***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Between 1971 and 1974 , 1,665 women with primary operable breast cancer were entered into a prospect i ve r and omized clinical trial ( NSABP Protocol No. B‐04 ) in order to compare the worth of radical mastectomy with alternative treatments . Six‐hundred forty‐six of the women , 352 clinical ly nodenegative and 294 node‐positive , were r and omized so that they were to have been treated with total mastectomy and postoperative radiation .  Due to a meticulous comprehensive program of radiation monitoring involving close cooperation between the NSABP Headquarters , the NSABP Radiation Monitoring Committee , the Radiological Physics Center at M. D. And erson Cancer Center and participating institutions , it has been possible to determine protocol compliance of the radiation administered and to correlate any variation of radiation employed with treatment outcome . At the onset of the study and prior to any evaluation of treatment results , the Radiation Monitoring Committee defined minor variations from the protocol which were acceptable and those variations which were more major and unacceptable . While it was found that 53 % of the 543 evaluable patients had been treated by radiation having some degree of variation from the protocol , it was ascertained that 77 % of the 2.172 irradiated fields of those patients ( 82 % in clinical ly node‐negative and 71 % in clinical ly node‐positive patients ) received radiation per protocol . Only 6.7 % of all sites were the recipients of a major ( unacceptabel ) variation in radiation . Analysis of data demonstrated that there was a remarkable similarity in the incidence and rate of treatment failure ( TF ) or mortality between patients having some radiation variation , regardless of its degree or extent and those who were treated with no protocol variation . Results were similar when comparisons were made taking into consideration either the degree ( minor or major low ) or the extent ( one or more than one field ) of the radiation variation . A substantial number of clinical ly positive axillary node patients received only the radiation to the axillary field intended for those with clinical ly negative nodes , i.e. , they failed to receive the specified radiation boost . Despite that deviation , there was no difference in TF or survival from those receiving the prescribed treatment . Moreover , findings were not different when the axilla was the only site of radiation deviation or there were deviations to other fields as well . Of singular importance was an inability to associate the localregional location of a recurrence with a low‐dose radiation deviation at the site . Almost all recurrences in clinical ly node‐negative patients were at sites treated per protocol . In positive‐node patients , supraclavicular and chest wall recurrences occurred in patients having acceptable radiation to those sites and axillary recurrences were equivalent in patients treated with or without deviations at that site . The findings from these investigations are not presented in order to indicate that the quality and quantity of radiation may be unimportant . They have been obtained under careful monitoring and the variations are within a relatively narrow range . Consequently , more general extrapolations from these must be made with circumspection . The observations do suggest , however , that there is some acceptable leeway in the use of radiation , at least for treatment of the extent of disease present in patients in this study . Moreover , they refute any consideration that the failure to demonstrate a significant advantage following the use of postoperative radiation in Protocol No. B‐04 could be related to the variation and inadequacy of radiation employed in a proportion of the patients . They tend to substantiate the contention that factors other than the type of operative procedure employed or the precision of administration of radiation are important in determining the survival of women with breast cancer . Finally , the mechanism whereby the radiation employed was quality controlled serves as a model for the m and atory monitoring of all modalities of therapy in cooperative clinical trials . Such monitoring , by providing more credible dat , will favorably affect the management of cancer patients . Cancer 46:1–13 , 1980 The aim of this study was to assess upper limb morbidity following treatment for operable breast cancer . Patients were r and omized to either mastectomy and axillary clearance ( 40 women : 12 with axillary nodal metastasis and 28 without axillary metastasis ) or mastectomy and axillary sampling ( 54 women ) .  Adjuvant radiotherapy was delivered to those in whom the sample revealed axillary nodal metastasis ( 28 women ) but not to those with no axillary nodal metastasis ( 26 women ) . A subjective assessment of the state of the arm was made using a st and ard question naire . Objective assessment included upper and forearm circumference , shoulder joint mobility and assessment of power in the pectoralis muscle . The mean age was 56·8 years ( range 33–77 years ) and the mean elapsed time from treatment was 5·72 years ( range 4·0–7·5 years ) . Subjective limb oedema was greatest in those who had axillary lymph node metastasis but there was no objective difference . Subjective joint mobility was reduced in the women who received radiotherapy and this was confirmed by objective assessment ( P<0·05 ) . The objective reduction in arm mobility was related to the treatment rather than the axillary lymph node status . There was no difference in power . In this study women receiving adjuvant radiotherapy had significantly reduced shoulder mobility . This may have implication s for current conservation studies using adjuvant radiotherapy BACKGROUND Axillary lymph node clearance ( ALNC ) improves locoregional control and provides prognostic information for early breast cancer treatment , but effects on survival are controversial . This multicentre , r and omized pragmatic equivalence trial compares outcomes for post-menopausal early invasive breast cancer patients after locoregional treatment with ALNC and adjuvant therapies to outcomes after locoregional treatment  without ALNC and adjuvant therapies . METHODS From 1995 - 2005 , women aged ≥ 50 years with early breast cancer ( tumor ≤ 10 mm ) and clinical ly-negative axillary nodes were r and omized to receive treatment with ALNC ( Ax ) or without ( no-Ax ) . Adjuvant therapies were prescribed according to hormonal receptor status and individual histological results . The primary endpoint was overall survival ( OS ) ; secondary endpoints were event-free survival ( EFS ) and functional outcomes . The trial was terminated due to lack of equivalence and low accrual after first interim analyses . TRIAL REGISTRATION NCT00210236 . RESULTS Of 625 patients , 297 no-Ax and 310 Ax patients were maintained for final per- protocol analyses . OS and EFS at five years were not equivalent ( Ax vs. no-Ax : 98 % vs. 94 % and 96 % vs. 90 % respectively ) . Recurrence was higher for no-Ax , particularly in the first five years after surgery . Axillary nodes were positive for 14 % Ax patients but only 2 % no-Ax patients experienced axillary node recurrence . Functional impairments were greater after ALNC . CONCLUSION Our results fail to demonstrate equivalence of outcomes when ALNC is omitted from post-menopausal early breast cancer patient treatment . However the low locoregional recurrence rates warrant further examination over a longer duration , in particular to consider whether these would impact on survival BACKGROUND If treatment of the axilla is indicated in patients with breast cancer who have a positive sentinel node , axillary lymph node dissection is the present st and ard . Although axillary lymph node dissection provides excellent regional control , it is associated with harmful side-effects . We aim ed to assess whether axillary radiotherapy provides comparable regional control with fewer side-effects . METHODS Patients with T1 - 2 primary breast cancer and no palpable lymphadenopathy were enrolled in the r and omised , multicentre , open-label , phase 3 non-inferiority EORTC 10981 - 22023 AMAROS trial . Patients were r and omly assigned ( 1:1 ) by a computer-generated allocation schedule to receive either axillary lymph node dissection or axillary radiotherapy in case of a positive sentinel node , stratified by institution . The primary endpoint was non-inferiority of 5-year axillary recurrence , considered to be not more than 4 % for the axillary radiotherapy group compared with an expected 2 % in the axillary lymph node dissection group . Analyses were by intention to treat and per protocol . The AMAROS trial is registered with Clinical Trials.gov , number NCT00014612 . FINDINGS Between Feb 19 , 2001 , and April 29 , 2010 , 4823 patients were enrolled at 34 centres from nine European countries , of whom 4806 were eligible for r and omisation . 2402 patients were r and omly assigned to receive  axillary lymph node dissection and 2404 to receive axillary radiotherapy . Of the 1425 patients with a positive sentinel node , 744 had been r and omly assigned to axillary lymph node dissection and 681 to axillary radiotherapy ; these patients constituted the intention-to-treat population . Median follow-up was 6·1 years ( IQR 4·1 - 8·0 ) for the patients with positive sentinel lymph nodes . In the axillary lymph node dissection group , 220 ( 33 % ) of 672 patients who underwent axillary lymph node dissection had additional positive nodes . Axillary recurrence occurred in four of 744 patients in the axillary lymph node dissection group and seven of 681 in the axillary radiotherapy group . 5-year axillary recurrence was 0·43 % ( 95 % CI 0·00 - 0·92 ) after axillary lymph node dissection versus 1·19 % ( 0·31 - 2·08 ) after axillary radiotherapy . The planned non-inferiority test was underpowered because of the low number of events . The one-sided 95 % CI for the underpowered non-inferiority test on the hazard ratio was 0·00 - 5·27 , with a non-inferiority margin of 2 . Lymphoedema in the ipsilateral arm was noted significantly more often after axillary lymph node dissection than after axillary radiotherapy at 1 year , 3 years , and 5 years . INTERPRETATION Axillary lymph node dissection and axillary radiotherapy after a positive sentinel node provide excellent and comparable axillary control for patients with T1 - 2 primary breast cancer and no palpable lymphadenopathy . Axillary radiotherapy results in significantly less morbidity . FUNDING EORTC Charitable Trust PURPOSE The American College of Surgeons Oncology Group trial Z0011 was a prospect i ve , r and omized , multicenter trial comparing overall survival between patients with positive sentinel lymph nodes ( SLNs ) who did and did not undergo axillary lymph node dissection ( ALND ) .  The current study compares complications associated with SLN dissection ( SLND ) plus ALND , versus SLND alone . PATIENTS AND METHODS From May 1999 to December 2004 , 891 patients were r and omly assigned to  SLND + ALND ( n = 445 ) or SLND alone ( n = 446 ) . Information on wound infection , axillary seroma , paresthesia , brachial plexus injury ( BPI ) , and lymphedema was available for 821 patients . RESULTS Adverse surgical effects were reported in 70 % ( 278 of 399 ) of patients after SLND + ALND and 25 % ( 103 of 411 ) after SLND alone ( P < or= .001 ) . Patients in the SLND + ALND group had more wound infections ( P < or= .0016 ) , seromas ( P < or= .0001 ) , and paresthesias ( P < or= .0001 ) than those in the SLND-alone group . At 1 year , lymphedema was reported subjectively by 13 % ( 37 of 288 ) of patients after SLND + ALND and 2 % ( six of 268 ) after SLND alone ( P < or= .0001 ) . The difference between the two groups ' lymphedema , assessed by arm measurements at 30 days ( P = .36 ) , 6 months ( P = .22 ) , and 1 year ( P = .078 ) , although close to the cutoff for significance at 1 year , was not significant . BPIs occurred in less than 1 % of patients . CONCLUSION In trial Z0011 , the use of SLND + ALND result ed in more wound infections , axillary seromas , and paresthesias than SLND alone . Lymphedema was more common after SLND + ALND but was significantly different only by subjective report . The use of SLND alone result ed in fewer complications A preliminary review of results from a r and om clinical trial which compared radical mastectomy with simple mastectomy plus radical radiotherapy in a group of 395 breast cancer patients has shown a nonsignificant trend toward a higher survival rate under radical mastectomy and differences in the pattern of complications . Under either treatment mortality rate increased linearly as a function of tumor size up to 5 - 6 cm and was higher among older postmenopausal women . A discriminant function based on measurements of 24-hour urine excretion of 17-hydroxycorticosteroids and etiocholanolone was developed which correlated closely with failure to respond to major endocrine procedures and reduced survival rate . Clinical trials follow-up and data analysis are continuing Background : The Royal Australasian College of Surgeons ( RACS ) SNAC trial is a r and omized controlled trial of sentinel node biopsy ( SNB ) versus axillary clearance ( AC ) . It opened in May  
    Output:
    
This review confirms the benefit of SLNB and axillary sampling as alternatives to ALND for axillary staging , supporting the view that ALND of the clinical ly and radiologically uninvolved axilla is no longer acceptable practice in people with breast cancer