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Neoadjuvant Trial of Dual HER2 Targeting Plus Lapatinib

By: Cordi Craig
Posted: Wednesday, January 17, 2018

According to the results from CALGB 40601, a regimen of lapatinib plus trastuzumab and paclitaxel significantly improved invasive disease–free survival in patients with HER2-positive breast cancer. The triplet therapy demonstrated better results than the standard paclitaxel and trastuzumab. Ian Krop, MD, PhD, of the Dana-Farber Cancer Institute in Boston, presented these phase III trial findings at the San Antonio Breast Cancer Symposium (SABCS; Abstract GS3-02).

A total of 305 patients were enrolled and randomized 1:1 to receive trastuzumab and paclitaxel with or without the addition of lapatinib 16 weeks prior to surgery. Invasive disease–free survival and gene-expression information were available for 261 patients.

After a median follow-up of 4.6 years, patients in the lapatinib arm experienced fewer invasive disease–free survival events after the primary treatment than did those receiving standard dual therapy at 7 versus 19 events, respectively. Furthermore, longer invasive disease–free survival was significant among patients who reached pathologic complete response than among those who do not and did not differ by hormone receptor status, clinical stage, tumor size, race, menopausal status, or age.

In a recent interview, Dr. Krop concluded that at this time, the data should only be hypothesis-generating. “A better understanding of the clinical and molecular features in HER2-positive breast cancer is likely to be key in rationally escalating and de-escalating therapy,” he commented.



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