A Randomized Trial Comparing Axillary Dissection to No Axillary Dissection in Older Patients With T1N0 Breast Cancer

Unit of Diagnostic Oncology and Out-Patient Clinic, Istituto Nazionale Tumori, Milan, Italy.
Annals of Surgery (Impact Factor: 8.33). 08/2005; 242(1):1-6; discussion 7-9. DOI: 10.1097/01.sla.0000167759.15670.14
Source: PubMed


Axillary dissection, an invasive procedure that may adversely affect quality of life, used to obtain prognostic information in breast cancer, is being supplanted by sentinel node biopsy. In older women with early breast cancer and no palpable axillary nodes, it may be safe to give no axillary treatment. We addressed this issue in a randomized trial comparing axillary dissection with no axillary dissection in older patients with T1N0 breast cancer.
From 1996 to 2000, 219 women, 65 to 80 years of age, with early breast cancer and clinically negative axillary nodes were randomized to conservative breast surgery with or without axillary dissection. Tamoxifen was prescribed to all patients for 5 years. The primary endpoints were axillary events in the no axillary dissection arm, comparison of overall mortality (by log rank test), breast cancer mortality, and breast events (by Gray test).
Considering a follow-up of 60 months, there were no significant differences in overall or breast cancer mortality, or crude cumulative incidence of breast events, between the 2 groups. Only 2 patients in the no axillary dissection arm (8 and 40 months after surgery) developed overt axillary involvement during follow-up.
Older patients with T1N0 breast cancer can be treated by conservative breast surgery and no axillary dissection without adversely affecting breast cancer mortality or overall survival. The very low cumulative incidence of axillary events suggests that even sentinel node biopsy is unnecessary in these patients. Axillary dissection should be reserved for the small proportion of patients who later develop overt axillary disease.

Download full-text


Available from: Gabriele Martelli
  • Source
    • "It is commonly acknowledged that the risk of developing metastases depends mainly on the biological behavior of the primary (seed and soil theory) (Engel et al. 2006). Moreover, a series of carefully performed prospective randomized trial focusing on axillary surgery in breast cancer exist showing a high rate of locoregional control achieved with multimodality therapy, even without axillary lymph node dissection (ALND) (Fisher et al. 2002; Group et al. 2006; Martelli et al. 2005; Giuliano et al. 2011). In fact, with the increasing influence of breast cancer biology on adjuvant treatment decisions, the relevance of nodal status is decreasing. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Since the performance of surgical procedures of the axilla in the treatment of early breast cancer is decreasing, the role of axillary ultrasound (AUS) as staging procedere has newly to be addressed. The aim of this study was to determine which patient or histopathological characteristics are related to false-negative AUS. In a retrospective study design data of 470 women with primary breast cancer were collected from patient charts and imaging and pathology records were reviewed. True positive and false negative axillary ultrasound groups were compared in terms of tumor size, histological subtype, grade, estrogen receptor (ER) and HER2 status, proliferation index, number and size of nodal metastases, extracapsular extension (ECE) and lymphovascular invasion (LVI). Of 470 patients, 166 (35%) were node positive, 79 of them with suspicious AUS. Factors associated with false negative AUS by univariate analysis were included in a multivariate model. By multivariate analysis, only size of nodal metastases was an independent factor for false negative AUS. In the sentinel lymph node biopsy (SLNB) subgroup, 45% of patients had nodal metastasis size less than or equal to 5 mm. In conclusion, AUS in preoperative staging of early stage breast cancer is limited by small size of metastases in a substantial number of patients. Prospective studies have to show whether small metastatic deposits leaving in patients in case of no axillary surgery have no negative effect on disease free and overall survival.
    Full-text · Article · Jul 2013 · SpringerPlus
  • Source
    • "OS: Overall survival(OS) was reported in three RCTs (Martelli et al., 2005; IBCSG et al., 2006; Krag et al., 2010), There was no heterogeneity across the trials, therefore, the fixed-effects model was used to pool data, there were no statistically significant differ¬ence between AD group and no AD group in 1 year OS Figure 1 "
    [Show abstract] [Hide abstract]
    ABSTRACT: Background: We performed this meta-analysis to assess the effectiveness and safety of axillary dissection in old women. Methods: The Cochrane Library, PubMed, EMBASE and Chinese Biomedical Literature Database were searched and all randomized controlled trials of axillary dissection in old women (at least 60 years old) were considered. Meta-analyses were completed using RevMan5.1. Results: Three eligible randomized controlled trials (RCTs) including 5,337 patients were considered. There was weak evidence in favour of axillary dissection (AD) in old women. The meta-analysis showed that the overall survival (OS) after 1, 3, 5 and 7 years and the disease free survival (DFS) after 1, 3 and 5 year were not statistically significantly different between AD and no AD groups. However, there was a difference in the 7 year DFS. Conclusions: Axillary dissection did not provide survival benefit to the old women with breast cancer analysed. Therefore, axillary dissection is not well-indicated in old women with breast cancer.
    Full-text · Article · Feb 2013 · Asian Pacific journal of cancer prevention: APJCP
  • Source
    • "Five-year results of our randomized trial comparing primary surgery with and without axillary clearance in T1N0 breast cancer patients ≥65 years of age showed that axillary surgery may be safely omitted without affecting breast cancer mortality or overall survival.14 The outcome of this trial fully supported the results of our previous retrospective analysis of consecutive prospectively recruited elderly patients with early breast cancer who also received conservative surgery with or without axillary dissection: After median follow-up of 75 months there was no difference in breast cancer mortality between the two groups.15 "
    [Show abstract] [Hide abstract]
    ABSTRACT: To assess the long-term safety of no axillary clearance in elderly patients with breast cancer and nonpalpable axillary nodes. Lymph node evaluation in elderly patients with early breast cancer and clinically negative axillary nodes is controversial. Our randomized trial with 5-year follow-up showed no breast cancer mortality advantage for axillary clearance compared with observation in older patients with T1N0 disease. We further investigated axillary treatment in a retrospective analysis of 671 consecutive patients, aged ≥ 70 years, with operable breast cancer and a clinically clear axilla, treated between 1987 and 1992; 172 received and 499 did not receive axillary dissection; 20 mg/day tamoxifen was prescribed for at least 2 years. We used multivariable analysis to take account of the lack of randomization. After median follow-up of 15 years (interquartile range 14-17 years) there was no significant difference in breast cancer mortality between the axillary and no axillary clearance groups. Crude cumulative 15-year incidence of axillary disease in the no axillary dissection group was low: 5.8% overall and 3.7% for pT1 patients. Elderly patients with early breast cancer and clinically negative nodes did not benefit in terms of breast cancer mortality from immediate axillary dissection in this nonrandomized study. Sentinel node biopsy could also be foregone due to the very low cumulative incidence of axillary disease in this age group. Axillary dissection should be restricted to the small number of patients who later develop overt axillary disease.
    Full-text · Article · Jan 2011 · Annals of Surgical Oncology
Show more