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: In a prospect i ve multicenter study , 186 patients with squamous cell esophageal carcinoma , who after evaluation were considered suitable for surgery , were r and omized to 4 treatment groups : Group 1 , surgery alone ; Group 2 , pre-operative chemotherapy ( cisplatin and bleomycin ) and surgery ; Group 3 , pre-operative irradiation ( 35 Gy ) and surgery ; Group 4 , pre-operative chemotherapy , radiotherapy , and surgery .  Three-year survival was significantly higher in the pooled groups receiving radiotherapy as compared with the pooled groups not receiving radiotherapy . Comparison of the groups having pre-operative chemotherapy with those not having chemotherapy showed no significant difference in survival .  Female patients had a significantly better survival than males . The results indicate that pre-operative irradiation had a beneficial effect on intermediate term survival , whereas the chemotherapy regime used did not influence survival . RésuméDans une étude prospect i ve , multicentrique , 186 patients ayant un cancer épidermoïde de l'oesophage ont été r and omisée dans quatre groupes : le groupe 1 a eu la chirurgie seule ; le groupe 2 , une chimiothérapie préopératoire ( cis-platine et bléomycine ) ; le groupe 3 , une radiothérapie préopératoire suivie de chirurgie ; et le groupe 4 , une chimiothérapie et une radiothérapie préopératoires suivies de chirurgie . La survie à trois ans a été supérieure chez l'ensemble des patients ayant reçu la radiothérapie préopératoire par rapport à ceux qui n'en ont pas eu . Aucune différence de survie n'a pu être mise en évidence dans les groupes ayant eu ou pas de chimiothérapie . La survie des femmes a été significativement supérieure à celle des hommes . Ces résultats indiquent que la radiothérapie préopératoire apporte un plus en ce qui concerne la survie à moyen terme , alors que la chimiothérapie n'influence pas la survie . ResumenEn un estudio prospect ivo multicéntrico sobre 186 pacientes con carcinoma escamocelular del esófago c and idatos para cirugía , se constituyeron cuatro grupos para r and omización : Grupo 1 , cirugía solamente ; Grupo 2 , quimioterapia preoperatoria ( cisplatino y bleomicina ) y cirugía ; Grupo 3 , irradiación preoperatoria ( 35 Gy ) y cirugía ; Grupo 4 , quimioterapia preoperatoria , radioterapia y cirugía . La comparación entre el grupo que recibió quimioterapia y el que no la recibió no demostró diferencia significativa en cuanto a supervivencia . Las pacientes femeninas exhibieron una mejor supervivencia que los pacientes masculinos . Los result ados indican que la irradiación preoperatoria tuvo un efecto benéfico sobre la sobrevida a término medio , en tanto que la quimioterapia , en el regimen utilizado , no tuvo influencia sobre la supervivencia PURPOSE We performed a clinical trial to determine whether postoperative adjuvant chemotherapy with two drugs versus one drug could prolong survival . PATIENTS AND METHODS From 1985 to 1996 , 85 patients with completely resected locally advanced gastric cancer were enrolled . The subjects were r and omized into two treatment groups , as follows : mitomycin ( MMC ) 10 to 20 mg/m2 intravenously ( i.v . ) on day 1 every 6 weeks plus ftorafur ( FT ) 500 mg/m2/d for 36 consecutive days ; or MMC alone , 10 to 20 mg/m2 i.v . every 6 weeks . All courses were repeated four times . RESULTS After a median follow-up duration of 62 months , the overall 5-year survival rates were 67 % for the MMC-FT group versus 44 % for the MMC group ( P = .04 ) . Subgroup analysis to compare survival curves using the method of Mantel-Cox showed survival rates significantly in favor of the MMC-FT group in the subsets of patients with node-negative disease ( P = .01 ) and those whose disease was stage IB or II ( P = .008 ) . CONCLUSION Significantly better survival results were observed for MMC-FT versus MMC alone . Subset analysis suggest a strong benefit in patients with node-negative and early-stage resected gastric cancer PURPOSE The first planned interim analysis ( median follow-up , 3 years ) of the Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer confirmed that the oral fluoropyrimidine derivative S-1 significantly improved overall survival , the primary end point . The results were therefore opened at the recommendation of an independent data and safety monitoring committee . We report 5-year follow-up data on patients enrolled onto the ACTS-GC study . PATIENTS AND METHODS Patients with histologically confirmed stage II or III gastric cancer who underwent gastrectomy with D2 lymphadenectomy were r and omly assigned to receive S-1 after surgery or surgery only . S-1 ( 80 to 120 mg per day ) was given for 4 weeks , followed by 2 weeks of rest . This 6-week cycle was repeated for 1 year . The primary end point was overall survival , and the secondary end points were relapse-free survival and safety . RESULTS The overall survival rate at 5 years was 71.7 % in the S-1 group and 61.1 % in the surgery-only group ( hazard ratio [ HR ] , 0.669 ; 95 % CI , 0.540 to 0.828 ) . The relapse-free survival rate at 5 years was 65.4 % in the S-1 group and 53.1 % in the surgery-only group ( HR , 0.653 ; 95 % CI , 0.537 to 0.793 ) . Subgroup analyses according to principal demographic factors such as sex , age , disease stage , and histologic type showed no interaction between treatment and any characteristic . CONCLUSION On the basis of 5-year follow-up data , postoperative adjuvant therapy with S-1 was confirmed to improve overall survival and relapse-free survival in patients with stage II or III gastric cancer who had undergone D2 gastrectomy BACKGROUND The prognosis for locally advanced gastric cancer is poor despite advances in adjuvant chemotherapy . We did the Stomach cancer Adjuvant Multi-Institutional group Trial ( SAMIT ) to assess the superiority of sequential treatment ( paclitaxel then tegafur and uracil [ UFT ] or paclitaxel then S-1 ) compared with monotherapy ( UFT or S-1 ) and also the non-inferiority of UFT compared with S-1 . METHODS We did this r and omised phase 3 trial with a two-by-two factorial design at 230 hospitals in Japan . We enrolled patients aged 20 - 80 years with T4a or T4b gastric cancer , who had had D2 dissection and a ECOG performance score of 0 - 1 . Patients were r and omly assigned to one of four treatment groups with minimisation for tumour size , lymph node metastasis , and study site . Patients received UFT only ( 267 mg/m(2 ) per day ) , S-1 only ( 80 mg/m(2 ) per day ) for 14 days , with a 7-day rest period or three courses of intermittent weekly paclitaxel ( 80 mg/m(2 ) ) followed by either UFT , or S-1 . Treatment lasted 48 weeks in monotherapy groups and 49 weeks in the sequential treatment groups . The primary endpoint was disease-free survival assessed by intention to treat . We assessed whether UFT was non-inferior to S-1 with a non-inferiority margin of 1·33 . This trial was registered at UMIN Clinical Trials Registry , number C000000082 . FINDINGS We r and omly assigned 1495 patients between Aug 3 , 2004 , and Sept 29 , 2009 . 374 patients were assigned to receive UFT alone , 374 to receive S-1 alone , 374 to received paclitaxel then UFT , and 373 to receive paclitaxel then S-1 . We included 1433 patients in the primary analysis after at least 3 years of follow-up ( 359 , 364 , 355 , and 355 in each group respectively ) . Protocol treatment was completed by 215 ( 60 % ) patients in the UFT group , 224 ( 62 % ) in the S-1 group , 242 ( 68 % ) in the paclitaxel then UFT group , and 250 ( 70 % ) in the paclitaxel then S-1  group . 3-year disease-free survival for monotherapy was 54·0 % ( 95 % CI 50·2 - 57·6 ) and that of sequential treatment was 57·2 % ( 53·4 - 60·8 ; hazard ratio [ HR ] 0·92 , 95 % CI 0·80 - 1·07 , p=0·273 ) . 3-year disease-free survival for the UFT group was 53·0 % ( 95 % CI 49·2 - 56·6 ) and that of the S-1 group was 58·2 % ( 54·4 - 61·8 ; HR 0·81 , 95 % CI 0·70 - 0·93 , p=0·0048 ; pnon-inferiority=0·151 ) . The most common grade 3 - 4 haematological adverse event was neutropenia ( 41 [ 11 % ] of 359 patients in the UFT group , 48 [ 13 % ] of 363 in the S-1 group , 46 [ 13 % ] of 355 in the paclitaxel then UFT group , and 83 [ 23 % ] of 356 in the paclitaxel then S-1  group ) . The most common grade 3 - 4 non-haematological adverse event was anorexia ( 21 [ 6 % ] , 24 [ 7 % ] , seven [ 2 % ] , and 18 [ 5 % ] , respectively ) . INTERPRETATION Sequential treatment did not improve disease-free survival , and UFT was not non-inferior to S-1 ( and S-1 was superior to UFT ) , therefore S-1 monotherapy should remain the st and ard treatment for locally advanced gastric cancer in Japan . FUNDING Epidemiological and Clinical Research Information Network PURPOSE OEO2 is a r and omized , controlled trial of preoperative chemotherapy in patients undergoing radical surgery for esophageal cancer . R and om assignment was to surgery alone ( S ) or to two cycles of combination cisplatin and fluorouracil before surgery ( CS ) . Initial results reported in 2002 demonstrated an advantage for both disease-free and overall survival in the CS group . The analysis has now been up date d after a median follow-up of 6 years . PATIENTS AND METHODS OEO2 recruited 802 patients , 400 on CS and 402 on S. The nature of the first recurrence event and cause of death are detailed . Survival has been determined from Kaplan-Meier curves and treatment comparisons made with the log-rank test . Survival by extent of resection is presented . RESULTS There were 655 deaths , 335 for S and 320 for CS . The survival benefit has been maintained with a hazard ratio ( HR ) of 0.84 ( 95 % CI , 0.72 to 0.98 ; P = .03 ) which in absolute terms is a 5-year survival of 23.0 % for CS compared with 17.1 % for S. The treatment effect is consistent in both adenocarcinoma and squamous cell carcinoma . The first disease-free survival event was macroscopic residual disease from incomplete resection ( R2 ) or no resection in 26.4 % of the S group versus 14.3 % of the CS P < .001 . Three-year survival by type of resection was R0 42.4 % , R1 was 18.0 % , and R2 was 8.6 % . CONCLUSION Long-term follow-up confirms that preoperative chemotherapy improves survival in operable esophageal cancer and should be considered as a st and ard of care INTRODUCTION Worldwide , gastric cancer remains one of the most common malignancies . Discouraging survival rates after surgical treatment promote the study of adjuvant therapy . A prospect ively , r and omized , controlled clinical trial was performed in order to determine whether pre-operative and intraoperative radiotherapy improves treatment results of gastrectomy for stomach carcinoma . METHODS From 1993 to 1998 , 112 patients were r and omized and underwent exploratory laparotomy ; among them 78 satisfied protocol requirements and entered in the trial . Patients in the experimental group were treated with pre-operative radiotherapy ( 20 Gy/5 days ) , gastrectomy and intraoperative radiotherapy ( 20 Gy using 8 - 12 electrons ) . Patients in the control group underwent surgery alone . RESULTS Incidence and distribution of post-operative complications were similar in both groups except significantly higher incidence of pancreatitis after surgical treatment . No late radiation-related morbidity was registered . There was 
    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: In a prospect i ve multicenter study , 186 patients with squamous cell esophageal carcinoma , who after evaluation were considered suitable for surgery , were r and omized to 4 treatment groups : Group 1 , surgery alone ; Group 2 , pre-operative chemotherapy ( cisplatin and bleomycin ) and surgery ; Group 3 , pre-operative irradiation ( 35 Gy ) and surgery ; Group 4 , pre-operative chemotherapy , radiotherapy , and surgery .  Three-year survival was significantly higher in the pooled groups receiving radiotherapy as compared with the pooled groups not receiving radiotherapy . Comparison of the groups having pre-operative chemotherapy with those not having chemotherapy showed no significant difference in survival .  Female patients had a significantly better survival than males . The results indicate that pre-operative irradiation had a beneficial effect on intermediate term survival , whereas the chemotherapy regime used did not influence survival . RésuméDans une étude prospect i ve , multicentrique , 186 patients ayant un cancer épidermoïde de l'oesophage ont été r and omisée dans quatre groupes : le groupe 1 a eu la chirurgie seule ; le groupe 2 , une chimiothérapie préopératoire ( cis-platine et bléomycine ) ; le groupe 3 , une radiothérapie préopératoire suivie de chirurgie ; et le groupe 4 , une chimiothérapie et une radiothérapie préopératoires suivies de chirurgie . La survie à trois ans a été supérieure chez l'ensemble des patients ayant reçu la radiothérapie préopératoire par rapport à ceux qui n'en ont pas eu . Aucune différence de survie n'a pu être mise en évidence dans les groupes ayant eu ou pas de chimiothérapie . La survie des femmes a été significativement supérieure à celle des hommes . Ces résultats indiquent que la radiothérapie préopératoire apporte un plus en ce qui concerne la survie à moyen terme , alors que la chimiothérapie n'influence pas la survie . ResumenEn un estudio prospect ivo multicéntrico sobre 186 pacientes con carcinoma escamocelular del esófago c and idatos para cirugía , se constituyeron cuatro grupos para r and omización : Grupo 1 , cirugía solamente ; Grupo 2 , quimioterapia preoperatoria ( cisplatino y bleomicina ) y cirugía ; Grupo 3 , irradiación preoperatoria ( 35 Gy ) y cirugía ; Grupo 4 , quimioterapia preoperatoria , radioterapia y cirugía . La comparación entre el grupo que recibió quimioterapia y el que no la recibió no demostró diferencia significativa en cuanto a supervivencia . Las pacientes femeninas exhibieron una mejor supervivencia que los pacientes masculinos . Los result ados indican que la irradiación preoperatoria tuvo un efecto benéfico sobre la sobrevida a término medio , en tanto que la quimioterapia , en el regimen utilizado , no tuvo influencia sobre la supervivencia PURPOSE We performed a clinical trial to determine whether postoperative adjuvant chemotherapy with two drugs versus one drug could prolong survival . PATIENTS AND METHODS From 1985 to 1996 , 85 patients with completely resected locally advanced gastric cancer were enrolled . The subjects were r and omized into two treatment groups , as follows : mitomycin ( MMC ) 10 to 20 mg/m2 intravenously ( i.v . ) on day 1 every 6 weeks plus ftorafur ( FT ) 500 mg/m2/d for 36 consecutive days ; or MMC alone , 10 to 20 mg/m2 i.v . every 6 weeks . All courses were repeated four times . RESULTS After a median follow-up duration of 62 months , the overall 5-year survival rates were 67 % for the MMC-FT group versus 44 % for the MMC group ( P = .04 ) . Subgroup analysis to compare survival curves using the method of Mantel-Cox showed survival rates significantly in favor of the MMC-FT group in the subsets of patients with node-negative disease ( P = .01 ) and those whose disease was stage IB or II ( P = .008 ) . CONCLUSION Significantly better survival results were observed for MMC-FT versus MMC alone . Subset analysis suggest a strong benefit in patients with node-negative and early-stage resected gastric cancer PURPOSE The first planned interim analysis ( median follow-up , 3 years ) of the Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer confirmed that the oral fluoropyrimidine derivative S-1 significantly improved overall survival , the primary end point . The results were therefore opened at the recommendation of an independent data and safety monitoring committee . We report 5-year follow-up data on patients enrolled onto the ACTS-GC study . PATIENTS AND METHODS Patients with histologically confirmed stage II or III gastric cancer who underwent gastrectomy with D2 lymphadenectomy were r and omly assigned to receive S-1 after surgery or surgery only . S-1 ( 80 to 120 mg per day ) was given for 4 weeks , followed by 2 weeks of rest . This 6-week cycle was repeated for 1 year . The primary end point was overall survival , and the secondary end points were relapse-free survival and safety . RESULTS The overall survival rate at 5 years was 71.7 % in the S-1 group and 61.1 % in the surgery-only group ( hazard ratio [ HR ] , 0.669 ; 95 % CI , 0.540 to 0.828 ) . The relapse-free survival rate at 5 years was 65.4 % in the S-1 group and 53.1 % in the surgery-only group ( HR , 0.653 ; 95 % CI , 0.537 to 0.793 ) . Subgroup analyses according to principal demographic factors such as sex , age , disease stage , and histologic type showed no interaction between treatment and any characteristic . CONCLUSION On the basis of 5-year follow-up data , postoperative adjuvant therapy with S-1 was confirmed to improve overall survival and relapse-free survival in patients with stage II or III gastric cancer who had undergone D2 gastrectomy BACKGROUND The prognosis for locally advanced gastric cancer is poor despite advances in adjuvant chemotherapy . We did the Stomach cancer Adjuvant Multi-Institutional group Trial ( SAMIT ) to assess the superiority of sequential treatment ( paclitaxel then tegafur and uracil [ UFT ] or paclitaxel then S-1 ) compared with monotherapy ( UFT or S-1 ) and also the non-inferiority of UFT compared with S-1 . METHODS We did this r and omised phase 3 trial with a two-by-two factorial design at 230 hospitals in Japan . We enrolled patients aged 20 - 80 years with T4a or T4b gastric cancer , who had had D2 dissection and a ECOG performance score of 0 - 1 . Patients were r and omly assigned to one of four treatment groups with minimisation for tumour size , lymph node metastasis , and study site . Patients received UFT only ( 267 mg/m(2 ) per day ) , S-1 only ( 80 mg/m(2 ) per day ) for 14 days , with a 7-day rest period or three courses of intermittent weekly paclitaxel ( 80 mg/m(2 ) ) followed by either UFT , or S-1 . Treatment lasted 48 weeks in monotherapy groups and 49 weeks in the sequential treatment groups . The primary endpoint was disease-free survival assessed by intention to treat . We assessed whether UFT was non-inferior to S-1 with a non-inferiority margin of 1·33 . This trial was registered at UMIN Clinical Trials Registry , number C000000082 . FINDINGS We r and omly assigned 1495 patients between Aug 3 , 2004 , and Sept 29 , 2009 . 374 patients were assigned to receive UFT alone , 374 to receive S-1 alone , 374 to received paclitaxel then UFT , and 373 to receive paclitaxel then S-1 . We included 1433 patients in the primary analysis after at least 3 years of follow-up ( 359 , 364 , 355 , and 355 in each group respectively ) . Protocol treatment was completed by 215 ( 60 % ) patients in the UFT group , 224 ( 62 % ) in the S-1 group , 242 ( 68 % ) in the paclitaxel then UFT group , and 250 ( 70 % ) in the paclitaxel then S-1  group . 3-year disease-free survival for monotherapy was 54·0 % ( 95 % CI 50·2 - 57·6 ) and that of sequential treatment was 57·2 % ( 53·4 - 60·8 ; hazard ratio [ HR ] 0·92 , 95 % CI 0·80 - 1·07 , p=0·273 ) . 3-year disease-free survival for the UFT group was 53·0 % ( 95 % CI 49·2 - 56·6 ) and that of the S-1 group was 58·2 % ( 54·4 - 61·8 ; HR 0·81 , 95 % CI 0·70 - 0·93 , p=0·0048 ; pnon-inferiority=0·151 ) . The most common grade 3 - 4 haematological adverse event was neutropenia ( 41 [ 11 % ] of 359 patients in the UFT group , 48 [ 13 % ] of 363 in the S-1 group , 46 [ 13 % ] of 355 in the paclitaxel then UFT group , and 83 [ 23 % ] of 356 in the paclitaxel then S-1  group ) . The most common grade 3 - 4 non-haematological adverse event was anorexia ( 21 [ 6 % ] , 24 [ 7 % ] , seven [ 2 % ] , and 18 [ 5 % ] , respectively ) . INTERPRETATION Sequential treatment did not improve disease-free survival , and UFT was not non-inferior to S-1 ( and S-1 was superior to UFT ) , therefore S-1 monotherapy should remain the st and ard treatment for locally advanced gastric cancer in Japan . FUNDING Epidemiological and Clinical Research Information Network PURPOSE OEO2 is a r and omized , controlled trial of preoperative chemotherapy in patients undergoing radical surgery for esophageal cancer . R and om assignment was to surgery alone ( S ) or to two cycles of combination cisplatin and fluorouracil before surgery ( CS ) . Initial results reported in 2002 demonstrated an advantage for both disease-free and overall survival in the CS group . The analysis has now been up date d after a median follow-up of 6 years . PATIENTS AND METHODS OEO2 recruited 802 patients , 400 on CS and 402 on S. The nature of the first recurrence event and cause of death are detailed . Survival has been determined from Kaplan-Meier curves and treatment comparisons made with the log-rank test . Survival by extent of resection is presented . RESULTS There were 655 deaths , 335 for S and 320 for CS . The survival benefit has been maintained with a hazard ratio ( HR ) of 0.84 ( 95 % CI , 0.72 to 0.98 ; P = .03 ) which in absolute terms is a 5-year survival of 23.0 % for CS compared with 17.1 % for S. The treatment effect is consistent in both adenocarcinoma and squamous cell carcinoma . The first disease-free survival event was macroscopic residual disease from incomplete resection ( R2 ) or no resection in 26.4 % of the S group versus 14.3 % of the CS P < .001 . Three-year survival by type of resection was R0 42.4 % , R1 was 18.0 % , and R2 was 8.6 % . CONCLUSION Long-term follow-up confirms that preoperative chemotherapy improves survival in operable esophageal cancer and should be considered as a st and ard of care INTRODUCTION Worldwide , gastric cancer remains one of the most common malignancies . Discouraging survival rates after surgical treatment promote the study of adjuvant therapy . A prospect ively , r and omized , controlled clinical trial was performed in order to determine whether pre-operative and intraoperative radiotherapy improves treatment results of gastrectomy for stomach carcinoma . METHODS From 1993 to 1998 , 112 patients were r and omized and underwent exploratory laparotomy ; among them 78 satisfied protocol requirements and entered in the trial . Patients in the experimental group were treated with pre-operative radiotherapy ( 20 Gy/5 days ) , gastrectomy and intraoperative radiotherapy ( 20 Gy using 8 - 12 electrons ) . Patients in the control group underwent surgery alone . RESULTS Incidence and distribution of post-operative complications were similar in both groups except significantly higher incidence of pancreatitis after surgical treatment . No late radiation-related morbidity was registered . There was 
    Output:
    