (P < .01). However, no cardiac-related deaths have been reported in the trastuzumab group. Reference Hera Study Team. Trastuzumab (H: Herceptin) following adjuvant chemotherapy (CT) significantly improves disease-free survival (DFS) in early breast cancer (BC) with HER2 overexpression: the HERA Trial. Program and abstracts of the 28th Annual San Antonio Breast Cancer Symposium; December 8-11, 2005; San Antonio, Texas. Abstract 11.