Computer program to assist in making decisions about adjuvant therapy for women with early breast cancer. Economic Analysis of Gene Expression Profile Data to Guide Adjuvant Treatment in Women with Early-Stage Breast Cancer A study of the impact of the 21-gene breast cancer assay on the use of adjuvant chemotherapy in women with breast cancer in a Mexican public hospital. Using the 21-gene assay to guide adjuvant chemotherapy decision-making in early-stage breast cancer: a cost-effectiveness evaluation in the German setting Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline update. American Society of Clinical Oncology 1998 update of recommended breast cancer surveillance guidelines. American Society of Clinical Oncology 2006 update of the breast cancer follow-up and management guidelines in the adjuvant setting. American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer. Can We Select Which Patients With Small Breast Cancers Should Receive Adjuvant Chemotherapy? Primary and adjuvant therapy, prognostic factors and survival in 1053 breast cancers diagnosed in a trial of mammography screening. Prospective Clinical Utility Study of the Use of the 21-Gene Assay in Adjuvant Clinical Decision Making in Women With Estrogen Receptor-Positive Early Invasive Breast Cancer: Results From the SWITCH Study. The Impact of the Oncotype DX Breast Cancer Assay on Treatment Decisions for Women With Estrogen Receptor-Positive, Node-Negative Breast Carcinoma in Hong Kong. The multiplex bead array approach to identifying serum biomarkers associated with breast cancer Sentinel Lymph Node Biopsy for Patients With Early-Stage Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update. Decreased Use of Adjuvant Breast Cancer Therapy in a Randomized Controlled Trial of a Decision Aid with Individualized Risk Information Role of axillary clearance after a tumor-positive sentinel node in the administration of adjuvant therapy in early breast cancer. Impact of a 21‐gene RT‐PCR assay on treatment decisions in early‐stage breast cancer
PURPOSE The goal of the computer program Adjuvant ! is to allow health professionals and their patients with early breast cancer to make more informed decisions about adjuvant therapy . METHODS Actuarial analysis was used to project outcomes of patients with and without  adjuvant therapy  based on estimates of prognosis largely derived from Surveillance , Epidemiology , and End- Results data and estimates of the efficacy of adjuvant therapy based on the 1998 overviews of r and omized trials of adjuvant therapy . These estimates can be refined using the Prognostic Factor Impact Calculator , which uses a Bayesian method to make adjustments based on relative risks conferred and prevalence of positive test results . RESULTS From the entries of patient information ( age , menopausal status , comorbidity estimate ) and tumor staging and characteristics ( tumor size , number of positive axillary nodes , estrogen receptor status ) , baseline prognostic estimates are made . Estimates for the efficacy of endocrine therapy ( 5 years of tamoxifen ) and of polychemotherapy ( cyclophosphamide/methotrexate/fluorouracil-like regimens , or anthracycline-based therapy , or therapy based on both an anthracycline and a taxane ) can then be used to project outcomes presented in both numerical and graphical formats . Outcomes for overall survival and disease-free survival and the improvement seen in clinical trials , are reasonably modeled by Adjuvant ! , although an ideal validation for all patient subsets with all treatment options is not possible . Additional speculative estimates of years of remaining life expectancy and long-term survival curves can also be produced . Help files supply general information about breast cancer . The program 's Internet links supply national treatment guidelines , cooperative group trial options , and other related information . CONCLUSION The computer program Adjuvant ! can play practical and educational roles in clinical setting Breast cancer is the second most common type of cancer among women in the United States with more than 200,000 women diagnosed with invasive disease and with approximately 40,000 dying annually from the disease ( 1 ) . As a result of early detection efforts , nearly half of these women present with lymph node negative hormone receptor positive disease . Current treatment for early-stage breast cancer ( ESBC ) with adjuvant hormonal therapy and /or chemotherapy is based on clinical and pathological criteria including the presence and number of involved lymph nodes , tumor size and grade , hormone receptor status , and the presence of HER2/neu overexpression among others . Treatment decisions may also take into consideration patient age or menopausal status due to the anticipated lower risk of cancer recurrence , and the potential for smaller benefit and greater toxicity with aggressive systemic chemotherapy in older women . These considerations form the basis for clinical practice guidelines for the management of patients with ESBC ( 2 , 3 ) . Current guidelines recommend adjuvant systemic chemotherapy and endocrine therapy for most women with lymph node negative , hormone receptor positive , ESBC . Unfortunately , such systemic chemotherapy is associated with considerable cost , proximal morbidity , as well as increasing evidence for serious delayed toxicities including neurocognitive dysfunction and secondary malignancies . The risk of distant recurrence is generally low among ESBC patients with lymph node negative , hormone receptor positive disease regardless of treatment with adjuvant chemotherapy . However , several r and omized controlled trials of adjuvant chemotherapy and meta-analyses have shown the value of adjuvant chemotherapy in reducing the risk of disease BACKGROUND The majority of breast cancer patients in Mexico are treated through the public health system and > 80 % receive adjuvant chemotherapy . The aim of this prospect i ve study was to characterize the impact of the Oncotype DX assay on adjuvant therapy decision making and the confidence in those decisions amongst public sector physicians in Mexico . METHODS Ninety-eight consecutive patients with ER+ , HER2- , stage I-IIIa , N0/N1 - 3 node-positive breast cancer from the Instituto Nacional de Cancerología were eligible for the study . The primary endpoint was the overall change in treatment recommendations after receiving the assay results . RESULTS Of 96 patients , 48 % received a  chemohormonal therapy recommendation  prior to testing . Following receipt of results , treatment decisions changed for 31/96 ( 32 % ) patients , including 17/62 ( 27 % ) node-negative patients and 14/34 ( 41 % ) node-positive patients . The proportion of patients with a chemotherapy-based recommendation decreased from 48 % pre- to 34 % post-assay ( P=0.024 ) . 92 % of physicians agreed that they were more confident in their treatment recommendation after ordering the assay . CONCLUSIONS These results suggest that use of the 21-gene assay in the Mexican public health system has a meaningful impact on adjuvant treatment recommendations that may reduce the overall use of chemotherapy Abstract Objective : The 21-gene assay ( Oncotype DX Breast Cancer Test ( Genomic Health Inc. , Redwood City , CA ) ) is a well vali date d test that predicts the likelihood of adjuvant chemotherapy benefit and the 10-year risk of distant recurrence in patients with ER+ , HER2− early-stage breast cancer . The aim of this analysis was to evaluate the cost-effectiveness of using the assay to inform adjuvant chemotherapy decisions in Germany . Methods : A Markov model was developed to make long-term projections of distant recurrence , survival , quality -adjusted life expectancy , and direct costs for patients with ER+ , HER2− , node-negative , or up to 3 node-positive early-stage breast cancer . Scenarios using conventional diagnostic procedures or the 21-gene assay to inform treatment recommendations for adjuvant chemotherapy were modeled based on a prospect i ve , multi-center trial in 366 patients . Transition probabilities and risk adjustment were based on published l and mark trials . Costs ( 2011 Euros ( € ) ) were estimated from a sick fund perspective based on re source use in patients receiving chemotherapy . Future costs and clinical benefits were discounted at 3 % annually . Results : The 21-gene assay was projected to increase mean life expectancy by 0.06 years and quality -adjusted life expectancy by 0.06 quality -adjusted life years ( QALYs ) compared with current clinical practice over a 30-year time horizon . Clinical benefits were driven by optimized allocation of adjuvant chemotherapy . Costs from a healthcare payer perspective were lower with the 21-gene assay by ∼€561 vs st and ard of care . Probabilistic sensitivity analysis indicated that there was an 87 % probability that the 21-gene assay would be dominant ( cost and life saving ) to st and ard of care . Limitations : Country-specific data on the risk of distant recurrence and quality -of-life were not available . Conclusions : Guiding decision-making on adjuvant chemotherapy using the 21-gene assay was projected to improve survival , quality -adjusted life expectancy , and be cost saving vs the current st and ard of care women with ER+ , HER2− early-stage breast cancer PURPOSE To provide evidence -based recommendations to practicing oncologists , surgeons , and radiation therapy clinicians to up date the 2005 clinical practice guideline on the use of sentinel node biopsy ( SNB ) for patients with early-stage breast cancer . METHODS The American Society of Clinical Oncology convened an Up date Committee of experts in medical oncology , pathology , radiation oncology , surgical oncology , guideline implementation , and advocacy . A systematic review of the literature was conducted from February 2004 to January 2013 in Medline . Guideline recommendations were based on the review of the evidence by Up date Committee . RESULTS This guideline up date reflects changes in practice since the 2005 guideline . Nine r and omized clinical trials ( RCTs ) met systematic review criteria for clinical questions 1 and 2 ; 13 cohort studies informed clinical question 3 . RECOMMENDATIONS Women without sentinel lymph node ( SLN ) metastases should not receive axillary lymph node dissection ( ALND ) .  Women with one to two metastatic SLNs planning to undergo breast-conserving surgery with whole-breast radiotherapy should not undergo ALND ( in most cases ) . Women with SLN metastases who will undergo mastectomy should be offered ALND . These three recommendation are based on RCTs . Women with operable breast cancer and multicentric tumors , with ductal carcinoma in situ ( DCIS ) who will undergo mastectomy , who previously underwent breast and /or axillary surgery , or who received preoperative/neoadjuvant systemic therapy may be offered SNB . Women who have large or locally advanced invasive breast cancer ( tumor size T3/T4 ) , inflammatory breast cancer , or DCIS ( when breast-conserving surgery is planned ) or are pregnant should not undergo SNB . These recommendations are based on cohort studies and /or informal consensus . In some cases , up date d evidence was insufficient to up date previous recommendations OBJECTIVE To determine an effective , evidence -based , postoperative surveillance strategy for the detection and treatment of recurrent breast cancer . Tests are recommended only if they have an impact on the outcomes specified by American Society of Clinical Oncology ( ASCO ) for clinical practice guidelines . POTENTIAL INTERVENTION All tests described in the literature for postoperative monitoring were considered . In addition , the data were critically evaluated to determine the optimal frequency of monitoring . OUTCOME Outcomes of interest include overall and disease-free survival , quality of life , toxicity reduction , and secondarily cost-effectiveness . EVIDENCE A search was performed to determine all relevant articles published over the past 20 years on the efficacy of  surveillance testing for breast cancer recurrence . These publications comprised both retrospective and prospect i ve studies . VALUES Levels of evidence and guideline grade s were rated by a st and ard process . More weight was given to studies that tested a hypothesis directly relating testing to one of the primary outcomes in a r and omized design . BENEFITS , HARMS , AND COSTS The possible consequences of false-positive and -negative tests were considered in evaluating a preference for one of two tests providing similar information . Cost alone was not a determining factor . RECOMMENDATIONS The attached guidelines and text summarize the up date d recommendations of the ASCO breast cancer expert panel . Data are sufficient to recommend monthly breast self-examination , annual mammography of the preserved and contralateral breast , and a careful history and physical examination every 3 to 6 months for 3 years , then every 6 to 12 months for 2 years , then annually . Data are not sufficient to recommend routine bone scans , chest radiographs , hematologic blood counts , tumor markers ( carcinoembryonic antigen , cancer antigen [ CA ] 15 - 5 , and CA 27.29 ) , liver ultrasonograms , or computed tomography scans . VALIDATION The recommendations of the breast cancer expert panel were evaluated and supported by the ASCO Health Services Research Committee review ers and the ASCO Board of Directors PURPOSE To up date the 1999 American Society of Clinical Oncology ( ASCO ) guideline on breast cancer follow-up and management in the adjuvant setting . METHODS An ASCO Expert Panel review ed pertinent information from the literature through March 2006 . More weight was given to studies that tested a hypothesis directly relating testing to one of the primary outcomes in a r and omized design . RESULTS The evidence supports regular history , physical examination , and mammography as the cornerstone of appropriate breast cancer follow-up . All patients should have a careful history and physical examination performed by a physician experienced in the surveillance of cancer patients and in breast examination . Examinations should be performed every 3 to 6 months for the first 3 years , every 6 to 12 months for years 4 and 5 , and annually thereafter . For those who have undergone breast-conserving surgery , a post-treatment mammogram should be obtained 1 year after the initial mammogram and at least 6 months after completion of radiation therapy . Thereafter , unless otherwise indicated , a yearly mammographic evaluation should be performed . Patients at high risk for familial breast cancer syndromes should be referred for genetic counseling . The use of CBCs , chemistry panels , bone scans , chest radiographs , liver ultrasounds , computed tomography scans , [18F]fluorodeoxyglucose-positron emission tomography scanning , magnetic resonance imaging , or tumor markers ( carcinoembryonic antigen , CA 15 - 3 , and CA 27.29 ) is not recommended for routine breast cancer follow-up in an otherwise asymptomatic patient with no specific findings on clinical examination . CONCLUSION Careful history taking , physical examination , and regular mammography are recommended for appropriate detection of breast cancer recurrence PURPOSE To develop a guideline for the use of sentinel node biopsy ( SNB ) in early stage breast cancer . METHODS An American Society of Clinical Oncology ( ASCO ) Expert Panel conducted a systematic review of the literature available through February 2004 on the use of SNB in early-stage breast cancer . The panel developed a guideline for clinicians and patients regarding the appropriate use of a sentinel lymph node identification and sampling procedure from hereon referred to as SNB . The guideline was review ed by selected experts in the field and the ASCO Health Services Committee and was approved by the ASCO Board of Directors . RESULTS The literature review identified one published prospect i ve r and omized controlled trial in which SNB was compared with axillary lymph node dissection ( ALND ) , four limited meta-analyses , and 69 published single-institution and multicenter trials in which the test performance of SNB was evaluated with respect to the results of ALND ( completion axillary dissection ) . There are currently no data on the effect of SLN biopsy on long-term survival of patients with breast cancer . However , a review of the available evidence demonstrates that , when performed by experienced clinicians , SNB appears to be a safe and acceptably accurate method for identifying early-stage breast cancer without involvement of the axillary lymph nodes . CONCLUSION SNB is an appropriate initial alternative to routine staging ALND for patients with early-stage breast cancer with clinical ly negative axillary nodes . Completion ALND remains st and ard treatment for patients with axillary metastases identified on SNB . Appropriately identified patients with negative results of SNB , when done under the direction of an experienced surgeon , need not have completion ALND . Isolated cancer cells detected by pathologic examination of the SLN with use of specialized techniques are currently of unknown clinical significance . Although such specialized techniques are often used , they are not a required part of SLN evaluation for breast cancer at this time . Data suggest that SNB is associated with less morbidity than ALND , but the comparative effects of these two approaches on tumor recurrence or patient survival are unknown Objective To identify the risk of systemic metastases from T1a and T1b N0 breast cancers in patients treated in an academic center , and to seek factors to identify the patients at greatest risk of such failure . Summary Background Data With the demonstration that adjuvant chemotherapy reduces the death rate from breast cancer by roughly one quarter across all risk groups , controversy has reigned regarding possible exclusions from therapy . T1a and T1b N0 tumors ( 1-cm diameter and smaller with negative axillary nodes ) have been considered at low risk for metastasis since the report from Memorial Sloan-Kettering Cancer Center of a 90 % survival rate at 10 years . Subsequent reports have suggested an even more favorable prognosis for this group . However , consensus statements advise selecting some of these women for treatment , and many do receive adjuvant chemotherapy . Methods Sequential patients with breast cancer at the Emory Clinic were prospect ively staged and followed up for outcome . The records of patients with T1a and T1b N0 tumors were review ed for exact tumor diameter , grade , receptor status , adjuvant therapy , and outcome . A corrected data set was stripped of patient identifiers and analyzed by Kaplan-Meier methods . Subgroups were formed based on tumor grade ( 1 vs. 3 ) , adjuvant chemotherapy ( use vs. no use ) , and adjuvant tamoxifen ( use vs. no use ) and were compared via log-rank tests . Results Two hundred eighty-two women were identified . Two developed metastatic disease and one experienced a local failure after breast-conserving treatment . The estimated disease-free survival rate at 10 years was 98.7 % . With only two distant failures and one local failure , there was no significant difference by grade , receptor status , or use of adjuvant chemotherapy or tamoxifen . Conclusions The risk of systemic failure from such tumors barely exceeded 1 % at 10 years . Unless future studies can identify a subgroup at higher risk , the cognitive changes associated with cytotoxic chemotherapy or the loss of estrogen involved do not appear to have sufficient off setting benefit to warrant chemotherapy for this group of women BACKGROUND As mammographic screening becomes more widespread , larger numbers of tumours are diagnosed while small and node negative . METHODS We examined detection mode , tumour size , node status , histological type , therapy and outcome in 1053 breast cancers diagnosed in one county of the Swedish Two-County Trial of mammographic screening for breast cancer . RESULTS Of patients undergoing total mastectomy with axillary dissection  , 65 % were found to be node negative . For tumours of size 1 - 9 mm , 95 % were node negative . The major effects on survival were tumour size , node status and histological type .  Primary adjuvant therapy had no significant association with survival . CONCLUSIONS The advent of mammography has substantially enhanced the possibilities for less radical treatment . There is an urgent need for therapeutic trials utilizing mammographic-pathological correlations to ascertain in advance which tumours can and which can not benefit from more radical therapy BACKGROUND The 21-gene Oncotype DX Recurrence Score assay is a vali date d assay to help decide the appropriate treatment for estrogen receptor-positive ( ER+ ) , early-stage breast cancer ( EBC ) in the adjuvant setting . The choice of adjuvant treatments might vary considerably in different countries according to various treatment guidelines . This prospect i ve multicenter study is the first to assess the impact of the Oncotype DX assay in the French clinical setting . METHODS A total of 100 patients with ER+ , human epidermal growth factor receptor 2-negative EBC , and node-negative ( pN0 ) disease or micrometastases in up to 3 lymph nodes ( pN1mi ) were enrolled . Treatment recommendations , physicians ' confidence before and after knowing the Recurrence Score value , and physicians ' perception of the assay were recorded . RESULTS Of the 100 patients , 95 were evaluable ( 83 pN0 , 12 pN1mi ) . Treatment recommendations changed in 37 % of patients , predominantly from chemoendocrine to endocrine treatment alone . The proportion of patients recommended chemotherapy  decreased from 52 % pretest to 25 % post-test . Of patients originally recommended chemotherapy , 61 % were recommended endocrine treatment alone after receiving the Recurrence Score result . For both pN0 and pN1mi patients , post-test recommendations appeared to follow the Recurrence Score result for low and high values . Physicians ' confidence improved significantly . CONCLUSION These are the first prospect i ve data on the impact of the Oncotype DX assay on adjuvant treatment decisions in France . Using the assay was associated with a significant change in treatment decisions and an overall reduction in chemotherapy use . These data are consistent with those presented from European and non-European studies BACKGROUND The Oncotype DX Breast Cancer Assay is vali date d to assess risk of distant recurrence and likelihood of  chemotherapy ( CT ) benefit in estrogen receptor-positive ESBC in various population s. In Hong Kong , > 80 % of breast cancers are early stage breast cancer ( ESBC ) and > 60 % of these women receive CT . This prospect i ve study measured changes in CT type and recommendations , as well as physician impression of assay impact in a homogenous Chinese population . METHODS Consecutive patients with estrogen receptor-positive , T1 - 3 N0 - 1mi M0 ESBC were offered enrollment . After surgery , physicians discussed treatment options with patients , then ordered the assay , then reassessed treatment recommendation considering assay results .  Changes in treatment recommendation , CT utilization , physician confidence , and physician rating of influence on their treatment recommendations were measured . RESULTS A total of 146 evaluable patients received pre- and post-testing treatment recommendations . CT recommendations ( including changes in intensity of CT ) were changed for 34 of 146 patients ( 23.3 % ; 95 % confidence interval , 16.7%-31.0 % ) ; change in intensity occurred in 7 of 146 ( 4.8 % ) . There were 27 changes in treatment recommendations of adding or removing CT altogether ( 18.5 % change ; 95 % confidence interval , 12.6%-25.8 % ) . CT recommendations decreased from 52.1 % to 37.7 % , a net absolute reduction of 14.4 % ( P < .001 ; 27.6 % net relative reduction ) . Pre-assay , 96 % of physicians agreed/strongly agreed that they were confident in their treatment recommendation ; post-assay , 90 % of physicians agreed/strongly agreed with the same statement . Thirty percent of physicians agreed/strongly agreed that the test had influenced their recommendation , similar to the proportion of changed recommendations . CONCLUSIONS The Oncotype DX Assay appears to influence physician ESBC adjuvant treatment recommendations in Hong Kong Introduction Breast cancer is the most common type of cancer seen in women in western countries . Thus , diagnostic modalities sensitive to early-stage breast cancer are needed . Antibody-based array platforms of a data -driven type , which are expected to facilitate more rapid and sensitive detection of novel biomarkers , have emerged as a direct , rapid means for profiling cancer-specific signatures using small sample s. In line with this concept , our group constructed an antibody bead array panel for 35 analytes that were selected during the discovery step . This study was aim ed at testing the performance of this 35-plex array panel in profiling signatures specific for primary non-metastatic breast cancer and validating its diagnostic utility in this independent population . Methods Thirty-five analytes were selected from more than 50 markers through screening steps using a serum bank consisting of 4,500 sample s from various types of cancer .  An antibody-bead array of 35 markers was constructed using the Luminex ™ bead array platform .  A study population consisting of 98 breast cancer patients and 96 normal subjects was analysed using this panel . Multivariate classification algorithms were used to find discriminating biomarkers and vali date d with another independent population of 90 breast cancer and 79 healthy controls . Results Serum concentrations of epidermal growth factor , soluble CD40-lig and and proapolipoprotein A1 were increased in breast cancer patients . High-molecular-weight-kininogen , apolipoprotein A1 , soluble vascular cell adhesion molecule-1 , plasminogen activator inhibitor-1 , vitamin-D binding protein and vitronectin were decreased in the cancer group . Multivariate classification algorithms distinguished breast cancer patients from the normal population with high accuracy ( 91.8 % with r and om forest , 91.5 % with support vector machine , 87.6 % with linear discriminant analysis ) . Combinatorial markers also detected breast cancer at an early stage with greater sensitivity . Conclusions The current study demonstrated the usefulness of the antibody-bead array approach in finding signatures specific for primary non-metastatic breast cancer and illustrated the potential for early , high sensitivity detection of breast cancer . Further validation is required before array-based technology is used routinely for early detection of breast cancer Purpose To provide current recommendations on the use of sentinel node biopsy ( SNB ) for patients with early-stage breast cancer . Methods PubMed and the Cochrane Library were search ed for r and omized controlled trials , systematic review s , meta-analyses , and clinical practice guidelines from 2012 through July 2016 . An Up date Panel review ed the identified abstract s. Results Of the eight publications identified and review ed , none prompted a change in the 2014 recommendations , which are reaffirmed by the up date d literature review . Conclusion Women without sentinel lymph node ( SLN ) metastases should not receive axillary lymph node dissection ( ALND ) . Women with one to two metastatic SLNs who are planning to undergo breast-conserving surgery with whole-breast radiotherapy should not undergo ALND ( in most cases ) . Women with SLN metastases who will undergo mastectomy should be offered ALND . These three recommendations are based on r and omized controlled trials . Women with operable breast cancer and multicentric tumors , with ductal carcinoma in situ , who will undergo mastectomy , who previously underwent breast and /or axillary surgery , or who received preoperative/neoadjuvant systemic therapy may be offered SNB .  Women who have large or locally advanced invasive breast cancer ( tumor size T3/T4 ) , inflammatory breast cancer , or ductal carcinoma in situ ( when breast-conserving surgery is planned ) or are pregnant should not undergo SNB Objective . Oncology patients often seek involvement in their medical consultations . Such involvement is endorsed by most health care providers and mirrored in practice guidelines . However , oncologists exhibit great variation in how they provide patients with disease-relevant information , and many remain reluctant to do so at all . The authors examined the impact of a patient-specific decision aid on women ’s decisions about adjuvant therapy for breast cancer . Method . 386 women with breast cancer were r and omized to receive either an informational pamphlet about adjuvant therapy ( usual care ) or a patient-specific , evidence -based decision aid about adjuvant therapy . The authors compared rates of adjuvant therapy between the groups controlling for age , education , marital status , race , tumor severity , and practice type of their physician ( university-based or community-based ) . Results . Among women with low tumor severity , only 58 % ( 35/60 ) of women in the decision aid group chose adjuvant therapy  , compared to 87 % ( 33/38 ) of their counterparts in usual care ( P < 0.01 ) . Conclusions . This study illustrates the important impact of medical decision aids on treatment choices , particularly for patients for whom treatment has little benefit . In the case of adjuvant therapy for breast cancer , providing individualized , evidence -based risk information for shared decision making result ed in fewer women with low tumor severity choosing adjuvant treatment PURPOSE The After Mapping of the Axilla : Radiotherapy or Surgery ? ( AMAROS ) phase III study compares axillary lymph node dissection ( ALND ) and axillary radiation therapy ( ART ) in early breast cancer patients with tumor-positive sentinel nodes . In the ART arm , the extent of nodal involvement remains unknown , which could have implication s on the administration of adjuvant therapy . In this preliminary analysis , we studied the influence of r and om assignment to ALND or ART on the choice for adjuvant treatment . PATIENTS AND METHODS In the first 2,000 patients enrolled in the AMAROS trial , we analyzed the administration of adjuvant systemic therapy . Multivariate analysis was used to assess variables affecting the administration of adjuvant chemotherapy . Adjuvant therapy was applied according to institutional guidelines . Results Of 2,000 patients , 566 patients had a positive sentinel node and were treated per r and om assignment . There was no significant difference in the administration of adjuvant systemic therapy .  In the ALND and ART arms , 58 % ( 175 of 300 ) and 61 % ( 162 of 266 ) of the patients , respectively , received  chemotherapy . Endocrine therapy  was administered in 78 % ( 235 of 300 ) of the patients in the ALND arm and in 76 % ( 203 of 266 ) of the patients in the ART arm . Treatment arm was not a significant factor in the decision , and no interactions between treatment arm and other factors were observed . Multivariate analysis showed that age , tumor grade , multifocality , and size of the sentinel node metastasis significantly affected the administration of chemotherapy .  Within the ALND arm , the extent of nodal involvement remained not significant in a sensitivity multivariate analysis . CONCLUSION Absence of knowledge regarding the extent of nodal involvement in the ART arm appears to have no major impact on the administration of adjuvant therapy The prognostic accuracy for distant recurrence‐free survival using a 21‐gene reverse‐transcriptase polymerase chain reaction ( RT‐PCR ) assay underwent validation in 668 lymph node‐negative , estrogen receptor‐positive women with early‐stage breast cancer receiving tamoxifen on National Surgical Adjuvant Breast Program ( NSABP ) B‐14 . The predictive accuracy for treatment efficacy also underwent validation in 651 patients r and omized on NSABP B‐20 and 645 patients on NSABP B‐14
RECOMMENDATIONS In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2 , the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX , EndoPredict , PAM50 , Breast Cancer Index , and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer .
No biomarker except for estrogen receptor , progesterone receptor , and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens .
PURPOSE To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer .