***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 this study was to evaluate the effectiveness of granulocyte-macrophage colony-stimulating factor ( GM-CSF ) mouthwashes in the prevention of severe mucositis induced by high doses of chemotherapy . PATIENTS AND METHODS Ninety consecutive patients affected by solid tumors and undergoing high-dose chemotherapy with autologous peripheral blood stem cell transplantation rescue were r and omized to receive placebo versus GM-CSF mouthwash 150 micro g/day . Patients were stratified on the basis of the conditioning treatment and the consequent different risk of severe oral mucositis . Treatment was administered from the day after the end of chemotherapy until the resolution of stomatitis and /or neutrophil recovery . RESULTS The statistical analyses were intention-to-treat and involved all patients who entered the study . The severity of stomatitis was evaluated daily by the physicians according to National Cancer Institute Common Toxicity Criteria . Both study and control groups were compared with respect to the frequency [ 30 % versus 36 % , chi(2 ) exact test , not significant ( NS ) ] and mean duration ( 4.8 + /- 4.7 versus 4.4 + /- 2.7 days , t-test , NS ) of severe stomatitis ( grade > or = 3 ) . Oral pain was evaluated daily by patients themselves by means of a 10 cm analog visual scale : the mean ( + /- st and ard error of the mean ) maximum mucositis scores were 4.8 + /- 3.5 versus 4.2 + /- 3.5 cm ( t-test , NS ) . Furthermore , 15/46 patients in the study group ( 33 % ) and 19/44 patients in the control group experienced pain requiring opioids ( chi(2 ) exact test , NS ) . CONCLUSION We did not find any evidence to indicate that prophylaxis with GM-CSF mouthwash can help to reduce the severity of mucositis in the setting of the patients we studied PURPOSE To compare granulocyte-macrophage colony-stimulating factor ( GM-CSF ) mouthwashes with sucralfate mouthwashes in the prevention of radiation-induced mucositis . METHODS AND MATERIAL S Forty patients with radically operated head- and -neck cancer were r and omly allocated to use either GM-CSF ( n = 21 ) or sucralfate ( n = 19 ) mouthwashes during postoperative radiotherapy ( RT ) . All patients received conventionally fractionated RT to a total dose of 50 - 60 Gy in 2-Gy daily fractions during 5 - 6 weeks to the primary site and regional lymphatics . A minimum of 50 % of the oral cavity and oropharyngeal mucosa was included in the clinical target volume . GM-CSF mouthwashes consisted of 37.5 microg GM-CSF and sucralfate mouthwashes of 1.0 g of sucralfate distilled in water . Both washes were used 4 times daily , beginning after the first week of RT and continued to the end of the RT course . Symptoms related to radiation mucositis and body weight , serum prealbumin level , and blood cell counts were monitored weekly . RESULTS Oral mucositis tended to be less severe in the GM-CSF group ( p = 0.072 ) . Complete ( n = 1 ) or partial ( n = 4 ) healing of mucositis occurred during the RT course in 5 patients ( 24 % ) in the GM-CSF group and in none of the patients in the sucralfate group ( p = 0.049 ) . Patients who received GM-CSF had less mucosal pain ( p = 0.058 ) and were less often prescribed opioids for pain ( p = 0.042 ) . Three patients in the sucralfate group needed hospitalization for mucositis during RT compared with none in the GM-CSF group . Four patients ( 21 % ) in the sucralfate group and none in the GM-CSF group required an interruption in the RT course ( p = 0.042 ) . No significant differences in weight , prealbumin level , or blood cell count were found between the groups , and both mouthwashes were well tolerated . CONCLUSION GM-CSF mouthwashes may be moderately more effective than sucralfate mouthwashes in preventing radiation-induced mucositis and mucositis-related pain , and their use may lead to less frequent RT course interruptions from mucositis . The present findings need to be confirmed before adopting GM-CSF mouthwashes in routine clinical use A multicentre , r and omised vehicle-controlled single-blind dose ranging trial of intravenous recombinant granulocyte colony-stimulating factor ( rhuG-CSF ) administration after BMT has been performed in 121 patients with non-myeloid malignancies . All the doses of rhuG-CSF used ( 2 - 20 micrograms/kg/day ) result ed in significant acceleration of neutrophil recovery , and a dose-response effect was apparent ( p < 0.05 ) . At the 20 micrograms/kg/day dose of rhuG-CSF the median time taken to achieve a neutrophil count of > 0.5 x 10(9)/1 was reduced from 19 to 13 days ( p < 0.001 ) and the time to achieve a neutrophil count > 1.0 x 10(9)/1 on the first of 3 consecutive days , from 26 to 14 days ( p < 0.001 ) . There was a trend to less antibiotic use in the rhuG-CSF recipients and the median time in hospital was markedly reduced by 11 - 15 days ( p < 0.01 ) . There was no toxicity in this study attributable to rhuG-CSF BACKGROUND Mucositis is one of the most frequent and severe side-effect of chemotherapy in childhood-cancer patients for which there is no prophylaxis available . The efficacy and feasibility of a TGF-beta(2)-enriched feeding for preventing oral and gastro-intestinal-mucositis in childhood-cancer patients were studied . PROCEDURE The study was design ed as a two-period cross-over , r and omized , double-blinded , placebo , controlled trial . Patients who had a high risk for developing mucositis and who would receive two comparable cycles of chemotherapy were eligible for the study . During one cycle of chemotherapy , TGF-beta(2)-enriched feeding was administered ; during the other , a " placebo " ( not enriched ) feeding was used . WHO toxicity scales of diarrhea , oral mucositis , fever , anal lesions and nausea/vomiting were scored daily . In addition , the incidence of occurrence of blood cultures , antibiotic therapy , and interventions or diagnostics related to mucositis were measured . RESULTS The feasibility of the study was good : 83 % of the patients completed two cycles and 86 % of the study -feeding was effectively consumed . Administration of TGF-beta(2 ) was safe as serum TGF-beta(2 ) did not increase , and renal and liver function were not affected during TGF-beta(2 ) consumption compared to normal feeding . Differences in toxicity , scored during the whole observation period and the number of days with WHO 3/4 toxicity , were not significantly different between cycles with TGF-beta(2 ) enriched and normal feeding . CONCLUSIONS TGF-beta(2 ) administration via feeding is well tolerated and safe . Although this study might have had limitations to show potential benefit of TGF-beta(2 ) , it does not provide evidence that TGF-beta(2 ) decreases the incidence or degree of mucositis induced by combination chemotherapy in childhood-cancer patients Purpose Pegylated granulocyte-colony-stimulating factor ( G-CSF ) is frequently used to prevent febrile neutropenia ( FN ) in patients undergoing chemotherapy with a high risk of myelosuppression . This phase II/III study was conducted to determine the adequate dose of pegteograstim , a new formulation of pegylated G-CSF , and to evaluate the efficacy and safety of pegteograstim compared to pegfilgrastim . Methods In the phase II part , 60 breast cancer patients who were undergoing DA ( docetaxel and doxorubicin ) or TAC ( docetaxel , doxorubicin , and cyclophosphamide ) chemotherapy  were r and omly selected to receive a single subcutaneous injection of 3.6 or 6.0 mg pegteograstim on day 2 of each chemotherapy cycle . The phase III part was seamlessly started to compare the dose of pegteograstim at selected in phase II with 6.0 mg pegfilgrastim in 117 breast cancer patients . The primary endpoint of both the phase II and III parts was the duration of grade 4 neutropenia in the chemotherapy cycle 1 . Results The mean duration of grade 4 neutropenia for the 3.6 mg pegteograstim ( n = 33 ) was similar to that for the 6.0 mg pegteograstim ( n = 26 ) ( 1.97 ± 1.79 days vs. 1.54 ± 0.95 days , p = 0.33 ) . The 6.0 mg pegteograstim was selected to be compared with the 6.0 mg pegfilgrastim in the phase III part . In the phase III part , the primary analysis revealed that the efficacy of pegteograstim ( n = 56 ) was non-inferior to that of pegfilgrastim ( n = 59 ) [ duration of grade 4 neutropenia , 1.64 ± 1.18 days vs. 1.80 ± 1.05 days ; difference , −0.15 ± 1.11 ( p = 0.36 , 97.5 % confidence intervals = 0.57 and 0.26 ) ] . The time to the absolute neutrophil count ( ANC ) recovery of pegteograstim ( ≥2000/μL ) was significantly shorter than that of pegfilgrastim ( 8.85 ± 1.45 days vs. 9.83 ± 1.20 days , p < 0.0001 ) . Other secondary endpoints showed no significant difference between the two groups . The safety profiles of the two groups did not differ significantly . Conclusions Pegteograstim was shown to be as effective as pegfilgrastim in the reduction of chemotherapy-induced neutropenia in the breast cancer patients who were undergoing chemotherapy with a high risk of myelosuppression 5587 Background : Mucositis is common in patients ( pts ) with SCCHN receiving RT , contributing to the need for tube feeds ( PEG ) and treatment delays . GCSF has decreased mucositis in pts receiving chemotherapy ( CT ) .  We evaluated its ability to decrease mucositis and related dysfunction during postoperative RT using a r and omized , placebo-controlled design . METHODS Eligible pts had completely resected , stage II-IV SCCHN , no prior RT or CT , and signed informed consent . Pts were stratified by primary site , then r and omized to receive GCSF 3 mcg/kg or placebo daily by subcutaneous injection during RT ( 63 Gy , 1.8 Gy/day ) . Pts and treating physicians were blinded to treatment assignment . ENDPOINTS need for PEG feeds ( primary ) , severity of mucositis/level of intervention for mucositis ( secondary ; both scored biweekly , grade s 0 - 3 ) . RESULTS 41 pts ( 132 planned ) were enrolled at MSKCC from 1/92 to 12/96 . Study was closed due to slow accrual . Pt characteristics ( GCSF v. placebo ) : median age 59 v. 54 ; pathologic stages : T3/4 32 v. 50 % , N2/3 68 v. 59 % , Stage IV 79 v. 68 % . Primary site distribution was comparable between groups . All pts Karnofsky ≥ 80 . Mean absolute neutrophil count during RT 24.1 v. 4.1 x109/L ( p<0.0001 ) . 9 pts treated with GCSF required dose reduction ( white blood count ≥ 40 x109/L , radiotherapist blinded ) , 2 pts had grade 2/3 bone pain , 3 pts total refused injection ( 2 GCSF , 1 placebo ) . 39 pts were evaluable . All received 63 Gy . Outcomes ( GCSF v. placebo ) : PEG rate 0 v. 10 % ( p=0.16 ) , RT interruption 0 v. 10 % ( p=0.16 ) , mean mucositis grade 0.84 v. 1.11 ( p=0.11 ) , mean level intervention 0.59 v. 0.95 ( p=0.076 ) , mean # of treatment days 35.9 v. 38.1 ( p=0.007 ) . 5-year actuarial survival ( intent to treat , 41 pts , median followup 7.6 years ) was 79 v. 47 % ( p=0.062 , log rank test ) . CONCLUSIONS GCSF during RT was feasible , led to trends for less PEG feeds and mucositis ( underpowered ) , significantly less # of treatment days , and no decrement in survival . Survival data are not 
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We would need to treat 10 adults with KGF in order to prevent one additional adult from developing this outcome ( 95 % CI 8 to 19).Due to the low volume of evidence , single- study comparisons and insufficient sample sizes , we found no compelling evidence of a benefit for any other cytokines or growth factors and there was no evidence on children .
There did not appear to be any serious adverse effects of any of the interventions assessed in this review .
We are confident that KGF is beneficial in the prevention of oral mucositis in adults who are receiving : a ) radiotherapy to the head and neck with cisplatin or fluorouracil ;  or b ) chemotherapy alone for mixed solid and haematological cancers .
KGF appears to be a relatively safe intervention .
Due to limited research , we are not confident that there are any beneficial effects of other cytokines and growth factors .
There is currently insufficient evidence to draw any conclusions about the use of cytokines and growth factors in children