***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: BACKGROUND The aim of the study was to analyse the toxicity and health related quality of life ( HRQoL ) of breast cancer patients treated with FAC ( 5-fluorouracil , doxorubicin , cyclophosphamide ) and TAC ( docetaxel , doxorubicin , cyclophosphamide ) with and without primary prophylactic G-CSF ( PPG ) .  PATIENTS AND METHODS This was a phase III study to compare FAC and TAC as adjuvant treatment of high-risk node-negative breast cancer patients . After the entry of the first 237 patients , the protocol was amended to include PPG in the TAC arm due to the high incidence of febrile neutropenia . A total of 1047 evaluable patients from 49 centres in Spain , two in Pol and and four in Germany were included in the trial .  Side-effects and the scores of the EORTC QLQ-C30 and QLQ BR-23 question naires were compared in the three groups ( FAC , TAC pre-amendment and TAC post-amendment ) . RESULTS The addition of PPG to TAC significantly reduced the incidence of neutropenic fever , grade 2 - 4 anaemia , asthenia , anorexia , nail disorders , stomatitis , myalgia and dysgeusia . Patient QoL decreased during chemotherapy , more with TAC than FAC , but returned to baseline values afterwards . The addition of PPG to TAC significantly reduced the percentage of patients with clinical ly relevant Global Health Status deterioration ( 10 or more points over baseline value ) at the end of chemotherapy ( 64 % versus 46 % , P<0.03 ) . CONCLUSIONS The addition of PPG significantly reduces the incidence of neutropenic fever associated with TAC chemotherapy as well as that of some TAC-induced haematological and extrahaematological side-effects . The HRQoL of patients treated with TAC is worse than that of those treated with FAC but improves with the addition of PPG , particularly in the final part of chemotherapy treatment Abstract Background . From March 1994 to March 1998 , breast cancer patients ( an estimated relapse risk with 70 % or more within five years with st and ard therapy ) were r and omised to treatment with tailored fluorouracil , epirubicin , and cyclophosphamide ( FEC ) therapy or FEC followed by marrow-supported high dose therapy in the Sc and inavian Breast Group 9401 study . The aim of the present paper was to investigate differences in toxicity and eight health-related quality of life ( HRQoL ) variables ( physical functioning , role functioning , emotional functioning , social functioning , cognitive functioning , fatigue , nausea-vomiting , and global quality of life ) between women in the six dose steps used in the tailored and granulocyte colony stimulating factor supported FEC-arm at the assessment point 16 weeks after r and om assignment to treatment . Methods . The European Organization and Treatment of Cancer Quality of Life Question naire EORTC QLQ-C30 were mailed to the patients . Results . A total of 157 ( 87 % ) in the tailored FEC-group  responded to the question naire within the time frame 16 weeks after inclusion in the study . Overall , toxicity was low , reaching grade 1–2 also in the higher dose steps . There were no overall differences between the dose steps on any of the tested HRQoL variables . Patients at dose step 4 scored statistically significantly higher on physical functioning than patients at dose step 1 ( p = 0.022 ) and compared to those at dose step 2 ( p = 0.014 ) . Patients at dose steps −2 and −1 ( combined to one group ) reported statistically significantly higher mean scores on cognitive functioning than patients at dose step 1 ( p = 0.022 ) . Conclusion . Patients who received higher doses , based on the tailored dosing strategy , did not seem to have worse HRQoL than those who had lower doses BACKGROUND The mouth is the most common site for measuring temperature . Oral mucositis may affect up to 40 % of patients who receive chemotherapy .  Thus far , mucositis has not been studied with regard to accurate thermometry . METHODS One hundred consecutive patients ( 25 per group ) were self-referred on the basis of perception of mucositis , temperature measurement at home , or malaise or were referred by a nurse on the basis of an assessment of a potential infectious process and /or mucositis .  Oral and tympanic temperature were assessed simultaneously in patients with no fever and no mucositis ( group A ) , those with mucositis ( group B ) , those with fever and no mucositis ( group C ) , and those with neutropenia but not fever or mucositis ( group D ) . RESULTS The 4 groups of patients had higher oral temperatures than tympanic temperatures ( group A , 36.9 degrees C vs. 36.8 degrees C [ delta = 0.12 degrees C ; P = .062 ] ; group B , 38.0 degrees C vs. 37.1 degrees C [ delta = 0.89 degrees C ; P < .001 ] ; group C , 38.7 degrees C vs. 38.4 degrees C [ delta = 0.27 degrees C ; P < .001 ] ; and group D , 37.0 degrees C vs. 36.7 degrees C [ delta = 0.27 degrees C ; P < .001 ] ) . Scheffe a-posteriori test revealed that only the delta temperature in group B differed significantly ( 95 % confidence limits , -2.471 , -1.584 ; P < .001 ) . A linear regression model that examined the effect of other variables on the delta temperature found that only mucositis was a significant factor ( 95 % confidence limits , 0.582 , 0.820 ; P < .001 ) . CONCLUSIONS Mucositis causes an increase in oral temperature but does not elevate systemic body temperature , thereby casting doubt on the diagnosis of infection . Conceivably , mucositis may provide an " inflammation bias " that could lead to the overuse of antibiotics and growth factors in 20%-40 % of patients with cancer . When one considers issues of antimicrobial resistance and cost , this concern should be tested and clarified in a prospect i ve study based on accurate temperature measurement 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 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 PURPOSE We report on the effects of granulocyte colony-stimulating factor ( G-CSF ) on hemoglobin ( Hb ) value in early breast cancer patients receiving high-dose epirubicin and cyclophosphamide ( EC ) adjuvant treatment .  METHODS Five hundred and six stage I or stage II female breast cancer patients were treated with E 120 mg/m2 and C 600 mg/m2  with or without G-CSF and r and omly assigned to receive in a factorial 2 x 2 design : EC ; EC + lonidamine ; EC + G-CSF ; EC + lonidamine + G-CSF . Five consecutive G-CSF schedules tested 100 r and omly assigned patients each : ( 1 ) 480 microg subcutaneously on days 8 to 14 ; ( 2 ) 480 microg on days 8 , 10 , 12 , 14 ; ( 3 ) 300 microg on days 8 to 14 ; ( 4 ) 300 microg on days 8 , 10 , 12 , and 14 ; and ( 5 ) 300 microg on days 8 and 12 . The mean Hb level of 246 patients receiving  EC plus G-CSF was compared with that of 240 patients receiving EC alone . The data presented are derived from an exploratory hypothesis-generating analysis . RESULTS The EC dose intensity did not statistically differ between the G-CSF and the control arm . From the third cycle onward , the mean Hb value result ed significantly lower in G-CSF arm compared with control at each time point of each cycle ( P < .0001 ) . No statistically significant difference in the mean Hb level was observed between schedule 5 and control . Of interest , from the second course onward , the mean Hb level tended to be lower in patients receiving seven or four G-CSF injections compared with those patients who received only two injections . CONCLUSION Our data suggest that a G-CSF dose-related effect may play a role in worsening anemia in patients receiving adjuvant EC BACKGROUND A phase 2 trial was done to study effects of varying treatment schedule of Filgrastim ( r-metHuG-CSF ) on hematologic recovery following chemotherapy . PATIENTS AND METHODS Forty-six patients with extensive small-cell carcinoma of the lung were r and omized to receive one of three Filgrastim schedules following cyclophosphamide , doxorubicin , and etoposide ( CAE ) chemotherapy for up to six cycles of treatment . Chemotherapy was delivered on days 1 - 3 of each 21-day cycle with Filgrastim initiated at 5 micrograms/kg/day subcutaneously ( SC ) beginning on day 4 , day 6 , or day 8 and continuing until post-nadir neutrophil recovery . RESULTS During the first cycle of chemotherapy , the duration of neutropenia was similar for all three schedules ; however , the pattern of absolute neutrophil count ( ANC ) recovery differed . In subsequent cycles of treatment , an improvement in the severity of neutropenia occurred in patients on the day-4 and day-6 schedules compared with the first cycle of chemotherapy . By contrast , patients on the day-8 schedule continued to experience neutropenia similar to that seen in cycle one . Patients on the day-8 schedule also experienced a greater magnitude of grade IV thrombocytopenia in later cycles of treatment . CONCLUSION Timing of Filgrastim administration post-chemotherapy has profound effects on hematologic recovery . Delay 
    Output:
    
In most trials , the chemotherapy regimens had a risk of FN that was below the threshold at which current guidelines recommend routine primary prophylaxis with CSFs .
In patients with breast cancer receiving chemotherapy , CSFs have shown evidence of beneﬁt in the prevention of FN .
There is evidence , though less reliable , of a decrease of all-cause mortality during chemotherapy and a reduced need for hospital care .
No reliable evidence was found for a reduction of infection-related mortality , a higher dose intensity of chemotherapy with CSFs or diminished rates of severe neutropenia and infections .
The majority of adverse events reported from CSF use were bone pain and injection-site reactions but no conclusions could be drawn regarding late-term side effects