A new study of adjuvant paclitaxel and trastuzumab combination in patients with stage I breast cancer found an encouraging progression free survival rate of 98.7% and recurrence risk of 2% . The study entitled, “Adjuvant Paclitaxel and Trastuzumab for Node-Negative, HER2-Positive Breast Cancer”, was published in The New England Journal of Medicine.
In nearly 15-20% of invasive breast cancers there is an overexpression of the human epidermal growth factor receptor type 2 (HER2), which is associated with poorer outcomes. Trastuzumab, a humanized monoclonal antibody that binds HER2, has been found to improve the clinical outcomes for patients with HER2-positive breast cancer.
Results from phase 3 randomized trials comprising more than 8,000 patients revealed that when trastuzumab was administered in combination or after chemotherapy, the risk of recurrence was decreased by approximately 50% and overall survival improved. However, these trials included patients with stage II or stage III HER2-positive breast cancers. At the moment, there is no single standard treatment for patients with small, node-negative, human epidermal growth factor receptor type 2 (HER2)–positive breast cancers.
Aware of this unmet medical need, Sara Tolaney, MD, MPH, of the Susan F. Smith Center for Women’s Cancers at Dana-Farber, and colleagues conducted a muticenter, uncontrolled, single group clinical trial to examine the efficacy of combined adjuvant paclitaxel and trastuzumab in 406 patients with small tumors (up to 3 cm). A weekly treatment of the combination therapy was given to patients for a total of twelve weeks. Subsequently, patients were given trastuzumab monotherapy for nine months.
After a median follow-up period of four years, results revealed a progression free survival rate of 98.7% and a 2% risk of cancer recurrence. In the trial, 12 patients relapsed, 2 of them due to metastasis. Furthermore, 7 cases of adverse events were observed. Grade 3 neuropathy was seen in 13 patients, and 2 patients suffered from symptomatic congestive heart failure.
In a recent new release, Eric Winer, MD, director of the Breast Oncology Program at the Susan F. Smith Center for Women’s Cancers at Dana-Farber and study’s senior author said, “Women with small, HER-2 positive, node-negative [no sign of spread to adjacent lymph nodes] breast tumors have a low, but still significant, risk of recurrence of their disease,” said the “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.”
In the news release, Dr. Tolaney added, “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,” “This study is a prime example of the value of that approach.”
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