***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 To compare capecitabine/cisplatin with 5-fluorouracil/cisplatin as first-line treatment for advanced gastric cancer ( AGC ) . PATIENTS AND METHODS In this r and omised , open-label , phase III study , patients received cisplatin ( 80 mg/m(2 ) i.v . day 1 ) plus oral capecitabine ( 1000 mg/m(2 ) b.i.d . , days 1 - 14 ) ( XP ) or 5-FU ( 800 mg/m(2)/day by continuous infusion , days 1 - 5 ) ( FP ) every 3 weeks . The primary end point was to confirm noninferiority of XP versus FP for progression-free survival ( PFS ) . RESULTS A total of 316 patients were r and omised to XP ( n = 160 ) or FP ( n = 156 ) . In the per- protocol population , median PFS for XP ( n = 139 ) versus FP ( n = 137 ) was 5.6 versus 5.0 months . The primary end point was met with an unadjusted hazard ratio ( HR ) of 0.81 [ 95 % confidence interval ( CI ) 0.63 - 1.04 , P < 0.001 versus noninferiority margin of 1.25 ] . Median overall survival was 10.5 versus 9.3 months for XP versus FP ( unadjusted HR = 0.85 , 95 % CI 0.64 - 1.13 , P = 0.008 versus noninferiority margin of 1.25 ) . The most common treatment-related grade 3/4 adverse events in XP versus FP patients were as follows : neutropenia ( 16 % versus 19 % ) , vomiting ( 7 % versus 8 % ) , and stomatitis ( 2 % versus 6 % ) . CONCLUSIONS XP showed significant noninferiority for PFS versus FP in the first-line treatment of AGC . XP can be considered an effective alternative to FP Summary This was a phase II study of capecitabine in substitution of 5-fluorouracil ( 5-FU ) in the chemoradiotherapy regimen for patients with localized squamous cell carcinoma of the anal canal . Background Combined chemoradiation with infusional 5-FU and mitomycin is the st and ard treatment for localized squamous cell carcinoma ( SCC ) of the anal canal . Capecitabine is an oral fluoropirimidine that has been shown to be equally effective to 5-FU in many solid tumors . However , the efficacy of the substitution of 5-FU for capecitabine in anal SCC needs confirmation . Methods Patients with SCC of anal cancer T2 - 4N0M0 or T ( any ) N1 - 3M0 , with good performance status and normal blood and renal function , were treated with capecitabine 825 mg/m2 bid during radiotherapy associated with a single dose of mitomycin 15 mg/m2 on day 1 . The primary objective was local control rate at 6 months determined by clinical examination and radiological assessment . Sample size was calculated using the Fleming single-stage design . Results From November 2010 to February 2014 , N = 51 patients were initially included ; however , 43 patients were assessed . Seventeen patients ( 39.5 % ) were stage II , 11 patients ( 25.6 % ) stage IIIA , and 15 patients ( 34.9 % ) stage IIIB . Four patients ( 9.3 % ) were HIV positive . With a median follow-up of 23.1 months ( range 4 to 44.4 months ) , 3 patients ( 7 % ) presented partial response , 37 ( 86 % ) had complete response , and 3 patients developed progression of the disease ( 7 % ) at 6 months . The colostomy rate was 18.6 % . It was observed a locoregional control of 86 % in 6 months ( CI 95 % 0.72–0.94 ) . The main grade 3–4 toxicities were grade 3 radiodermitis in 10 patients ( 23.2 % ) , grade 3 lymphopenia in 5 patients ( 11.6 % ) , and grade 3 neutropenia in 2 patients ( 6.9 % ) . One HIV-positive patient had septic shock , pneumonia , herpetic encephalitis , atrial fibrillation , and macrophage activation syndrome .  Conclusions Capecitabine can safely substitute infusional 5-FU in the st and ard chemoradiation regimen for SCC of the anal cancer , with a locoregional control of 86 % in 6 months ( CI 95 % 0.72–0.94 ) PURPOSE On initial publication of GI Intergroup Radiation Therapy Oncology Group ( RTOG ) 98 - 11 [ A Phase III R and omized Study of 5-Fluorouracil ( 5-FU ) , Mitomycin , and Radiotherapy Versus 5-Fluorouracil , Cisplatin and Radiotherapy in Carcinoma of the Anal Canal ] , concurrent chemoradiation ( CCR ) with fluorouracil ( FU ) plus mitomycin ( MMC ) decreased colostomy failure ( CF ) when compared with induction plus concurrent FU plus cisplatin ( CDDP ) , but did not significantly impact disease-free survival ( DFS ) or overall survival ( OS ) for anal canal carcinoma . The intent of the up date d analysis was to determine the long-term impact of treatment on survival ( DFS , OS , colostomy-free survival [ CFS ] ) , CF , and relapse ( locoregional failure [ LRF ] , distant metastasis ) in this patient group . PATIENTS AND METHODS Stratification factors included sex , clinical node status , and primary size . DFS and OS were estimated univariately by the Kaplan-Meier method , and treatment arms were compared by log-rank test . Time to relapse and CF were estimated by the cumulative incidence method and treatment arms were compared by using Gray 's test . Multivariate analyses used Cox proportional hazard models to test for treatment differences after adjusting for stratification factors . RESULTS Of 682 patients accrued , 649 were analyzable for outcomes .  DFS and OS were statistically better for RT + FU/MMC versus RT + FU/CDDP ( 5-year DFS , 67.8 % v 57.8 % ; P = .006 ; 5-year OS , 78.3 % v 70.7 % ; P = .026 ) . There was a trend toward statistical significance for CFS ( P = .05 ) , LRF ( P = .087 ) , and CF ( P = .074 ) . Multivariate analysis was statistically significant for treatment and clinical node status for both DFS and OS , for tumor diameter for DFS , and for sex for OS . CONCLUSION CCR with FU/MMC has a statistically significant , clinical ly meaningful impact on DFS and OS versus induction plus concurrent FU/CDDP , and it has borderline significance for CFS , CF , and LRF . Therefore , RT + FU/MMC remains the preferred st and ard of care PURPOSE To investigate the potential gain of the concomitant use of radiotherapy and chemotherapy in improving local control and reducing the need for colostomy , a r and omized phase III trial was performed in patients with locally advanced anal cancer . MATERIAL S AND METHODS From 1987 to 1994 , 110 patients were r and omized between radiotherapy alone and a combination of radiotherapy and chemotherapy .  The patients had T3 - 4NO-3 or T1 - 2N1 - 3 anal cancer .  Radiotherapy consisted of 45 Gy given in 5 weeks , with a daily dose of 1.8 Gy . After a rest period of 6 weeks , a boost of 20 or 15 Gy was given in case of partial or complete response , respectively . Surgical resection as part of the primary treatment was performed if possible in patients who had not responded 6 weeks after 45 Gy or with residual palpable disease after the completion of treatment . Chemotherapy was given during radiotherapy : 750 mg/m2 daily fluorouracil as a continuous infusion on days 1 to 5 and 29 to 33 , and a single dose of mitomycin 15 mg/m2 administered on day 1 . RESULTS The addition of chemotherapy to radiotherapy result ed in a significant increase in the complete remission rate from 54 % for radiotherapy alone to 80 % for radiotherapy and chemotherapy , and from 85 % to 96 % , respectively , if results are considered after surgical resections . This led to a significant improvement of locoregional control and colostomy-free interval ( P = .02 and P = .002 , respectively ) , both in favor of the combined modality treatment . The locoregional control rate improved by 18 % at 5 years , while the colostomy-free rate at that time increased by 32 % by the addition of chemotherapy to radiotherapy . No significant difference was found when severe side effects were considered , although anal ulcers were more frequently observed in the combined-treatment arm . The survival rate remained similar in both treatment arms . Skin ulceration , nodal involvement , and sex were the most important prognostic factors for both local control and survival . These remained significant after multivariate analysis . The improvement seen in local control by adding chemotherapy to radiotherapy also remained significant after adjusting for prognostic factors in the multivariate analysis . Event-free survival , defined as free of locoregional progression , no colostomy , and no severe side effects or death , showed significant improvement ( P = .03 ) in favor of the combined-treatment modality . The 5-year survival rate was 56 % for the whole patient group . CONCLUSION The concomitant use of radiotherapy and chemotherapy result ed in a significantly improved locoregional control rate and a reduction of the need for colostomy in patients with locally advanced anal cancer without a significant increase in late side effects CONTEXT Chemoradiation as definitive therapy is the preferred primary therapy for patients with anal canal carcinoma ; however , the 5-year disease-free survival rate from concurrent fluorouracil/mitomycin and radiation is only approximately 65 % . OBJECTIVE To compare the efficacy of cisplatin-based ( experimental ) therapy vs mitomycin-based ( st and ard ) therapy in treatment of anal canal carcinoma . DESIGN , SETTING , AND PARTICIPANTS US Gastrointestinal Intergroup trial RTOG 98 - 11 , a multicenter , phase 3 , r and omized controlled trial comparing treatment with fluorouracil plus mitomycin and radiotherapy vs treatment with fluorouracil plus cisplatin and radiotherapy in 682 patients with anal canal carcinoma enrolled between October 31 , 1998 , and June 27 , 2005 . Stratifications included sex , clinical nodal status , and tumor diameter . INTERVENTION Participants were r and omly assigned to 1 of 2 intervention groups : ( 1 ) the mitomycin-based group ( n = 341 ) , who received fluorouracil ( 1000 mg/m2 on days 1 - 4 and 29 - 32 ) plus mitomycin ( 10 mg/m2 on days 1 and 29 ) and radiotherapy ( 45 - 59 Gy ) or ( 2 ) the cisplatin-based group ( n = 341 ) , who received fluorouracil ( 1000 mg/m2 on days 1 - 4 , 29 - 32 , 57 - 60 , and 85 - 88 ) plus cisplatin ( 75 mg/m2 on days 1 , 29 , 57 , and 85 ) and radiotherapy ( 45 - 59 Gy ; start day = day 57 ) . MAIN OUTCOME MEASURES The primary end point was 5-year disease-free survival ; secondary end points were overall survival and time to relapse . RESULTS A total of 644 patients were assessable . The median follow-up for all patients was 2.51 years . Median age was 55 years , 69 % were women , 27 % had a tumor diameter greater than 5 cm , and 26 % had clinical ly positive nodes .  The 5-year disease-free survival rate was 60 % ( 95 % confidence interval [ CI ] , 53%-67 % ) in the mitomycin-based group and 54 % ( 95 % CI , 46%-60 % ) in the cisplatin-based group ( P = .17 ) . The 5-year overall survival rate was 75 % ( 95 % CI , 67%-81 % ) in the mitomycin-based group and 70 % ( 95 % CI , 63%-76 % ) in the cisplatin-based group ( P = .10 ) . The 5-year local-regional recurrence and distant metastasis rates were 25 % ( 95 % CI , 20%-30 % ) and 15 % ( 95 % CI , 10%-20 % ) , respectively , for mitomycin-based treatment and 33 % ( 95 % CI , 27%-40 % ) and 19 % ( 95 % CI , 14%-24 % ) , respectively , for cisplatin-based treatment . The cumulative rate of colostomy was significantly better for mitomycin-based than cisplatin-based treatment ( 10 % vs 19 % ; P = . 
    Output:
    
Capecitabine is an acceptable and more convenient alternative to infusional 5-FU in the CRT for localised SCCAC , offering similar clinical CRR to those reported by phase-III trials