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: 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 Background Despite curative resection , 50%–90 % of gastric cancer patients die of disease relapse . Although some clinical trials have indicated that chemotherapy and immunochemotherapy may be effective modalities , more recent studies have not been able to define the st and ard treatment for advanced gastric cancer . The present study evaluated the effect of adjuvant immunochemotherapy with the use of BCG ( bacille Calmette-Guérin ) and FAM ( 5-fluorouracil , adriamycin , mitomycin C ) chemotherapy on the survival of  patients with locally advanced resectable gastric cancer . Methods A total of 156 patients with stage III or IV gastric cancer who had undergone curative resection were r and omly assigned to three treatment groups : BCG + FAM ( immunochemotherapy ) , FAM ( chemotherapy ) , and control ( surgery only ) . Treatment was continued for 2 years or until death . Further postsurgical follow up was carried on for up to 10 years . Results Overall 10-year survival was 47.1 % for the immunochemotherapy group ( P < 0.037 vs FAM and P < 0.0006 vs control ) , 30 % for the chemotherapy group ( vs control , NS ) , and 15.2 % for the control group . In patients with pT2/T3 primary tumors , 10-year survival was 55.3 % for BCG + FAM vs 28.2 % for FAM ( P < 0.01 ) and 14.6 % for the control group ( P < 0.00018 ) . BCG + FAM signifi-cantly improved the survival of patients with intestinal-type but not diffuse-type cancer . Immunochemotherapy was well tolerated . Conclusion This study , based on a limited number of patients , indicates that adjuvant immunochemotherapy ( BCG + FAM ) may prolong the survival of gastric cancer patients after curative gastrectomy ; in particular , in patients with pT2/T3 tumors and intestinal-type primary tumors . There was no survival benefit from FAM adjuvant chemotherapy 102 patients with operable gastric carcinoma were r and omly allocated to untreated control , polychemotherapy , chemoimmunotherapy . At a median follow-up of 5 years , chemotherapy did not improve the overall survival rate . However , in certain subgroups , patients with lymphnode metastases and intestinal tumor type showed a significant survival benefit when treated with adjuvant chemotherapy . Furthermore , we found the site of first recurrence very closely related to the type of tumor histology . Regardless of the positive effect of chemotherapy in retrospective subset- analysis , we do not generally recommend the use of polychemotherapy in operable gastric carcinoma OBJECTIVE To compare therapeutic results and five year survival after two regimens of adjuvant chemotherapy after resections for gastric cancer . DESIGN Prospect i ve r and omised multicentre trial . SETTING S 21 departments of surgery . SUBJECTS 243 patients with stage II , III , or IV gastric cancer . INTERVENTIONS All patients received an intravenous bolus of mitomycin C 20 mg on the day of operation , and 10 mg on the first postoperative day . They were then r and omised to receive either tegafur 600 mg or tegafur-uracil 600 mg orally daily beginning two weeks after operation and continuing for two years . Patients with histological confirmed stage IV disease also received mitomycin C 10 mg every three months starting one month after operation . MAIN OUTCOME MEASURES Survival and side effects . RESULTS 13 patients ( 5 % ) were withdrawn from the study , leaving 230 for analysis . There were no serious side effects and both drugs were safe when given continuously for two years . There were no significant differences in 5 year survival ( though patients who were given tegafur-uracil tended to live longer ) , except when patients who had histological curative resections were compared with and those with poorly differentiated adenocarcinoma ( p = 0.04 ) BACKGROUND The aim of this study was to evaluate the efficacy of adjuvant chemotherapy after resection for gastric cancer in a r and omized controlled trial . PATIENTS AND METHODS After curative resection , stage II-III-IVM0 gastric cancer patients were r and omly assigned to postoperative chemotherapy or surgery alone . 5-Fluorouracil ( 5-FU ) 800 mg/m(2 ) daily ( 5-day continuous infusion ) was initiated before day 14 after resection . One month later , four 5-day cycles of 5-FU ( 1 g/m(2 ) per day ) plus cisplatin ( 100 mg/m(2 ) on day 2 ) were administered every 4 weeks . RESULTS The study was closed prematurely after enrollment of 260 patients ( 79.7 % N+ ) , owing to poor accrual . At 97.8 months median follow-up , 5- and 7-year overall survival were 41.9 % and 34.9 % in the control group versus 46.6 % and 44.6 % in the chemotherapy group ( P=0.22 ) . Cox model hazard ratios were 0.74 [ 95 % confidence interval ( CI ) 0.54 - 1.02 ; P=0.063 ] for death and 0.70 ( 95 % CI 0.51 - 0.97 ; P=0.032 ) for recurrence . An invaded/removed lymph nodes ratio > 0.3 was the main independent poor prognostic factor identified by multivariate analysis ( P=0.0001 ) . Because of toxicity , only 48.8 % of patients received more than 80 % of the planned dose . CONCLUSION There was no statistically significant survival benefit with this toxic cisplatin-based adjuvant chemotherapy , but a risk reduction in recurrence was observed Background Intergroup 0116 ( Southwest Oncology Group 9008 ) , a national , multicenter , two-armed , prospect i ve , r and omized trial of adjuvant postoperative chemoradiotherapy , has demonstrated significant benefit . Methods We prospect ively captured complete surgical information , including the treatment of various lymph node stations , for 553 of the 556 eligible participants in this trial . Before any survival analysis , we coded D level by using the Japanese general rules and used the Maruyama program to estimate the likelihood of disease in undissected regional node stations , defining the sum of these estimates as the Maruyama Index of Unresected Disease ( MI ) . We analyzed survival with Cox multivariate regression  . Results Fifty-four percent of participating patients underwent D0 lymphadenectomy . The median MI was 70 ( range , 0–429 ) . In contrast to D level , MI proved to be an independent prognostic factor , even with adjustment for the potentially linked variables of T stage and number of positive nodes . We detected no significant interaction between surgical or pathologic variables and the favorable effect of adjuvant treatment , but the power to detect such interaction was generally low . Conclusions MI , a measure of unresected regional nodal disease in gastric cancer , proved an independent predictor of survival . Surgical undertreatment , as observed in this trial , clearly undermined survival Although intravenous ( IV ) 5-fluorouracil ( 5-FU ) and uracil/futraful ( UFT ) have comparable antitumour efficacy in the treatment of metastatic colorectal cancer ( MCC ) , we wanted to assess which of these two regimens would be preferred by our patients . We r and omized 20 previously untreated patients with MCC at our centre to receive oral UFT or bolus IV 5-FU both associated with leucovorin . After the first cycle patients were crossed over to the other arm . Before the third cycle we left patients to choose one of the regimens to continue their treatment until disease progression . Two patients chose 5-FU and 18 chose UFT ( P < 0.001 ) . Fewer side effects ( 50 % ) and convenience of home treatment ( 40 % ) were the main reasons for their choice for the oral regimen . UFT induced less mucositis ( P = 0 . 02 ) and diarrhoea ( P = 0 . 01 ) . We conclude that convenience and lower toxicity may explain the observed preference for oral UFT 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 The primary objective was to prospect ively investigate the efficacy and toxicity of bolus 5-fluorouracil ( 5-FU ) chemotherapy compared with the infusional 5-FU in combination with preoperative radiation in patients with locally advanced rectal cancer . Furthermore , in light of previous reports , toxicity profiles between men and women were also compared . Eighty-four consecutive patients with rectal adenocarcinoma were prospect ively treated 
    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: 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 Background Despite curative resection , 50%–90 % of gastric cancer patients die of disease relapse . Although some clinical trials have indicated that chemotherapy and immunochemotherapy may be effective modalities , more recent studies have not been able to define the st and ard treatment for advanced gastric cancer . The present study evaluated the effect of adjuvant immunochemotherapy with the use of BCG ( bacille Calmette-Guérin ) and FAM ( 5-fluorouracil , adriamycin , mitomycin C ) chemotherapy on the survival of  patients with locally advanced resectable gastric cancer . Methods A total of 156 patients with stage III or IV gastric cancer who had undergone curative resection were r and omly assigned to three treatment groups : BCG + FAM ( immunochemotherapy ) , FAM ( chemotherapy ) , and control ( surgery only ) . Treatment was continued for 2 years or until death . Further postsurgical follow up was carried on for up to 10 years . Results Overall 10-year survival was 47.1 % for the immunochemotherapy group ( P < 0.037 vs FAM and P < 0.0006 vs control ) , 30 % for the chemotherapy group ( vs control , NS ) , and 15.2 % for the control group . In patients with pT2/T3 primary tumors , 10-year survival was 55.3 % for BCG + FAM vs 28.2 % for FAM ( P < 0.01 ) and 14.6 % for the control group ( P < 0.00018 ) . BCG + FAM signifi-cantly improved the survival of patients with intestinal-type but not diffuse-type cancer . Immunochemotherapy was well tolerated . Conclusion This study , based on a limited number of patients , indicates that adjuvant immunochemotherapy ( BCG + FAM ) may prolong the survival of gastric cancer patients after curative gastrectomy ; in particular , in patients with pT2/T3 tumors and intestinal-type primary tumors . There was no survival benefit from FAM adjuvant chemotherapy 102 patients with operable gastric carcinoma were r and omly allocated to untreated control , polychemotherapy , chemoimmunotherapy . At a median follow-up of 5 years , chemotherapy did not improve the overall survival rate . However , in certain subgroups , patients with lymphnode metastases and intestinal tumor type showed a significant survival benefit when treated with adjuvant chemotherapy . Furthermore , we found the site of first recurrence very closely related to the type of tumor histology . Regardless of the positive effect of chemotherapy in retrospective subset- analysis , we do not generally recommend the use of polychemotherapy in operable gastric carcinoma OBJECTIVE To compare therapeutic results and five year survival after two regimens of adjuvant chemotherapy after resections for gastric cancer . DESIGN Prospect i ve r and omised multicentre trial . SETTING S 21 departments of surgery . SUBJECTS 243 patients with stage II , III , or IV gastric cancer . INTERVENTIONS All patients received an intravenous bolus of mitomycin C 20 mg on the day of operation , and 10 mg on the first postoperative day . They were then r and omised to receive either tegafur 600 mg or tegafur-uracil 600 mg orally daily beginning two weeks after operation and continuing for two years . Patients with histological confirmed stage IV disease also received mitomycin C 10 mg every three months starting one month after operation . MAIN OUTCOME MEASURES Survival and side effects . RESULTS 13 patients ( 5 % ) were withdrawn from the study , leaving 230 for analysis . There were no serious side effects and both drugs were safe when given continuously for two years . There were no significant differences in 5 year survival ( though patients who were given tegafur-uracil tended to live longer ) , except when patients who had histological curative resections were compared with and those with poorly differentiated adenocarcinoma ( p = 0.04 ) BACKGROUND The aim of this study was to evaluate the efficacy of adjuvant chemotherapy after resection for gastric cancer in a r and omized controlled trial . PATIENTS AND METHODS After curative resection , stage II-III-IVM0 gastric cancer patients were r and omly assigned to postoperative chemotherapy or surgery alone . 5-Fluorouracil ( 5-FU ) 800 mg/m(2 ) daily ( 5-day continuous infusion ) was initiated before day 14 after resection . One month later , four 5-day cycles of 5-FU ( 1 g/m(2 ) per day ) plus cisplatin ( 100 mg/m(2 ) on day 2 ) were administered every 4 weeks . RESULTS The study was closed prematurely after enrollment of 260 patients ( 79.7 % N+ ) , owing to poor accrual . At 97.8 months median follow-up , 5- and 7-year overall survival were 41.9 % and 34.9 % in the control group versus 46.6 % and 44.6 % in the chemotherapy group ( P=0.22 ) . Cox model hazard ratios were 0.74 [ 95 % confidence interval ( CI ) 0.54 - 1.02 ; P=0.063 ] for death and 0.70 ( 95 % CI 0.51 - 0.97 ; P=0.032 ) for recurrence . An invaded/removed lymph nodes ratio > 0.3 was the main independent poor prognostic factor identified by multivariate analysis ( P=0.0001 ) . Because of toxicity , only 48.8 % of patients received more than 80 % of the planned dose . CONCLUSION There was no statistically significant survival benefit with this toxic cisplatin-based adjuvant chemotherapy , but a risk reduction in recurrence was observed Background Intergroup 0116 ( Southwest Oncology Group 9008 ) , a national , multicenter , two-armed , prospect i ve , r and omized trial of adjuvant postoperative chemoradiotherapy , has demonstrated significant benefit . Methods We prospect ively captured complete surgical information , including the treatment of various lymph node stations , for 553 of the 556 eligible participants in this trial . Before any survival analysis , we coded D level by using the Japanese general rules and used the Maruyama program to estimate the likelihood of disease in undissected regional node stations , defining the sum of these estimates as the Maruyama Index of Unresected Disease ( MI ) . We analyzed survival with Cox multivariate regression  . Results Fifty-four percent of participating patients underwent D0 lymphadenectomy . The median MI was 70 ( range , 0–429 ) . In contrast to D level , MI proved to be an independent prognostic factor , even with adjustment for the potentially linked variables of T stage and number of positive nodes . We detected no significant interaction between surgical or pathologic variables and the favorable effect of adjuvant treatment , but the power to detect such interaction was generally low . Conclusions MI , a measure of unresected regional nodal disease in gastric cancer , proved an independent predictor of survival . Surgical undertreatment , as observed in this trial , clearly undermined survival Although intravenous ( IV ) 5-fluorouracil ( 5-FU ) and uracil/futraful ( UFT ) have comparable antitumour efficacy in the treatment of metastatic colorectal cancer ( MCC ) , we wanted to assess which of these two regimens would be preferred by our patients . We r and omized 20 previously untreated patients with MCC at our centre to receive oral UFT or bolus IV 5-FU both associated with leucovorin . After the first cycle patients were crossed over to the other arm . Before the third cycle we left patients to choose one of the regimens to continue their treatment until disease progression . Two patients chose 5-FU and 18 chose UFT ( P < 0.001 ) . Fewer side effects ( 50 % ) and convenience of home treatment ( 40 % ) were the main reasons for their choice for the oral regimen . UFT induced less mucositis ( P = 0 . 02 ) and diarrhoea ( P = 0 . 01 ) . We conclude that convenience and lower toxicity may explain the observed preference for oral UFT 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 The primary objective was to prospect ively investigate the efficacy and toxicity of bolus 5-fluorouracil ( 5-FU ) chemotherapy compared with the infusional 5-FU in combination with preoperative radiation in patients with locally advanced rectal cancer . Furthermore , in light of previous reports , toxicity profiles between men and women were also compared . Eighty-four consecutive patients with rectal adenocarcinoma were prospect ively treated 
    Output:
    