***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: Abstract Objective : To compare chemotherapy given at home with outpatient treatment in terms of  colorectal cancer patients ' safety , compliance , use of health services , quality of life , and satisfaction with treatment . Design : R and omised controlled trial . Setting : Large teaching hospital . Participants : 87 patients receiving adjuvant or palliative chemotherapy for colorectal cancer . Interventions : Treatment with fluorouracil ( with or without folinic acid or levamisole ) at outpatient clinic or at home . Main outcome measures : Treatment toxicity ; patients ' compliance with treatment , quality of life , satisfaction with care , and use of health re sources . Results : 42 patients were treated at outpatient clinic and 45 at home . The two groups were balanced in terms of age , sex , site of cancer , and disease stage . Treatment related toxicity was similar in the two groups ( difference 7 % ( 95 % confidence interval −12 % to 26 % ) ) , but there were more voluntary withdrawals from treatment in the outpatient group than in the home group ( 14 % v 2 % , difference 12 % ( 1 % to 24 % ) ) . There were no differences between groups in terms of quality of life scores during and after treatment . Levels of patient satisfaction were higher in the home treatment group , specifically with regard to information received and nursing care . There were no significant differences in use of health services . Conclusions : Home chemotherapy seemed an acceptable and safe alternative to hospital treatment for patients with colorectal cancer that may improve compliance and satisfaction with treatment . What is already known on this topic Home chemotherapy programmes have been proposed as an alternative to hospital treatment However , they are more costly , and there is little evidence on their impact on outcomes such as compliance , quality of life , or use of other health services What this study adds Home chemotherapy was not associated with an increased use of health services such as primary care or emergency departments Home chemotherapy had no effect on patients ' quality of life but increased their compliance with treatment and satisfaction , particularly with regard to nursing care Home chemotherapy seems an acceptable and safe alternative to outpatient treatment that may improve compliance with Significant morbidity and expense result from frequent recurrences of nonmuscle-invasive bladder cancer ( NMIBC ) after st and ard treatment , and carcinoma in situ ( Tis ) is a poor prognostic factor . Predicated on observational and pre clinical data strongly supporting cyclooxygenase-2 ( COX-2 ) in the pathogenesis , and the activity of COX-2 inhibitors , in bladder cancer , we conducted a r and omized , double-blind , placebo-controlled trial to determine whether celecoxib could reduce the time-to-recurrence ( TTR ) in NMIBC patients at high risk for recurrence . A total of 146 patients were r and omized to celecoxib ( 200 mg ) or placebo orally twice daily for at least 12 months . The average treatment duration was 1.25 years . Primary intent-to-treat analysis revealed celecoxib did not statistically significantly prolong TTR compared with placebo ( P = 0.17 , log rank ) with a median follow-up of 2.49 years . The recurrence-free rate at 12 months with celecoxib was 88 % ( 95 % CI : 0.81–0.96 ) versus 78 % ( 95 % CI : 0.69–0.89 ) with placebo . After controlling for covariates with Cox regression analysis , recurrence rates did not differ between the two study arms ( HR = 0.69 ; 95 % CI : 0.37–1.29 ) . However , celecoxib had a marginally significant effect on reducing metachronous recurrences ( vs. placebo ) with HR of 0.56 ( 95 % CI : 0.3–1.06 ; P = 0.075 ) . Celecoxib was well tolerated , with similar adverse events and quality -of-life in both arms . Our clinical trial results do not show a clinical benefit for celecoxib in preventing NMIBC recurrence but further investigation of COX-2 inhibitors in this setting is warranted . Cancer Prev Res ; 4(10 ) ; 1580–9 . © 2011 AACR PURPOSE Bacillus Calmette-Guérin and intravesical chemotherapy represent viable adjuvant options for intermediate risk nonmuscle invasive bladder cancer . Although bacillus Calmette-Guérin is perceived as less tolerable than intravesical chemotherapy , to our knowledge no comparative studies have addressed quality of life issues . We compared the quality of life of patients with nonmuscle invasive bladder cancer who received adjuvant intravesical gemcitabine or 1/3 dose bacillus Calmette-Guérin . MATERIAL S AND METHODS Our multicenter , prospect i ve , r and omized , phase II study included 120 patients with intermediate risk nonmuscle invasive bladder cancer . Of these patients 88 remained assessable at 1-year followup . Only 1 patient was withdrawn because of adverse events . Overall 61 patients received 2,000 mg/50 cc gemcitabine weekly for 6 weeks ( maintenance monthly for 1 year ) while 59 received 1/3 dose bacillus Calmette-Guérin Connaught weekly for 6 weeks ( maintenance 3 weekly instillations at 3 , 6 and 12 months ) . Quality of life was measured by the EORTC QLQ-C30 ( European Organization for the Research and Treatment of Cancer Quality of Life Question naire Core 30 version 3.0 ) and QLQ-BLS24 ( Quality of Life Superficial Bladder Cancer-Specific 24 ) question naires . Group differences were calculated using ANOVA ( ANOVA/MANOVA ) . RESULTS Treatment was well tolerated in both groups , although local and systemic side effects were more frequently reported in the bacillus Calmette-Guérin arm . Multivariate analyses showed no significant differences between the 2 groups in all quality of life dimensions . No significant changes over time in quality of life domains were detected for patients on bacillus Calmette-Guérin and gemcitabine except for physical functioning , which decreased significantly in both groups ( p = 0.002 ) . No significant differences were detected in terms of recurrence and progression between the 2 groups at 1-year followup . CONCLUSIONS While a higher rate of side effects , albeit mild to moderate , was detected with 1/3 dose bacillus Calmette-Guérin compared to gemcitabine , our study failed to show significant differences between the 2 drugs in terms of quality of life Background Bacillus Calmette-Guérin ( BCG ) is considered the most effective treatment to reduce recurrence and progression of non-muscle invasive bladder cancer ( NMIBC ) but can induce local side effects leading to treatment discontinuation or interruption . Aim of this exploratory study is to investigate if the sequential administration of Hyaluronic acid ( HA ) may reduce local side effects of BCG . Methods 30 consecutive subjects undergoing BCG intravesical administration for high risk NMIBC were r and omized to receive BCG only ( Group A ) or BCG and HA ( Group B ) . A 1 to 10 Visual Analog Scale ( VAS ) for bladder pain , International Prostate Symptom Score ( IPSS ) and number of micturitions per day were evaluated in the two groups before and after six weekly BCG instillations . Patients were also evaluated at 3 and 6 months by means of cystostopy and urine cytology . Results One out of 30 ( 3,3 % ) patients in group A dropped out from the protocol , for local side effects . Mean VAS for pain was significantly lower in group B after BCG treatment ( 4.2 vs. 5.8 , p = 0.04 ) . Post vs. pre treatment differences in VAS for pain , IPSS and number of daily micturitions were all significantly lower in group B. Three patients in group A and 4 in group B presented with recurrent pathology at 6 month follow up . Conclusions These preliminary data suggest a possible role of HA in reducing BCG local side effects and could be used to design larger r and omized controlled trials , assessing safety and efficacy of sequential BCG and HA administration . Trial registration NCT02207608 ( Clinical Trials.gov ) 01/08/2014Policlinico Tor Vergata Ethics Committee , resolution n 69–2011 Abstract Objective The aim of the study was to evaluate the impact of  transurethral resection of bladder tumour ( TURBT )  on patients ’  quality of life ( QoL ) and to vali date a tool to quantify problems associated with TURBT  in a Danish population . Material s and methods A prospect i ve study was carried out using a combination of question naires and interviews . The study included 165 consecutive patients undergoing a TURBT owing to non-muscle-invasive bladder cancer ( NMIBC ) from 1 May 2011 to 30 April 2012 . Seven patients were selected for interviews . The Danish translation of the QLQ-NMIBC24 Quality of Life Question naire for NMIBC , from the European Organisation for Research and Treatment of Cancer ( EORTC ) , was used . The interviews were semi-structured . The reliability of the subscales quantifying QoL as defined by the EORTC was tested by computing Cronbach ’s coefficient alpha and confirmatory factor analysis . The interviews were analysed using the phenomenological method . Results The question naire was returned by 121 ( 77 % ) patients at a mean of 12 days after hospital discharge . Over half had substantial voiding problems and one-third had emotional concerns . These results were confirmed by the interviews . The mean ± SD score for urinary symptoms was 45.21 ± 23.9 and the mean score for the future worries subscale was 39.9 ± 29.9 . Cronbach ’s coefficient alpha was 0.84 for the urinary symptom subscale and 0.93 for the future worries subscale , which satisfied the reliability criterion for clinical use . Conclusions This first prospect i ve study on QoL following TURBT in patients with NMIBC shows that TURBT has a significant impact on QoL. The Danish version of the EORTC question naire QLQ-NMIBC24 has been vali date d and confirmed in a Danish population OBJECTIVES We carried out a prospect i ve , r and omized , controlled trial to investigate the efficacy and safety of both induction and maintenance therapy with intravesical instillation of bacillus Calmette-Guérin ( BCG ) for high-risk non-muscle invasive bladder cancer ( NMIBC ) . METHODS Intravesical instillation of 80 mg Tokyo strain was given to patients with high-risk NMIBC , including carcinoma in situ ( CIS ) , once weekly for eight consecutive weeks as induction therapy . Patients who achieved complete response ( CR )  were r and omly assigned to either the maintenance group or the observation group . RESULTS A total of 90 patients were enrolled . After induction therapy , 75 % of the patients achieved CR and 53 of them were enrolled in the r and omized comparative phase . A total of four maintenance instillations were given . Median follow-up was 26.5 and 28.7 months after r and omization in the maintenance and the observation group , respectively . Although it was not statistically significant , the 2-year recurrence-free survival rate in the maintenance group ( 95.8 % ) was higher than that in the observation group ( 74.1 % , P = 0.078 ) . Univariate analysis identified maintenance therapy as a significant factor influencing recurrence . During induction therapy , 82.2 % of patients experienced urination-related adverse drug reactions , but most events were not serious . There were fewer adverse drug reactions with maintenance therapy than with induction therapy . Neither induction therapy nor maintenance therapy reduced patients ' quality of life ( QOL ) . CONCLUSIONS These findings show high levels of efficacy and safety of BCG induction treatment for high-risk NMIBC , and suggest that the number of maintenance instillations could probably be reduced without reducing treatment efficacy or influencing QOL PURPOSE In the treatment of cancer the subjective evaluation of therapy induced side effects and quality of life must be considered . Adjuvant intravesical bacillus Calmette-Guerin ( BCG ) immunotherapy is regarded as highly effective but associated with significant side effects . To clarify whether these side effects significantly impact on patient satisfaction with life , a prospect i ve survey of the health related quality of life and side effects was performed during an intravesical BCG treatment course . MATERIAL S AND METHODS Symptoms and side effects were recorded daily during the 6-week instillation period in 30 patients . The quality of life was determined before , during and after intravesical therapy with the assistance of a self-reported question naire . RESULTS Due to a detailed subjective assessment of side effects , the course of local symptoms could be characterized with great reliability . Although side effects occurred , satisfaction with life in the patients studied was high and was not impaired during the treatment . The incidence of side effects correlated well with patient subjective evaluation of quality of life . CONCLUSIONS Assessment of side effects and quality of life , as presented in this pilot study , can assist in the quantification of localized symptoms in intravesical therapy could contribute to the comparability of clinical studies . With regard to intravesical BCG immunotherapy , our results suggest that the specific side effects do not seriously impair satisfaction with life in these patients PURPOSE We studied the safety , tolerability and pharmacokinetics of a single immediate post-transurethral resection intravesical instillation of apaziquone for patients with nonmuscle invasive bladder cancer . MATERIAL S AND METHODS Patients with cTa-T1 , G1-G2 urothelial cell carcinoma of the bladder underwent transurethral 
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The EORTC QLQ-C30 plus the NMIBC24 module was best aligned to the conceptual model , but failed to represent six outcomes important to NMIBC patients .
Conclusions Currently , some outcomes important in NMIBC are inadequately covered by generic and cancer-specific measures despite similar conceptual models .
This review identified gaps in the literature regarding assessment of symptoms and other PROs considered important by NMIBC patients .