Taxol/Herceptin Effective in Stage I HER2-Positive, Node-Negative Breast Cancer

Taxol/Herceptin Effective in Stage I HER2-Positive, Node-Negative Breast Cancer

The combination of Taxol® (paclitaxel) and Herceptin® (trastuzumab) followed by Herceptin alone showed benefit and was well tolerated by women with stage I HER2-positive, node-negative breast cancer, according to the results of a study presented at the 2013 San Antonio Breast Cancer Symposium

Breast cancer is the second leading cause of cancer-related death among women. This year an estimated 226,870 women will be diagnosed with breast cancer, and 39,510 will die from the disease.

Herceptin is a targeted therapy that binds to a protein known as HER2. Twenty to thirty percent of breast cancers overexpress (make too much of) HER2, and could potentially respond to treatment with Herceptin.

Scientists have debated the best course of treatment for women with tumors that measure less than 3 centimeters—and few studies have evaluated chemotherapy and Herceptin in this population.

The APT study included 406 women with HER2-positive, node-negative tumors that measured less than 3 cm. The study was a nonrandomized prospective trial to define the outcomes in a uniformly treated cohort. Patients received Taxol/Herceptin for 12 weeks followed by 9 months of Herceptin.

After a median follow-up of 3.6 years, disease-free survival was 98.7 percent and recurrence or death occurred in 2.5 percent of patients. There were no new contralateral primary breast cancers. Distant recurrences were observed in two patients. By hormone receptor status, disease-free survival rates were 98.5 percent in receptor-positive patients and 99.2 percent in receptor-negative patients.

Two patients developed symptomatic congestive heart failure. Few other adverse events were noted.

The limitations of the study were that it was a non-randomized, single-arm study and about 20 percent of patients had T1a tumors, which are already associated with a favorable prognosis. Still, the researchers concluded that this adjuvant regimen should be considered a standard strategy to prevent recurrence in stage I HER2-positive, node-negative breast cancer.

Reference:

Tolaney SM, Barry WT, Dang CT, et al. A phase II study of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC). Presented at the 2013 San Antonio Breast Cancer Symposium. Abstract S1-04.

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