***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: BACKGROUND Oral capecitabine achieves a superior response rate with an improved safety profile compared with bolus 5-fluorouracil-leucovorin ( 5-FU/LV ) as first-line treatment for patients with metastatic colorectal cancer . We report here the results of a large phase III trial investigating adjuvant oral capecitabine compared with 5-FU/LV ( Mayo Clinic regimen ) in Dukes ' C colon cancer . PATIENTS AND METHODS Patients aged 18 - 75 years with resected Dukes ' C colon carcinoma were r and omized to receive 24 weeks of treatment with either oral capecitabine 1250 mg/m(2 ) twice daily , days 1 - 14 every 21 days ( n = 993 ) , or i.v . bolus 5-FU 425 mg/m(2 ) with i.v . leucovorin 20 mg/m(2 ) on days 1 - 5 , repeated every 28 days ( n = 974 ) . RESULTS Patients receiving capecitabine experienced significantly ( P < 0.001 ) less diarrhea , stomatitis , nausea/vomiting , alopecia and neutropenia , but more h and -foot syndrome than those receiving 5-FU/LV . Fewer patients receiving capecitabine experienced grade 3 or 4 neutropenia , febrile neutropenia/sepsis and stomatitis ( P < 0.001 ) , although more experienced grade 3 h and -foot syndrome than those treated with 5-FU/LV ( P < 0.001 ) . Capecitabine demonstrates a similar , favorable safety profile in patients aged < 65 years or > or = 65 years old . CONCLUSIONS Based on its improved safety profile , capecitabine has the potential to replace 5-FU/LV as st and ard adjuvant treatment for patients with colon cancer . Efficacy results are expected to be available in Keywords : Adjuvant treatment , capecitabine , chemotherapy , colorectal PURPOSE To report the results of a planned safety analysis from a phase III trial comparing capecitabine plus oxaliplatin ( XELOX ) with bolus fluorouracil/leucovorin ( FU/LV ) as adjuvant therapy for stage III colon cancer . PATIENTS AND METHODS Patients with stage III colon carcinoma were r and omly assigned to receive either XELOX ( intravenous oxaliplatin plus oral capecitabine ; 3-week cycle for eight cycles ) or st and ard intravenous bolus FU/LV administered as the Mayo Clinic ( Mayo ; Rochester , MN ) or Roswell Park ( RP ; Buffalo , NY ) regimen for a similar length of time . A total of 1,886 patients were r and omly assigned . RESULTS The safety population comprised 1,864 patients , of whom 938 received XELOX and 926 received FU/LV . Most treatment-related adverse events ( AEs ) occurred at similar rates in both treatment arms . However , patients receiving XELOX experienced less all- grade diarrhea , alopecia , and more neurosensory toxicity , vomiting , and h and -foot syndrome than those patients receiving FU/LV . Compared with Mayo , XELOX showed fewer grade 3/4 hematologic AE and more grade 3/4 gastrointestinal AE . Compared with RP , XELOX showed less grade 3/4 gastrointestinal AE and more grade 3/4 hematologic AE . As expected grade 3/4 neurosensory toxicity and grade 3 h and -foot syndrome were higher with XELOX . Treatment-related mortality within 28 days from the last study dose was 0.6 % in the XELOX group and 0.6 % in the FU/LV group . CONCLUSION XELOX has a manageable tolerability profile in the adjuvant setting . Efficacy data will be available within the next 24 months OBJECTIVES Health decision-makers involved with coverage and payment policies are increasingly developing policies that seek information on " real-world " ( RW ) outcomes . Motivated by these initiatives , the International Society for Pharmacoeconomics and Outcomes Research ( ISPOR ) created a Task Force on Real-World Data to develop a framework to assist health-care decision-makers in dealing with RW data , especially related to coverage and payment decisions . METHODS Task Force cochairs were selected by the ISPOR Board of Directors . Cochairs selected chairs for four working groups on : clinical outcomes , economic outcomes , patient-reported outcomes , and evidence hierarchies . Task Force members included representatives from academia , the pharmaceutical industry , and health insurers . The Task Force met on several occasions , conducted frequent correspondence and exchanges of drafts , and solicited comments on three drafts from a core group of external review ers and from the ISPOR membership . RESULTS We defined RW data as data used for decision-making that are not collected in conventional r and omized controlled trials ( RCTs ) . We considered several characterizations : by type of outcome ( clinical , economic , and patient-reported ) , by hierarchies of evidence ( which rank evidence according to the strength of research design ) , and by type of data source ( supplementary data collection alongside RCTs , large simple trials , patient registries , administrative cl aims data base , surveys , and medical records ) . Our report discusses eight key issues : 1 ) the importance of RW data ; 2 ) limitations of RW data ; 3 ) the fact that the level of evidence required depends on the circumstance ; 4 ) the need for good research practice s for collecting and reporting RW data ; 5 ) the need for good process in using RW data in coverage and reimbursement decisions ; 6 ) the need to consider costs and benefits of data collection ; 7 ) the ongoing need for modeling ; and 8) the need for continued stakeholder dialogue on these topics . CONCLUSIONS Real-world data are essential for sound coverage and reimbursement decisions . The types and applications of such data are varied , and context matters greatly in determining the value of a particular type in any circumstance . It is critical that policymakers recognize the benefits , limitations , and method ological challenges in using RW data , and the need to consider carefully the costs and benefits of different forms of data collection in different situations BACKGROUND The st and ard adjuvant treatment of colon cancer is fluorouracil plus leucovorin ( FL ) . Oxaliplatin improves the efficacy of this combination in patients with metastatic colorectal cancer . We evaluated the efficacy of treatment with FL plus oxaliplatin in the postoperative adjuvant setting . METHODS We r and omly assigned 2246 patients who had undergone curative resection for stage II or III colon cancer to receive FL alone or with oxaliplatin for six months . The primary end point was disease-free survival . RESULTS A total of 1123 patients were r and omly assigned to each group . After a median follow-up of 37.9 months , 237 patients in the group given FL plus oxaliplatin had had a cancer-related event , as compared with 293 patients in the FL group ( 21.1 percent vs. 26.1 percent ; hazard ratio for recurrence , 0.77 ; P=0.002 ) . The rate of disease-free survival at three years was 78.2 percent ( 95 percent confidence interval , 75.6 to 80.7 ) in the group given FL plus oxaliplatin and 72.9 percent ( 95 percent confidence interval , 70.2 to 75.7 ) in the FL group ( P=0.002 by the stratified log-rank test ) . In the group given FL plus oxaliplatin , the incidence of febrile neutropenia was 1.8 percent , the incidence of gastrointestinal adverse effects was low , and the incidence of grade 3 sensory neuropathy was 12.4 percent during treatment , decreasing to 1.1 percent at one year of follow-up . Six patients in each group died during treatment ( death rate , 0.5 percent ) . CONCLUSIONS Adding oxaliplatin to a regimen of fluorouracil and leucovorin improves the adjuvant treatment of colon cancer Oral capecitabine ( Xeloda ® ) is an effective drug with favourable safety in adjuvant and metastatic colorectal cancer .  Oxaliplatin-based therapy is becoming st and ard for Dukes ' C colon cancer in patients suitable for combination therapy , but is not yet approved by the UK National Institute for Health and Clinical Excellence ( NICE ) in the adjuvant setting . Adjuvant capecitabine is at least as effective as 5-fluorouracil/leucovorin ( 5-FU/LV ) , with significant superiority in relapse-free survival and a trend towards improved disease-free and overall survival . We assessed the cost-effectiveness of adjuvant capecitabine from payer ( UK National Health Service ( NHS ) ) and societal perspectives . We used clinical trial data and published sources to estimate incremental direct and societal costs and gains in quality -adjusted life months ( QALMs ) . Acquisition costs were higher for capecitabine than 5-FU/LV , but higher 5-FU/LV  administration costs result ed in 57 % lower chemotherapy costs for capecitabine . Capecitabine vs 5-FU/LV-associated  adverse events required fewer medications and hospitalisations ( cost savings £ 3653 ) . Societal costs , including patient travel/time costs , were reduced by > 75 % with capecitabine vs 5-FU/LV ( cost savings £ 1318 ) , with lifetime gain in QALMs of 9 months . Medical re source utilisation is significantly decreased with capecitabine vs 5-FU/LV , with cost savings to the NHS and society . Capecitabine is also projected to increase life  expectancy vs 5-FU/LV  . Cost savings and better outcomes  make capecitabine a preferred adjuvant therapy for Dukes ' C colon cancer . This pharmacoeconomic analysis strongly supports replacing 5-FU/LV with capecitabine in the adjuvant treatment of colon cancer in the UK BACKGROUND Intravenous bolus fluorouracil plus leucovorin is the st and ard adjuvant treatment for colon cancer . The oral fluoropyrimidine capecitabine is an established alternative to bolus fluorouracil plus leucovorin as first-line treatment for metastatic colorectal cancer . We evaluated capecitabine in the adjuvant setting . METHODS We r and omly assigned a total of 1987 patients with resected stage III colon cancer to receive either oral capecitabine ( 1004 patients ) or bolus fluorouracil plus leucovorin ( Mayo Clinic regimen ; 983 patients ) over a period of 24 weeks . The primary efficacy end point was at least equivalence in disease-free survival ; the primary safety end point was the incidence of grade 3 or 4 toxic effects due to fluoropyrimidines . RESULTS Disease-free survival in the capecitabine group was at least equivalent to that in the fluorouracil-plus-leucovorin group ( in the intention-to-treat analysis , P<0.001 for the comparison of the upper limit of the hazard ratio with the noninferiority margin of 1.20 ) . Capecitabine improved relapse-free survival ( hazard ratio , 0.86 ; 95 percent confidence interval , 0.74 to 0.99 ; P=0.04 ) and was associated with significantly fewer adverse events than fluorouracil plus leucovorin ( P<0.001 ) . CONCLUSIONS Oral capecitabine is an effective alternative to intravenous fluorouracil plus leucovorin in the adjuvant treatment of colon cancer The oral , tumour-selective fluoropyrimidine capecitabine represents a major new strategy for the treatment of colorectal cancer . Pooled results from two large , multicentre , open-label , phase III studies comparing oral capecitabine ( 1250 mg/m2 twice daily for 14 days every 3 weeks ) with the Mayo Clinic regimen ( 5-fluorouracil [ 5-FU ] 425 mg/m2 plus leucovorin 20 mg/m2 days 1 - 5 , every 4 weeks ) provide information on over 1200 patients receiving first-line chemotherapy for metastatic colorectal cancer . Analysis of all r and omised patients demonstrated a significantly superior overall response rate as assessed by the investigator for capecitabine compared with 5-FU/leucovorin ( 25.7 % versus 16.7 % , P<0.0002 ) , reinforcing the individual trial results . Median time to disease progression , overall survival and duration of response were equivalent in the two treatment groups . Furthermore , capecitabine showed a superior safety profile compared with 5-FU/leucovorin , with a significantly lower incidence ( P<0.001 ) of diarrhoea , stomatitis , nausea and alopecia , together with a reduced treatment-related hospitalisation rate . In addition , the incidence of neutropenic fever/sepsis was significantly lower in patients receiving capecitabine 
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To date , the economic evaluation literature has consistently projected or found that capecitabine is not only a cost-effective treatment for adjuvant or for metastatic colorectal cancer ( i.e. , providing good value for money ) but , furthermore , would actually be cost saving in the majority of country setting