***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 
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    Input: Objectives The aim of this phase II study was to evaluate the response rate to gemcitabine combined with cisplatin in patients with locally advanced , metastatic or recurrent biliary tract cancer who had received no prior chemotherapy . Methods The treatment consisted of cisplatin 70 mg/m2 in intravenous infusion followed by gemcitabine 1,250 mg/m2 in 30-min intravenous infusion on days 1 and 8 , repeated every 3 weeks until disease progression , unacceptable toxicity , patient ’s refusal or up to 8 cycles . Results Thirty-nine patients with advanced biliary cancer were enrolled between March 2003 and August 2003 . Fourteen patients ( 40 % ) had gall bladder cancer and 20 patients ( 57 % ) had cholangiocarcinoma . Thirty-two patients ( 91 % ) had metastatic disease at study entry with liver being the most commonly involved site of metastasis . About 84.5 and 94.2 % of the initially planned dose were administered for gemcitabine and cisplatin , respectively . In the ITT population ( n = 35 ) , six partial responses were observed for an objective response rate of 17.1 % ( 95 % CI ; 4.7–29.6 % ) . Ten patients ( 28.6 % ) had stable disease , 16 ( 45.7 % ) progressed , and three ( 8.6 % ) were not evaluable . For the 35 patients in the ITT population , the median overall survival time was 8.6 months ( 95 % CI ; 6.1–10.4 months ) . The median time to disease progression was 3.2 months ( 95 % CI ; 2.3–4.9 months ) and the median time to treatment failure was 3.1 months ( 95 % CI ; 1.9–4.1 months ) . Among the six tumor responders , the median duration of tumor response was 7.3 months ( 95 % CI ; 5.6–11.0 months ) . The most common grade 3/4 maximum toxicities were nausea ( 3.4 % ) and vomiting ( 2.7 % ) . Conclusion The combination chemotherapy with gemcitabine and cisplatin in this trial demonstrated moderate antitumor activity with favorable toxicity profile Owing to the lack of r and omised controlled trials no st and ard of chemotherapy exists in the treatment of advanced biliary tract carcinoma .  5-fluorouracil or gemcitabine is recommended based on small and predominately phase II trials . The aim of this analysis was to analyse existing trials , even small and nonr and omised , and identify superior regimens . Chemotherapy  trials published in English from 1985 to July 2006 were analysed as well as ASCO abstract s from 1999 to 2006 .  Response rate ( RR = CR+PR ) , tumour control rate ( TCR = CR+PR+SD ) , time to tumour progression ( TTP ) , overall survival ( OS ) , and toxicity were analysed . One hundred and four trials comprising 112 trial arms and 2810 patients , thereof 634 responders and 1368 patients with tumour control were analysed .  Pooled RR and TCR were 22.6 and 57.3 % , respectively . Significant correlations of RR and TCR with survival times were found . Subgroup analysis showed superior RRs for gallbladder carcinoma ( GBC ) compared with cholangiocarcinoma , but shorter OS for GBC . Furthermore , superior RRs and TCRs of gemcitabine and platinum containing regimens were found with highest RRs and TCRs in the combination subgroup . Based on published results of predominately phase II trials , gemcitabine combined with platinum compounds represents the provisional st and ard of chemotherapy in advanced biliary tract cancer , unless a new evidence -based st and ard has been defined BACKGROUND Patients with advanced biliary tract carcinoma face a particularly dismal prognosis , and no st and ard palliative chemotherapy has yet been defined . Among several different single agents , mitomycin C and , more recently , the oral fluoropyrimidine capecitabine and the nucleoside analogue gemcitabine , have been reported to exert antitumour activity . In view of a potential drug synergy , the present r and omised phase II trial was initiated . The aim was to investigate the therapeutic efficacy and tolerance of mitomycin C ( MMC ) in combination with gemcitabine ( GEM ) or capecitabine ( CAPE ) in previously untreated patients with advanced biliary tract cancer . PATIENTS AND METHODS A total of 51 patients were entered in this study and r and omly allocated to treatment with MMC 8 mg/m2 on day 1 in combination with GEM 2000 mg/m2 on days 1 and 15 every 4 weeks , or MMC 8 mg/m2 on day 1 plus CAPE 2000 mg/m2/day on days 1 - 14 , every 4 weeks . In both arms , chemotherapy was administered for a total of 6 months unless progressive disease occurred earlier . RESULTS Pretreatment characteristics were well balanced between the two treatment arms . The overall independent review committee-confirmed response rate among those treated with MMC + GEM was 20 % ( five of 25 ) compared with 31 % ( eight of 26 ) among those treated with MMC + CAPE . Similarly , median progression-free survival ( PFS ; 4.2 versus 5.3 months ) and median overall survival ( OS ; 6.7 versus 9.25 months ) tended to be superior in the latter combination arm . Chemotherapy was fairly well tolerated in both arms , with a comparably low rate of only grade 1 and 2 non-haematological adverse reactions . Also , only four ( 17 % ) patients in both treatment arms experienced grade 3 leukocytopenia , and three ( 13 % ) and four ( 17 % ) had grade 3 thrombocytopenia in the MMC + GEM and MMC + CAPE arm , respectively . CONCLUSIONS The results of this study indicate that both combination regimens are feasible , tolerable and clinical ly active . The MMC + CAPE arm , however , seems to be superior in terms of response rate , PFS and OS , and should therefore be selected for further clinical investigation in advanced biliary tract cancer The purpose of this study was to determine whether epirubicin , cisplatin and infused 5FU ( ECF ) improves overall survival ( OS ) compared to 5FU , etoposide and leucovorin ( FELV ) in patients with previously untreated advanced biliary cancer in a prospect i ve r and omised study . Patients were r and omly assigned to receive epirubicin , cisplatin and infused 5FU ECF or bolus 5FU etoposide and leucovorin ( FELV ) . The primary end point was OS with secondary end points of objective response rate ( ORR ) , failure-free survival ( FFS ) , quality of life ( QOL ) and toxicity . In all , 54 patients were recruited with 27 r and omly assigned to each arm . The median OS for ECF was 9.02 months ( 95 % confidence interval ( CI ) : 6.46–11.51 ) and FELV 12.03 months ( 95 % CI : 9.3–14.7 ) , P=0.2059 . Objective response rates were similar for both arms : ECF 19.2 % ( 95 % CI : 6.55–39.3 ) ; FELV 15 % ( 95 % CI : 3.2–37.9 ) , P=0.72 . There was significantly increased grade 3/4 neutropenia with FELV vs ECF ( 53.8 vs 29.5 % , respectively , P=0.020 ) . Symptom resolution was impressive for both regimens . This is the largest reported r and omised study to date in this setting . ECF did not improve OS compared to FELV , but was associated with less acute toxicity . These data suggest that chemotherapy can prolong OS and achieve good symptomatic relief in advanced biliary cancer & NA ; We evaluated the efficacy and toxicity of gemcitabine with or without cisplatin in 11 chemonaive patients with histologically confirmed advanced gallbladder cancer . All were symptomatic and had stage IV disease . Eight patients received gemcitabine 1 g/m2 on days 1 and 8 along with cisplatin 70 mg/m2 on day 1 . Three received gemcitabine alone . Treatment cycles were repeated every 21 days . One patient ( 9 % ) had complete remission of disease and 6 ( 55 % ) achieved a partial response to chemotherapy with an overall response rate of 64 % . Median time to progression was 28 weeks and median overall survival was 42 weeks . Toxicity was easily manageable , and no treatment‐related deaths occurred . We conclude that gemcitabine in combination with cisplatin may be one of the most effective therapies for patients with advanced gallbladder cancer . If confirmed by others , it may provide an important therapeutic option in managing these patients who otherwise have a dismal prognosis BACKGROUND Combination chemotherapy with gemcitabine and a platinum-based agent is regarded as a st and ard treatment for patients with advanced biliary-tract cancer . Results of phase 2 trials of single-agent erlotinib in biliary-tract cancer and of gemcitabine plus erlotinib in pancreatic cancer have shown modest benefits . Therefore , we aim ed to investigate the efficacy of gemcitabine and oxaliplatin plus erlotinib versus chemotherapy alone for advanced biliary-tract cancer . METHODS In this open label , r and omised , phase 3 trial , we r and omly assigned patients ( in a 1:1 ratio ) with metastatic biliary-tract cancer ( cholangiocarcinoma , gallbladder cancer , or ampulla of Vater cancer ) to receive either first-line treatment with  chemotherapy alone ( gemcitabine 1000 mg/m(2 ) on day 1 and oxaliplatin 100 mg/m(2 ) on day 2 ) or chemotherapy plus erlotinib ( 100 mg daily ) . Treatment was repeated every 2 weeks until disease progression or unacceptable toxic effects . R and omisation was done central ly ( stratified by participating centre and presence of measurable lesion ) . The primary endpoint was progression-free survival . Analyses were by intention-to-treat . This study is registered with Clinical Trials.gov , number NCT01149122 . FINDINGS 133 patients were r and omly assigned to the chemotherapy alone group and 135 to the chemotherapy plus erlotinib group . The groups were balanced except for a higher proportion of patients with cholangiocarcinoma in the group given erlotinib than in the chemotherapy alone group ( 96 [ 71 % ] patients vs 84 [ 63 % ] ) . Median progression-free survival was 4·2 months ( 95 % CI 2·7 - 5·7 ) in the chemotherapy alone group and 5·8 months ( 95 % CI 4·6 - 7·0 ) in the chemotherapy plus erlotinib group ( hazard ratio [ HR ] 0·80 , 95 % CI 0·61 - 1·03 ; p=0·087 ) . Significantly more patients had an objective response  in the chemotherapy plus erlotinib group than in the chemotherapy alone group ( 40 patients vs 21 patients ; p=0·005 ) , but median overall survival was the same in both groups ( 9·5 months [ 95 % CI 7·5 - 11·5 ] in the chemotherapy alone group and 9·5 months [ 7·6 - 11·4 ] in the chemotherapy plus erlotinib group ; HR 0·93 , 0·69 - 1·25 ; p=0·611 ) . All-cause deaths within 30 days of r and om assignment occurred in one ( 1 % ) of the patients in the chemotherapy alone group and in four ( 3 % ) of those in the chemotherapy plus erlotinib group . The most common grade 3 - 4 adverse event was febrile neutropenia ( eight [ 6 % ] patients in the chemotherapy alone group and six [ 4 % ] in the chemotherapy plus erlotinib group ) . No patient died of treatment-related causes during the study . Subgroup analyses by primary site of disease showed that for patients with cholangiocarcinoma , the addition of erlotinib to chemotherapy significantly prolonged median progression-free survival ( 5·9 months [ 95 % CI 4·7 - 7·1 ] for chemotherapy plus erlotinib vs 3·0 months [ 1·1 - 4·9 ] for chemotherapy alone ; HR 0·73 , 95 % CI 0·53 - 1·00 ; p=0·049 ) . INTERPRETATION Although no significant difference in progression-free survival was noted between groups , the addition of erlotinib to gemcitabine and oxaliplatin showed antitumour activity and might be a treatment option for patients with cholangiocarcinoma . FUNDING None BACKGROUND Biliary tract cancers are uncommon tumors with a poor prognosis and most patients present with invasive and inoperable disease at diagnosis . Chemotherapy represents a palliative treatment , with poor response rates and a median survival of less than 6 months . Oxaliplatin and gemcitabine have shown an interesting activity as single agents in this group of patients . PATIENTS AND METHODS We carried out a mult 
    Output:
    
These results suggest that the Gem/CDDP regimen with cisplatin ( 25–35 mg/m2 ) administered on days 1 and 8 is associated with survival advantage than Gemox regimen but with addition of toxicity