***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: Purpose We aim ed to examine the safety and antitumor effects of a combination of S-1 and paclitaxel in patients with unresectable or recurrent gastric cancer in a phase I/II setting . Patients and methods The study was design ed as a phase I/II clinical trial . In phase I portion , the dose of paclitaxel was escalated to estimate the maximum-tolerated dose ( MTD ) and recommended dose ( RD ) of paclitaxel with fixed dose of S-1 . S-1 ( daily dose , 80 mg/m2 ) was given orally on days 1–21 every 35-day cycle ( rest on days 22–35 ) . Paclitaxel was administered intravenously on days 1 , 8 and 15 , at an initial dose of 40 mg/m2 , stepping up to 70 mg/m2 in 10-mg/m2 increment . Dose-limiting toxicity ( DLT ) was defined as grade 4 hematological toxicity , grade 3 or higher nonhematological toxicity , and treatment discontinuation due to adverse reactions during the first course of treatment . In phase II portion , the efficacy and toxicity at the RD of paclitaxel with S-1 were assessed . Results The MTD of paclitaxel was estimated to be 60 mg/m2 , because > 33.3 % of patients ( 2/3 ) developed DLTs . DLT included postponement of treatment due to grade 2 neutropenia , and grade 3 stomatitis , anorexia , and nausea . Therefore , the RD of paclitaxel was estimated to be 50 mg/m2 . In the phase II portion , 22 patients were evaluated with 50 mg/m2 paclitaxel and 80 mg/m2 S-1 in a 35-day cycle . The response rate was 54.5 % ( 95 % CI , 32.2–75.6 % ) . The median survival time was 283 days ( 95 % CI , 218–508 days ) . The median number of treatment courses was 4 ( range 1–10 ) , indicating that this regimen could be given repeatedly . Conclusions This phase I/II trial of combination therapy with S-1 and paclitaxel in patients with unresectable or recurrent gastric cancer showed that this regimen has substantial antitumor activity and can be given safely Background : A combination of S-1 and cisplatin has been shown to be effective with acceptable safety for the first-line treatment of far-advanced gastric cancer in Japan . This is the first r and omised phase II trial to compare S-1+paclitaxel with S-1+cisplatin in this setting . Methods : Patients with unresectable and /or recurrent advanced gastric cancer were r and omly assigned to receive one of the two regimens : S-1 ( 40 mg m−2 twice daily ) on days 1–14 plus paclitaxel ( 60 mg m−2 ) on days 1 , 8 , and 15 of a 4-week cycle ( S-1+paclitaxel ) or S-1 ( 40 mg m−2 twice daily ) on days 1–21 plus cisplatin ( 60 mg m−2 ) on day 8 of a 5-week cycle ( S-1+cisplatin ) . The primary end point was the response rate ( RR ) . Secondary end points included progression-free survival ( PFS ) , overall survival ( OS ) , and safety . Results : A total of 83 patients were eligible for safety and efficacy analyses . In the S-1+paclitaxel and S-1+cisplatin groups , RRs ( 52.3 % vs 48.7 % ; P=0.74 ) and median PFS ( 9 vs 6 months ; P=0.50 ) were similar . The median OS was similar in the S-1+paclitaxel and S-1+cisplatin groups ( 16 vs 17 months ; P=0.84 ) . The incidence of grade 3 or higher haematological toxicity was 19.0 % with S-1+paclitaxel and 19.5 % with S-1+cisplatin . The incidence of grade 3 or higher non-haematological toxicity was 14.2 % with S-1+paclitaxel and 17.1 % with S-1+cisplatin . Conclusion : S-1+paclitaxel was suggested to be a feasible and effective non-platinum-based regimen for chemotherapy in patients with advanced gastric cancer . Our results should be confirmed in multicenter , phase III-controlled clinical trials The purpose of this study was to evaluate the feasibility and efficacy of 3-hour infusional paclitaxel for the treatment of advanced gastric cancer with measurable metastatic diseases . Eligibility criteria included no more than one regimen of prior chemotherapy .  Paclitaxel was administered as an intravenous infusion over 3 hours at a dose of 210 mg/m2 every 3 weeks . Premedication of dexamethazone , ranitidine , and diphenhydramine were given to all patients . Sixteen patients were registered in the study . One patient did not receive paclitaxel because of gastrointestinal bleeding before the initiation of drug 's administration . Thirteen of the 15 patients had a prior history of chemotherapy .  Although 10 patients ( 67 % ) developed grade 4 neutropenia , no serious infections occurred during the study . Nonhematologic toxicities were generally mild . Three ( 20 % ) patients who showed evidence s of resistance to the previous intensive regimen achieved a partial response . In conclusion , a 3-hour infusion of paclitaxel is a safe and promising treatment for advanced gastric cancer .  Paclitaxel appears to be non-cross resistant to other agents that are commonly used for gastric cancer . A large-scale phase II study is now underway Abstract The aim of this study was to investigate the efficacy and safety of combination chemotherapy with weekly paclitaxel and 5-fluorouracil ( 5-FU ) as first-line treatment in patients with advanced or recurrent gastric carcinoma . A total of 65 patients were treated with the following regimen , administered every 28 days ; 5-FU 600 mg/m2 by 24-hour continuous infusion from days 1 through 5 , and weekly paclitaxel 80 mg/m2 by 3-hour intravenous infusion on days 8 , 14 , and 21 . A total of 272 cycles were conducted with a median of 4 ( 2 - 13 ) cycles per case . Out of 57 patients with measurable disease by RECIST criteria , there were 2 complete responses ( 3.5 % ) , 20 partial responses ( 35.1 % ) and 25 cases with stable disease ( 43.9 % ) . The overall response rate was 38.6 % ( 95%CI : 26.0 - 51.2 % ) . The median survival time and 1-year survival rates were 329 days and 47.4 % , respectively . Both hematologic and non-hematologic toxicities were well tolerated 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 Purpose This Phase II study assessed the activity and safety of biweekly paclitaxel and oral S-1 as treatment for unresectable and recurrent gastric cancer . The maximum tolerated dose for this regimen had been established previously in a Phase I study performed in Japanese patients . Patients and methods Chemotherapy was performed using two anticancer agents , S-1 and paclitaxel . Oral S-1 ( 80 mg/m2 ) was administered twice a day after meals for two consecutive weeks from Day 1 to 14 , followed by a 2 week recovery period ; paclitaxel ( 120 mg/m2 ) was administered intravenously , biweekly , on Days 1 and 15 . The patient received cycles of this regimen every 4 weeks ( q 28-day cycles ) . The primary end point was the response rate according to the Response Evaluation Criteria in Solid Tumors . Results A total of 39 patients ( median age , 65 years ) were enrolled ; 13 other patients were screened , but found to be ineligible . All patients had unresectable and recurrent gastric cancer . The most common treatment-related Grade 3/4 adverse events were neutropenia ( 37.5 % ) , appetite loss , diarrhea , decreased sodium ( each 5 % ) , and anemia , increased alanine aminotransferase , general fatigue , and dizziness ( each 2.5 % ) . Almost all the patients experienced alopecia . Intent-to-treat analysis showed a response rate of 43.6 % . With a median follow-up of 14 months ( range 8–21 months ) , median survival was 256 days and the median time to progression was 4 months . Conclusion A combination regimen of biweekly paclitaxel and oral S-1 was well tolerated and showed promising activity against unresectable and recurrent gastric cancer Background . In an attempt to decrease the toxic effects of fluorouracil , doxorubicin , and methotrexate ( FAMTX ) by reducing the dose of methotrexate from 1500 mg/m2 , according to the original regimen , to 1000 mg/m2 , the authors design ed the modified FAMTX treatment that was evaluated in a prospect i ve Phase II‐III r and omized trial S-1 is a novel oral anticancer drug , composed of tegafur ( FT ) , gimestat ( CDHP ) and otastat potassium ( Oxo ) in a molar ratio of 1:0.4:1 , based on the biochemical modulation of 5-fluorouracil ( 5-FU ) . CDHP inhibits dihydropyrimidine dehydrogenase ( DPD ) , an enzyme which de grade s 5-FU , and maintains prolonged 5-FU concentrations in the blood and tumours . Oxo is distributed in the gastrointestinal tract at a high concentration after oral administration and alleviates gastrointestinal toxicity due to 5-FU . S-1 improves the tumour-selective toxicity of 5-FU by the actions of two modulators , CDHP and Oxo . We conducted a late phase II clinical trial of S-1 as an open trial in patients with advanced gastric cancer , to confirm its antitumour effect and adverse reactions . 51 patients with advanced gastric cancer were enrolled in the trial .  S-1 was administered orally twice daily after meals , at a st and ard dose of 80 mg/m2/day . One course consisted of consecutive administration for 28 days and 14 days ' rest . Administration was repeated over four courses . A complete response was obtained in 1 patient and partial responses in 24 patients , producing a response rate of 49 % ( 25/51 ) ( 95 % confidence interval ( CI ) 35.9 - 62.3 % ) . The incidence of adverse 
    Output:
    
PTX plus S-1 was associated with almost equivalent safety and a lower progressive disease rate compared with PTX plus 5-FU .
PTX plus S-1 is a good alternative strategy for patients who can not tolerate a continuous intravenous infusion