human
***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: Patients with metastatic gastric cancer are currently not considered operative c and i date s and are most often offered systemic therapy . Palliative resection of the primary tumor has been considered irrelevant to the outcome and has been recommended only for palliation of symptoms . We have examined the role of palliative gastrectomy and its impact on survival in patients with stage IV gastric cancer at initial diagnosis between 1990 and 2000 . A total of 105 patients with stage IV disease were identified during this period ; 81 of them ( 77.1 % ) had no resection , and 24 ( 22.9 % ) underwent palliative gastric resection .  Mean survival in those without resection who received chemotherapy ( with or without radiation ) treatment was 5.9 months ( 95 % confidence interval 4.2–7.6 ) . For those with resection and adjuvant therapy , mean survival time was 16.3 months ( 95 % confidence interval 4.3–28.8 months ) . Kaplan-Meier survival analysis showed significantly better survival in those with resection and adjuvant therapy ( log-rank test , P = 0.01 ) . Mortality and morbidity rates associated with palliative resection were 8.7 % and 33.3 % , respectively , which did not differ statistically from the 3.7 % and 25.3 % in patients who underwent curative gastrectomy during same period of time . However , the length of hospitalization ( 22 versus 16 days ) was significantly higher compared with those without stage IV disease . These data suggest that palliative resection combined with adjuvant therapy may improve survival in a selected group of patients with stage IV gastric cancer .  Palliative gastrectomy plus systemic therapy should be compared with systemic therapy alone in a r and omized trial CONTEXT Although chronic Helicobacter pylori infection is associated with gastric cancer , the effect of H pylori treatment on prevention of gastric cancer development in chronic carriers is unknown . OBJECTIVE To determine whether treatment of H pylori infection reduces the incidence of gastric cancer . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve , r and omized , placebo-controlled , population -based primary prevention study of 1630 healthy carriers of H pylori infection from Fujian Province , China , recruited in July 1994 and followed up until January 2002 . A total of 988 participants did not have precancerous lesions ( gastric atrophy , intestinal metaplasia , or gastric dysplasia ) on study entry . INTERVENTION Patients were r and omly assigned to receive H pylori eradication treatment : a 2-week course of omeprazole , 20 mg , a combination product of amoxicillin and clavulanate potassium , 750 mg , and metronidazole , 400 mg , all twice daily ( n = 817 ) ; or placebo ( n = 813 ) . MAIN OUTCOME MEASURES The primary outcome measure was incidence of gastric cancer during follow-up , compared between H pylori eradication and placebo groups . The secondary outcome measure was incidence of gastric cancer in patients with or without precancerous lesions , compared between the 2 groups . RESULTS Among the 18 new cases of gastric cancers that developed , no overall reduction was observed in participants who received H pylori eradication treatment ( n = 7 ) compared with those who did not ( n = 11 ) ( P = .33 ) . In a subgroup of patients with no precancerous lesions on presentation , no patient developed gastric cancer during a follow-up of 7.5 years after H pylori eradication treatment compared with those who received placebo ( 0 vs 6 ; P = .02 ) . Smoking ( hazard ratio [ HR ] , 6.2 ; 95 % confidence interval [ CI ] , 2.3 - 16.5 ; P<.001 ) and older age ( HR , 1.10 ; 95 % CI , 1.05 - 1.15 ; P<.001 ) were independent risk factors for the development of gastric cancer in this cohort . CONCLUSIONS We found that the incidence of gastric cancer development at the population level was similar between participants receiving H pylori eradication treatment and those receiving placebo during a period of 7.5 years in a high-risk region of China . In the subgroup of H pylori carriers without precancerous lesions , eradication of H pylori significantly decreased the development of gastric cancer . Further studies to investigate the role of H pylori eradication in participants with precancerous lesions are warranted BACKGROUND / AIMS Most patients with gastric cancer will have resection , even if their disease stage is beyond curability . Proper criteria to assess tumor load in patients deemed noncurative are lacking , and therefore , it is not clear which of these patients will benefit from resection . METHODOLOGY Of 996 gastric cancer patients who had laparotomy in a national r and omized trial of lymphadenectomy for gastric cancer , 285 ( 29 % ) were found to be noncurable because of remnant tumor , peritoneal metastases , distant lymph node metastases or liver metastases . They underwent a palliative procedure considered appropriate by the surgeon . Tumor load in this group was analyzed retrospectively by calculating the number of noncurability signs .  RESULTS The number of signs of noncurability was related to the type of surgical palliation chosen by the surgeon : of those patients with only one sign of noncurability , 68 % had a palliative stomach resection but , of patients with two or more positive signs of noncurability only 36 % had a stomach resection .  Median survival after palliative resection  was 253 days compared to 169 days after a nonresective procedure ( P = 0.002 ) . This survival advantage for resected patients disappeared when two or more signs of noncurability were found . CONCLUSIONS For patients deemed noncurative , survival depends on tumor load . Accurate preoperative assessment of tumor spread may prevent unnecessary high-risk surgical interventions for patients with noncurative gastric cancer A phase III r and omised study , comparing treatment with fluorouracil , epidoxorubicin and methotrexate ( FEMTX ) with the best supportive care , was conducted in patients with unresectable or metastatic gastric cancer . During the period from July 1986 to June 1992 , 41 patients were r and omised to receive FEMTX or best supportive care . MTX was given in a dose of 1500 mg m-2 intravenously ( i.v . ) followed after 1 h by 5-FU 1500 mg m-2 i.v . on day 1 ; leucovorin rescue was started after 24 h ( 30 mg orally every 6 h for 48 h ) and epidoxorubicin 60 mg m-2 i.v . was administered on day 15 . In addition both groups received tablets containing vitamins A and E. Response rates for FEMTX were as follows : complete response ( CR ) , 19 % ( 4/21 ) ; partial response ( PR ) , 10 % ( 2/21 ) ; no change ( NC ) , 33 % ( 7/21 ) ; and progressive disease ( PD ) , 24 % ( 5/21 ) . Response rates in the control group were : NC , 20 % ( 4/20 ) ; and PD , 80 % ( 16/20 ) . Increased pain was observed in one patient in the treated group and in 11 patients in the control group within the first 2 months . WHO grade III/IV toxicity in the chemotherapy group was as follows : nausea/vomiting 40 % , diarrhoea 10 % , stomatitis 15 % , leucopenia 50 % and thrombocytopenia 10 % . One possible treatment-related death was due to sepsis . The median time to progression in the FEMTX group was 5.4 months [ 95 % confidence interval ( CI ) 3.1 - 11.7 months ] , but only 1.7 months in the control group ( 95 % CI 1.2 - 2.7 months ) ( P = 0.0013 ) . Similarly , the FEMTX group displayed significantly ( P = 0.0006 ) prolonged survival compared with the control group , i.e. median survival 12.3 months ( 95 % CI 7.1 - 15.6 months ) vs 3.1 months ( 95 % CI 1.6 - 4.6 months ) . In conclusion , FEMTX combined with vitamin A and E is a fairly well-tolerated treatment , giving a response rate of 29 % in patients with advanced gastric cancer , and also prolonging patients ' survival . It can be used as a reference treatment in testing new investigational combinations A r and omized controlled trial has started in both Japan and Korea to evaluate the role of gastrectomy in the management of incurable advanced gastric cancer ( AGC ) . Patients with AGC diagnosed as having a single non-curable factor are r and omized to gastrectomy plus chemotherapy or chemotherapy alone . Surgeons at 33 specialized centers in Japan and at 15 high-volume hospitals in Korea will recruit 330 patients . Primary end-point is overall survival , and secondary end-points are progression-free survival and adverse events associated with either gastrectomy or chemotherapy BACKGROUND Phase I/II clinical trials of S-1 plus cisplatin for advanced gastric cancer have yielded good responses and the treatment was well tolerated . In this S-1 Plus cisplatin versus S-1 In RCT In the Treatment for Stomach cancer ( SPIRITS ) trial , we aim ed to verify that overall survival was better in patients with advanced gastric cancer treated with S-1 plus cisplatin  than with  S-1 alone . METHODS In this phase III trial , chemotherapy-naive patients with advanced gastric cancer were enrolled between March 26 , 2002 , and Nov 30 , 2004 , at 38 centres in Japan , and r and omly assigned to S-1 plus cisplatin or S-1 alone .  In patients assigned to S-1 plus cisplatin , S-1 ( 40 - 60 mg depending on patient 's body surface area ) was given orally , twice daily for 3 consecutive weeks , and 60 mg/m(2 ) cisplatin was given intravenously on day 8 , followed by a 2-week rest period , within a 5-week cycle . Those assigned to S-1 alone received the same dose of S-1 twice daily for 4 consecutive weeks , followed by a 2-week rest period , within a 6-week cycle . The primary endpoint was overall survival . Secondary endpoints were progression-free survival , proportions of responders , and safety . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00150670 . FINDINGS 305 patients were enrolled ; seven patients were ineligible or withdrew consent , therefore , 148 patients were assigned to S-1 plus cisplatin and 150 patients were assigned to S-1 alone .  Median overall survival was significantly longer in patients assigned to S-1 plus cisplatin ( 13.0 months [ IQR 7.6 - 21.9 ] ) than in those assigned to S-1 alone ( 11.0 months [ 5.6 - 19.8 ] ; hazard ratio for death , 0.77 ; 95 % CI 0.61 - 0.98 ; p=0.04 ) . Progression-free survival was significantly longer in patients assigned to S-1 plus cisplatin than in those assigned to S-1 alone ( median progression-free survival 6.0 months [ 3.3 - 12.9 ] vs 4.0 months [ 2.1 - 6.8 ] ; p<0.0001 ) . Additionally , of 87 patients assigned S-1 plus cisplatin who had target tumours , one patient had a complete response and 46 patients had partial responses , ie , a total of 54 % ( range 43 - 65 ) . Of 106 patients assigned S-1 alone who had target tumours , one patient had a complete response and 32 had partial responses , ie , a total of 31 % ( 23 - 41 ) . We recorded more grade 3 or 4 adverse events including leucopenia , neutropenia , anaemia , nausea , and anorexia , in the group assigned to S-1 plus cisplatin than in the group assigned to S-1 alone . There were no treatment-related deaths in either group . INTERPRETATION S-1 plus cisplatin holds promise of becoming a st and ard first-line treatment for patients with advanced gastric cancer Objective Whether resection of the primary tumour is of benefit to patients with incurable rectal cancer ( RC ) remains a matter of debate . In this study we analyse prospect ively recorded data from a national cohort BACKGROUND Effective palliation rather than cure is often the most appropriate goal in the management of patients with advanced gastric cancer . The literature to date is limited by the imprecise use of the term palliative and subsequent variable design ation of patients into evaluable groups . STUDY DESIGN Between July 1985 and July 2001 , 1,595 patients were entered into a prospect i ve data base after undergoing a resection for gastric adenocarcinoma . Patients who received a noncurative ( R1/R2 ) resection were identified . A procedure was defined as palliative if it was performed explicitly to palliate symptoms or improve quality of life . RES 
    Output:
    
agent
***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: Patients with metastatic gastric cancer are currently not considered operative c and i date s and are most often offered systemic therapy . Palliative resection of the primary tumor has been considered irrelevant to the outcome and has been recommended only for palliation of symptoms . We have examined the role of palliative gastrectomy and its impact on survival in patients with stage IV gastric cancer at initial diagnosis between 1990 and 2000 . A total of 105 patients with stage IV disease were identified during this period ; 81 of them ( 77.1 % ) had no resection , and 24 ( 22.9 % ) underwent palliative gastric resection .  Mean survival in those without resection who received chemotherapy ( with or without radiation ) treatment was 5.9 months ( 95 % confidence interval 4.2–7.6 ) . For those with resection and adjuvant therapy , mean survival time was 16.3 months ( 95 % confidence interval 4.3–28.8 months ) . Kaplan-Meier survival analysis showed significantly better survival in those with resection and adjuvant therapy ( log-rank test , P = 0.01 ) . Mortality and morbidity rates associated with palliative resection were 8.7 % and 33.3 % , respectively , which did not differ statistically from the 3.7 % and 25.3 % in patients who underwent curative gastrectomy during same period of time . However , the length of hospitalization ( 22 versus 16 days ) was significantly higher compared with those without stage IV disease . These data suggest that palliative resection combined with adjuvant therapy may improve survival in a selected group of patients with stage IV gastric cancer .  Palliative gastrectomy plus systemic therapy should be compared with systemic therapy alone in a r and omized trial CONTEXT Although chronic Helicobacter pylori infection is associated with gastric cancer , the effect of H pylori treatment on prevention of gastric cancer development in chronic carriers is unknown . OBJECTIVE To determine whether treatment of H pylori infection reduces the incidence of gastric cancer . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve , r and omized , placebo-controlled , population -based primary prevention study of 1630 healthy carriers of H pylori infection from Fujian Province , China , recruited in July 1994 and followed up until January 2002 . A total of 988 participants did not have precancerous lesions ( gastric atrophy , intestinal metaplasia , or gastric dysplasia ) on study entry . INTERVENTION Patients were r and omly assigned to receive H pylori eradication treatment : a 2-week course of omeprazole , 20 mg , a combination product of amoxicillin and clavulanate potassium , 750 mg , and metronidazole , 400 mg , all twice daily ( n = 817 ) ; or placebo ( n = 813 ) . MAIN OUTCOME MEASURES The primary outcome measure was incidence of gastric cancer during follow-up , compared between H pylori eradication and placebo groups . The secondary outcome measure was incidence of gastric cancer in patients with or without precancerous lesions , compared between the 2 groups . RESULTS Among the 18 new cases of gastric cancers that developed , no overall reduction was observed in participants who received H pylori eradication treatment ( n = 7 ) compared with those who did not ( n = 11 ) ( P = .33 ) . In a subgroup of patients with no precancerous lesions on presentation , no patient developed gastric cancer during a follow-up of 7.5 years after H pylori eradication treatment compared with those who received placebo ( 0 vs 6 ; P = .02 ) . Smoking ( hazard ratio [ HR ] , 6.2 ; 95 % confidence interval [ CI ] , 2.3 - 16.5 ; P<.001 ) and older age ( HR , 1.10 ; 95 % CI , 1.05 - 1.15 ; P<.001 ) were independent risk factors for the development of gastric cancer in this cohort . CONCLUSIONS We found that the incidence of gastric cancer development at the population level was similar between participants receiving H pylori eradication treatment and those receiving placebo during a period of 7.5 years in a high-risk region of China . In the subgroup of H pylori carriers without precancerous lesions , eradication of H pylori significantly decreased the development of gastric cancer . Further studies to investigate the role of H pylori eradication in participants with precancerous lesions are warranted BACKGROUND / AIMS Most patients with gastric cancer will have resection , even if their disease stage is beyond curability . Proper criteria to assess tumor load in patients deemed noncurative are lacking , and therefore , it is not clear which of these patients will benefit from resection . METHODOLOGY Of 996 gastric cancer patients who had laparotomy in a national r and omized trial of lymphadenectomy for gastric cancer , 285 ( 29 % ) were found to be noncurable because of remnant tumor , peritoneal metastases , distant lymph node metastases or liver metastases . They underwent a palliative procedure considered appropriate by the surgeon . Tumor load in this group was analyzed retrospectively by calculating the number of noncurability signs .  RESULTS The number of signs of noncurability was related to the type of surgical palliation chosen by the surgeon : of those patients with only one sign of noncurability , 68 % had a palliative stomach resection but , of patients with two or more positive signs of noncurability only 36 % had a stomach resection .  Median survival after palliative resection  was 253 days compared to 169 days after a nonresective procedure ( P = 0.002 ) . This survival advantage for resected patients disappeared when two or more signs of noncurability were found . CONCLUSIONS For patients deemed noncurative , survival depends on tumor load . Accurate preoperative assessment of tumor spread may prevent unnecessary high-risk surgical interventions for patients with noncurative gastric cancer A phase III r and omised study , comparing treatment with fluorouracil , epidoxorubicin and methotrexate ( FEMTX ) with the best supportive care , was conducted in patients with unresectable or metastatic gastric cancer . During the period from July 1986 to June 1992 , 41 patients were r and omised to receive FEMTX or best supportive care . MTX was given in a dose of 1500 mg m-2 intravenously ( i.v . ) followed after 1 h by 5-FU 1500 mg m-2 i.v . on day 1 ; leucovorin rescue was started after 24 h ( 30 mg orally every 6 h for 48 h ) and epidoxorubicin 60 mg m-2 i.v . was administered on day 15 . In addition both groups received tablets containing vitamins A and E. Response rates for FEMTX were as follows : complete response ( CR ) , 19 % ( 4/21 ) ; partial response ( PR ) , 10 % ( 2/21 ) ; no change ( NC ) , 33 % ( 7/21 ) ; and progressive disease ( PD ) , 24 % ( 5/21 ) . Response rates in the control group were : NC , 20 % ( 4/20 ) ; and PD , 80 % ( 16/20 ) . Increased pain was observed in one patient in the treated group and in 11 patients in the control group within the first 2 months . WHO grade III/IV toxicity in the chemotherapy group was as follows : nausea/vomiting 40 % , diarrhoea 10 % , stomatitis 15 % , leucopenia 50 % and thrombocytopenia 10 % . One possible treatment-related death was due to sepsis . The median time to progression in the FEMTX group was 5.4 months [ 95 % confidence interval ( CI ) 3.1 - 11.7 months ] , but only 1.7 months in the control group ( 95 % CI 1.2 - 2.7 months ) ( P = 0.0013 ) . Similarly , the FEMTX group displayed significantly ( P = 0.0006 ) prolonged survival compared with the control group , i.e. median survival 12.3 months ( 95 % CI 7.1 - 15.6 months ) vs 3.1 months ( 95 % CI 1.6 - 4.6 months ) . In conclusion , FEMTX combined with vitamin A and E is a fairly well-tolerated treatment , giving a response rate of 29 % in patients with advanced gastric cancer , and also prolonging patients ' survival . It can be used as a reference treatment in testing new investigational combinations A r and omized controlled trial has started in both Japan and Korea to evaluate the role of gastrectomy in the management of incurable advanced gastric cancer ( AGC ) . Patients with AGC diagnosed as having a single non-curable factor are r and omized to gastrectomy plus chemotherapy or chemotherapy alone . Surgeons at 33 specialized centers in Japan and at 15 high-volume hospitals in Korea will recruit 330 patients . Primary end-point is overall survival , and secondary end-points are progression-free survival and adverse events associated with either gastrectomy or chemotherapy BACKGROUND Phase I/II clinical trials of S-1 plus cisplatin for advanced gastric cancer have yielded good responses and the treatment was well tolerated . In this S-1 Plus cisplatin versus S-1 In RCT In the Treatment for Stomach cancer ( SPIRITS ) trial , we aim ed to verify that overall survival was better in patients with advanced gastric cancer treated with S-1 plus cisplatin  than with  S-1 alone . METHODS In this phase III trial , chemotherapy-naive patients with advanced gastric cancer were enrolled between March 26 , 2002 , and Nov 30 , 2004 , at 38 centres in Japan , and r and omly assigned to S-1 plus cisplatin or S-1 alone .  In patients assigned to S-1 plus cisplatin , S-1 ( 40 - 60 mg depending on patient 's body surface area ) was given orally , twice daily for 3 consecutive weeks , and 60 mg/m(2 ) cisplatin was given intravenously on day 8 , followed by a 2-week rest period , within a 5-week cycle . Those assigned to S-1 alone received the same dose of S-1 twice daily for 4 consecutive weeks , followed by a 2-week rest period , within a 6-week cycle . The primary endpoint was overall survival . Secondary endpoints were progression-free survival , proportions of responders , and safety . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00150670 . FINDINGS 305 patients were enrolled ; seven patients were ineligible or withdrew consent , therefore , 148 patients were assigned to S-1 plus cisplatin and 150 patients were assigned to S-1 alone .  Median overall survival was significantly longer in patients assigned to S-1 plus cisplatin ( 13.0 months [ IQR 7.6 - 21.9 ] ) than in those assigned to S-1 alone ( 11.0 months [ 5.6 - 19.8 ] ; hazard ratio for death , 0.77 ; 95 % CI 0.61 - 0.98 ; p=0.04 ) . Progression-free survival was significantly longer in patients assigned to S-1 plus cisplatin than in those assigned to S-1 alone ( median progression-free survival 6.0 months [ 3.3 - 12.9 ] vs 4.0 months [ 2.1 - 6.8 ] ; p<0.0001 ) . Additionally , of 87 patients assigned S-1 plus cisplatin who had target tumours , one patient had a complete response and 46 patients had partial responses , ie , a total of 54 % ( range 43 - 65 ) . Of 106 patients assigned S-1 alone who had target tumours , one patient had a complete response and 32 had partial responses , ie , a total of 31 % ( 23 - 41 ) . We recorded more grade 3 or 4 adverse events including leucopenia , neutropenia , anaemia , nausea , and anorexia , in the group assigned to S-1 plus cisplatin than in the group assigned to S-1 alone . There were no treatment-related deaths in either group . INTERPRETATION S-1 plus cisplatin holds promise of becoming a st and ard first-line treatment for patients with advanced gastric cancer Objective Whether resection of the primary tumour is of benefit to patients with incurable rectal cancer ( RC ) remains a matter of debate . In this study we analyse prospect ively recorded data from a national cohort BACKGROUND Effective palliation rather than cure is often the most appropriate goal in the management of patients with advanced gastric cancer . The literature to date is limited by the imprecise use of the term palliative and subsequent variable design ation of patients into evaluable groups . STUDY DESIGN Between July 1985 and July 2001 , 1,595 patients were entered into a prospect i ve data base after undergoing a resection for gastric adenocarcinoma . Patients who received a noncurative ( R1/R2 ) resection were identified . A procedure was defined as palliative if it was performed explicitly to palliate symptoms or improve quality of life . RES 
    Output:
    