***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 The aim of this study was to determine whether early tumor shrinkage ( ETS ) at 6 weeks after treatment correlates with progression-free survival ( PFS ) and overall survival ( OS ) in advanced biliary tract cancer ( BTC ) patients receiving gemcitabine plus oxaliplatin ( GEMOX ) , with or without erlotinib .  Methods This was a multicenter , open label , r and omized , phase III trial of 103 BTC patients ( Clinical Trials.gov Identifier ; NCT01149122 , and Rigistration date ; January , 7 , 2010 ) , comparing GEMOX with GEMOX plus erlotinib .  Tumor shrinkage was expressed as a relative decrease compared to baseline and was dichotomized according to a previously reported cutoff value of 10 % . Results Fifty-four patients ( 52.4 % ) received GEMOX and 49 patients ( 47.6 % ) received GEMOX plus erlotinib . The latter achieved a better overall response rate ( RR ) ( 40.8 % vs. 18.6 % , p = 0.02 ) and showed ETS more frequently ( 63.2 % vs. 40.7 % , p = 0.03 ) . ETS was significantly correlated with the overall RR ( correlation coefficient , 0.53 ; p < 0.01 ) . The median PFS and OS did not differ according to erlotinib administration . However , the median PFS ( 7.3 vs. 2.1 months , p < 0.01 ) and OS ( 10.7 vs. 5.8 months , p < 0.01 ) were significantly longer amongst patients with ETS at 6 weeks after treatment , irrespective of erlotinib administration . In patients with wild-type KRAS who were treated with GEMOX plus erlotinib , ETS was a significant prognostic factor for PFS ( p < 0.01 ) . Conclusions ETS might predict PFS and OS in BTC patients treated with GEMOX with or without erlotinib . Additionally , ETS may be an indication for adding erlotinib to chemotherapy for BTC patients wild-type KRAS . These findings need to be prospect ively vali date Purpose : Immunotherapeutic agents produce antitumor effects by inducing cancer-specific immune responses or by modifying native immune processes . Result ing clinical response patterns extend beyond those of cytotoxic agents and can manifest after an initial increase in tumor burden or the appearance of new lesions ( progressive disease ) . Response Evaluation Criteria in Solid Tumors or WHO criteria , design ed to detect early effects of cytotoxic agents , may not provide a complete assessment of immunotherapeutic agents . Novel criteria for the evaluation of antitumor responses with immunotherapeutic agents are required . Experimental Design : The phase II clinical trial program with ipilimumab , an antibody that blocks CTL antigen-4 , represents the most comprehensive data set available to date for an immunotherapeutic agent . Novel immune therapy response criteria proposed , based on the shared experience from community workshops and several investigators , were evaluated using data from ipilimumab phase II clinical trials in patients with advanced melanoma . Results : Ipilimumab monotherapy result ed in four distinct response patterns : ( a ) shrinkage in baseline lesions , without new lesions ; ( b ) durable stable disease ( in some patients followed by a slow , steady decline in total tumor burden ) ; ( c ) response after an increase in total tumor burden ; and ( d ) response in the presence of new lesions . All patterns were associated with favorable survival . Conclusion : Systematic criteria , design ated immune-related response criteria , were defined in an attempt to capture additional response patterns observed with immune therapy in advanced melanoma beyond those described by Response Evaluation Criteria in Solid Tumors or WHO criteria . Further prospect i ve evaluations of the immune-related response criteria , particularly their association with overall survival , are warranted . ( Clin Cancer Res 2009;15(23):7412–20 PURPOSE To determine whether irinotecan plus oxaliplatin ( mIROX ) is superior to irinotecan plus infusional 5-fluorouracil , leucovorin ( FUFIRI ) as first-line therapy of patients with metastatic colorectal cancer ( mCRC ) . PATIENTS AND METHODS A phase III , r and omised , open-label multicentre study compared st and ard treatment with FUFIRI ( irinotecan 80 mg/m(2 ) , 5-fluorouracil 2000 mg/m(2 ) , folinic acid 500 mg/m(2 ) weekly times 6 ) to mIROX using an identical schedule of irinotecan plus oxaliplatin 85 mg/m(2 ) applied on days 1 , 15 and 29 of a 7-week cycle . The primary end-point was progression-free survival ( PFS ) . RESULTS A total of 479 eligible patients were r and omly assigned . Progression-free survival was 7.2 months in the mIROX arm and 8.2 months in the FUFIRI arm [ hazard ratio=1.14 ; 95 % confidence interval ( CI ) 0.94 - 1.37 ; P=0.178 ] . Comparable results were also obtained for overall survival time with 19 months in the mIROX-arm and 22 months in the FUFIRI-arm ( hazard ratio=1.08 , P=0.276 ) . Both regimens induced an identical objective response rate ( ORR ) of 41 % , but disease control rate ( ORR plus stable disease ) was significantly greater in the FUFIRI group ( 81 % versus 68 % , P=0.001 ) . Most frequent grade s 1 - 4 side-effects of mIROX and FUFIRI treatment were nausea ( 80 % versus 73 % ) and delayed diarrhoea ( 79 % versus 68 % ) . Grade s 3 - 4 toxicities were generally below 10 % , except for diarrhoea which was more frequent in the mIROX-arm compared to the FUFIRI-arm ( 19 % versus 30 % , P=0.006 ) CONCLUSION mIROX failed to show superior activity compared to high-dose 5-FU/folinic acid plus irinotecan . Due to better tolerability the combination of high-dose 5-FU/folinic acid and irinotecan remains a st and ard of care in first-line treatment of metastatic colorectal cancer This paper is an overview of the new response evaluation criteria in solid tumours :  revised RECIST guideline ( version 1 . 1 ) , with a focus on up date d contents 
    Output:
    
The results of the present trial-level analysis report a good performance of two response-related endpoints , DCR and ETS , and suggest that they could be differently used depending on the setting of disease and the type of medical treatment