***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 This r and omised study compared protracted venous infusion ( PVI ) fluorouracil ( 5-FU ) with PVI 5-FU plus mitomycin C ( MMC ) in patients with advanced oesophago-gastric cancer . PATIENTS AND METHODS Two hundred and fifty-four patients with adenocarcinoma , squamous cell carcinoma or undifferentiated carcinoma involving the oesophagus , oesophago-gastric junction or the stomach were r and omised . The major end points were tumour response , survival , toxicity and quality of life . RESULTS The median age of patients treated was 72 years and the two arms were well-balanced for baseline demographic factors . The overall response rate was 16.1 % [ 95 % confidence interval ( CI ) 9.5 % to 22.7 % ] in patients treated with PVI 5-FU alone compared with 19.1 % ( 95 % CI 12.0 % to 26.0 % ) for those treated with PVI 5-FU plus MMC ( P = 0.555 ) . Median time to treatment failure was 3.9 months for PVI 5-FU and 3.8 months for PVI 5-FU plus MMC ( P = 0.195 ) . Median survival was 6.3 months for PVI 5-FU and 5.3 months for PVI 5-FU plus MMC ( P = 1.0 ) . Toxicity was mild for both treatments . Symptomatic benefit measured by improvement in pain control , weight loss , dysphagia and oesophageal reflux was observed in over 64 % of patients in each arm . Quality of life scores were comparable in each arm . CONCLUSIONS PVI 5-FU is a safe , effective form of palliation for patients with advanced oesophago-gastric cancer although the addition of MMC adds little extra benefit BACKGROUND We aim ed to establish the superiority ( or noninferiority if superiority was not achieved ) in terms of time to progression ( TTP ) of irinotecan/5-fluorouracil ( IF ) over cisplatin/5-fluorouracil ( CF ) in chemonaive patients with adenocarcinoma of the stomach/esophagogastric junction . PATIENTS AND METHODS Patients received either IF : i.v . irinotecan 80 mg/m(2 ) 30 min , folinic acid 500 mg/m(2 ) 2 h , 5-fluorouracil ( 5-FU ) 2000 mg/m(2 ) 22 h , for 6/7 weeks or CF : cisplatin 100 mg/m(2 ) 1 - 3 h , with 5-FU 1000 mg/m(2)/day 24 h , days 1 - 5 , every 4 weeks . RESULTS In all , 333 patients were r and omized and treated ( IF 170 , CF 163 ) . Patient characteristics were balanced except more IF patients had Karnofsky performance status 100 % . TTP for IF was 5.0 months [ 95 % confidence interval ( CI ) 3.8 - 5.8 ] and 4.2 months ( 95 % CI 3.7 - 5.5 ) for CF ( P = 0.088 ) . Overall survival ( OS ) was 9.0 versus 8.7 months , response rate 31.8 % versus 25.8 % , time to treatment failure ( TTF ) 4.0 versus 3.4 months for IF and CF , respectively . The difference in TTF was statistically significant ( P = 0.018 ) . IF was better in terms of toxic deaths ( 0.6 % versus 3 % ) , discontinuation for toxicity ( 10.0 % versus 21.5 % ) , severe neutropenia , thrombocytopenia and stomatitis , but not diarrhea . CONCLUSION IF did not yield a significant TTP or OS superiority over CF , and the results of noninferiority of IF were borderline . However , IF may provide a viable , platinum-free front-line treatment alternative for metastatic gastric cancer BACKGROUND Clinical data showed promising antitumour activity with feasible tolerability for matuzumab plus epirubicin , cisplatin and capecitabine ( ECX ) chemotherapy in untreated advanced oesophago-gastric ( OG ) cancer . The aim was to evaluate the efficacy of matuzumab plus ECX versus ECX alone . PATIENTS AND METHODS In this multicentre , r and omised open-label phase II study , 72 patients with metastatic OG cancer were r and omly assigned to either 800 mg matuzumab weekly plus epirubicin 50 mg/m² , cisplatin 60 mg/m² on day 1 and capecitabine 1250 mg/m² daily in a 21-day cycle ( ECX ) or the same ECX regimen alone . The primary end point was objective response . Secondary end points included progression-free survival ( PFS ) , overall survival ( OS ) , quality of life , safety and tolerability . RESULTS Following r and om assignment , 35 patients ( median age 59 years ) received ECX/matuzumab and 36 patients ( median age 64 years ) ECX . The addition of matuzumab to ECX did not improve objective response : 31 % for ECX/matuzumab [ 95 % confidence interval ( CI ) 17 - 49 ] compared with 58 % for the ECX arm ( 95 % CI 41 - 74 ) P = 0.994 ( one sided ) . There was no significant difference in median PFS : 4.8 months ( 95 % CI 2.9 - 8.1 ) for ECX/matuzumab versus 7.1 months ( 95 % CI 4.4 - 8.5 ) for ECX , or in median OS : 9.4 months ( 95 % CI 7.5 - 16.2 ) , compared with 12.2 months ( 95 % CI 9.8 - 13.8 months ) . Grade 3/4 treatment-related toxicity was observed in 27 and 25 patients in the ECX/matuzumab and ECX groups , respectively . CONCLUSION Matuzumab 800 mg weekly combined with ECX chemotherapy does not increase response or survival for patients with advanced OG cancer .  Therefore , ECX/matuzumab should not be examined further in phase III trials Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more The purpose of the study was to establish the optimal dose of capecitabine ( X ) to be used within a multicentre , r and omised study evaluating the potential roles of oxaliplatin ( O ) and X in chemonaive patients ( pts ) with advanced oesophagogastric cancer . Two by two design was used , and pts were r and omised to one of four regimens and stratified for extent of disease , performance status ( PS ) and centre . The treatment regimens are epirubicin , cisplatin , 5-fluorouracil ( ECF ) , EOF , ECX or EOX . Doses : E 50 mg m−2 , C 60 mg m−2 and O 130 mg m−2 i.v . 3 weekly ; F 200 mg m−2 day−1 i.v . and X 500 mg m−2 b.i.d.−1 ( escalated to 625 mg m−2 b.i.d.−1 after results of first interim analysis ) p.o . , continuously . First interim analysis was performed when 80 pts had been r and omised . Dose-limiting fluoropyrimidine toxicities were stomatitis , palmar plantar erythema ( PPE ) and diarrhoea ; 5.1 % of X-treated pts experienced grade 3/4 toxicity . Protocol planned dose escalation of X to 625 mg m−2 b.i.d.−1 was instituted and a second interim analysis has been performed ; results are presented in this paper . A total of 204 pts were r and omised at the time of the protocol planned 2nd interim analysis . Grade 3/4 fluoropyrimidine-related toxicity was seen in 13.7 % pts receiving F , 8.4 % pts receiving X 500 mg m−2 b.i.d.−1 and 14.7 % pts receiving X 625 mg m−2 b.i.d.−1 . Combined complete and partial response rates were ECF 31 % ( 95 % CI 18.7–46.3 ) , EOF 39 % ( 95 % CI 25.9–53.1 ) , ECX 35 % ( 95 % CI 21.4–50.3 ) , EOX 48 % ( 95 % CI 33.3–62.8 ) . Grade 3/4 fluoropyrimidine toxicity affected 14.7 % of pts treated with X 625 mg m−2 b.i.d.−1 , which is similar to that observed with F , confirming this to be the optimal dose . The replacement of C by O and F by X does not appear to impair efficacy . The trial continues to total accrual of 1000 pts OBJECTIVES : A dramatic rise in incidence , an aging population , and expensive palliative treatments have led to an escalating burden on clinicians managing inoperable esophageal cancer with only limited evidence of effectiveness . This study compares the clinical effectiveness and cost-effectiveness of self-exp and ing metal stents ( SEMSs ) with other palliative therapies to aid clinicians in making an evidence -based treatment choice . METHODS : We conducted a prospect i ve , multicenter , r and omized , controlled , clinical trial with 215 patients followed until death or study closure . The primary outcome measures were dysphagia , quality of life ( QL ) 6 weeks following treatment , and total cost of treatment . Secondary outcome measures included treatment-associated morbidity , mortality , survival , and cost-effectiveness . An intention-to-treat analysis was carried out . RESULTS : There was a significant difference in mean dysphagia grade between treatment arms 6 weeks following treatment ( P=0.046 ) , with worse swallowing reported by rigid stent – treated patients ( mean dysphagia score difference=−0.49 ; 95 % confidence interval ( CI ) −0.10 to −0.89 , P=0.014 ) . Global QL scores were lower at both 1 and 6 weeks following treatment for patients treated by SEMSs ( mean difference QL index week 1=−0.66 ; 95 % CI : −0.02 to −1.30 , P=0.04 ; mean difference QL index week 6=−1.01 ; 95 % CI −0.30 to −1.72 , P=0.006 ) . These findings were associated with higher post-procedure pain scores in the SEMS patient group ( mean difference of the European Organisation for Research and Treatment of Cancer QLQ C-30 pain symptom score at week 1=11.13 ; 95 % CI : 2.89–19.4 ; P=0.01 ) . Although mean EQ-5D QL values differed between the treatments ( P<0.001 ) , this difference dissipated following generation of quality -adjusted life year values . Total costs varied between treatment arms but these findings canceled out when SEMSs were compared with non-SEMS therapies ( 95 % CI −845.15–1,332.62 ) . These results were robust to sensitivity analysis . There were no differences in the in-hospital mortality or early complication rates , but late complications were more frequent after rigid stenting ( risk ratio=2.47 ; 95 % CI 1.88–3.04 ) . There was a survival advantage for non-stent-treated patients ( log-rank statistic=4.21 , P=0.04 ) . CONCLUSIONS : The treatment choice for patients with inoperable esophageal cancer should be between a SEMS or a non-stent treatment after consideration has been given to both patient and tumor characteristics and clinician and patient preferences PURPOSE Between 1994 and 1997 , 22 patients with dysphagia from advanced incurable esophageal cancer were enrolled in a phase I/II prospect i ve study to assess the palliative benefit and toxicity of a short course of radiotherapy with chemotherapy . METHODS The study population included 17 men and five women with a median age of 69 ( range 43 - 84 ) . Patients were treated with 30 Gy in ten fractions to the mediastinum with a concurrent single course of chemotherapy ( 5-FU , 1000 mg/m(2 ) , days 1 - 4 and mitomycin-C 10 mg/m(2 ) , day 1 ) . Swallowing ability was recorded each day on a self-administered diary card using the five point dysphagia index of the MRC ( UK ) . The median baseline MRC swallowing score was 4 ( can not swallow solids ) . RESULTS Treatment was generally well tolerated , but seven ( 32 % ) patients had transient worsening of dysphagia scores immediately following treatment because of esophagitis ; fifteen ( 68 % ) achieved a complete response ( score  
    Output:
    
All phase II chemotherapy studies reported maintained HRQL or improved dysphagia combined with low level of toxicity .