scholarly journals Axillary dissection versus axillary observation for low risk, clinically node-negative invasive breast cancer: a systematic review and meta-analysis

Breast Cancer ◽  
2021 ◽  
Author(s):  
Mahaveer S. Sangha ◽  
Rose Baker ◽  
Muneer Ahmed

Abstract Purpose 1. To systematically analyse studies comparing survival outcomes between axillary lymph-node dissection (ALND) and axilla observation (Obs), in women with low-risk, clinically node-negative breast cancer. 2. To consider results in the context of current axillary surgery de-escalation trials and studies. Methods 9 eligible studies were identified, 6 RCTs and 3 non-randomized studies (4236 women in total). Outcomes assessed: overall survival (OS) and disease-free survival (DFS). The logged (ln) hazard ratio (HR) was calculated and used as the statistic of interest. Data was grouped by follow-up. Results Meta-analyses found no significant difference in OS at 5, 10 and 25-years follow-up (5-year ln HR = 0.08, 95% CI − 0.09, 0.25, 10-year ln HR =  0.33, 95% CI − 0.07, 0.72, 25-year ln HR = 0.00, 95% CI − 0.18, 0.19). ALND caused improvement in DFS at 5-years follow-up (ln HR = 0.16, 95% CI 0.03, 0.29), this was not demonstrated at 10 and 25-years follow-up (10-year ln HR = 0.07, 95% CI − 0.09, 0.23, 25-year ln HR = − 0.03, 95% CI − 0.21, 0.16). Studies supporting ALND for DFS at 5-years follow-up had greater relative chemotherapy use in the ALND cohort. Conclusion ALND does not cause a significant improvement in OS in women with clinically node-negative breast cancer. ALND may improve DFS in the short term by tailoring a proportion of patients towards chemotherapy. Our evidence suggests that when the administration of systemic therapy is balanced between the two arms, axillary de-escalation studies will likely find no difference in OS or DFS.

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10610-10610
Author(s):  
J. Ahn ◽  
S. Kim ◽  
B. Son ◽  
S. Ahn ◽  
W. Kim

10610 Background: Recently, adjuvant AC followed by paclitaxel has improved disease-free survival (DFS) or overall survival (OS) of node-positive breast cancer. Although adjuvant TAC, as compared with FAC, significantly improves DFS and OS rate in node-positive breast cancer, AC→T has not been yet compared with FAC. Since 2001, we discussed the options of adjuvant CAF versus AC→T with patients who had 4 or more positive axillary nodes. We evaluated the efficacies of adjuvant CAF and AC→T, retrospectively. Methods: Between September 2001 and July 2004, a total of 1,394 patients underwent surgery and received adjuvant chemotherapy. Among them, 253 (18.1%) patients had 4 or more than axillary nodes and received either six cycles of CAF (n = 116) or 4 cycles of AC→T) (n = 137). The medical records and pathologic data of these patients were reviewed, retrospectively. Results: Median age of all patients was 46 years (range, 22∼76 years). The two groups were well balanced in terms of demographic and tumor characteristics. With a median follow-up period of 24 months (range, 6∼90 months), 49 (19.4%) patients had disease recurrence including 27 (23.3%) in CAF group and 22 (16.1%) in AC→T group (p = 0.155). The 3 year-DFS rate was 68.3% in CAF group and 71.1% in AC→T group (p = 0.9366), and the estimated 3-year OS rate was 90.3% and 92.3%, respectively (p = 0.8237). There was no significant difference in 3-year DFS rate according to hormone-receptor status. Febrile neutropenia occurred in 11 (9.6%) patients in CAF group and 7 (5.1%) patients in AC→T group (p = 0.222). Conclusion: Our data suggest that there is no significant difference in DFS or OS rates between six cycles of CAF and 4 cycles of AC followed by 4 cycles of paclitaxel as adjuvant chemotherapy in patients with 4 or more than involved axillary nodes. However, long-term follow-up period and prospective studies are needed to define better regimen. No significant financial relationships to disclose.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 10586-10586
Author(s):  
M. Colleoni ◽  
N. Rotmensz ◽  
S. Andrighetto ◽  
P. Maisonneuve ◽  
A. Sonzogni ◽  
...  

10586 Background: Peritumoral vascular invasion (PVI) has been recently recognized as a significant prognostic indicator for women with operable breast cancer, yet the clinical relevance of the degree of PVI in patients with no or limited involvement of the axillary nodes is unknown. Methods: 2606 consecutive patients with pT1–3, pN0 (1586)-1a (1020), and M0, operated and counseled for medical therapy from 1/2000 to 12/2002 were prospectively classified according to the degree of PVI: absent (2017, 77.4%), focal (368, 14.1%), moderate (51, 2.0%) and extensive (170, 6.5%). The median follow-up was 3.8 years for disease-free survival (DFS) and 4.3 years for overall survival (OS). Results: Patients with extensive PVI were more likely be younger, to have larger tumors, high tumor grade, axillary positive nodes, high Ki-67 expression, and HER2/neu over-expression if compared with patients having less amount if PVI (p for trend, <.0001). Patients with diffuse PVI were prescribed significantly more frequently anthracycline containing chemotherapy and less endocrine therapy alone (p for trend, <.0001). In patients with node negative disease a statistically significant difference in DFS, risk of distant metastases and OS was observed at the multivariate analysis for diffuse PVI versus no PVI (Hazard Ratios: 2.11, 95% CI, 1.02 to 4.34, P<.0001 for DFS; 4.51, 95% CI, 1.96 to 10.4, P<.0001 for distant metastases; 3.55, 95% CI, 1.24 to 10.1, P=.02 for OS). Conclusions: Extensive peritumoral vascular invasion has a prognostic role in patients with axillary lymph node negative breast cancer. The extent of vascular invasion should be considered in the therapeutic algorithm in order to proper select targeted adjuvant treatment. No significant financial relationships to disclose.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 516-516 ◽  
Author(s):  
J. A. Sparano ◽  
M. Wang ◽  
S. Martino ◽  
V. Jones ◽  
E. Perez ◽  
...  

516 Background: Evidence suggests that docetaxel is more effective than paclitaxel, and paclitaxel is more effective when given weekly than every 3 weeks in metastatic breast cancer (BC). Methods: Eligibility included axillary lymph node positive or high-risk (tumor at least 2 cm) node-negative BC. All patients received 4 cycles of AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2) every 3 weeks, followed by either: (1) paclitaxel 175 mg/m2 every 3 weeks × 4 (P3), (2) paclitaxel 80 mg/m2 weekly × 12 (P1), (3) docetaxel 100 mg/m2 every 3 weeks × 4 (D3), or (4) docetaxel 35 mg/m2 weekly × 12 (D1). The primary comparisons included taxane (P vs. D) and schedule (every 3 weeks vs. weekly), and secondary comparisons included P3 vs. other arms. The trial had 86% power to detect a 17.5% decrease in disease-free survival (DFS) for either primary comparison, and 80% power to detect a 22% decrease for the secondary comparisons (2-sided nomimal 5% level tests corrected for multiple comparisons). Results: A total of 4,950 eligible patients were accrued. There was no difference in the primary comparisons afer 856 DFS events and 483 deaths after a median follow-up of 46.5 months at the 4th interim analysis ( www.sabcs.org , abstract 48). This is the final pre-specified analysis for the primary comparisons after 1,042 DFS events and 650 deaths (with 1,020 DFS events at this time, to be updated at the meeting). After a median followup of 60.2 months, there remains no significant difference in the hazard ratio (HR) for the taxane (1.02; p=0.73) or schedule (1.07; p=0.30) (as in the first analysis). In secondary comparisons of the standard arm (P3) with the other arms (HR > 1 favoring the experimental arms), the HRs were 1.30 (p = 0.003) for arm P1, 1.24 (p=0.02) for arm D3, and 1.09 (p=0.33) for arm D1. Analysis of interaction by hormone-receptor status will be presented. The incidence of worst grade toxicity (grade 3/4) was 24%/6% for arm P3, 24%/3% for arm P1, 21%/50% for arm D3, and 38%/6% for arm D1. Conclusions: There were no differences in DFS when comparing taxane or schedule overall. DFS was significantly improved in the weekly paclitaxel and every 3-week docetaxel arms compared with the every 3-week paclitaxel arm. [Table: see text]


2020 ◽  
Author(s):  
Chengyu Luo ◽  
Guang Cao ◽  
wenbin Guo ◽  
Jie Yang ◽  
Qiuru Sun ◽  
...  

Abstract Backgroud: Longer follow-up was necessary to testify the exact value of mastoscopic axillary lymph node dissection (MALND).Methods:From January 1, 2003 to December 31, 2005,1027 patients with operable breast cancer were randomly assigned to two groups: MALND and CALND. 996 eligible patients were enrolled. The end points are disease free survival and overall survival.Results:The final cohort of 996 patients was followed for an average of 184 months. The distribution of all events was fairly similar between two groups of patients. The incidence of local in-breast events did not differ in a significant manner between two cohorts. Similarly, the rate of distant metastases was not significantly different with 30.0% in MLND and 32.6% in CALND. And no significant difference was observed in other primary tumor between two groups (p=0.46). Patients who remain alive with no event comprise a total of 37.2% in MALND and 35.4% in CALND. Other primary cancers and deaths from other causes were distributed equally between two groups. The 15-year disease-free survival rates were41.1 percent for the MALND group and 39.6 percent for the CALND group (p=0.79). MALND was found to be not inferior for overall survival (P =0.54). The 15-year overall survival rates were 49.5 percentafter MALND and 51.2 percentafter CALND (p=0.86). Probability of overall survival was not significantly different between two groups.Conclusions:MALND does not increase unfavorable events, and also does not affect the long-term survival of patients. Therefore, MALND should be one of the preferred approaches for breast cancer surgery.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 511-511 ◽  
Author(s):  
Sara M. Tolaney ◽  
William Thomas Barry ◽  
Hao Guo ◽  
Deborah Dillon ◽  
Chau T. Dang ◽  
...  

511 Background: Retrospective data suggest that patients (pts) with small HER2+ cancers have more than just minimal risk of disease recurrence. The APT trial was designed to address treatment for such pts. We have previously reported 3-yr disease-free survival (DFS) and here we provide an updated analysis with 7-yr DFS. Methods: APT is a single arm multicenter, phase II study of TH. Pts with HER2+ BC (IHC 3+ and/or FISH ratio > 2.0) with negative nodes (a single axillary lymph node micrometastasis was allowed) and tumor size < 3 cm were eligible. Pts received T (80 mg/m2) with H x 12 weekly (w), followed by H (weekly or q3w) x 39w. The primary endpoint was DFS. Recurrence Free Interval (RFI), Breast Cancer Specific Survival (BCSS), and overall survival (OS) were also analyzed. Intrinsic subtyping by PAM50 was performed on the nCounter Analysis system on archival tissue. Results: 410 pts were enrolled from September 2007 to September 2010 and 406 began protocol therapy. 67% had hormone-receptor (HR)+ tumors. Distribution by tumor size: 2% T1mi; 17% T1a; 30% T1b; 42% T1c, and 9% T2 ≤ 3 cm. 6 pts had a nodal micrometastasis. With a median follow-up of 6.5 yrs, there were 23 DFS events observed: 4 (1.0%) distant recurrences, 5 local/regional recurrences (1.2%), 6 new contralateral BC (1.5%), and 8 deaths without documented recurrence (2.0%). The 7-yr DFS was 93.3% (95% CI 90.4-96.2); 7-yr DFS for HR+ pts was 94.6% (95% CI 91.8-97.5) and for HR- pts was 90.7% (95% CI 84.6-97.2). 7-yr RFI was 97.5% (95% CI 95.9-99.1); 7-year BCSS is 98.6% (95% CI 97.0-100); and 7-yr OS was 95.0% (95% CI 92.4-97.7). Ongoing PAM50 testing (n = 227 pts) identified 142 (63%) HER2-enriched; 22 (10%) luminal A, 26 (11%) luminal B, and 20 (9%) basal-like; 17 samples had a poor quality assay. Additional testing and associations with clinical outcomes will be presented at the meeting. Conclusions: These data suggest that TH as adjuvant therapy for node-negative HER2+ BC is associated with few recurrences and only 4 distant recurrences with longer follow-up. Based on these data, if chemotherapy/trastuzumab is given to a pt with stage I HER2+ breast cancer, the TH regimen should be considered a standard treatment. Clinical trial information: NCT00542451.


2021 ◽  
Author(s):  
Omer Diker ◽  
Burak Yasin Aktas ◽  
Recep Ak ◽  
Bahadır Koylu ◽  
Onur Bas ◽  
...  

Background: In node-negative HER2-overexpressed breast cancers, adjuvant paclitaxel plus trastuzumab treatment is a successful de-escalation approach with excellent survival outcomes. Methods: All patients with HER2+ breast cancer treated in our centers were retrospectively reviewed. Results: We analyzed 173 patients who were treated with adjuvant paclitaxel plus trastuzumab. The mean tumor size was 2.2 cm. There were eight invasive disease events or death: four distant recurrences (2.3%), three locoregional recurrences (1.7%) and one death without documented recurrence after a 52 month follow-up. The 3-year disease-free survival and recurrence-free interval rate was 96.6%. Conclusion: This real-life experience with adjuvant paclitaxel plus trastuzumab demonstrated few distant recurrences and is compatible with the APT trial findings.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10757-10757
Author(s):  
N. D. Bajic ◽  
D. D. Scepanovic

10757 Background: The aim of this study was to analyse in which order known traditional prognostic factors predict disease free survival (DFS) and overall survival (OS) in breast cancer patients (pts) who are patohystologicaly axillary node negative. Methods: From 1998 till 2004, 258 patients were treated of axillary node negative breast cancer. We analysed 3 and 5 years (yrs) DFS and 3 and 5 yrs OS for all patients as well as for premenopausal (96 pts, 37%) and postmenopausal (162 pts, 63%). The mean follow-up time for DFS was 60 months (mo) (min 30, max 136 mo) and for OS was 66 mo (min 36, max 140 mo). As prognostic factors for DFS and OS, age, tumour size, HG as well as adjuvant treatment (locoregional and systemic) were analysed accordingly. Fifty two patients (20%) were HG1 while 190 pts (74%), were HG2 & 3; 30 pts (11%) had tumour up to 1cm and 157 pts (61%) had tumours up to 3cm and 71 pts (28%) above 3cm. Radical mastectomy was performed in 92 pts (36%) while conservative surgery were performed in 166 pts (64%). Systemic therapy was applied in 224 pts (87% of which 57% were treated with hormonotherapy). Results: 3 yrs DFS for 258 treated pts were 87% - there was no statistically significant difference among pre- and postmenopausal pts; 5 yrs DFS were 73% with no statistically significant difference among pre- and postmenopausal group of pts (p > 0.05). 3 yrs overall survival were 94% and 5 yrs 80% with no statistically significant difference among pre- and postmenopausal pts (p > 0.05). There were statistically different DFS and OS among those pts treated with adjuvant radiotherapy as well as for those with adjuvant systemic therapy in both group of pts (p < 0.001). Also as independent prognostic factor for DFS and OS were HG (Cox regression model). Conclusions: Although, HG and adjuvant therapy are the most important prognostic factors for DFS and OS in premenopausal and postmenopausal patients, we found that there is no statistically significant difference between the groups respectively. However, life-expectancy for premenopausal patients is longer. Therefore further adjuvant therapy research is needed to achieve better DFS and OS in this group of pts. No significant financial relationships to disclose.


2000 ◽  
Vol 15 (2) ◽  
pp. 135-138 ◽  
Author(s):  
J.-L. Floiras ◽  
K. Hacene ◽  
F. Turpin ◽  
F. Spyratos

The impact of ER levels on the response to tamoxifen was evaluated in 1,623 postmenopausal primary breast cancer patients treated at our center (median follow-up 8.2 years). In patients receiving adjuvant tamoxifen a significantly longer disease-free survival (DFS) was observed when ER levels were elevated (p<0.00001). Very high ER (>424 fmol/mg protein) appeared to be detrimental in node-negative patients not treated with tamoxifen.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ke Wang ◽  
Xiaoyan Jin ◽  
Weilan Wang ◽  
Xiuyan Yu ◽  
Jian Huang

Abstract Background It has been demonstrated that postmastectomy radiation therapy (PMRT) was beneficial for breast cancer patients who are axillary lymph node-positive. However, the effectiveness of radiotherapy in pathological negative nodes (ypN0) after neoadjuvant chemotherapy (NAC) remains open to considerable debate. Here, we aim to evaluate whether PMRT improves loco-regional control and survival for such patients. Methods The literature from January 2004 to June 2019 was searched. The effects of PMRT on local-regional recurrence (LRR) and survival was evaluated in a meta-analysis. Pooled relative risk (RR) values with 95% confidence intervals (CIs) were computed using random and fixed-effect model. Subgroup and heterogeneity analyses were also conducted. Results Twelve studies that included 17,747 patients met the inclusion criteria. Pooled results showed that PMRT was associated with reduced LRR (RR, 0.38; 95% CI, 0.19–0.77, P = 0.007), particularly in patients with stage III breast cancer (RR, 0.16; 95% CI, 0.07–0.37, P < 0.001). However, no significant difference in disease-free survival were observed with the addition of PMRT for ypN0 patients (RR, 0.70; 95% CI, 0.21–2.27, P = 0.55). Also, there was no statistically significant association between radiotherapy with overall survival (RR, 0.81; 95% CI, 0.64–1.04, P = 0.10). Conclusions Our meta-analysis indicated that PMRT might reduce local-regional recurrence for ypN0 patients after NAC, but lack of benefit for survival outcomes. Prospective randomized clinical trial data will be needed to confirm our results.


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