***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 VEGFR-2 has a role in gastric cancer pathogenesis and progression . We assessed whether ramucirumab , a monoclonal antibody VEGFR-2 antagonist , in combination with paclitaxel would increase overall survival in patients previously treated for advanced gastric cancer compared with  placebo plus paclitaxel . METHODS This r and omised , placebo-controlled , double-blind , phase 3 trial was done at 170 centres in 27 countries in North and South America , Europe , Asia , and Australia . Patients aged 18 years or older with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression on or within 4 months after first-line chemotherapy ( platinum plus fluoropyrimidine with or without an anthracycline )  were r and omly assigned with a central ised interactive voice or web-response system in a 1:1 ratio to receive ramucirumab 8 mg/kg or placebo intravenously on days 1 and 15 , plus paclitaxel 80 mg/m(2 ) intravenously on days 1 , 8 , and 15 of a 28-day cycle . A permuted block r and omisation , stratified by geographic region , time to progression on first-line therapy , and disease measurability , was used . The primary endpoint was overall survival . Efficacy analysis was by intention to treat , and safety analysis included all patients who received at least one treatment with study drug . This trial is registered with Clinical Trials.gov , number NCT01170663 , and has been completed ; patients who are still receiving treatment are in the extension phase . FINDINGS Between Dec 23 , 2010 , and Sept 23 , 2012 , 665 patients were r and omly assigned to treatment-330 to ramucirumab plus paclitaxel and 335 to placebo plus paclitaxel . Overall survival was significantly longer in the ramucirumab plus paclitaxel group than in the placebo plus paclitaxel group ( median 9·6 months [ 95 % CI 8·5 - 10·8 ] vs 7·4 months [ 95 % CI 6·3 - 8·4 ] , hazard ratio 0·807 [ 95 % CI 0·678 - 0·962 ] ; p=0·017 ) . Grade 3 or higher adverse events that occurred in more than 5 % of patients in the ramucirumab plus paclitaxel group versus placebo plus paclitaxel  included neutropenia ( 133 [ 41 % ] of 327 vs 62 [ 19 % ] of 329 ) , leucopenia ( 57 [ 17 % ] vs 22 [ 7 % ] ) , hypertension ( 46 [ 14 % ] vs eight [ 2 % ] ) , fatigue ( 39 [ 12 % ] vs 18 [ 5 % ] ) , anaemia ( 30 [ 9 % ] vs 34 [ 10 % ] ) , and abdominal pain ( 20 [ 6 % ] vs 11 [ 3 % ] ) . The incidence of grade 3 or higher febrile neutropenia was low in both groups ( ten [ 3 % ] vs eight [ 2 % ] ) . INTERPRETATION The combination of ramucirumab with paclitaxel significantly increases overall survival compared with placebo plus paclitaxel , and could be regarded as a new st and ard second-line treatment for patients with advanced gastric cancer . FUNDING Eli Lilly and Company Background Treatment of patients with advanced or metastatic esophagogastric adenocarcinoma should not only prolong life but also provide relief of symptoms and improve quality of life ( QOL ) . Esophagogastric adenocarcinoma mainly occurs in elderly patients , but they are underrepresented in most clinical trials and often do not receive effective combination chemotherapy , most probably for fear of intolerance . Using vali date d instruments , we prospect ively assessed QOL within the r and omized FLOT65 + phase II trial . Methods Within the FLOT65 + trial , a total of 143 patients aged ≥65 years were r and omly allocated to receive biweekly oxaliplatin plus 5-fluorouracil ( 5-FU ) continuous infusion and folinic acid ( FLO ) or the same regimen in combination with docetaxel 50 mg/m2 ( FLOT ) . The European Organisation for Research and Treatment of Cancer Quality of Life Question naire C30 ( EORTC QLQ-C30 ) and the gastric module STO22 were administered every 8 weeks until progression . Time to definitive deterioration of QOL parameters was analyzed and compared within the treatment arms . Results The median age of patients was 70 years . Patients receiving FLOT exhibited higher response rates and had improved disease-free and progression-free survival ( PFS ) . The proportions of patients with evaluable baseline EORTC QLQ-C30 and STO22 question naires were balanced ( 83 % in FLOT and 89 % in FLO ) . Considering evaluable patients with assessable question naires ( n = 123 ) , neither functioning nor symptom parameters differed significantly in favor of one of the two treatment groups . Particularly , there was no significant difference regarding time to definitive deterioration of global health status/ quality of life from baseline ( primary endpoint ) . Notably , patients receiving FLO or FLOT as palliative treatment ( n = 98 ) achieved comparable QOL results . Conclusions Although toxicity was higher in patients receiving FLOT , no negative impact of the addition of docetaxel on QOL parameters could be demonstrated . Thus , elderly patients in need of intensified chemotherapy may receive FLOT without compromising patient-reported outcome parameters 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 We report the final results of a prospect ively r and omized study that compared the combination of epirubicin , cisplatin and protracted venous infusion fluorouracil ( 5-FU ) ( ECF regimen ) with the st and ard combination of 5-FU , doxorubicin and methotrexate ( FAMTX ) in previously untreated patients with advanced oesophagogastric cancer . Between 1992 and 1995 , 274 patients with adenocarcinoma or undifferentiated carcinoma were r and omized from eight oncology centres in the UK and analysed for response and survival . The overall response rate was 46 % ( 95 % confidence interval ( CI ) , 37–55 % ) with ECF , and 21 % ( 95 % CI , 13–28 % ) with FAMTX ( P = 0.00003 ) . The median survival was 8.7 months with ECF and 6.1 months with FAMTX ( P = 0.0005 ) . The 2-year survival rates were 14 % ( 95 % CI , 8–20 % ) for the ECF arm , and 5 % ( 95 % CI , 2–10 % ) for the FAMTX arm ( P = 0.03 ) . Histologically complete surgical resection following chemotherapy was achieved in ten patients in the ECF arm ( three pathological complete responses to chemotherapy ) and three patients in the FAMTX arm ( no pathological complete responses ) . The ECF regimen result ed in a response and survival advantage compared with FAMTX chemotherapy . The probability of long-term survival following surgical resection of residual disease is increased by this treatment . The high response rates seen with ECF support its use in the neoadjuvant setting BACKGROUND Irinotecan , in combination with 5-fluorouracil ( 5-FU ) or cisplatin , has demonstrated efficacy against advanced gastric cancer ( AGC ) . PATIENTS AND METHODS Chemotherapy-naive AGC patients were r and omly assigned to receive irinotecan 150 mg/m(2 ) on day 1 , leucovorin 20 mg/m(2 ) and a 22-h infusion of 5-FU 1000 mg/m(2 ) on days 1 and 2 ( ILF ) or ILF plus cisplatin 30 mg/m(2 ) on day 2 ( PILF ) . Treatment was repeated every 2 weeks . RESULTS Of 91 registered patients , 45 patients were treated with ILF and 45 with PILF .  For both arms , 687 chemotherapy cycles were delivered ( median = 7 for ILF and 8 for PILF ) . Both ILF and PILF were generally well tolerated and there was no relevant difference in the occurrence of overall grade 3/4 toxic effects between the two arms . Four patients died during treatment : one in the ILF and three in the PILF arm . The objective response rate was 42 % for both arms . There was no significant difference in therapeutic efficacy between ILF and PILF with respect to progression-free survival ( 4.8 versus 6.2 months ; P = 0.523 ) and overall survival ( 10.7 versus 10.5 months ; P = 0.850 ) . CONCLUSION Both ILF and PILF are active as first-line chemotherapy for AGC . The addition of cisplatin , however , has no clear advantage over ILF 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 OBJECTIVES More than half of cases of gastric cancer ( GC ) are diagnosed in elderly patients ( ≥70years ) . While doublet combination with fluoropyrimidines and platinum is currently considered st and ard first-line chemotherapy in advanced GC , the main goal of chemotherapy remains palliation . MATERIAL S 
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HRQoL reporting did not improve over time , and it did not improve following the publication of the CONSORT-PRO statement in 2013 .
The publication of HRQoL findings in a separate article and second-line treatment were associated with better reporting .
Conclusions HRQoL reporting in RCTs concerning palliative systemic therapy for advanced esophagogastric cancer is limited and has not improved over time .