Originally published as JCO Early Release 10.1200/JCO.2005.02.8340 on January 3 2006

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Palifermin Reduces Patient-Reported Mouth and Throat Soreness and Improves Patient Functioning in the Hematopoietic Stem-Cell Transplantation Setting

Patrick J. Stiff, Christos Emmanouilides, William I. Bensinger, Teresa Gentile, Bruce Blazar, Thomas C. Shea, John Lu, John Isitt, Alessandra Cesano, Ricardo Spielberger

From the Cardinal Bernardin Cancer Center, Maywood, IL; University of California, Los Angeles; Amgen Inc, Thousand Oaks; City of Hope National Cancer Center, Duarte, CA; Fred Hutchison Research Cancer Center, Seattle, WA; State University of New York Upstate Medical University, Syracuse, NY; University of Minnesota, Minneapolis, MN; and University of North Carolina, Chapel Hill, NC

Address reprint requests to Patrick J. Stiff, MD, Cardinal Bernardin Cancer Center, Loyola University Medical Center, 2160 S First Avenue, Bldg 112, Rm 240, Maywood, IL 60153; email: pstiff{at}lumc.edu

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 µg/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.

published online ahead of print at www.jco.org on November 6, 2006.

Supported by Amgen Inc, Thousand Oaks, CA.

Presented as interim results at the 45th Annual Meeting of the American Society of Hematology, San Diego, CA, December 6-9, 2003; 40th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, June 5-8, 2004; and the Annual Meeting of the American Society for Blood and Marrow Transplantation, Keystone, CO, February 10-14, 2005.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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