Roche preoperative treatment found effective against breast cancer

In the multi-center, open-label trial designed to investigate the activity of a short non-anthracycline-based preoperative treatment for early breast cancer in both HER2-negative and HER2-positive patients, promising results were achieved after only four cycles of pre-surgical treatment as compared to the standard eight cycles. The majority of the 156 patients responded to the Xeloda-based therapy regardless of HER2 status, and both patient groups experienced a clinically significant reduction in tumor size.

In the interim analysis, following four treatment cycles, the combination of Xeloda, Taxotere and Herceptin in HER2-positive patients resulted in a 73% clinical response rate (complete and partial response) and a 50% pathologic response (pathologic complete response, which is the absence of histological evidence of cancer cells in the tissue specimen, plus near pathological complete response, which is less than or equal to 5 millimeters of residual cancer). Additionally, HER2-negative patients experienced a clinical response rate of 76% and 15% pathological response with the combination of solely Xeloda and Taxotere. In patients with HER2-negative tumors, a decrease from 6.1 to 2.8 centimeters was observed; in HER2-positive patients, the reduction was from 5.6 to 1.6 centimeters.

The multi-center, open-label XeNA trial enrolled 157 (156 evaluable) patients with newly-diagnosed invasive breast cancer (planned sample size 122 HER2-negative; 34 HER2-positive) and was designed to investigate the activity of a short non-anthracycline-based preoperative treatment for early breast cancer. Efficacy results for 134 patients as well as toxicity data for the total evaluable population (156 patients) were included in this interim analysis. The primary endpoint was the rate of pathological complete response rate (pCR) plus near pCR in the affected breast after preoperative administration of Xeloda and Taxotere for HER2-negative patients and in combination with Herceptin for HER2-positive patients. Secondary endpoints included safety profile, quality of life, local recurrence, disease-free survival, distant disease-free survival and overall survival.

Patients received four three-week cycles of the treatment regimen. HER2-negative patients received Xeloda 825 mg/m2 twice a day for 14 days with seven days off, and also received Taxotere 75 mg/m2 IV on the first day. HER2-positive patients were on the same regimen, but also received Herceptin each week with a loading dose of 4 mg/kg for 90 minutes followed by 2 mg/kg for 30 minutes for a total of 12 weeks before definitive surgery.

Lars Birgerson, vice president of medical affairs at Roche, said: “The XeNA results demonstrate the potential for oral Xeloda to serve as the cornerstone of combination chemotherapy in the treatment of early invasive breast cancer.”