Prospective randomized trial of combined oncological therapy for gastric carcinoma Phase II study of Taxol in patients with advanced gastric carcinoma. Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer. Modified therapy with 5‐fluorouracil, doxorubicin, and methotrexate in advanced gastric cancer Cost-effectiveness of palliative chemotherapy in advanced gastrointestinal cancer. Retrospective comparison of infusional 5-fluorouracil, doxorubicin, and mitomycin-C (modified FAM) combination chemotherapy versus palliative therapy in treatment of advanced gastric cancer. Weekly treatment with irinotecan, folinic acid and infusional 5-fluorouracil (ILF) in patients with advanced gastric cancer Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer.
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 PURPOSE Taxol ( paclitaxel ) represents a new class of anticancer agent with activity against a wide variety of solid tumors . It has been found to be active in patients with adenocarcinoma and squamous cell carcinoma of the esophagus . To determine its activity against gastric adenocarcinoma , we conducted a phase II trial of Taxol in chemotherapy-naive patients with advanced disease . PATIENTS AND METHODS Patients with measurable , unresectable , metastatic gastric carcinoma with performance status < or = 2 by Zubrod scale were eligible . Patients had to have normal liver , renal , and bone marrow functions . Written informed consent was obtained from all patients . The starting dose of Taxol was 200 mg/m2 infused over either 3 hours ( in the first 15 patients ) or 24 hours ( in the subsequent 18 patients ) . Taxol was repeated every 21 days . Response was evaluated after two courses . RESULTS Thirty-three patients were registered . The median number of courses was two ( range , 1 to 12 ; total , 112 courses ) . Thirty patients were evaluable for response and toxicity . Among the first 15 patients ( two inevaluable ) receiving Taxol over 3 hours , there were one partial response ( PR ) ( one of 13 patients , or 8 % ; 95 % confidence interval , 0 % to 36 % ) and three minor responses ( MRs ) . However , among the 18 patients ( one inevaluable ) receiving Taxol over 24 hours , there were four PRs ( four of 17 patients or 23 % ; 95 % confidence interval , 7 % to 50 % ) and three MRs . The overall PR rate was 17 % ( five of 30 patients ; 95 % confidence interval , 6 % to 35 % ) . The median duration of PR was 6.5 months ( range , 2.3 months to 11.3 + months . There were no treatment-related deaths . Myelosuppression was more severe with the 24-hour schedule than with the 3-hour schedule . CONCLUSIONS Taxol has a modest degree of activity against gastric carcinoma . It is well tolerated by the patients . Further studies of Taxol in combination with other active agents against gastric carcinoma should be considered 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 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 BACKGROUND Chemotherapy may relieve tumor-related symptoms , may improve quality of life and prolong survival in advanced gastrointestinal cancer . The extent of such improvements is unclear despite the extensive use of this treatment modality , and there are no studies concerning the economic cost of any gain achieved in the quantity and quality of life by chemotherapy . PATIENTS AND METHODS Between January 1991 and May 1992 , 61 patients with inoperable cancer ( 18 gastric , 22 pancreatic or biliary , and 21 colorectal ) were r and omized to either primary chemotherapy in addition to best supportive care or to best supportive care . Chemotherapy was allowed in the latter group if the supportive measures did not achieve palliation . All economic costs for medical care were prospect ively recorded , and marginal cost-effectiveness analyses were performed . RESULTS More patients in the primary chemotherapy group ( 19/33 , 58 % ) had improved/prolonged high quality of life ( QoL-patient , minimum duration 4 months ) than in the best supportive care group ( 8/28 , 29 % , p < 0.05 ) . Overall survival and quality -adjusted survival were significantly longer in the primary chemotherapy group ( median 9 vs. 4 months , p < 0.05 ) , and median 7 vs. 2 months , p < 0.05 , respectively ) . When analysed by cancer site , survival was significantly prolonged in gastric cancer patients ( median 10 vs. 4 months , p < 0.02 ) , but not in colorectal ( median 12 vs. 6 months , p = 0.1 ) and pancreatic-biliary cancer patients ( median 8 vs. 5 months , p = 0.8 ) . The average cost for all medical care was approximately 50 % higher in the primary chemotherapy group , but the average cost per day was the same in the two groups . Hospitalization accounted for most of the costs in both groups . The incremental costs per gained year of life was SEK 166,400 ( $ 21,300 ) , per gained quality -adjusted year of life SEK 157,200 ( $ 20,200 ) , and per QoL-patient SEK 160,300 ( $ 20,600 ) . These costs were lower for gastric and colorectal cancer patients , and much higher for pancreatic-biliary cancer patients . CONCLUSIONS The results of this study suggest that palliative chemotherapy is cost-effective in patients with advanced gastric and colorectal cancer . Knowledge about survival and quality of life benefits is still limited in patients suffering from gastric and pancreatic-biliary cancer About one-third of patients with gastric cancer are unresectable at the time of diagnosis . Their median survival is < 6 months , with a grave prognosis . The purpose of this study was to assess the efficacy of a modified FAM ( mFAM ) regimen in advanced gastric cancer . We retrospectively review ed the clinical records of 409 advanced gastric cancer patients who had not received curative surgery . Among 409 patients , 202 patients were treated with an mFAM regimen ( infusional 5-FU + doxorubocin + mitomycin-C )  , and 207 patients received no chemotherapy ( control group ) .  No differences were found in clinical parameters between the two groups . The 1-year survival rates were 34.1 % for the mFAM-treated group and 22.5 % for the control group ( p = 0.0135 ) . In subset analysis , a higher 1-year survival rate was demonstrated in patients with mFAM and palliative surgery . Of the 154 evaluable patients in the mFAM-treated group , the response rate was 17.5 % . In these patients , median response duration was 30 weeks , and progression-free survival was 23 weeks . Overall toxicity of mFAM regimen was relatively tolerable and reversible . In conclusion , FAM combination chemotherapy , which has been used as a st and ard therapy , prolonged survival after modification of the administration schedule and combination with palliative surgery . A prospect i ve r and omized study is warranted to confirm this conclusion from our retrospective study Although 5-fluorouracil remains the mainstay of treatment for advanced gastric cancer ( AGC ) , no st and ard chemotherapy regimen exists . Combinations of irinotecan with folinic acid and infusional 5-fluorouracil ( 5-FU ) ( ILF ) have shown good efficacy with acceptable toxicity in patients with metastatic colorectal cancer . At present , only sparse data on ILF are available for AGC . Therefore we conducted a prospect i ve study of this combination in 25 consecutive patients with metastatic gastric cancer . Median age was 63 years , 10 had received prior chemotherapy and 13 presented initially with peritoneal carcinosis . Treatment consisted of irinotecan 80 mg/m2 , folinic acid 500 mg/m2 and infusional 5-FU 2.0 g/m2 over 24 h , given weekly for 6 weeks followed by a 1-week rest . Grade 3/4 hematologic toxicity occurred in six patients ( anemia = 4 , neutropenia = 1 and leukopenia = 1 ) . Non-hematologic toxicity consisted mainly of nausea/vomiting ( grade 3/4 in six patients ) and diarrhea ( grade 3/4 in 10 patients ) . The overall response rate was 20 % for first- and second-line treatment , with two complete and three partial responses . Another nine patients ( 36 % ) had stable disease , for a tumor control rate of 56 % . Median time to progression was 4 months , median overall survival and survival for patients with tumor control was 7 and 13 months , respectively . We conclude that ILF is a feasible outpatient regimen with manageable toxicity that provides tumor control in a high proportion of patients with advanced gastric cancer , even among those with unfavorable prognostic features BACKGROUND The extent to which chemotherapy may relieve tumour-related symptoms , improve quality of life and prolong survival in patients with gastric cancer is not known in spite of the extensive use of this treatment modality . The aim of this study was to estimate any gain in the quantity and quality of life produced by chemotherapy in these patients . PATIENTS AND METHODS Between January 1991 and February 1995 , 61 patients with gastric cancer were r and omized to either chemotherapy in addition to best supportive care or to best supportive care . Chemotherapy was allowed in the latter group if the supportive measures did not lead to palliation . Chemotherapy was the ELF-regimen consisting of 5-fluorouracil , leucovorin and etoposide , or , in elderly patients with poor performance , a 5-fluorouracil/leucovorin regimen ( FLv ) .  Quality of life was evaluated with the EORTC-QLQ-C30 instrument . RESULTS More patients in the chemotherapy group ( 45 % , 14/31 ) had an improved or prolonged high quality of life for a minimum period of 4 months compared to those in the best supportive care group ( 20 % , 6/30 , P < 0.05 ) . A similar difference was seen in the treating physician 's evaluation of whether the patient was subjectively improved or continued to do well for at least 4 months ( 17/31 , 55 % versus 6/30 , 20 % , P < 0.01 ) . Overall survival was longer in the chemotherapy group ( median 8 vs. 5 months ) although the difference was not statistically significant ( P = 0.12 ) . After corrections for imbalances in pretreatment characteristics , chemotherapy treatment was , however , associated with a survival benefit ( P = 0.003 ) . Also , the quality -adjusted survival time and time to disease progression were longer for patients r and omized to chemotherapy ( median 5 vs. 2 months , P = 0.03 ) . CONCLUSIONS The results show that chemotherapy can add to both quantity and quality of life in advanced gastric cancer . The number of patients who benefit from treatment is , however , still rather limited
The aim of the present study was to compare the efficacy of chemotherapy and support treatment in patients with advanced non-resectable gastric cancer in a systematic review and meta- analysis of r and omized clinical trials that included a comparison of chemotherapy and support care treatment in patients diagnosed with gastric adenocarcinoma , regardless of their age , gender or place of treatment .