What are the indications for neoadjuvant chemotherapy in breast cancer?

From the Guidelines

Neoadjuvant chemotherapy is primarily indicated for patients with high-risk HER2-positive early breast cancer, including those with tumor diameter ≥2 cm, and/or node-positive disease, as well as locally advanced breast cancer, inflammatory breast cancer, and large tumors to enable breast-conserving surgery. The treatment approach involves neoadjuvant chemotherapy plus pertuzumab–trastuzumab for high-risk patients, while those with node-negative disease and tumor diameter <2 cm may undergo upfront surgery followed by paclitaxel and trastuzumab, with the option to add pertuzumab if necessary 1.

Key Indications for Neoadjuvant Chemotherapy

• Locally advanced breast cancer (stage III)
• Inflammatory breast cancer
• Large tumors (typically >5 cm)
• HER2-positive or triple-negative breast cancer with tumors larger than 2 cm or positive lymph nodes
• Tumors that may require downsizing to facilitate breast-conserving surgery

Treatment Approach

• Neoadjuvant chemotherapy plus pertuzumab–trastuzumab for high-risk HER2-positive patients
• Upfront surgery followed by paclitaxel and trastuzumab for lower-risk patients, with the option to add pertuzumab if necessary
• Treatment typically lasts 4-6 months before surgery
• Pathologic complete response to neoadjuvant therapy correlates with improved long-term outcomes and may guide subsequent adjuvant treatment decisions, as supported by recent guidelines 1.

Monitoring and Assessment

• Patients should undergo core needle biopsy with clip placement before starting treatment to mark the tumor site
• Regular clinical assessments during therapy to monitor response
• Imaging plays a vital role in managing women with locally advanced breast cancer, including assessing the primary lesion, staging, and monitoring patients before, during, and after completion of initial therapy 1.

From the FDA Drug Label

Docetaxel Injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Docetaxel Injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.

The indications for neoadjuvant chemotherapy in breast cancer are not explicitly stated in the provided drug labels. However, adjuvant treatment of operable node-positive breast cancer with Docetaxel Injection in combination with doxorubicin and cyclophosphamide is mentioned.

• Neoadjuvant chemotherapy is not directly mentioned in the labels.
• The labels do provide information on the use of Docetaxel Injection for locally advanced or metastatic breast cancer after failure of prior chemotherapy. However, this is not the same as neoadjuvant chemotherapy, which is given before the main treatment. Since the FDA label does not directly address the question of neoadjuvant chemotherapy indications for breast cancer, no conclusion can be drawn from the provided information 2, 2, 2.

From the Research

Indications for Neoadjuvant Chemotherapy in Breast Cancer

The indications for neoadjuvant chemotherapy in breast cancer are based on the type and stage of the cancer.

• HER2-positive breast cancer: Neoadjuvant treatment with a combination of sequential chemotherapy and HER2-targeted therapy is currently the standard of care 3.
• Triple-negative breast cancer: Neoadjuvant chemotherapy has been shown to be effective in downstaging locally advanced tumors and improving pathological complete response rates 4, 5.
• Hormone receptor-positive, HER2-negative breast cancer: Neoadjuvant chemotherapy can be used to downstage locally advanced tumors, but the optimal regimen is unknown 6.

Benefits of Neoadjuvant Chemotherapy

The benefits of neoadjuvant chemotherapy include:

• Downstaging locally advanced tumors, making them more amenable to surgery 3, 4.
• Providing early information on tumor response to treatment 3.
• Allowing for the assessment of new therapies in vivo 3.
• Reducing treatment duration and introducing new targeted therapies into clinical routine 3.

Factors Predicting Response to Neoadjuvant Chemotherapy

Several factors have been identified as predictors of response to neoadjuvant chemotherapy, including:

• Tumor type: Triple-negative breast cancer has been shown to have a higher pathological complete response rate compared to other subtypes 4.
• Hormone receptor status: Premenopausal women with hormone receptor-positive tumors are more likely to achieve a pathological complete response 6.
• Race: Non-white populations have been shown to have inferior invasive disease-free survival rates 6.