***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: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results BACKGROUND Neutropenia is common in patients receiving myelotoxic chemotherapy .  Pegfilgrastim , a sustained- duration filgrastim is a once-per-cycle therapy for prophylactic neutrophil support . PATIENTS AND METHODS Women , treated with four cycles of doxorubicin/docetaxel chemotherapy every 21 days , received pegfilgrastim or filgrastim 24 h after chemotherapy as a single subcutaneous injection per chemotherapy cycle ( pegfilgrastim 30 , 60 or 100 microg/kg ) or daily subcutaneous injections ( filgrastim 5 microg/kg/day ) . Safety , efficacy and pharmacokinetics were analyzed . RESULTS The incidence of grade 4 neutropenia in cycle 1 was 95 , 90 and 74 % , in patients who received pegfilgrastim 30 , 60 and 100 microg/kg , respectively , and 76 % in patients who received filgrastim .  Mean duration of grade 4 neutropenia in cycle 1 was 2.7,2 and 1.3 days for doses of pegfilgrastim , and 1.6 days for filgrastim . The pharmacokinetics of pegfilgrastim were non-linear and dependent on both dose and neutrophil count . Pegfilgrastim  serum concentration was sustained until the neutrophil nadir occurred then declined rapidly as neutrophils started to recover , consistent with a self-regulating neutrophil-mediated clearance mechanism . The safety profiles of pegfilgrastim and filgrastim were similar . CONCLUSIONS A single subcutaneous injection of pegfilgrastim 100 microg/kg provided neutrophil support and a safety profile comparable to daily subcutaneous injections of filgrastim during multiple chemotherapy cycles In order to evaluate the potential clinical and economic benefits of granulocyte colony-stimulating factor ( G-CSF , filgrastim ) following peripheral blood progenitor cells ( PBPC ) rescue after high-dose chemotherapy ( HDCT ) , 23 consecutive patients aged less than 60 years with poor-prognosis , high- grade non-Hodgkin 's lymphoma ( NHL ) were entered into a prospect i ve r and omized trial between May 1993 and September 1995 . Patients were r and omized to receive either PBPC alone ( n = 12 ) or PBPC+G-CSF ( n = 11 ) after HDCT with busulphan and cyclophosphamide . G-CSF ( 300 microg day[-1 ] ) was given from day + 5 until recovery of granulocyte count to greater than 1.0 x 10(9 ) l(-1 ) for 2 consecutive days . The mean time to achieve a granulocyte count > 0.5 x 10(9 ) l(-1 ) was significantly shorter in the G-CSF arm ( 9.7 vs 13.2 days ; P<0.0001 ) as was the median duration of hospital stay ( 12 vs 15 days ; P = 0.001 ) . In addition the recovery periods ( range 9 - 12 vs 11 - 17 days to achieve a count of 1.0 x 10(9 ) l[-1 ] ) and hospital stays ( range 11 - 14 vs 13 - 22 days ) were significantly less variable in patients receiving G-CSF in whom the values clustered around the median . There were no statistically significant differences between the study arms in terms of days of fever , documented episodes of bacteraemia , antimicrobial drug usage and platelet/red cell transfusion requirements . Taking into account the costs of total occupied-bed days , drugs , growth factor usage and haematological support , the mean expenditure per inpatient stay was pound sterling 6500 ( range pound sterling 5465-pound sterling 8101 ) in the G-CSF group compared with pound sterling 8316 ( range pound sterling 5953-pound sterling 15,801 ) in the group not receiving G-CSF , with an observed mean saving of 1816 per patient ( or 22 % of the total cost ) in the G-CSF group . This study suggests that after HDCT and PBPC rescue , the use of G-CSF leads to more rapid haematological recovery periods and is associated with a more predictable and shorter hospital stay . Furthermore , and despite the additional costs for G-CSF , these clinical benefits are not translated into increased health care expenditure Summary : A phase III , r and omized , double-blind , placebo-controlled , multi-center trial was conducted in order to compare the incidence of microbiologically defined infections occurring after high-dose chemotherapy ( HDT ) and ASCT in 98 patients given lenograstim ( Granocyte ® ) and 94 patients given placebo after transplantation . Hematopoietic recovery , the use of i.v . antibiotics , the numbers of red blood cell and platelet transfusions , the days spent in hospital , and the days on parenteral nutrition were also compared . The incidence of infections until neutrophil recovery was significantly less in patients who received lenograstim after HDT and ASCT as compared to patients who received placebo ( 66 of 98 vs 86 of 94 patients , P<0.001 ) . Lenograstim also significantly reduced the use of i.v . antibiotics ( P<0.001 ) and the median duration of i.v . antibiotic treatment ( 8 days vs 10 days , P=0.04 ) , improved neutrophil recovery ( absolute neutrophil count > 0.5 × 109/l : 11 days vs 15 days , P<0.001 ) and reduced the number of days spent in hospital ( 15 days vs 17 days , P<0.001 ) . The administration of lenograstim after HDT and ASCT significantly reduces the incidence of microbiologically defined infections until neutrophil recovery . It also leads to less use of antibiotics and earlier discharge from hospital PURPOSE The aim of this prospect i ve r and omized trial was to examine the efficacy and safety of filgrastim after high-dose chemotherapy and autologous bone marrow transplantation ( ABMT ) . PATIENTS AND METHODS Patients with poor-risk non-Hodgkin 's lymphoma or relapsed Hodgkin 's disease were treated in a r and omized , open-label trial to study the use of filgrastim as an adjunct to high-dose chemotherapy and ABMT . Of 43 assessable patients , 19 were r and omized to receive filgrastim by continuous subcutaneous infusion at a dose of 10 micrograms/kg/d , 10 to filgrastim 20 micrograms/kg/d , and 14 to a parallel control group that received no filgrastim after ABMT . RESULTS For all filgrastim-treated patients analyzed together , the median time to neutrophil recovery > or = 0.5 x 10(9)/L after the day of ABMT was significantly accelerated to 10 days compared with 18 days in control patients ( P = .0001 ) . The median number of platelet transfusions was identical in both groups . Clinical parameters , including the median number of days with fever ( 1 v 4 , P = .0418 ) and neutropenic fever ( 5 v 13.5 , P = .0001 ) were significantly shorter in the filgrastim than in the control group . The number of days on intravenous antibiotics and duration of hospitalization were also shorter in the treated groups ; however , the differences did not reach statistical significance . For patients treated with the two different dose levels of filgrastim , the neutrophil recovery and clinical results were similar .  Filgrastim-associated toxicity appeared to be minimal , with five adverse events considered at least possibly related to filgrastim : two in the higher-dose group and three in the lower-dose group . All of these were rated moderate , except one case of severe bone pain that did not preclude continued filgrastim treatment at a lower dose . Survival and relapse-free survival were similar for control and filgrastim-treated patients . CONCLUSION Taken together , the results of this first r and omized study support the role of filgrastim given as an adjunct to ABMT in accelerating neutrophil recovery , as well as in reducing treatment-related morbidity and overall duration of the treatment procedure BACKGROUND TAC ( docetaxel/doxorubicin/cyclophosphamide ) is associated with high incidences of grade 4 neutropenia and febrile neutropenia ( FN ) . This analysis compared the efficacies of four regimens for primary prophylaxis of FN and related toxic effects in breast cancer patients receiving neoadjuvant TAC . PATIENTS AND METHODS Patients with stage T2-T4 primary breast cancer were scheduled to receive 6 - 8 cycles of TAC .  Primary prophylaxis was : ciprofloxacin 500 mg orally twice daily on days 5 - 14 ( n = 253 patients ; 1478 cycles ) , daily granulocyte colony-stimulating factor ( G-CSF ) ( filgrastim 5 microg/kg/day or lenograstim 150 microg/m(2)/day ) on days 5 - 10 ( n = 377 ; 2400 cycles ) , pegfilgrastim 6 mg on day 2 ( n = 305 ; 1930 cycles ) , or pegfilgrastim plus ciprofloxacin ( n = 321 ; 1890 cycles ) . RESULTS Pegfilgrastim with/without ciprofloxacin was significantly more effective than daily G-CSF or ciprofloxacin in preventing FN ( 5 % and 7 % versus 18 % and 22 % of patients ; all P < 0.001 ) , grade 4 neutropenia , and leukopenia .  Pegfilgrastim plus ciprofloxacin completely prevented first cycle FN ( P < 0.01 versus pegfilgrastim alone ) and fatal neutropenic events . CONCLUSION Ciprofloxacin alone , or daily G-CSF from day 5 - 10 ( as in common practice ) , provided suboptimal protection against FN and related toxic effects in patients receiving TAC . Pegfilgrastim was significantly more effective in this setting , especially if given with ciprofloxacin The management of older patients with aggressive non-Hodgkin 's lymphoma presents a challenge to the physician . Age is a poor prognostic indicator , due to reduced ability to tolerate and maintain dose-intensive chemotherapy . Generally , older patients demonstrate a lower response rate , reduced survival and increased toxicity , although the majority of large r and omised trials exclude older patients . This r and omised trial was conducted in patients 60 years or over to compare CHOP ( cyclophosphamide 750 mg m−2 , doxorubicin 50 mg m−2 , vincristine 1.4 mg m−2 , prednisolone 100 mg ) with PMitCEBO ( mitoxantrone 7 mg m−2 , cyclophosphamide 300 mg m−2 , etoposide 150 mg m−2 , vincristine 1.4 mg m−2 , bleomycin 10 mg m−2 and prednisolone 50 mg ) . Due to the myelosuppressive nature of these regimens , patients were also r and omised to the addition of G-CSF . The formal results of this trial with long-term follow-up are now reported . Data were analysed to assess efficacy and toxicity . Overall response rate was 84 % in the CHOP arm and 83 % in the PMitCEBO arm , with overall response rates of 83 % for the use of G-CSF and 84 % for no G-CSF . At median 44 months follow-up , there was no significant difference in failure-free , progression-free or overall survival between the CHOP and PMitCEBO arms . At 3 years , the actuarial failure-free survival was 44 % in CHOP recipients and 42 % in PMitCEBO recipients and the 3-year actuarial overall survival was 46 % and 45 % respectively . There was no significant difference in the failure-free , progression-free or overall survival with the 
    Output:
    
Both trials showed non-significant results favouring antibiotics for the prevention of fever or hospitalisation for febrile neutropenia .
AUTHORS ' CONCLUSIONS There is no evidence for or against antibiotics compared to G(M)-CSFs for the prevention of infections in cancer patients