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: One hundred forty‐two patients with all stages of gastric carcinoma were prospect ively stratified into two divisions according to T.N.M. stage following , but irrespective of the type of surgical procedure . Division I ( T 1‐3 , N 1‐2 , M O ) was r and omized into a control group , and a treatment group who received 2000 rad in 8 fractions over 10 days with intravenous 5 Fluorouracil ( 5 F.U. ) at a dose of 500 mg daily × 4 days preirradiation and then 12.5 mg/kg daily for 5 days every 28 days for six courses . Division II ( T4 or M1 ) was r and omized into three groups ; a control group , a group who received radiotherapy and 5 F.U. in the same schedule as division one and a group who received Thiotepa 45 mg intravenously daily for three days and then every 28 days for 6 months . Four and one‐half years after commencement of the trial 86 % of the patients had died . There was no difference in survival rate between the treatment and control groups , ( p > 0.5 ) in Division I or II . Survival appeared to correlate with the T.N.M. stage of disease and not therapy . Blind assessment of the quality of life showed no difference between the treatment groups and the controls . In the dose schedules used , this form of oncological therapy had no efect on survival or quality of life in patients with gastric carcinoma . Cancer 44:385‐391 , 1979 In this prospect ively r and om study , the effect of oral Ftorafur as an adjuvant chemotherapy was compared with that of oral placebo in patients with Stage II and Stage III gastric cancer . Patients had undergone a subtotal gastrectomy with a resection margin that should have been free of tumors .  Ftorafur ( 10 mg/kg ) was given daily to 59 Group A patients .  Multiple vitamins were given twice a week to 56 Group B patients . We found that there was no statistical significance in Stage II patients with regard to survival . In Stage III patients , those treated with oral Ftorafur had better 3-year and 5-year survival rates than those receiving oral placebo . This preliminary report on this ongoing study seems to indicate that long-term postoperative Ftorafur treatment may be beneficial to Stage III gastric cancer patients Summary Two hundred and seventeen patients with advanced gastric cancer were classified according to the resectability of the tumour into two groups : I , resectable ( non-radical surgery ) , 99 patients , and II , non-resectable carcinoma , 118 patients . Within each group patients were r and omly assigned to receive 5-fluorouracil ( 5-FU ) + BCG , 5-FU , or no further treatment ( surgery only ) . BCG was given by scarification . A 2-year follow-up is reported . The group of patients with resectable tumours and receiving chemoimmunotherapy had a statistically significant prolongation of survival compared with the 5-FU and surgery only groups . No differences in survival were observed between these treatment modalities in patients with non-resectable tumour . These observations indicate that chemoimmunotherapy may be of benefit for a selected group of patients with gastric cancer Combination chemotherapy ( CT ) has , in some groups of patients with gastric cancer ( GC ) , who are at a high risk for relapse , result ed in a small but measurable improvement in palliation and patient survival not reaching statistical significance and therefore remaining applicable in an investigational setting . Based on the above data , we studied adjuvant CT with FEM ( 5-fluorouracil ( 5-FU ) , epirubicin , mitomycin C ) in a r and omized study of patients with completely resected stage III GC and patients with stages T1 - 3 with a low histologic grade .  CT was started 2 - 3 weeks after surgery . From August 1988 until February 1994 , 84 patients with completely resected tumors and lymph nodes were r and omized to either group A  ( FEM ) or group B ( no treatment ) .  Patients were eligible for r and omization if they had a Karnofsky score > 60 , no postoperative evidence of residual tumor , and normal cardiac , hepatic and renal functions . Forty-two patients were r and omized to each group , with no significant differences regarding : age distribution , group A 53 years ( 41 - 65 ) , group B 57 years ( 35 - 66 ) ; sex , group A 32/10 , group B 25/17 ( men/women ) ; site of primary tumor , group A 22/20 , group B 25/17 ( pylorus/antrum ) ; histologic grade , group A 0/19/23 , group B 0/25/17 ( grade s I/II/III ) ; lymph node metastases , group A 30 , group B 32 , and surgical procedure , group A 33/9/6 , group B 35/7/9 ( total gastrectomy/partial gastrectomy/splenectomy ) . Group A received 5-FU 600 mg/m2/day i.v . on days 1 , 8 , 29 and 36 , epirubicin 45 mg/m2/day i.v . on days 1 and 29 , and mitomycin C 10 mg/m2 i.v . on day 1 . The schedule was repeated every 56 days for 3 cycles . Group B received no treatment odd was only subjected to the regular follow-up . At the last follow-up at 66 months , 27/42 patients in group A ( 64 % ) had relapsed or died , compared to 34/42 patients in group B ( 81 % ) . The differences in the relapse and the disease-free and the overall survival rates were not statistically significant . Only the subgroup of patients with histologic grade III tumors receiving adjuvant FEM  demonstrated a trend towards improved survival ( p = 0.085 ) . Main therapy-related toxicities for the treatment group were grade I-II anemia , neutropenia , and throbocytopenia in 16 , 45 , and 22 % of patients , respectively , and grade I-II nausea and vomiting in 29 % of patients . Based on the present findings and those of previous studies , even if one considers the difference reaching statistical significance in the latter for histologic grade III tumors , it becomes evident that with current therapeutic modalities adjuvant therapy has no established role in the management of resectable GC . Studies of new-generation regimens , such as FAMTX ( 5-FU , Adriamycin and methotrexate ) as well as ELF ( etoposide , Leucoverin , and 5-FU ) , should be conducted in the adjuvant therapy setting with a nontherapy control group , in order to clarify the issue of adjuvant CT in resectable GC Sixty-eight patients admitted for resection of gastric carcinoma entered a prospect ively r and omized trial . Patients in the therapy group ( n = 34 ) received a preoperative controlled infusion of 10 mg Propionibacterium avidum KP-40 . The therapy and control group did not differ with regard to postoperative complications , tumor recurrence rates ( therapy group : 41 % , control group : 38 % ) , and patient survival rates ( survival rate in the therapy group after 25 months : 53 % , in the control group after 25 months : 50 % ) From September 1979 through March 1981 , a total of 302 patients with gastric cancer and undergoing gastrectomy at the Department of Surgery at Chiba University Hospital and its 14 affiliated hospitals was studied for clinical effectiveness of immunotherapy with Nocardia rubra cell wall skeleton . The patients were stratified by gross stage of cancer and degree of operative curability . They were then assigned r and omly to either chemotherapy group or chemotherapy plus immunotherapy group . Immunotherapy used was intradermal injection of 400 micrograms of N. rubra cell wall skeleton which was given weekly for the first month and monthly thereafter . After the specimen was examined microscopically , the patients were classified by histological stage of cancer and radicality of surgical intervention into curative or noncurative groups . The patients were surveyed for survival period in December 1981 . The postoperative survival rate was compared in patients of histologically curative or noncurative resection cases between the two treatment groups . No statistical difference was detected between the groups in age , sex , or operative procedures that might influence the patient 's survival . As a result , statistical intergroup difference in survival rates was not seen in patients of the curative group , probably due to a short observation period . However , the intergroup difference in survival rates was statistically significant in patients of the noncurative group ( p less than 0.01 ) . These results indicate the adjunctive effect of N. rubra cell wall skeleton as an immunotherapeutic agent in patients undergoing gastrectomy for gastric cancer BACKGROUND In Japan the surgical approach to treatment of potentially curable gastric cancer , including extended lymphadenectomy , seems in retrospective surveys to give better results than the less radical procedures favoured in Western countries . There has , however , been no evidence from r and omised trials that extended lymphadenectomy ( D2 gastric resection ) confers a survival advantage . This question was addressed in a trial involving thirty-two surgeons in Europe . METHODS In a prospect i ve r and omised controlled trial , D1 resection ( level 1 lymphadenectomy ) was compared with D2 resection ( levels 1 and 2 lymphadenectomy ) . Central r and omisation ( 200 patients in each arm ) followed a staging laparotomy . FINDINGS The D2 group had greater postoperative hospital mortality ( 13 % vs 6.5 % ; p=0.04 [ 95 % Cl 9 - 18 % for D2 , 4 - 11 % for D1 ] and higher overall postoperative morbidity ( 46 % vs 28 % ; p<0.001 ) ; their postoperative stay was also longer . The excess postoperative morbidity and mortality in the D2 group was accounted for by distal pancreaticosplenectomy and splenectomy . In the whole group ( 400 patients ) , survival beyond three years was 30 % in patients whose gastrectomy included en-bloc pancreatico-splenic resection versus 50 % in the remainder . INTERPRETATION D2 gastric resections are followed by higher morbidity and mortality than D1 resections . These disadvantages are consequent upon additional pancreatectomies and distal splenectomies , and in long-term follow-up the higher mortality when the pancreas and spleen are resected may prove to nullify any survival benefit from D2 procedures After en bloc resection of gastric adenocarcinoma , 180 patients were r and omized to 2 years of 5‐fluorouracil ( 5‐FU ) + semustine ( MeCCNU ) chemotherapy or to observation only . After a median follow‐up time of 64 months , 48 of 89 control patients and 51/91 treated patients recurred ( P < 0.71 ) . The sites of recurrent cancer were similar for both groups : liver , 32 % ; local esophagus or stomach , 51 % ; abdominal nodes and peritoneum , 38 % ; and extra‐abdominal nodes , 14 % . The survival curves overlap ; 51/89 controls and 57/91 treated patients died with a median survival of 32.7 and 36.6 months , respectively ( P < 0.73 ) . Treated patients experienced clinical ly important hematologic toxicity and two treated patients died of marrow failure with leukemia . Because of the toxicity and the lack of effectiveness , adjuvant 5‐FU + MeCCNU is not recommended for patients with resectable gastric cancer OBJECTIVE Surgeons have postulated on numerous occasions that cancer resection may participate in the dissemination of a malignancy . This r and omized trial sought to determine whether a large volume of chemotherapy solution used perioperatively to flood the peritoneal cavity could eliminate microscopic residual disease and thereby improve survival of patients with gastric cancer . SUMMARY BACKGROUND DATA Surgical treatment failures in patients with gastric cancer are confined to the abdomen in most patients . Resection site and peritoneal surface spread , along with liver metastases , are the most common areas of recurrence . Survival and quality of life of patients with gastric cancer would be improved if disease progression at these anatomic sites was reduced . METHODS In a prospect i ve r and omized trial of 248 patients , intraperitoneal mitomycin C on day 1 and intraperitoneal 5-fluorouracil on days 2 through 5 were administered after gastric cancer resection .  Patients who were thought to have stage II or stage III disease were r and omized after resection to surgery alone versus surgery plus early postoperative intraperitoneal chemotherapy . After final pathologic examinations , there were 39 patients with stage I , 50 with stage II 95 with stage III , and 64 with resected stage IV cancer . RESULTS The 5-year survival of the surgery-only group was 29.3 % , and the surgery-plus-intraperitoneal chemotherapy group was 38.7 % ( p = 0.219 ) . In a subset analysis , the patients with stage I , stage II , and stage IV disease showed no statistically significant difference in survival . The 5-year survival rate of patients with stage III disease who underwent surgery only was 18 
    Output:
    
agent
Furthermore , this therapy could increase the dem and on radiation re sources .
There is no evidence on which to make a recommendation for patients with node-negative tumours that have not penetrated the muscularis propria .
For patients unable to undergo radiation , adjuvant chemotherapy alone may be of benefit , particularly for those with lymph-node metastases .
There is insufficient evidence from r and omized trials to recommend neoadjuvant chemotherapy , or neoadjuvant or adjuvant radiotherapy or immunotherapy , either alone or in combination , outside a clinical trial .
***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: One hundred forty‐two patients with all stages of gastric carcinoma were prospect ively stratified into two divisions according to T.N.M. stage following , but irrespective of the type of surgical procedure . Division I ( T 1‐3 , N 1‐2 , M O ) was r and omized into a control group , and a treatment group who received 2000 rad in 8 fractions over 10 days with intravenous 5 Fluorouracil ( 5 F.U. ) at a dose of 500 mg daily × 4 days preirradiation and then 12.5 mg/kg daily for 5 days every 28 days for six courses . Division II ( T4 or M1 ) was r and omized into three groups ; a control group , a group who received radiotherapy and 5 F.U. in the same schedule as division one and a group who received Thiotepa 45 mg intravenously daily for three days and then every 28 days for 6 months . Four and one‐half years after commencement of the trial 86 % of the patients had died . There was no difference in survival rate between the treatment and control groups , ( p > 0.5 ) in Division I or II . Survival appeared to correlate with the T.N.M. stage of disease and not therapy . Blind assessment of the quality of life showed no difference between the treatment groups and the controls . In the dose schedules used , this form of oncological therapy had no efect on survival or quality of life in patients with gastric carcinoma . Cancer 44:385‐391 , 1979 In this prospect ively r and om study , the effect of oral Ftorafur as an adjuvant chemotherapy was compared with that of oral placebo in patients with Stage II and Stage III gastric cancer . Patients had undergone a subtotal gastrectomy with a resection margin that should have been free of tumors .  Ftorafur ( 10 mg/kg ) was given daily to 59 Group A patients .  Multiple vitamins were given twice a week to 56 Group B patients . We found that there was no statistical significance in Stage II patients with regard to survival . In Stage III patients , those treated with oral Ftorafur had better 3-year and 5-year survival rates than those receiving oral placebo . This preliminary report on this ongoing study seems to indicate that long-term postoperative Ftorafur treatment may be beneficial to Stage III gastric cancer patients Summary Two hundred and seventeen patients with advanced gastric cancer were classified according to the resectability of the tumour into two groups : I , resectable ( non-radical surgery ) , 99 patients , and II , non-resectable carcinoma , 118 patients . Within each group patients were r and omly assigned to receive 5-fluorouracil ( 5-FU ) + BCG , 5-FU , or no further treatment ( surgery only ) . BCG was given by scarification . A 2-year follow-up is reported . The group of patients with resectable tumours and receiving chemoimmunotherapy had a statistically significant prolongation of survival compared with the 5-FU and surgery only groups . No differences in survival were observed between these treatment modalities in patients with non-resectable tumour . These observations indicate that chemoimmunotherapy may be of benefit for a selected group of patients with gastric cancer Combination chemotherapy ( CT ) has , in some groups of patients with gastric cancer ( GC ) , who are at a high risk for relapse , result ed in a small but measurable improvement in palliation and patient survival not reaching statistical significance and therefore remaining applicable in an investigational setting . Based on the above data , we studied adjuvant CT with FEM ( 5-fluorouracil ( 5-FU ) , epirubicin , mitomycin C ) in a r and omized study of patients with completely resected stage III GC and patients with stages T1 - 3 with a low histologic grade .  CT was started 2 - 3 weeks after surgery . From August 1988 until February 1994 , 84 patients with completely resected tumors and lymph nodes were r and omized to either group A  ( FEM ) or group B ( no treatment ) .  Patients were eligible for r and omization if they had a Karnofsky score > 60 , no postoperative evidence of residual tumor , and normal cardiac , hepatic and renal functions . Forty-two patients were r and omized to each group , with no significant differences regarding : age distribution , group A 53 years ( 41 - 65 ) , group B 57 years ( 35 - 66 ) ; sex , group A 32/10 , group B 25/17 ( men/women ) ; site of primary tumor , group A 22/20 , group B 25/17 ( pylorus/antrum ) ; histologic grade , group A 0/19/23 , group B 0/25/17 ( grade s I/II/III ) ; lymph node metastases , group A 30 , group B 32 , and surgical procedure , group A 33/9/6 , group B 35/7/9 ( total gastrectomy/partial gastrectomy/splenectomy ) . Group A received 5-FU 600 mg/m2/day i.v . on days 1 , 8 , 29 and 36 , epirubicin 45 mg/m2/day i.v . on days 1 and 29 , and mitomycin C 10 mg/m2 i.v . on day 1 . The schedule was repeated every 56 days for 3 cycles . Group B received no treatment odd was only subjected to the regular follow-up . At the last follow-up at 66 months , 27/42 patients in group A ( 64 % ) had relapsed or died , compared to 34/42 patients in group B ( 81 % ) . The differences in the relapse and the disease-free and the overall survival rates were not statistically significant . Only the subgroup of patients with histologic grade III tumors receiving adjuvant FEM  demonstrated a trend towards improved survival ( p = 0.085 ) . Main therapy-related toxicities for the treatment group were grade I-II anemia , neutropenia , and throbocytopenia in 16 , 45 , and 22 % of patients , respectively , and grade I-II nausea and vomiting in 29 % of patients . Based on the present findings and those of previous studies , even if one considers the difference reaching statistical significance in the latter for histologic grade III tumors , it becomes evident that with current therapeutic modalities adjuvant therapy has no established role in the management of resectable GC . Studies of new-generation regimens , such as FAMTX ( 5-FU , Adriamycin and methotrexate ) as well as ELF ( etoposide , Leucoverin , and 5-FU ) , should be conducted in the adjuvant therapy setting with a nontherapy control group , in order to clarify the issue of adjuvant CT in resectable GC Sixty-eight patients admitted for resection of gastric carcinoma entered a prospect ively r and omized trial . Patients in the therapy group ( n = 34 ) received a preoperative controlled infusion of 10 mg Propionibacterium avidum KP-40 . The therapy and control group did not differ with regard to postoperative complications , tumor recurrence rates ( therapy group : 41 % , control group : 38 % ) , and patient survival rates ( survival rate in the therapy group after 25 months : 53 % , in the control group after 25 months : 50 % ) From September 1979 through March 1981 , a total of 302 patients with gastric cancer and undergoing gastrectomy at the Department of Surgery at Chiba University Hospital and its 14 affiliated hospitals was studied for clinical effectiveness of immunotherapy with Nocardia rubra cell wall skeleton . The patients were stratified by gross stage of cancer and degree of operative curability . They were then assigned r and omly to either chemotherapy group or chemotherapy plus immunotherapy group . Immunotherapy used was intradermal injection of 400 micrograms of N. rubra cell wall skeleton which was given weekly for the first month and monthly thereafter . After the specimen was examined microscopically , the patients were classified by histological stage of cancer and radicality of surgical intervention into curative or noncurative groups . The patients were surveyed for survival period in December 1981 . The postoperative survival rate was compared in patients of histologically curative or noncurative resection cases between the two treatment groups . No statistical difference was detected between the groups in age , sex , or operative procedures that might influence the patient 's survival . As a result , statistical intergroup difference in survival rates was not seen in patients of the curative group , probably due to a short observation period . However , the intergroup difference in survival rates was statistically significant in patients of the noncurative group ( p less than 0.01 ) . These results indicate the adjunctive effect of N. rubra cell wall skeleton as an immunotherapeutic agent in patients undergoing gastrectomy for gastric cancer BACKGROUND In Japan the surgical approach to treatment of potentially curable gastric cancer , including extended lymphadenectomy , seems in retrospective surveys to give better results than the less radical procedures favoured in Western countries . There has , however , been no evidence from r and omised trials that extended lymphadenectomy ( D2 gastric resection ) confers a survival advantage . This question was addressed in a trial involving thirty-two surgeons in Europe . METHODS In a prospect i ve r and omised controlled trial , D1 resection ( level 1 lymphadenectomy ) was compared with D2 resection ( levels 1 and 2 lymphadenectomy ) . Central r and omisation ( 200 patients in each arm ) followed a staging laparotomy . FINDINGS The D2 group had greater postoperative hospital mortality ( 13 % vs 6.5 % ; p=0.04 [ 95 % Cl 9 - 18 % for D2 , 4 - 11 % for D1 ] and higher overall postoperative morbidity ( 46 % vs 28 % ; p<0.001 ) ; their postoperative stay was also longer . The excess postoperative morbidity and mortality in the D2 group was accounted for by distal pancreaticosplenectomy and splenectomy . In the whole group ( 400 patients ) , survival beyond three years was 30 % in patients whose gastrectomy included en-bloc pancreatico-splenic resection versus 50 % in the remainder . INTERPRETATION D2 gastric resections are followed by higher morbidity and mortality than D1 resections . These disadvantages are consequent upon additional pancreatectomies and distal splenectomies , and in long-term follow-up the higher mortality when the pancreas and spleen are resected may prove to nullify any survival benefit from D2 procedures After en bloc resection of gastric adenocarcinoma , 180 patients were r and omized to 2 years of 5‐fluorouracil ( 5‐FU ) + semustine ( MeCCNU ) chemotherapy or to observation only . After a median follow‐up time of 64 months , 48 of 89 control patients and 51/91 treated patients recurred ( P < 0.71 ) . The sites of recurrent cancer were similar for both groups : liver , 32 % ; local esophagus or stomach , 51 % ; abdominal nodes and peritoneum , 38 % ; and extra‐abdominal nodes , 14 % . The survival curves overlap ; 51/89 controls and 57/91 treated patients died with a median survival of 32.7 and 36.6 months , respectively ( P < 0.73 ) . Treated patients experienced clinical ly important hematologic toxicity and two treated patients died of marrow failure with leukemia . Because of the toxicity and the lack of effectiveness , adjuvant 5‐FU + MeCCNU is not recommended for patients with resectable gastric cancer OBJECTIVE Surgeons have postulated on numerous occasions that cancer resection may participate in the dissemination of a malignancy . This r and omized trial sought to determine whether a large volume of chemotherapy solution used perioperatively to flood the peritoneal cavity could eliminate microscopic residual disease and thereby improve survival of patients with gastric cancer . SUMMARY BACKGROUND DATA Surgical treatment failures in patients with gastric cancer are confined to the abdomen in most patients . Resection site and peritoneal surface spread , along with liver metastases , are the most common areas of recurrence . Survival and quality of life of patients with gastric cancer would be improved if disease progression at these anatomic sites was reduced . METHODS In a prospect i ve r and omized trial of 248 patients , intraperitoneal mitomycin C on day 1 and intraperitoneal 5-fluorouracil on days 2 through 5 were administered after gastric cancer resection .  Patients who were thought to have stage II or stage III disease were r and omized after resection to surgery alone versus surgery plus early postoperative intraperitoneal chemotherapy . After final pathologic examinations , there were 39 patients with stage I , 50 with stage II 95 with stage III , and 64 with resected stage IV cancer . RESULTS The 5-year survival of the surgery-only group was 29.3 % , and the surgery-plus-intraperitoneal chemotherapy group was 38.7 % ( p = 0.219 ) . In a subset analysis , the patients with stage I , stage II , and stage IV disease showed no statistically significant difference in survival . The 5-year survival rate of patients with stage III disease who underwent surgery only was 18 
    Output:
    