***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: Objective : The study aim ed at evaluating the activity and toxicity of gemcitabine monochemotherapy in a unselected series of elderly patients with advanced bladder cancer . The secondary objectives were to establish whether there is a correlation between treatment and Comprehensive Geriatric Assessment ( CGA ) and , in addition , to determine overall patient survival . Methods : Treatment consisted of six courses of chemotherapy with gemcitabine at a dosage of 1,200 mg/m2 on days 1 and 8 , every 21 days . CGA , as described by Gruppo Italiano di Oncologia Geriatrica , was assessed for evaluating the functional status of patients before , during , and after treatment . Results : Twenty-five patients were enrolled ( M/F 22/3 ) , 22 of these were evaluable for response and 23 for toxicity . Characteristics of patients : median age 76 years ( range 71–87 ) ; ECOG performance status ( PS ) 1 in 12 patients and 2 in 13 patients ; clinical stage III in 6 patients and IV in 19 patients . At the end of the therapy the parameters of CGA improved in 4 cases ( 17 % ) , remained unchanged in 17 cases ( 74 % ) and worsened only in 2 cases ( 9 % ) . Two patients were not evaluable . Response evaluation showed 3 ( 13.5 % ) complete responses ( CRs ) and 7 ( 32 % ) partial responses ( PRs ) , for an overall response rate of 45.5 % [ 95 % confidence interval ( CI ) , 24.3–65.7 % ] . Three ( 13.5 % ) patients had stable disease ( SD ) and 9 ( 41 % ) disease progression ( DP ) . Median overall survival was 8 months and median time to progression was 5 months . Treatment was generally well tolerated , with 1 patient having grade 3 gastrointestinal toxicity and 3 having grade 4 neutropenia . Conclusions : We conclude that gemcitabine can be safely administered in monochemotherapy , is effective and does not worsen the functional status of elderly patients with advanced bladder cancer PURPOSE To evaluate the efficacy and toxicity of weekly paclitaxel and gemcitabine in patients with advanced transitional-cell carcinoma ( TCC ) of the urothelial tract . PATIENTS AND METHODS Patients with advanced unresectable TCC were enrolled onto this multicenter , community-based , phase II trial . Initially , patients were treated with paclitaxel 110 mg/m(2 ) and gemcitabine 1,000 mg/m(2 ) by intravenous infusion on days 1 , 8 , and 15 every 28 days . Patients who had an objective response or stable disease continued treatment for a maximum of six courses . Paclitaxel was decreased to 90 mg/m(2 ) and gemcitabine was decreased to 800 mg/m(2 ) for the last 12 patients because of a concerning incidence of pulmonary toxicity in the first 24 patients . RESULTS Thirty-six patients were enrolled between September 1998 and March 2003 . Twenty-four patients received the higher doses of paclitaxel and gemcitabine , and 12 patients received the lower doses . Twenty-five ( 69.4 % ) of 36 patients had major responses to treatment , including 15 patients ( 41.7 % ) with complete responses . With a median follow-up time of 38.7 months , the median survival time was 15.8 months . Grade 3 and 4 toxicities included granulocytopenia ( 36.1 % ) , thrombocytopenia ( 8.3 % ) , and neuropathy ( 16.7 % ) . Five patients ( 13.9 % ) had grade s 3 to 5 pulmonary toxicity , and one patient had grade 2 pulmonary toxicity . CONCLUSION Weekly paclitaxel and gemcitabine is an active regimen in the treatment of patients with advanced TCC . However , because of the high incidence of pulmonary toxicity associated with this schedule of paclitaxel and gemcitabine , we recommend against the use of this regimen in this patient population BACKGROUND To investigate a novel schedule of gemcitabine ( G ) , paclitaxel ( P ) , and carboplatin ( C ) , based on pre clinical studies demonstrating greater activity and decreased toxicity of administering P prior to C. MATERIAL / METHODS The effect of the P and C drug sequence on tumor cell viability was assessed with a tetrazolium assay on T24 bladder and DU145 prostate cancer cells . Patients with transitional cell cancer ( TCC ) and other advanced malignancies were treated with G and P on days 1 , 8 , and 15 of each 28 day cycle . C was administered on day 2 at an AUC of 5 . Doses of G and P were varied among cohorts of three patients . RESULTS Pre clinical studies demonstrated that the sequence of P followed by C induced greater cytotoxicity than the reverse sequence . The recommended phase II dose ( RPTD ) was defined as 70 mg/m2 P , 300 mg/m2 G , and C with AUC of 5 . Therapy was well tolerated ; fever and neutropenia occurred in only one patient at the RPTD . Grade 3 thrombocytopenia occurred in 5 of 21 patients treated at the RPTD . Out of all 37 patients treated on study , 9 achieved a partial tumor response ( PR ) and two patients achieved a complete response ( CR ) . Out of the 15 patients with TCC , six had a PR and two had a CR . CONCLUSIONS Pre clinical studies demonstrated that the sequence of paclitaxel followed by carboplatin was more effective than the opposite sequence . Administration of gemcitabine and paclitaxel followed by carboplatin was well tolerated and clinical ly active . GCP should be compared to other combination regimens under investigation for the treatment of TCC Our objective was to determine the response to gemcitabine plus docetaxel in advanced urothelial transitional cell carcinoma in a phase II trial , and gemcitabine distribution between plasma and erythrocytes , following docetaxel administration . Patients with locally advanced or metastatic transitional cell carcinoma , following a maximum of one prior chemotherapy regimen , were given gemcitabine 800 mg/m2 on days 1 and 8 plus docetaxel 85 mg/m2 on day 8 , every 21 days . Gemcitabine was measured in the plasma and erythrocytes of nine patients before and after docetaxel administration . Thirty-four patients ( median 63 years ; range 49–79 years ) , of whom seven had prior chemotherapy and 27 were chemotherapy-naive  , received a median of six cycles ( range 1–6 ) . Complete and partial remissions were observed in two and 16 ( including three pretreated ) patients , respectively , for an overall response rate of 53 % . Median response duration was 5 months ( range 1–39 + ) . Haematoxicity was manageable , despite grade 3 infections in 24 % of patients , but other toxicities were mostly mild . An apparent shift of gemcitabine from plasma to erythrocytes occurred after docetaxel in five of six patients evaluable for this analysis . We conclude gemcitabine plus docetaxel is tolerable and highly active in treated and untreated patients with advanced transitional cell carcinoma BACKGROUND Despite the fact that new drugs have emerged from clinical research in urothelial cancer during the last decade , the prognosis of patients with advanced disease remains poor with a median survival of 12 to 14 months . We design ed a feasibility study of gemcitabine and oxaliplatin ( GO ) in patients with advanced urothelial cancer . PATIENTS AND METHODS Twenty patients received bimonthly cycles of gemcitabine 1500 mg/m2 and oxaliplatin 85 mg/m2 . The cycles were given at 2-week intervals without G-CSF support . Thirteen patients were treated with the GO combination as first-line chemotherapy because of a poor performance status or a creatinine clearance < 1 ml/s . RESULTS The median number of cycles of GO was 5 ( 1 - 7 ) . The median number of days between cycles was 14 throughout the treatment . Seven ( 8 % ) out of 87 cycles had to be delayed because of neutropenia or asthenia . A 25 % dose reduction in the doses of cytotoxic drugs was necessary in 2 patients . Chemotherapy was stopped before the sixth cycle because of an early death related to a myocardial infa rct ion in 1 patient , a grade 3 neuropathy in 1 patient and a progressive disease in 9 patients . CONCLUSION Using these doses and schedules , the GO regimen appears a safe therapy for patients with advanced urothelial cancer . Phase II studies are required to assess the possible role of this combination in advanced urothelial cancer AIM Chemotherapeutic agents are active in transitional cell cancer of the urothelium , and combinations have shown promising results . The objective of this study was to evaluate the palliative chemotherapy with gemcitabine , paclitaxel , and cisplatin for transitional cell carcinoma . METHODS Thirty-four patients with advanced transitional cell carcinoma of the urothelium were treated between 2000 and 2007 . All patients received chemotherapy with intravenous gemcitabine at a dose of 1000 mg/m2 on days I and VIII , intravenous paclitaxel at a dose of 80 mg/m2 on days I and VIII , and intravenous cisplatin at a dose of 50 mg/m2 on day II . Treatment courses were repeated every 21 days . After completion of four to six courses in this regimen an application of intravenous gemcitabine at a dose of 1000 mg/m2 followed repeating every 28 days . RESULTS Twelve patients ( 35.3 % ) had 1 visceral sites of metastases . Twenty two patients ( 64.7 % ) had achieved objective responses to treatment ( 29.4 % complete responses ) . The median actuarial survival was 18.5 months , and the actuarial one-year and two-year survival rates were 56 % and 26 % respectively . After a median follow-up of 16.3 months , 18 patients remained alive . The median progression-free survival was 7 months . Median survival time for patients with ECOG status 0 , 1 , and 2 was 45 , 12 , and 10.5 months respectively . Grade 3 - 4 neutropenia occurred in 41.2 % of patients . CONCLUSIONS The combination of gemcitabine , paclitaxel , and cisplatin is a highly effective and tolerable regimen for patients with advanced transitional cell carcinoma of the urothelium . This treatment should be considered as a suitable option that deserves further prospect i ve evaluation . ECOG performance status and visceral metastases are important predictive factors for survival Clinical trials in urothelial cancer exclude a large population of patients . An observational study evaluated the behavior of frail patients not eligible for  cisplatin- or carboplatin-based regimens  . Urothelial cancer patients requiring chemotherapy with either chronic renal failure ( creatinine clearance < 60 ml/min ) , and /or performance status ( PS ) ≥2 and /or cardiac dysfunction were prospect ively observed . The treatment associated gemcitabine 1200 mg/m2 and oxaliplatin 85 mg/m2 , bimonthly ( GO ) . Over 2 years , 31 of 45 ( 69 % ) patients with urothelial cancer requiring chemotherapy were not eligible for cisplatin- or carboplatin-based chemotherapy . Sixteen ( 52 % ) had a PS ≥2 , 23 ( 74 % ) had creatinine clearance < 60 ml/min , and 20 ( 65 % ) had an underlying cardiopathy . A total of 178 cycles of GO were administered ( median 6 per patient , range 2–12 ) . No aggravation of renal or cardiac status was noted . Acute grade 3 and 4 neutropenia and thrombocytopenia were observed in 16 and 13 % of patients , respectively , with one febrile neutropenia . The median progression-free and overall survival values were 4.2 and 9.5 months , respectively . The majority of urothelial cancer patients have severe renal or cardiac comorbidities , and we conclude that in this subset of patients the combination of gemcitabine and oxaliplatin is well tolerated , and its clinical activity warrants further evaluation PURPOSE To determine the efficacy of gemcitabine and cisplatin combination therapy in patients with advanced and /or metastatic transitional cell urothelial carcinoma . PATIENTS AND METHODS Forty-two chemonaïve patients with Karnofsky performance status ( KPS ) > or = 70 were treated with cisplatin 35 mg/m2 followed by gemcitabine 1000 mg/m2 ( 30 min i.v . infusion ) on days 1 , 8 , and 15 every twenty-eight days . RESULTS Thirty-eight patients were evaluable for efficacy . Half had visceral disease . There were seven complete ( 18 % ) and nine partial responses ( 24 % ) , for a response rate of 42 % ( 95 % confidence interval ( 95 % CI ) : 26%-59 % ) . Responses were independently review ed . Median response duration was 13.5 months ( 95 % CI : 8.5 - 18.1 months ) 
    Output:
    
• Gemcitabine combined chemotherapy is active in the management of metastatic bladder cancer .
• GCis may be considered an alternative regime to MVAC . •