The clinical relevance of axillary reverse mapping (ARM): study protocol for a randomized controlled trial

Area of Science:

• Oncology
• Surgical Oncology
• Lymphedema Research

Background:

• Axillary lymph node dissection (ALND) for breast cancer can cause upper-limb lymphedema.
• Axillary reverse mapping (ARM) identifies lymphatic drainage to preserve limb-specific lymphatics.
• Preserving these lymphatics may reduce lymphedema risk.

Purpose of the Study:

• To determine the clinical relevance of selective axillary lymph node (LN) and lymphatic preservation using ARM.
• To evaluate if preserving ARM nodes and lymphatics decreases side effects of ALND.
• To assess the impact on lymphedema, pain, and quality of life in breast cancer patients.

Main Methods:

• A randomized trial involving 280 breast cancer patients with sentinel lymph node (SLN) metastasis requiring completion ALND.
• Patients randomized to standard ALND or ALND with preservation of ARM nodes and lymphatics.
• Primary outcome: lymphedema incidence measured by water displacement at 6, 12, and 24 months.

Main Results:

• Data on lymphedema, pain, paresthesia, shoulder mobility, quality of life, and recurrence risk will be collected.
• The study aims to provide evidence on the efficacy of ARM-guided lymphatic preservation.
• Results will inform surgical decision-making for breast cancer patients undergoing ALND.

Conclusions:

• The benefit of ALND in positive SLN patients is debated.
• ALND remains the treatment of choice for many breast cancer patients.
• This trial will offer evidence on reducing ALND side effects through ARM-guided preservation.