***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 
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    ***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 Conditioning therapy in connection with haematopoietic SCT ( HSCT ) induces a disruption of the intestinal barrier function facilitating the permeation of bacteria and endotoxin through the bowel wall with subsequent increased risk of septicaemia and a worsening of GVHD in the allogeneic setting . Palifermin ( recombinant human keratinocyte growth factor ) reduces the severity of oral mucositis with HSCT . The present trial investigates its effect on intestinal barrier function .  Seventeen lymphoma patients undergoing autologous HSCT received palifermin .  Intestinal permeability was assessed before the conditioning therapy and on days + 4 and + 14 . Clinical oral and gastrointestinal toxicity was prospect ively assessed in parallel . A comparison was made with matched historical study patients ( n=21 ) . Patients treated with palifermin had a significantly better preserved intestinal barrier function ( P=0.01 on day + 4 ) and were in less need of total parenteral nutrition ( P=0.005 ) as compared with controls . No significant reduction of clinical gastrointestinal or oral toxicity was observed . The intestinal barrier function , normally disrupted by the conditioning therapy , is preserved by palifermin . Whether intestinal barrier preservation protects from invasive infections , and in the allogeneic setting diminishes GVHD severity , remains to be investigated in r and omized controlled trials Oral mucositis is a frequent side effect of myeloablative chemo- and radiotherapy preceding stem cell transplantation . It causes pain , poor food intake , and is a port of entry for infection . We studied whether GM-CSF applied topically in the oral cavity can prevent or ameliorate this mucositis . In 36 consecutive patients undergoing a stem cell transplantation , we performed a double-blind placebo-controlled study of 300 µg GM-CSF in a 2 % methylcellulose gel daily versus a 2 % methylcellulose gel alone . Both were locally applied in the oral cavity . The primary end-point was mucositis as measured by the WHO toxicity scale for mucositis , oral assessment scale , and a subjective pain scale , all scored daily . The secondary end-points were need to give parenteral nutrition and morphine , incidence of fever and infections , and duration of neutropenia and hospitalization . No differences were found in the median subjective pain scores , WHO scores , and oral assessment scores between the placebo and the GM-CSF groups . In both groups , nine patients required morphine for pain control . Ten patients in the placebo group and 11 in the GM-CSF group received parenteral nutrition . Documented infections , use of broad-spectrum antibiotics , and number of days with fever were similar in the placebo and the GM-CSF groups . The duration of neutropenia below 0.5 × 109/l ( median 14.5 days in the placebo group versus 17 days in the GM-CSF group ) and the duration of hospitalization ( 28.5 versus 29 days ) was also not significantly different . We found no beneficial effect of 300 µg GM-CSF dissolved in a 2 % methylcellulose gel applied locally for chemo- and radiotherapy-induced mucositis in patients undergoing a stem cell transplantation PURPOSE Oral mucositis ( OM ) is one of the most debilitating and common side effects in patients treated with high-dose chemotherapy supported by haematopoietic stem cell transplantation ( HSCT ) . We tested the effectiveness of palifermin to avoid oral mucosal injury induced by the conditioning regimen . PATIENTS AND METHODS Twenty patients with haematological malignancies were treated with palifermin for prevention of OM during HSCT procedures . Nine patients received allogeneic haematopoietic stem cells , and in 11 autologous HSCT was performed . The control group was composed of patients who had been treated with HSCT previously , before the palifermin era . The source of graft was peripheral blood . RESULTS Among patients treated with palifermin no grade 2 - 4 OM was observed . No patient had to receive opioid analgesics or total parenteral nutrition . 30 % of the patients developed grade 1 OM of 4 - 5 days ' duration . In the control group OM was observed in all cases , with 50 % of the patients developing grade 3 - 4 OM . Median duration of OM was 10 and 12 days for auto- and allogeneic patients , respectively . In comparison with the control group , treatment with palifermin was associated with significant reduction of grade 2 - 4 OM , shorter duration of OM , less analgesics intake , and reduced number of days with antibiotic treatment . Additionally , allogeneic patients treated with palifermin had shorter time to platelet engraftment . CONCLUSION Palifermin reduces incidence , severity and duration of OM , and decreases the number of days with analgesics and antibiotics . For allogeneic patients it can shorten the time to platelet engraftment , but this observation needs further studies Autologous hematopoietic cell transplantation ( AHCT ) has presented a revolutionary advance in the management of hematologic malignancies with low toxicity . However , oral mucositis ( OM ) remains a distressing toxic effect of AHCT and one of the major side effects of the conditioning . This prospect i ve , observational study aim ed to evaluate the severity of oral cavity pain and quality of life ( QOL ) and explore incidence , duration , and potential risk factors of moderate/severe OM . Thirty-nine patients receiving prophylactic palifermin post-AHCT were enrolled .  QOL and severity of pain were assessed using vali date d question naires ( Functional Assessment of Cancer Therapy-General ( FACT-G ) and mouth and throat soreness ( MTS ) , respectively ) . The incidence of moderate/severe OM was 28.2 % with a median duration of 5 days and was associated with younger age and female gender . Severity of pain related to OM was generally low or moderate with only 25 % of patients reporting a score > 6 on the MTS scale of 0–10 on day + 7 . Health-related QOL was worse on day + 7 in the transplant unit compared to day 1 , while on discharge day , all scores recovered and the total FACT-G score was not different from that on day 1 . In our population , the incidence and duration of OM and the severity of pain related to OM appeared to be lower compared to that reported in previous studies . The impact of OM on QOL assessment s seemed to be reversible with optimal supportive care despite the major transient disabilities mainly attributable to OM PURPOSE Patients with inflammatory breast cancer ( IBC ) or locally advanced breast cancer ( LABC ) were r and omly assigned to 21-day doxorubicin and cyclophosphamide administered for five cycles ( st and ard arm ) versus weekly doxorubicin and daily oral cyclophosphamide administered with granulocyte colony-stimulating factor support for 15 weeks ( continuous arm ) . All patients had subsequent weekly paclitaxel for 12 weeks before surgery . PATIENTS AND METHODS Patients ( n = 372 ) were r and omly assigned to the st and ard arm  ( n = 186 ) or the continuous arm  ( n = 186 ) stratified by disease type ( LABC , n = 256 ; IBC , n = 116 ) . The primary outcome was microscopic pathologic complete response ( pCR ) at surgery . Secondary outcomes included disease-free survival , overall survival , and toxicity . RESULTS More patients in the st and ard arm had grade 3 to 4 leukopenia and neutropenia , but there were more instances of stomatitis/pharyngitis and h and -foot skin reaction in the continuous arm . Assessed among 356 eligible patients , pCR was not different between the treatment groups stratified by disease type ( P = .42 ) . In subset analysis , higher pCR rates were observed in the continuous arm versus the st and ard arm only for stage IIIB disease ( P = .0057 ) and in IBC ( P = .06 ) . Comparison of overall survival and disease-free survival showed no difference between treatment groups ( P = .37 and P = .87 , respectively ) . CONCLUSION No significant clinical benefit was seen for the investigational arm in this trial overall This r and omized-controlled trial studied the efficacy of palifermin in a chemotherapy-only , high-dose Melphalan ( HDM ) transplant setting , to reduce oral mucositis ( OM ) and its sequelae measured by patient-reported outcomes ( PRO ) and medical re source use . Palifermin , relative to placebo was given either pre-/post-HDM or pre-HDM in patients with multiple myeloma ( MM ) undergoing auto-SCT at 39 European centers . Oral cavity assessment ( WHO ) and PRO question naires ( oral mucositis daily question naire ( OMDQ ) and EQ 5D ) were used in 281 patients ( mean age 56 , ±s.d 
    Output:
    
The previous suggestion against the use of topical  GM-CSF  for the prevention of OM in the setting of high-dose chemotherapy followed by autologous or allogeneic stem cell transplantation remains unchanged .
Of the growth factors and cytokines studied for the management of OM , the evidence supports a recommendation in favor of KGF-1 and a suggestion against GM-CSF in certain clinical setting