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Study shows adjuvant Herceptin in breast cancer without the heart problems

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New research published in the October 6, 2011 issue of the New England Journal of Medicine shows that patients with early-stage HER2-positive breast cancer could potentially avoid some of the late-onset cardiac toxicity associated with anthracycline-based therapy (i.e. involving doxorubicin) used with the humanized monoclonal antibody Herceptin (trastuzumab) in the adjuvant setting.

Investigators—led by Dr. Dennis Slamon, the pioneering figure who championed Herceptin in the 1980s and early 1990s when few of his colleagues would do so—randomized a total of 3,222 women diagnosed with HER2-positive early-stage breast cancer into three arms:

-- AC-T: doxorubicin and cyclophosphamide followed by docetaxel every 3 weeks.
-- AC-T + trastuzumab: doxorubicin and cyclophosphamide followed by docetaxel every 3 weeks plus 52 weeks of trastuzumab
-- TCH: docetaxel and carboplatin plus 52 weeks of trastuzumab

The primary end point was disease-free survival (DFS). Secondary end points included overall survival (OS) and safety.

Median follow-up was 65 months, and the estimated disease-free survival rates at 5 years:

-- AC-T: 75 percent
-- AC-T + trastuzumab:84 percent
-- TCH:81 percent

Estimated rates of overall survival:

-- AC-T: 87 percent
-- AC-T + trastuzumab:92 percent
-- TCH: 91 percent

Congestive heart failure and cardiac toxicity issues were found to be much higher in the AC-T + trastuzumab arm than in the TCH arm, while of the handful of secondary leukemias that occurred, all but one were found in the anthracycline-based therapies.

Researchers concluded that adding 52 weeks of trastuzumab "significantly improved disease-free and overall survival among women with HER2-positive breast cancer."

Source

Slamon D et al. Adjuvant Trastuzumab in HER2-Positive Breast Cancer. N Engl J Med 2011; 365:1273-1283 | October 6, 2011.

 

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