Axillary treatment for patients with early breast cancer and lymph node metastasis: systematic review protocol (original) (raw)
Related papers
A Radiation Oncologist’s Guide to Axillary Management in Breast Cancer: a Walk Through the Trials
Current Breast Cancer Reports, 2019
Purpose of review: The axilla is the most common site for breast cancer nodal metastases. Aggressive management includes axillary lymph node dissection (ALND), radiotherapy, and systemic therapy, but carries the risks of lymphedema and "overtreatment". We review the clinical trials that led to de-escalation of axillary management and their nuances that are often overlooked. Recent findings: With the rise of sentinel lymph node biopsy, several trials conclude that ALND can be omitted in specific populations. However, the subtleties in those trials, such as the role of chemotherapy and radiotherapy, have yet to be clarified. These discussions carry forward into the era of neoadjuvant chemotherapy, where ongoing trials investigate who needs ALND and/or radiation. Summary: This review examines the clinical trials that form the standard of care, and highlights why axillary management is individualized today.
The Breast Journal, 2019
In recent decades, there has been de-escalation in the surgical management of metastatic axillary sentinel nodes in early breast cancer patients. The American College of Surgeons Oncology Group Z0011 prospective randomized trial 1 (Z0011) was a landmark study published at the end of 2010. This study investigated the loco-regional recurrence and survival of patients with node positive early breast cancer managed with breast-conserving surgery followed by whole breast radiotherapy and either axillary sentinel node biopsy (SLNB) alone or completion axillary lymph node dissection (ALND). The recent cumulative 10-year follow-up found that the overall survival in the SLNB alone group was noninferior to the overall survival of the ALND group (86.3% SLNB alone vs 83.6% ALND, noninferiority P = 0.02), 2 and there was no difference in the locoregional recurrence between the two groups (6.2% ALND vs 5.3% SLNB alone, P = 0.36). 3
Trials
Background: Complete lymph node removal through conventional axillary dissection (ALND) has been standard treatment for breast cancer patients for almost a century. In the 1990s, however, and in parallel with the advent of the sentinel lymph node (SLN) procedure, ALND came under increasing scrutiny due to its association with significant patient morbidity. Several studies have since provided evidence to suggest omission of ALND, often in favor of axillary radiation, in selected clinically node-negative, SLN-positive patients, thus supporting the current trend in clinical practice. Clinically node-positive patients, by contrast, continue to undergo ALND in many cases, if only for the lack of studies reassessing the indication for ALND in these patients. Hence, there is a need for a clinical trial to evaluate the optimal treatment for clinically node-positive breast cancer patients in terms of surgery and radiotherapy. The TAXIS trial is designed to fill this gap by examining in particular the value of tailored axillary surgery (TAS), a new technique for selectively removing positive lymph nodes. Methods: In this international, multicenter, phase-III, non-inferiority, randomized controlled trial (RCT), including 34 study sites from four different countries, we plan to randomize 1500 patients to either receive TAS followed by ALND and regional nodal irradiation excluding the dissected axilla, or receive TAS followed by regional nodal irradiation including the full axilla. All patients undergo adjuvant whole-breast irradiation after breast-conserving surgery and chest-wall irradiation after mastectomy. The main objective of the trial is to test the hypothesis that treatment with TAS and axillary radiotherapy is non-inferior to ALND in terms of disease-free survival of clinically node-positive breast cancer patients in the era of effective systemic therapy and extended regional nodal irradiation. The trial was activated on 31 July 2018 and the first patient was randomized on 7 August 2018.
Position Statement on Management of the Axilla in Patients With Invasive Breast Cancer
Sentinel lymph node (SLN) biopsy has replaced axillary lymph node dissection (ALND) for the staging of clinically node-negative breast cancer patients, demonstrating equivalent survival to ALND for lymph node–negative patients 1 while resulting in reduced morbidity. 2 For the majority of patients with pathologically positive SLNs, completion ALND is recommended by the American Society of Clinical Oncology Guidelines and the National Comprehensive Cancer Network (NCCN). 3,4 However, recent data from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial suggest that ALND may be omitted in selected patients with 1 or 2 positive SLNs. 5,6 In the ACOSOG Z0011 trial, 813 patients with clinical T1-2 node-negative tumors who were found to have hematoxylin and eosin (H&E)-positive SLNs were randomized to ALND vs no further axillary surgery. Patients with palpable lymph nodes or clinical T3 tumors were not eligible for this study. The protocol mandated the use of standard whole-breast radiation without an axillary field. Patients with >3 positive SLNs were excluded from the study. The trial was closed early due to poor accrual with an enrollment of only 47% of the targeted 1900 patients. It still showed equivalent results between the 2 treatment arms for loco-regional failure and survival. At 6.3 years' follow-up, no differences were found between the 2 groups in the rates of axillary recurrence (0.5% vs 0.9%), in-breast recurrence (3.6% vs 1.9%), or overall locoregional recurrence (4.1% vs 2.8%, P = 0.53). 5 Disease-free and overall survival were similar (82.2% vs 83.8% and 91.9% vs 92.5%) between the groups. 6 The majority of women in this trial were older than 50 years (64%), had clinical T1 tumors (68%), had ER-positive tumors (77%), had only 1 positive SLN (60%), received whole-breast radiation (89%), and received systemic therapy (96%: 58% adjuvant chemotherapy and 46% adjuvant hormonal therapy). Forty percent of patients had micrometastases or isolated tumor cells and 60% had macrometastases in the sentinel nodes. Additional positive axillary nodes were found in 27.3% of the ALND patients. This study excluded patients undergoing mastectomy and patients receiving neoadjuvant chemotherapy.
Journal of Clinical Oncology, 2004
Purpose Axillary dissection is the standard management of the axilla in invasive breast carcinoma. This surgery is responsible for functional sequelae and some options are considered, including axillary radiotherapy. In 1992, we published the initial results of a prospective randomized trial comparing lumpectomy plus axillary radiotherapy versus lumpectomy plus axillary dissection. We present an update of this study with a median follow-up of 180 months (range, 12 to 221 months). Patients and Methods Between 1982 and 1987, 658 patients with a breast carcinoma less than 3 cm in diameter and clinically uninvolved lymph nodes were randomly assigned to axillary dissection or axillary radiotherapy. All patients underwent wide excision of the tumor and breast irradiation. Results The two groups were similar for age, tumor-node-metastasis system stage, and presence of hormonal receptors; 21% of the patients in the axillary dissection group were node-positive. Our initial results showed an ...
2021
Background: To evaluate and compare overall survival and locoregional recurrence between patients with invasive breast tumors and sentinel node metastasis undergoing sentinel lymph node dissection (SLND) alone and those undergoing complete axillary lymph node dissection (ALND).Methods: In this retrospective cohort study, we reviewed medical records of all consecutive patients with primary invasive breast carcinoma who had undergone conservative surgery at a public university hospital in Brazil between 2008 and 2018. We evaluated the overall survival and the onset of locoregional recurrence using Kaplan-Meier and Cox regression analyses, respectively. Results: Overall, 97 participants underwent conservative breast surgery, 41 in the ALND group, and 56 in the SLND group. The mean age was 57.8 years. Only 17% of the patients in the ALND group had an additional biopsy-proven axillary disease, and 83% were treated with complete dissection unnecessarily. The 5-year survival rates were 80....