PMID- 16391299
OWN - NLM
STAT- MEDLINE
DCOM- 20061218
LR  - 20181201
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 24
IP  - 33
DP  - 2006 Nov 20
TI  - Palifermin reduces patient-reported mouth and throat soreness and improves 
      patient functioning in the hematopoietic stem-cell transplantation setting.
PG  - 5186-93
AB  - PURPOSE: To describe patient-reported outcomes of mouth and throat soreness (MTS) 
      and related sequelae on daily activities from a phase III study of palifermin in 
      the autologous hematopoietic stem-cell transplantation (HSCT) setting and to 
      compare patient self-evaluations with clinicians' assessments of oral mucositis 
      using objective scales. PATIENTS AND METHODS: Patients (n = 212) received 
      palifermin (60 microg/kg/d) or placebo for 3 days before total-body irradiation 
      (12 Gy), etoposide 60 mg/kg, and cyclophosphamide 100 mg/kg, and 3 days after 
      HSCT. Patients completed a daily questionnaire (Oral Mucositis Daily 
      Questionnaire [OMDQ]) evaluating MTS severity and its effects on daily functional 
      activities. Patients' self-assessment data were compared with clinicians' 
      assessments of oral mucositis using the objective scales. RESULTS: Palifermin 
      reduced the incidence and duration of severe oral mucositis, as assessed by both 
      clinicians and patients. Comparisons between patient and clinician assessments 
      demonstrated that the average daily scores between mucositis grade and subjective 
      (MTS) instruments were similar, although patients reported MTS onset, peak, and 
      resolution earlier (1 to 3 days) than clinicians' assessments. Patients receiving 
      palifermin reported statistically significant improvements (P < .001) in daily 
      functioning activities (swallowing, drinking, eating, talking, sleeping) and 
      required significantly less narcotic opioids (P < .001); improvement in the 
      patient's overall physical and functional well-being was also reported. This was 
      confirmed by the results of the Functional Assessment of Cancer Treatment 
      questionnaire. CONCLUSION: These results support the clinical benefit of 
      palifermin in the HSCT setting, providing evidence that a patient's 
      self-assessment instrument (OMDQ) may serve as an alternative tool to assess oral 
      mucositis severity in clinical trials.
FAU - Stiff, Patrick J
AU  - Stiff PJ
AD  - Cardinal Bernardin Cancer Center, Maywood, IL 60153, USA. pstiff@lumc.edu
FAU - Emmanouilides, Christos
AU  - Emmanouilides C
FAU - Bensinger, William I
AU  - Bensinger WI
FAU - Gentile, Teresa
AU  - Gentile T
FAU - Blazar, Bruce
AU  - Blazar B
FAU - Shea, Thomas C
AU  - Shea TC
FAU - Lu, John
AU  - Lu J
FAU - Isitt, John
AU  - Isitt J
FAU - Cesano, Alessandra
AU  - Cesano A
FAU - Spielberger, Ricardo
AU  - Spielberger R
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20060103
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 126469-10-1 (Fibroblast Growth Factor 7)
RN  - 6PLQ3CP4P3 (Etoposide)
RN  - 8N3DW7272P (Cyclophosphamide)
SB  - IM
CIN - J Clin Oncol. 2006 Nov 20;24(33):5183-5. PMID: 17075108
CIN - J Clin Oncol. 2012 Feb 10;30(5):564-5; 565-567. PMID: 22215750
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse 
      effects
MH  - Chemotherapy, Adjuvant
MH  - Cyclophosphamide/administration & dosage/adverse effects
MH  - Deglutition
MH  - Dose Fractionation, Radiation
MH  - Double-Blind Method
MH  - Drinking
MH  - Eating
MH  - Etoposide/administration & dosage/adverse effects
MH  - Female
MH  - Fibroblast Growth Factor 7/administration & dosage/*therapeutic use
MH  - Hematopoietic Stem Cell Transplantation/*adverse effects
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Mouth Mucosa/*drug effects
MH  - Quality of Life
MH  - Radiotherapy, Adjuvant
MH  - Severity of Illness Index
MH  - Sleep
MH  - Speech
MH  - Stomatitis/*drug therapy/etiology/*prevention & control
MH  - Surveys and Questionnaires
MH  - Time Factors
MH  - Treatment Outcome
MH  - Whole-Body Irradiation/adverse effects
EDAT- 2006/01/05 09:00
MHDA- 2006/12/19 09:00
CRDT- 2006/01/05 09:00
PHST- 2006/01/05 09:00 [pubmed]
PHST- 2006/12/19 09:00 [medline]
PHST- 2006/01/05 09:00 [entrez]
AID - JCO.2005.02.8340 [pii]
AID - 10.1200/JCO.2005.02.8340 [doi]
PST - ppublish
SO  - J Clin Oncol. 2006 Nov 20;24(33):5186-93. doi: 10.1200/JCO.2005.02.8340. Epub 
      2006 Jan 3.