ACOSOG Z0011 TRIAL PDF

Objective To determine the effects of complete axillary lymph node dissection ALND on survival of patients with sentinel lymph node SLN metastasis of breast cancer. The American College of Surgeons Oncology Group Z trial, a phase 3 noninferiority trial conducted at sites and enrolling patients from May to December Patients were women with clinical T1-T2 invasive breast cancer, no palpable adenopathy, and 1 to 2 SLNs containing metastases identified by frozen section, touch preparation, or hematoxylin-eosin staining on permanent section. Targeted enrollment was women with final analysis after deaths, but the trial closed early because mortality rate was lower than expected. Interventions All patients underwent lumpectomy and tangential whole-breast irradiation. Those randomized to ALND underwent dissection of 10 or more nodes.

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Objective To determine the effects of complete axillary lymph node dissection ALND on survival of patients with sentinel lymph node SLN metastasis of breast cancer. The American College of Surgeons Oncology Group Z trial, a phase 3 noninferiority trial conducted at sites and enrolling patients from May to December Patients were women with clinical T1-T2 invasive breast cancer, no palpable adenopathy, and 1 to 2 SLNs containing metastases identified by frozen section, touch preparation, or hematoxylin-eosin staining on permanent section.

Targeted enrollment was women with final analysis after deaths, but the trial closed early because mortality rate was lower than expected. Interventions All patients underwent lumpectomy and tangential whole-breast irradiation. Those randomized to ALND underwent dissection of 10 or more nodes. Systemic therapy was at the discretion of the treating physician. Main Outcome Measures Overall survival was the primary end point, with a noninferiority margin of a 1-sided hazard ratio of less than 1.

Disease-free survival was a secondary end point. At a median follow-up of 6. The hazard ratio for treatment-related overall survival was 0. Surgical Morbidities Paresthesias, shoulder pain, weakness, lymphedema, and axillary web syndrome are recognized morbidities of ALND.

Lymphedema in the ALND group was significantly more common by subjective report and also tended to be higher by objective assessment of arm circumference.

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Dr. Morrow Describes the ACOSOG Z11 Trial

Bottom Line Axillary lymph node dissection does not improve survival or local control compared to nodal observation in patients with T breast cancer and a positive sentinel lymph node biopsy undergoing lumpectomy and whole-breast radiation. Major Points Axillary lymph node dissection ALND has historically been a means of maintaining regional control of breast cancer, especially in patients with initial presentation of metastatic nodal disease. Sentinel lymph node biopsy is a commonly used method of detecting micrometastatic axillary disease at initial presentation. Due to the significant morbidity of ALND, including paresthesias, lymphedema, seroma, and infection, judicious use of the procedure is important. The American College of Surgeons Oncology Group ACOSOG Z trial was a multicenter noninferiority study which enrolled and randomized patients with breast cancer, T disease, clinically negative axillary nodes, 1 or 2 macrometastatic nodes on SLNB, and a plan for breast conserving therapy consisting of lumpectomy and whole-breast radiation. Patients were randomized to either completion ALND with a minimum of 10 nodes, or to observation.

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