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These studies suggest that adjuvant antiestrogen therapy and chemotherapy are effective for stage II breast cancer, particularly for estrogen receptor positive tumors, while BCG immunotherapy shows no clear benefit.
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Stage 2 breast cancer is characterized by the presence of a tumor that is larger than in stage 1 but has not spread extensively. Treatment typically involves a combination of surgery, chemotherapy, radiation, and hormone therapy, depending on the specific characteristics of the tumor.
Neoadjuvant chemotherapy is often administered before surgery to shrink the tumor, making it easier to remove and potentially allowing for breast-conserving surgery. A study involving the I-SPY2 trial demonstrated that adding pembrolizumab, an immunotherapy drug, to standard neoadjuvant chemotherapy significantly improved pathologic complete response (pCR) rates in patients with early-stage breast cancer. Specifically, the pCR rates were more than doubled in both hormone receptor-positive/ERBB2-negative and triple-negative breast cancer cohorts when pembrolizumab was added to the treatment regimen.
The I-SPY2 trial results indicated that pembrolizumab, when combined with taxane- and anthracycline-based NACT, shifted the residual cancer burden (RCB) distribution to a lower disease burden and improved long-term outcomes. Patients achieving a pCR had high event-free survival rates, with 93% at three years follow-up.
Adjuvant therapy, which is treatment given after primary surgery, often includes chemotherapy and hormone therapy. A clinical trial with a 48-month follow-up showed that women with estrogen receptor-positive (ER-positive) tumors had a better prognosis when treated with tamoxifen, an antiestrogen drug, in addition to chemotherapy. However, for estrogen receptor-negative (ER-negative) patients, none of the adjuvant regimens provided a clear advantage .
A 72-month follow-up study further confirmed that the combination of tamoxifen and chemotherapy (cyclophosphamide, methotrexate, and fluorouracil) significantly delayed recurrence in ER-positive patients, particularly those who were postmenopausal, had four or more positive nodes, or had tumors larger than 3 cm. The addition of bacillus Calmette-Guerin (BCG) immunotherapy did not improve disease-free survival.
Patients with HER2-positive breast cancer often receive neoadjuvant HER2-targeted therapy. However, those with residual invasive disease post-surgery are at a higher risk of recurrence. A multicenter phase II study investigated the use of two HER2 vaccines (WOKVAC and DC1) to enhance anti-tumor immunity and reduce recurrence risk. The study found that both vaccines were well-tolerated and induced immune responses, with common side effects being mild and manageable.
The treatment timeline for stage 2 breast cancer involves a multi-faceted approach, including neoadjuvant chemotherapy, surgery, and adjuvant therapy. The addition of pembrolizumab to neoadjuvant chemotherapy has shown promising results in improving pCR rates and long-term outcomes. For ER-positive patients, tamoxifen combined with chemotherapy remains a cornerstone of adjuvant therapy, while ongoing research into HER2 vaccines offers hope for reducing recurrence in HER2-positive patients. Continued advancements in treatment protocols and personalized medicine are essential for improving prognosis and survival rates in stage 2 breast cancer patients.
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