Axillary dissection may not be needed in early-stage breast cancer with clinically negative axilla- cohort prospective study

Abstract

Author(s): Maher Jabbar Salih*, Ohood S. Leabi, Ahmed Abdulhadi Abdulbaqi Safar, Mazin Hawwaz Abdulridha Al-Hawwaz and Asaad Q. Al-Yassen

Background: Over many years breast cancer is managed by surgery to the primary tumor site and complete surgical axillary dissection. The last was done for proper axillary staging and may improve the loco-regional recurrence and overall survival. Axillary lymph node dissection is associated with many complications and morbidity, especially lymphedema. When the sentinel lymph node biopsy was introduced to the field of breast cancer management, it greatly decreased the need for axillary dissection and its sequela. In areas like our locality (Iraq-Basrah governorate), the sentinel lymph node biopsy procedure is not available. Avoiding axillary dissection in a breast cancer patient with clinically negative axilla is a challenging one for the patient who is afraid of avoiding such surgery and the relevant doctors who are not sure about its safety as the relevant studies about this issue are few. In this study, we will assess the management of early-stage breast cancer and clinically negative axilla with primary breast surgery and adjuvant treatment (chemotherapy and radiotherapy, and hormonal treatment according to the indications) only without axillary dissection and compare them with a similar group of patients with axillary dissection. This study aimed to answer the question: is the omission of the axillary lymph node dissection safe in early-stage breast cancer with clinically negative axilla?

Patients and methods: A single-center cohort study was conducted at Basra Oncology center. The study included 99 females aged ≥ 18 years with histologically confirmed invasive breast cancer stage I, II, and III, with clinically negative axillary lymphadenopathy (by clinical examination, ultrasound, CT scan ± PET scan). Out of those patients, 48 females had undergone surgery (mastectomy or BCS) without axillary surgery defined as (Cases) and the remaining females had primary breast surgery with axillary lymph node surgical assessment and were defined later as (controls). All the patients have undergone a surgical intervention to the negative margins (no tumor at ink), followed by adjuvant systemic therapy (including hormonal treatment for five years for hormone receptor-positive disease), and followed by whole breast opposing tangential field radiotherapy. Patients with distant metastasis were excluded from the study. All patients were followed up for 3 years for assessment of disease recurrence according to the recommended clinical practice of the European Society for Medical Oncology (ESMO) guidelines. Annual mammography was performed. The progression-free survival (the period from diagnosis of breast cancer until the loco-regional progression (axillary, internal mammary, supraclavicular or sub-clavicular LAP), distant metastasis, or death) between the two groups was the primary end-point of the study, in addition, to the other adverse events like lymphedema over 3 years. Statistical analysis was done using Statistical Package for the Social Sciences version 26 (SPSS Inc.).

Results: A total of ninety-nine patients were diagnosed with breast cancer. There were no significant differences regarding the mean age, the past medical history, the type of surgery, chemotherapy and radiotherapy regimens, locoregional metastasis, distant metastasis, and lymphedema between both cases and controls. While the study showed significant differences between cases and controls in terms of the grade of carcinoma. Although, the study showed slightly higher rates of axillary and systemic recurrence (4.2%, and 0.0%) and metastasis to the ipsilateral shoulder (2.1%, 0.0%) among cases compared to controls respectively. Additionally, controls had a slightly higher rate of lymphedema compared to cases (11.8%. 8.3%) respectively.

Conclusions: the study showed no significant differences regarding the Loco regional metastasis, and distant metastasis between the two groups, lymphedema was low among those without axillary dissection, although locoregional recurrences were higher in the group with axillary dissection.

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