***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: Purpose To prospect ively compare SIRT and DEB-TACE for treating hepatocellular carcinoma ( HCC ) . Methods From 04/2010–07/2012 , 24 patients with histologically proven unresectable N0 , M0 HCCs were r and omized 1:1 to receive SIRT or DEB-TACE . SIRT could be repeated once in case of recurrence ; while , TACE was repeated every 6 weeks until no viable tumor tissue was detected by MRI or contraindications prohibited further treatment . Patients were followed-up by MRI every 3 months ; the final evaluation was 05/2013 . Results Both groups were comparable in demographics ( SIRT : 8males/4females , mean age 72 ± 7 years ; TACE : 10males/2females , mean age 71 ± 9 years ) , initial tumor load ( 1 patient ≥25 % in each group ) , and BCLC ( Barcelona Clinic Liver Cancer ) stage ( SIRT : 12 × B ; TACE  1 × A , 11 × B ) . Median progression-free survival ( PFS ) was 180 days for SIRT versus 216 days for TACE patients ( p = 0.6193 ) with a median TTP of 371 days versus 336 days , respectively ( p = 0.5764 ) . Median OS was 592 days for SIRT versus 788 days for TACE patients ( p = 0.9271 ) . Seven patients died in each group . Causes of death were liver failure ( n = 4 SIRT group ) , tumor progression ( n = 4 TACE  group ) , cardiovascular events , and inconclusive ( n = 1 in each group ) . Conclusions No significant differences were found in median PFS , OS , and TTP . The lower rate of tumor progression in the SIRT group was nullified by a greater incidence of liver failure . This pilot study is the first prospect i ve r and omized trial comparing SIRT and TACE for treating HCC , and results can be used for sample size calculations of future studies BACKGROUND & AIMS Conventional transarterial chemoembolization ( cTACE ) is used to treat patients with hepatocellular carcinoma ( HCC ) . Radioembolization is a minimally invasive procedure that involves implantation of radioactive micron-sized particles loaded with yttrium-90 ( Y90 ) inside the blood vessels that supply a tumor . We performed a r and omized , phase 2 study to compare the effects of cTACE and Y90 radioembolization in patients with HCC . METHODS From October 2009 through October 2015 , we review ed patients with HCC of all Barcelona Clinic Liver Cancer ( BCLC ) stages for eligibility . Of these , 179 patients with BCLC stages A or B met our enrollment criteria and were c and i date s for cTACE or Y90 therapy .  Patients were assigned r and omly to groups that received Y90 therapy ( n = 24 ; 50 % Child-Pugh A ) or cTACE ( n = 21 ; 71 % Child-Pugh A ) . The primary outcome was time to progression ( TTP ) , evaluated by intention-to-treat analysis . Secondary outcomes included safety , rate of response ( based on tumor size and necrosis criteria ) , and Kaplan-Meier survival time . We performed inverse probability of censoring weighting and competing risk analyses . RESULTS Patients in the Y90 radioembolization group had significant longer median TTP ( > 26 mo ) than patients in the cTACE group ( 6.8 mo ; P = .0012 ) ( hazard ratio , 0.122 ; 95 % confidence interval [ CI ] , 0.027 - 0.557 ; P = .007 ) . This was confirmed by competing risk and inverse probability of censoring weighting analyses accounting for transplantation or death . A significantly greater proportion of patients in the cTACE group developed diarrhea ( 21 % ) than in the Y90 group ( 0 % ; P = .031 ) or hypoalbuminemia ( 58 % in the cTACE group vs 4 % in the Y90 group ; P < .001 ) . Similar proportions of patients in each group had a response to therapy , marked by necrosis ( 74 % in the cTACE group vs 87 % in the Y90 group ) ( P = .433 ) . The median survival time , censored to liver transplantation , was 17.7 months for the cTACE group ( 95 % CI , 8.3-not calculable ) vs 18.6 months for the Y90 group ( 95 % CI , 7.4 - 32.5 ) ( P = .99 ) . CONCLUSIONS In a r and omized phase 2 study of patients with HCC of BCLC stages A or B , we found Y90 radioembolization to provide significantly longer TTP than cTACE . Y90 radioembolization provides better tumor control and could reduce drop-out from transplant waitlists . Clinical Trials.gov no. NCT00956930 UNLABELLED Yttrium-90 radioembolization ( Y90RE ) is a novel approach to radiation therapy for hepatocellular carcinoma ( HCC ) , never tested in phase 2 studies . Fifty-two patients with intermediate ( n.17 ) to advanced ( n.35 ) HCC were prospect ively recruited to assess , as the primary endpoint , efficacy of Y90RE on time-to-progression ( TTP ) . Secondary endpoints were tumor response , safety , and overall survival ( OS ) .  All patients were Eastern Cooperative Oncology Group ( ECOG ) score 0 - 1 , Child-Pugh class A-B7 .  Y90RE treatments aim ed at a lobar delivery of 120 Gy . Retrospective dosimetric correlations were conducted and related to response . Fifty-eight treatments were performed on 52 patients . The median follow-up was 36 months . The median TTP was 11 months with no significant difference between portal vein thrombosis ( PVT ) versus no PVT ( 7 versus 13 months ) . The median OS was 15 months ( 95 % confidence interval [ CI ] , 12 - 18 months ) with a nonsignificant trend in favor of non-PVT versus PVT patients ( 18 versus 13 months ) . Five complete responses occurred ( 9.6 % ) , and the 2 year-progression rate was 62 % . Objective response was 40.4 % , whereas the disease control rate ( 78.8 % ) significantly affected survival ( responders versus nonresponders : 18.4 % versus 9.1 % ; P = 0.009 ) . Tumor response significantly correlated with absorbed dose in target lesions ( r = 0.60 , 95 % CI , 0.41 - 0.74 , P < 0.001 ) and a threshold of 500 Gy predicted response ( area under the curve , 0.78 ) . Mortality at 30 - 90 days was 0%-3.8 % . Various grade s of reduction in liver function occurred within 6 months in 36.5 % of patients , with no differences among stages . On multivariate analysis , tumor response was the sole variable affecting TTP ( P < 0.001 ) and the second affecting survival ( after Child-Pugh class ) . CONCLUSION Y90RE is an effective treatment in intermediate to advanced HCC , particularly in the case of PVT . Further prospect i ve evaluations comparing Y90RE with conventional treatments are warranted BACKGROUND & AIMS To investigate the safety and adverse event profile of sorafenib plus radioembolization ( Y90 ) compared to Y90 alone in patients awaiting liver transplantation . METHODS 20 patients with HCC were r and omized to Y90 alone ( Group A ) or Y90+sorafenib ( Group B ) . Adverse events , dose reductions , and peri-transplant complications were assessed . RESULTS All patients in the sorafenib group necessitated dose reductions . Seventeen of 20 patients underwent liver transplantation ; median time-to-transplant was 7.8 months ( range : 4.2 - 20.3 ) and similar between groups ( p = 0.35 ) . In the sorafenib group , there were 4/8 peri-transplant ( < 30 days ) biliary complications ( p = 0.029 ) and 3/8 acute rejections ( p = 0.082 ) ; there were none in the Y90-only  group . Survival rates were 70 % ( Group A ) and 72 % ( Group B ) at 3 years ( p = 0.57 ) . CONCLUSIONS The addition of sorafenib to Y90 necessitated dose reductions in all patients awaiting transplantation . Preliminary data suggest that the combination was associated with more peri-transplant biliary complications and potentially trended towards more acute rejections . Caution should be exercised when considering sorafenib in the transplant setting . Further investigation is warranted BACKGROUND Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics : both tumour shrinkage ( objective response ) and disease progression are useful endpoints in clinical trials . Since RECIST was published in 2000 , many investigators , cooperative groups , industry and government authorities have adopted these criteria in the assessment of treatment outcomes . However , a number of questions and issues have arisen which have led to the development of a revised RECIST guideline ( version 1.1 ) . Evidence for changes , summarised in separate papers in this special issue , has come from assessment of a large data warehouse ( > 6500 patients ) , simulation studies and literature review s. HIGHLIGHTS OF REVISED RECIST 1.1 : Major changes include : Number of lesions to be assessed : based on evidence from numerous trial data bases merged into a data warehouse for analysis purpose s , the number of lesions required to assess tumour burden for response determination has been reduced from a maximum of 10 to a maximum of five total ( and from five to two per organ , maximum ) . Assessment of pathological lymph nodes is now incorporated : nodes with a short axis of 15 mm are considered measurable and assessable as target lesions . The short axis measurement should be included in the sum of lesions in calculation of tumour response . Nodes that shrink to < 10 mm short axis are considered normal . Confirmation of response is required for trials with response primary endpoint but is no longer required in r and omised studies since the control arm serves as appropriate means of interpretation of data . Disease progression is clarified in several aspects : in addition to the previous definition of progression in target disease of 20 % increase in sum , a 5 mm absolute increase is now required as well to guard against over calling PD when the total sum is very small . Furthermore , there is guidance offered on what constitutes ' unequivocal progression ' of non-measurable/non-target disease , a source of confusion in the original RECIST guideline . Finally , a section on detection of new lesions , including the interpretation of FDG-PET scan assessment is included . Imaging guidance : the revised RECIST includes a new imaging appendix with up date d recommendations on the optimal anatomical assessment of lesions . FUTURE WORK A key question considered by the RECIST Working Group in developing RECIST 1.1 was whether it was appropriate to move from anatomic unidimensional assessment of tumour burden to either volumetric anatomical assessment or to functional assessment with PET or MRI . It was concluded that , at present , there is not sufficient st and ardisation or evidence to ab and on anatomical assessment of tumour burden . The only exception to this is in the use of FDG-PET imaging as an adjunct to determination of progression . As is detailed in the final paper in this special issue , the use of these promising newer approaches requires appropriate clinical validation studies In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias OBJECTIVES To analyze sources search ed in Cochrane review s , to determine the proportion of trials included in review s that are indexed in major data bases , and to compare the quality of these trials with those from other sources . METHODS All new systematic review s in the Cochrane Library , Issue1 2001 , that were restricted to r and omized controlled trials ( RCTs ) or quasi- RCTs were selected . The sources search ed in the review s were recorded , and the trials included were checked to see whether they were indexed in four major data bases . Trials not indexed were checked to determine how they could be identified . The quality of trials found in major data bases was compared with those found from other sources . RESULTS The range in the number of data bases search ed per review ranged between one and twenty-seven . The proportion of the trials in the four data bases 
    Output:
    
On the basis of the two included r and omised clinical trials , single-session radioembolisation appeared to be as safe as multiple sessions of chemoembolization for intermediate stage hepatocellular carcinoma and had a similar impact on quality of life , but data were too sparse to exclude even major differences .
Radioembolisation followed by sorafenib appeared to be as well tolerated as sorafenib alone for advanced stage hepatocellular carcinoma , but data were too sparse to exclude even major differences .
There was insufficient evidence to assess the beneficial and harmful effects of yttrium-90 microsphere radioembolisation for people with unresectable hepatocellular carcinoma .