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Paclitaxel, trastuzumab conferred low recurrence risk in HER-2-positive breast cancer
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Few women with stage I HER-2–positive breast cancer experienced early disease recurrence after receipt of adjuvant paclitaxel and trastuzumab, according to study results.
“Women with small, HER-2–positive, node-negative breast tumors have a low, but still significant, risk of recurrence of their disease,” researcher Eric Winer, MD, director of the Breast Oncology Program at the Susan F. Smith Center for Women’s Cancers at Dana-Farber Cancer Institute, said in a press release. “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.”
Sara M. Tolaney
Winer and colleagues evaluated data from 406 patients with tumors up to 3 cm in the greatest dimension. The median age of patients was 55 years (range, 24-85), and a majority of patients had high-grade tumors (56.2%).
Patients received paclitaxel and trastuzumab (Herceptin, Genentech) weekly for 12 weeks, followed by 9 months of trastuzumab alone. A majority of patients (87.7%) completed all 52 weeks of therapy.
Median follow-up was 4 years, and the maximum follow-up was 6.2 years.
Twelve patients experienced invasive disease events or died during follow-up. Of these patients, two developed distant metastases, four developed local or regional recurrence, and four developed contralateral breast cancer.
The 3-year rate for survival free from invasive disease — which served as the study’s primary endpoint — was 98.7% (95% CI, 97.6-99.8). The 3-year rate for RFS was 99.2% (95% CI, 98.4-100).
Overall, 30 patients discontinued therapy due to adverse events.
Fourteen patients (3.4%) experienced at least one episode of grade 3 neuropathy. Two patients (0.5%) experienced grade 3 systolic dysfunction of the left ventricle, which resolved after the discontinuation of trastuzumab.
Thirteen patients (3.2%) experienced a clinically significant asymptomatic decline in ejection fraction leading to interruption of trastuzumab therapy. Two of these patients were unable to resume treatment with trastuzumab.
“We’re committed to identifying treatment regimens that are geared not only to the specific biological features of a woman’s cancer, but also to the stage of the cancer — the size of the tumor and how far it has advanced,” researcher Sara M. Tolaney, MD, MPH, a breast oncologist with the Susan F. Smith Center for Women’s Cancers at Dana-Farber Cancer Institute, said in the press release. “This study is a prime example of the value of that approach.”
Disclosure: The study was funded by Genentech. See the study for a full list of the researchers’ relevant financial disclosures.
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