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Chemotherapy Plus Targeted Therapy Reduces Recurrence in Women With Early-Stage HER2-Positive Breast Cancer

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Key Points

  • A phase II study of adjuvant paclitaxel and trastuzumab inwomen with stage I HER2-positive breast cancer has found the 3-year rate of survival free from invasive disease was 98.7%.
  • The treatment side effects were generally milder than those associated with traditional chemotherapy regimens.
  • The study findings may help establish the combination therapy as the first standard treatment approach for patients with small, node-negative, HER2-positive breast cancer.

A phase II clinical study of adjuvant paclitaxel and trastuzumab (Herceptin) in women with stage I HER2-positive breast cancer has found the 3-year rate of survival free from invasive disease was 98.7%. The findings may help establish the combination therapy as the first standard treatment approach for patients with small, node-negative, HER2-positive breast cancer. The study by Tolaney et al is published in The New England Journal of Medicine.

Study Methodology

The uncontrolled, single-group, multicenter study included 406 patients (median age, 55 years) with HER2-positive, node-negative breast tumors smaller than 3 cm in the greatest dimension; there was no lower limit on tumor size. The patients were enrolled in the study between October 9, 2007, and September 3, 2010.

The treatment consisted of weekly doses of paclitaxel and trastuzumab for 12 weeks, followed by 9 months of trastuzumab monotherapy. The primary endpoint was survival free from invasive disease. The median follow-up period was 4 years.

Study Findings

The researchers found the 3-year rate of survival free from invasive disease was 98.7%. Among the 12 relapses seen, two were due to distant metastatic breast cancer. Excluding contralateral HER2-negative breast cancers and nonbreast cancers, seven disease-specific events were noted.

The treatment was generally well tolerated with a total of 13 patients reporting at least one episode of grade 3 neuropathy, and two had symptomatic congestive heart failure, both of whom had normalization of the left ventricular ejection fraction after discontinuation of trastuzumab. A total of 13 patients had significant asymptomatic declines in ejection fraction, but 11 of these patients were able to resume trastuzumab therapy after a brief interruption.

“Women with small, HER2-positive, node-negative breast tumors have a low, but still significant, risk of recurrence of their disease,” Eric Winer, MD, Director of the Breast Oncology Program at the Susan F. Smith Center for Women’s Cancers at Dana-Farber Cancer Institute and senior author of the study, said in a statement. “This study demonstrates that a combination of lower-intensity chemotherapy and trastuzumab, which is associated with fewer side effects than traditional chemotherapy regimens, is an appealing standard of care for this group of patients.”

Dr. Winer is the corresponding author for this article in The New England Journal of Medicine.

The study was funded by Genentech and Susan G. Komen for the Cure.

For full disclosures of the study authors, visit www.nejm.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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